Below is a list of various articles and excerpts about the latest developments here at Capsugel, as well as important industry news. Simply click on a title to see the full article.

NanoGuardian and Capsugel Announce Global Collaboration to Help Protect Medications from Counterfeiting and Illegal Diversion

New CFS 1500 C Capsule Filing and Sealing System

New Xcelolab™ Powder Dispenser from Capsugel

"10 out of 10" for Xcelodose® Precision Powder Micro-dosing System

Licaps® Drug Delivery System at GSK

Capsugel Obtains Australia’s TGA Certification for it’s Licaps® Liquid-fill Capsule Manufacturing Facility

New Generation Xcelodose^®S Precision Drug Powder Micro-filling System Offers 50% Increased Throughput

Capsugel's Liquid Dosage Form Technology Utilized by Eight of the Top 10 Pharmaceutical Companies

Capsugel Announces License Agreement with Teijin Pharma to Offer Vcaps^® HPMC Capsules for Dry Powder Inhalation

Capsugel Launches Pearlized Licaps^® Liquid Capsules, a Liquid Delivery System Beautified With Pearlescent Capsules

Capsugel Announces Biggest Licaps^® Liquid Capsules As Powerful Alternative To Softgels

Capsugel $17 Million Expansion to Add 45 Jobs in Greenwood, SC

Capsugel Launches Pearlcaps, an Alluring Pearlescent Capsule Effect

Capsugel Launches an Improved Laboratory-Scale Liquid Capsule Filling and Sealing (CFS) Machine

DSEA SupplySide East Fundraising Dinner a Roaring Success

Clinical Trial Materials: Outsourcing Provides Niche Expertise – reprint from Tablets and Capsules Magazine

The World's Most Advanced Capsule Plant Opens in China

Capsugel Opens Laboratory in America to Create Liquid-fill Formulas for Dietary Supplements

Capsugel Launches Online Nutritional Supplements Bibliography

Pfizer Acquires Bharti Healthcare Ltd. Located in Dharuhera, India

Americas Region Formulation Center Meets Call for Fast-to-Market Delivery of Quality Liquid Supplements

Key Personnel for Americas Region Formulation Center

Licaps^® Distinctive Technology Yields Distinctive Benefits in Liquid Market

Capsugel Formulators Create One-of-a-Kind Licaps^® Products with Competitive Edge

Capsugel Takes Over Excipient-free Capsule Technology – reprint from in-Pharma Technologist.com

NanoGuardian and Capsugel Announce Global Collaboration to Help Protect Medications from Counterfeiting and Illegal Diversion

Powerful Alliance of Industry Leaders Helps Protect Pharmaceutical Supply Chain

February 22, 2010 - Skokie, Illinois: NanoGuardian^TM, a division of NanoInk® that delivers brand protection solutions to defend against illegal diversion and counterfeiting, announced today that it entered into a license agreement with Capsugel, a division of Pfizer and the global leader in providing capsule-based drug delivery systems, that gives Capsugel global access to NanoGuardian's NanoEncryption^TM technology for the protection of capsule-based medications against counterfeiting and illegal diversion.

NanoGuardian's NanoEncryption technology works directly on capsules, tablets, vial caps, and single-use syringes to provide a layered security strategy consisting of overt, covert and forensic security features. NanoGuardian's multi-layered security provides a dual-protective benefit to manufacturers by fighting both counterfeiting and illegal diversion with a single technology. The overt and covert security features allow dose-level authentication at any point in a manufacturer's supply chain, while forensic NanoCodes^TM provide comprehensive tracing information on each and every dose. NanoGuardian's technology provides a strong benefit over other on-dose technologies given that NanoGuardian's security features are implemented with no additional chemicals being added to the medication.

"Capsugel is committed to providing cutting-edge advancements in capsule dosage delivery technology. Given the concerning rise in counterfeit and illegally diverted medications throughout the world, we wanted to bring value to our customers by helping to protect their brands, companies, and the patients they serve. After evaluating available security technologies, we chose NanoGuardian as a technology partner because of the sophistication, sustainability and benefits of their NanoEncryption technology. This will allow our pharmaceutical customers to authenticate and trace every single dose, from plant-to-patient," said Guido Driesen, President and General Manager of Capsugel.

In addition to the traditional NanoGuardian model of using a proprietary machine to implement the NanoEncryption technology, Capsugel will offer
pre-NanoEncrypted capsule shells to pharmaceutical companies, eliminating any significant additions to their current manufacturing process. Capsugel will market this new technology to current and future Capsugel customers and expects it to be able to supply NanoEncrypted capsules by mid-2010.

"NanoGuardian is a leader in the on-dose brand protection marketplace so it makes perfect sense for us to partner with the global leader in capsule-delivery systems. Together, NanoGuardian and Capsugel can extend product security and integrity to the dose level for capsule-based medications and help provide confidence to the millions of patients who rely on these medications for their health and well being," said James Hussey, chief executive officer of NanoGuardian.

About NanoGuardian
NanoGuardian^TM, a division of NanoInk®, focuses exclusively on delivering brand protection solutions to fight illegal diversion and counterfeiting. Anchored by NanoInk's novel NanoEncryption^TM technology, NanoGuardian enables manufacturers to authenticate and trace the integrity of their products across the supply chain. More information about NanoGuardian is available at www.nanoguardian.net.

About Capsugel
Capsugel, a division of Pfizer Inc. with over 2,800 colleagues and 13 locations around the world, is a global leader in innovative dosage forms and solutions for the healthcare industry. Offering a comprehensive array of products and services, from hard gelatin, softgel, and vegetarian capsules, to innovative R&D equipment and liquid formulations as part of its Licaps® Drug Delivery System, Capsugel is at the forefront of drug delivery innovation providing support to customers from formulation to final production.

Contacts:
Joshua Taustein, Dresner Corporate Services for NanoGuardian, 312-780-7219, jtaustein@dresnerco.com.
David Gutierrez, Dresner Corporate Services for NanoGuardian, 312-780-7204, dgutierrez@dresnerco.com.
Alyssa Augustine, Director of Communications for Capsugel, 908-901-6584, alyssa.augustine@pfizer.com.

New CFS 1500 C Capsule Filing and Sealing System

A Safer, Faster Route to Early Phase Trials for Poorly Water Soluble and Potent Compounds

February 10, 2010 - Cambridge, UK: Capsugel, the world's leading provider of dosage form solutions to the pharmaceutical and related healthcare industries, is delighted to announce its new automated CFS 1500 C (Containment) Capsule Filling and Sealing system is now available to provide rapid and safe filling and sealing of capsules containing lipid-based formulations or potent compounds for use in early phase clinical trials.

The new CFS 1500 C system, which utilizes Capsugel's patented and proprietary Licaps® Drug Delivery System technology, offers many of the same time saving benefits as Capsugel's established CFS 1200 Capsule Filling and Sealing system, has been developed to enable easy movement and integration into suitable containment equipment. Additionally, the CFS 1500 C system has been designed to facilitate ease of cleaning and also to ensure that compounds remain within the working area. It has readily accessible moving parts which can be removed for manual or auto washer cleaning. This combination of useful features is designed to help ensure scientists can safely work with lipid-based formulations or potent compounds confident that these won't contaminate their equipment or different capsule batches.

The CFS 1500 C system has an increased throughput of 1,500 filled and sealed capsules per hour and is scalable to commercial manufacturing using the LEMS® 70 Liquid Encapsulation Micro-spray Sealing system, which is capable of sealing up to 70,000 capsules per hour. Using the LEMS® 70 Liquid Encapsulation Micro-spray Sealing system's unique micro-spraying technology in conjunction with Capsugel's Licaps® capsules, the CFS 1500 C system can fill and seal capsules with a robust, impervious seal. One of the key factors in getting the best seal for a liquid-filled capsule is a clean precise dosing system; to enable this, the CFS 1500 C system features Capsugel's unique new liquid dosing technology which allows precision dosing and prevents the occurrence of drips. In addition, the completely new software design provides much greater functionality and, in combination with a new weigh cell feature, measures the weight of each filled capsule to ensure compliance with 21 CFR part 11 requirements.

David Edwards, Director, Pharmaceutical Technology Group at Capsugel, explained: "We have developed the CFS 1500 C system in response to requests from our customers for an improved and faster system which is easier to clean and could be used in a suitable containment system, particularly for more potent compounds. The resulting CFS 1500 C system provides an excellent solution for formulation scientists who want high integrity filled capsules of these challenging formulations without compromising safety in manufacturing or the supply chain.

Throughout the development process, our engineers have consulted with our customers at several stages, to ensure we produce the equipment according to market needs. The CFS 1500 C system is a very useful addition to our range of liquid filling and sealing equipment and will be of considerable benefit to companies working with not only early stage lipid-based compounds, but also generic and OTC companies seeking a differentiating delivery system for their products and for companies looking to extend their product life cycles."

New Xcelolab™ Powder Dispenser from Capsugel

Saves Clinical Trial Manufacturing Time, Resource and Money While Improving Accuracy with Laboratory Weighing Applications

February 10, 2010 - Cambridge, UK: Capsugel, the world's leading provider of dosage form solutions to the pharmaceutical and related healthcare industries, is pleased to announce that the benchtop Xcelolab™ powder dispenser is now available, offering scientists a rapid and reproducible solution for precise weighting tasks.

The Xcelolab™ dispenser, the latest addition to Capsugel's market-leading Xcelodose® precision powder micro-dosing range has been created in response to demand from existing Xcelodose® system customers. To avoid losing valuable clinical trial manufacturing time, resource and money, pharmaceutical company development teams can now perform method development, powder dispense head selection and powder characterization studies in the laboratory environment using the Xcelolab™ dispenser. The data produced and methods developed can then be directly transferred to their Xcelodose® system so they can continue manufacture of clinical trial materials without interruption or unnecessary downtime.

The Xcelolab™ dispenser uses Capsugel's proven and precise powder dispensing technology which builds "micro-bridges", making it ideal for scientists who repeatedly weigh small amounts of any type of powder by hand or need to dispense amounts too small to be accurately dosed by conventional techniques. Using the "micro-bridge" technology it is possible to dispense any type of powder, whether cohesive, micronized, free flowing or inhalation powder.

The unique Xcelolab™ dispenser offers unprecedented flexibility, allowing users to dispense powder weights as low as 100µg up to 230g precisely with a typical RSD of ~2%. A range of interchangeable balances makes it easy to dispense into a variety of receptacles including capsules, vials, beakers and flasks, etc. The simple, touch screen operation, featuring a color-coded progress bar means scientists can run fully automated dispense cycles as soon as the system is installed, as well as easily program and store multiple settings for different samples. The Xcelolab™ dispenser has many dispense options from a manual one button dispense right through to full method development, making applications such as powder characterization, sample preparation or stability testing both quick and easy to set up.

Mike Savill, Manager, Pharmaceutical Technology Group at Capsugel stated: "Many laboratory scientists manually dispense small amounts into vials or capsules by hand, a task that is difficult to perform reproducibly and adds a risk of sample contamination or degradation. Our precision powder dosing technology, which is currently only available to top pharmaceutical facilities, is ideal for these smaller scale laboratories, making it suitable for a scientist to dispense any type of powder." Savill added: "The Xcelolab™ dispenser is a significant development and means our unrivalled technology is accessible to laboratories needing to improve the speed and accuracy of their powder dispensing applications."

"10 out of 10" for Xcelodose® Precision Powder Micro-dosing System

World's 10 Largest Pharmaceutical Companies Adopt Novel Approach to Speed Time to Market

September 11, 2009 - Cambridge, UK: Capsugel, the world's leading provider of dosage form solutions to the pharmaceutical and related healthcare industries, announced today that with its latest installation of the Xcelodose® precision powder micro-dosing system, the world's 10 largest pharmaceutical companies have adopted Xcelodose system technology.

The Xcelodose systems installed in these leading pharmaceutical companies offer accurate and reproducible dosing down to as little as 100 g of powder. The Xcelodose system models in use include: the Xcelodose 600S system, a fully automated system for micro-dosing powder into gelatin and HPMC capsules ranging from size 000 to 4; and the Xcelodose 120S system, a semi-automated machine which fills gelatin and HPMC capsules ranging from size 000 to 5, as well as other compact dose containers such as vials, tubes, blisters and cassettes.

The Xcelodose system software is rigorously designed to meet regulatory standards, enabling it to be easily integrated into a 21 CFR Part 11 compliant workflow. Additionally, the installation and validation documentation available for Xcelodose 600S systems are aligned with Good Manufacturing Practice (GMP) standards, enabling customers to rapidly begin operation within their GMP facilities.

The Xcelodose system often serves to eliminate some of the time consuming formulation and stability studies via the direct dosing into capsules of microgram amounts of active pharmaceutical ingredients (APIs). The highly robust machine design can reproducibly dose tiny amounts of API without having to add excipients or bulking agents, realizing a faster route to Phase I trials.

"With the number of competing powder dosing technologies increasing, we are pleased to see the Xcelodose system achieving very favorable reviews. The ease of integration of the system into so many diverse formulation development programs is an excellent endorsement that our stated performance capabilities match expectations," said Keith Hutchison, Vice President of R&D at Capsugel. "The utilization of the Xcelodose systems by these leading companies demonstrates to biotech or pharmaceutical firms wanting to rapidly move compounds to early stage trials that leveraging the unique dosing technology within an Xcelodose precision powder micro-dosing system is a well-validated strategy to adopt, thereby helping them achieve 'faster time to first in human'."

For further information contact Sue Peffer, Marketing and Commercial Executive of Pharmaceutical Technology Group,
at +44 (0)1304 644791.

¹The top 10 pharma companies referred to are those listed by Contract Pharma magazine and Pharmaceutical Executive.

Licaps® Drug Delivery System at GSK

Allows Rapid In-house Manufacture of Capsules with a High Integrity Seal

May 11, 2009 - Bornem, Belgium: Capsugel, the world's leading provider of dosage form solutions to the pharmaceutical and related healthcare industries, is delighted to announce that its integrated Licaps® Drug Delivery System of Licaps® capsules and Liquid Encapsulation Microspray Sealing (LEMS®) equipment is being successfully used in major healthcare company, GlaxoSmithKline (GSK) to produce new capsule lines with a proven secure seal.

Production scientists in one of GSK's Consumer Healthcare centers in Herrenberg, Germany are filling Capsugel's Licaps® two-piece gelatin capsules with liquid formulations containing pumpkin seed; pumpkin seed oil or herbal extracts such as saw palmetto or hop extract. The filled capsules are then sealed using Capsugel's LEMS® automated capsule sealing system and the finished capsules are marketed by GSK as pharmaceuticals to treat several types of urological conditions or as nutraceuticals.

Dr. Stephan Wurtz, Head of Production at GSK in Herrenberg explained: "These capsule products are new lines for GSK, so we decided to determine the optimal production method by comparing two different automated capsule sealing techniques. The capsules produced by the Licaps® Drug Delivery System had intact seals during the complete period of stability testing and we could not detect any leakage. Capsule integrity is a key parameter used to predict product shelf-life and especially helps with preventing too many product returns and this is why we decided to continue using the Licaps® Drug Delivery System for our capsule filling."

Dr. Wurtz added: "The Licaps® Drug Delivery System has integrated well with our Bosch capsule filling equipment and because of the expert technical assistance we have had from Capsugel's installation and formulation teams, we have in a very short time put in place a number of new validated production processes with five fully trained operators, who can perform them. During one shift using the Licaps® Drug Delivery System up to 350,000 Licaps® capsules can be filled. We now have full in-house control of the manufacture of our drug and supplement lines, which gives us a number of benefits."

Keith Hutchison, Vice President R&D at Capsugel concluded: "We are delighted such an innovative company like GSK was willing to embrace and test the Licaps® Drug Delivery System so extensively with their new pharmaceutical and nutraceuticals product lines. Their work leads the way for other pharma and healthcare companies seeking rapid scale up and production of high integrity oil filled capsules and shows that assessing a Licaps® Drug Delivery System is a well-informed strategic decision."

For further information contact Sue Peffer, Marketing and Commercial Executive of Pharmaceutical Technology Group,
at +44 1304 644791.

Capsugel Obtains Australia’s TGA Certification for it’s Licaps® Liquid-fill Capsule Manufacturing Facility

An important pre-requisite for product sales in Australia and beyond.

August 7, 2008 – Capsugel, a global leader in dosage form development and manufacturing, has received certification from the Therapeutic Goods Administration (TGA), a division of the Australian Department of Health and Ageing, for its Licaps® liquid-fill capsule production facility in Greenwood, S.C. (USA).

The TGA is Australia’s principal regulatory authority for all therapeutic goods, including pharmaceuticals, dietary and nutritional supplements, as well as complementary medicines. Lawful sale of such products in Australia requires that the product is included on the Australian Register of Therapeutic Goods (ARTG). To obtain certification, which is product-specific, a marketer must demonstrate compliance with TGA requirements. One such requirement is that the manufacturing operations used to produce the product meet the current Australian Code of Good Manufacturing Practice (GMP) for Medicinal Products.

"The Australian GMP code is very thorough because it covers all medicines and is highly respected by many regulatory authorities around the world. In conjunction with the growing demand for products that utilize the Licaps liquid delivery system, our customers can now more readily access important global markets. Certainly, our experience is that the important benefits of the Licaps delivery system, which include heightened consumer preference and improved bioavailability, address global needs," said Robert Whitelaw, Director of Sales, Marketing and Business Development for Capsugel’s Americas Region.

With this TGA certification in place for a key manufacturing operation, marketers can more readily expand their product lines delivered via the Licaps technology into the Australian market – as well as elsewhere around the world because of the certification’s high credibility.

"Capsugel is well positioned with the resources to help customers develop TGA certified products," Whitelaw concluded.

For more information contact Missy Lowery at 864-942-3063 or Jacqueline Savaiano at 310-827-0531.

New Generation Xcelodose^®S Precision Drug Powder Micro-filling System Offers 50% Increased Throughput

CAMBRIDGE, England, 1st November 2007. Capsugel will unveil the successor to its unique Xcelodose system for micro-dosing of drug powders into capsules and vials at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting in San Diego (November 11th -15th, 2007).

The new Xcelodose S system will feature a 50% increase in throughput rate for filled capsules. Additional improvements include an integral High Throughput Unit and expanded software functionality.

These enhancements will be available in both the 120 and 600 models, which will replace the existing Xcelodose products. The Xcelodose system, launched in 2002, revolutionized the preparation of drug materials for early stage clinical trials and formulation development. For the first time, pharmaceutical companies could fill pure Active Pharmaceutical Ingredient (API) directly into capsules or other small dose containers, with a level of accuracy and precision previously unattainable.

By automatically dispensing drug substance alone into capsules, pharmaceutical companies can benefit from a reduction in development time by as much as six months. Eliminating the need for formulation for early stage trials enables companies to more quickly reach the crucial "Go/No Go" point for continuing development following Phase I clinical studies. In short, the Xcelodose system has made achieving the goal of "Faster Time to First in Man" a reality.

David Edwards, Director of Pharmaceutical Technology for Capsugel, said the impetus behind the new generation of Xcelodose machines was increased throughput. "Since we originally launched Xcelodose, we have found that batch sizes have increased tenfold; from thousands of capsules per batch, to tens of thousands or more per batch. It became clear that the number one customer requirement was for increased throughput, followed closely by reliability over longer runs."

Keith Hutchison, Capsugel's Vice-President of R&D, re-affirmed the company's commitment to innovation. "With more than 50 Xcelodose systems installed at pharmaceutical, biotech and CRO companies worldwide, capsule micro-filling has become an established technology for early stage clinical trials. Our goal with the Xcelodose S is to substantially advance our strategy of providing innovative solutions to our customers."

The new Xcelodose S system will be featured at Capsugel Booth #691 at the AAPS Annual Meeting.

For further information contact David Edwards, Director of Pharmaceutical Technology, at +44 1304 644791.

Capsugel's Liquid Dosage Form Technology Utilized by Eight of the Top 10 Pharmaceutical Companies

CAMBRIDGE, England, October 16 -- Capsugel, the leading global provider of dosage form solutions, announced today that its CFS1000/1200 capsule filling and sealing machines have now been licensed by eight of the top 10 global pharmaceutical companies. An integral part of the Licaps(R) Drug Delivery System, these companies are using the CFS1000/1200 capsule filling and sealing machines in early stage development and manufacturing of Phase 1 clinical trial materials.

Both the CFS1000 and CFS1200 models eliminate the need for banding capsules, while providing a secure and impervious capsule seal. By filling and sealing in one operation, it helps accelerate the development timeframe and achieve faster time to "First in Man" - the critical Phase 1 go/no go decision point for new molecules within the pharmaceutical development process.

Capsugel's Director of Pharmaceutical Technology, David Edwards said there is a reason for the increased customer interest: ''We see a growing number of poorly soluble molecules coming through R&D pipelines. The new CFS1200 facilitates rapid and scaleable development, thereby cutting R&D timescales and getting drugs into clinical trials as soon as possible. What we are finding now is that the CFS1200 is proving so invaluable that many companies are looking to purchase additional machines in order to capitalize on this unique technology."

In addition, a number of leading Contract Research Organisations (CROs), both in the United States and the European Union, have acquired CFS1000/1200 machines. These are being used to service pharmaceutical companies that wish to evaluate the Licaps drug delivery technology, as well as to provide additional capacity to those companies who already have the CFS1000/1200 equipment in place.

The CFS1200 will be on display on the Capsugel stand at the AAPS Annual Meeting in San Diego, Calif., USA, November 11-15th 2007 (http://www.aapspharmaceutica.com/meetings/annualmeet/am07/index.asp).

The CFS1200 is also available for demonstrations at Capsugel's sites in Illkirch, France; Bornem, Belgium; Greenwood, S.C., USA; and Sagamihara, Japan.

For further information please visit http://www.capsugel.com/equipment/cfs1200.php.

Capsugel Announces License Agreement with Teijin Pharma to Offer Vcaps^® HPMC Capsules for Dry Powder Inhalation

September 13, 2007 - Capsugel, the leading global provider of dosage form solutions, has announced it will offer its Vcaps® HPMC (hypromellose) capsules for use in dry powder inhalation (DPI) products worldwide. The announcement follows the successful conclusion of a license agreement between Capsugel and Teijin Pharma Limited, part of the Teijin Group of Japan. The agreement grants Capsugel a license to Teijin's entire patent portfolio related to the use of HPMC capsules for inhalation products.

"We are extremely pleased with this agreement as it allows us to offer our innovative HPMC capsules in new therapeutic areas and new geographic markets," said Guido Driesen, President of Capsugel. "It supports our strategy to offer a wider range of drug delivery solutions to our customers around the world." Inhalation drug delivery technology offers benefits to patients beyond the traditional treatments for asthma and chronic obstructive pulmonary disorder. The technology holds promise for systemic inhalation therapies that improve speed-of-onset of action and provide an alternative to needle injection. DPI devices are one of the preferred ways to administer these drugs.

HPMC-based capsules have a number of advantages when used in DPI devices, such as low moisture content and easy piercing of capsules. These characteristics allow optimal release of the drug formulation from the capsule. Capsugel's Vcaps capsules will ensure minimum powder retention after use.

As the world's leading provider of HPMC capsules, Capsugel focuses on superior quality and process controls, assuring consistent batch-to-batch performance.

About Teijin Limited:

The Teijin Group is a wide range of businesses, including fibers, films, plastics, pharmaceuticals and home healthcare, fiber products marketing and information technology-related services, with about 150 companies and over 18,000 employees internationally.

Teijin Pharma Limited, the core company of Teijin Group's medical and pharmaceutical business, focuses on three key therapeutic categories: respiratory, bone/joint, and cardiovascular/metabolic diseases, with about 1,700 employees. Teijin Pharma has strong marketing positions particularly in the respiratory and bone/joint areas. In its home healthcare business, it enjoys strong market share in home oxygen therapy in Japan.

For more information, contact William Chekan at 908-901-6573.

Capsugel Launches Pearlized Licaps^® Liquid Capsules, a Liquid Delivery System Beautified With Pearlescent Capsules

Alluring colored effect boosts marketability with sophisticated appeal

September 11, 2007 - Capsugel, the leading global provider of dosage form solutions, has announced the introduction of pearlized Licaps® capsules. The pearlized Licaps capsules couple Capsugel's proprietary liquid supplement delivery technology with a pearled effect capsule. They are available in a wide array of color options.

The pearled effect is not simply an added coloring, but results from the unique combination of the capsule shell material with a light-reflecting pigment. It is available in all Licaps capsule sizes, including the new size 000 Licaps capsule with a 1200 milligram-fill capacity (similar to the most common softgel size).

The use of all-natural Candurin® pigment, a light-reflecting colorant composed of natural mica and titanium dioxide, creates the pearled appearance. Candurin® can be used alone to produce a striking pearl white capsule. It also can be mixed with other approved dyes to create a wide palette of pearled colors, as well as various two-color capsule combinations. In addition, it can be formulated into metallic colors, such as bronze, silver, and gold.

This introduction builds on Capsugel's earlier launch of pearlized capsules for dry powder fill applications, available in both plant-based HPMC capsules and gelatin capsules.

"The success of both the pearled effect capsules and Capsugel's proprietary Licaps liquid delivery system made for an ideal product extension," said Robert Whitelaw, Director of Sales, Marketing, and Business Development for Capsugel.

Whitelaw explained that the Licaps brand is well known for its distinctive technology that can help preserve the potency of oxygen-sensitive liquid fills. After a capsule is filled with liquid, it is flushed with nitrogen to purge oxygen from the final sealed product, evidenced by a nitrogen bubble that is visible through transparent capsules. Enhancing the barrier to oxygen is a band-free robust seal created by Capsugel's proprietary LEMS® capsule sealing process, which effectively fuses the capsule into one piece.

"This aesthetic and eye-catching pearled effect can add sophistication to Licaps products. It helps make visually bland formulations more attractive. The use of shiny or metallic colors can fashion distinctive appearances to differentiate brands," Whitelaw elaborated.

He added that pearled effect capsules have been well received in two markets in particular: Oral Cosmetic products and Sports Nutrition products. "The pearlescent look can complement and capitalize on the trend toward 'beauty from within' in both market segments. Shiny, iridescent packaging and displays are in vogue, and now the product itself can look as distinctive."

Previously used in topical applications and tablet coatings, Candurin® pigment was approved for use in food and supplements by the Federal Drug Administration on July 20, 2006.

For more information, contact Missy Lowery at 864-942-3063.

Candurin® pigment is a registered trademark of Merck KGaA.

Capsugel Announces Biggest Licaps^® Liquid Capsules As Powerful Alternative To Softgels

New Size 000 Licaps^® capsule a major improvement over softgels for booming fish oil and sports nutrition segments

June 22, 2007 - Capsugel, the global leader in capsule manufacturing, announced today the availability of the 000-sized Licaps^® capsules. Capsugel views this new size as a "superior delivery alternative to soft gels" in the dietary supplement industry.

Favorite formulas from all category segments that were previously encapsulated in size 0 and 00 Licaps can now be delivered in this largest Licaps size. The new capsule size offers a 1200 mg fill capacity, which is roughly equivalent to the most common soft gel size, 20 minims or one gram per dose. The new size can accommodate the fill of a 22 minim soft gel depending on the bulk density of the liquid formulation.

"Licaps capsules are the growing alternative with advantages over soft gels," said Robert Whitelaw, director of sales, marketing, and business development for Capsugel's Americas Region.

Those advantages include:

• Protection against oxidation and potential degradation of the liquid
  • After the capsule is filled with the liquid, it is flushed with nitrogen to eliminate oxygen from the final sealed product, evidenced by a nitrogen bubble visible through the transparent capsule. Because the capsule has no plasticizers, it provides an effective barrier to oxygen transmission.
  • The robust seal further enhances the barrier to oxygen. Capsugel's patented liquid encapsulation by microspray (LEMS^®) capsule sealing process creates eight times the seal zone area of a banded capsule, resulting in no need for banding and an effective one-piece fused capsule.
• Because the capsule is less permeable than soft gels to oxygen, it effectively masks taste and unpleasant odors.
• The "clean label" concept, i.e. no plasticizers, no additives, fewer excipients, no allergens, no GMOs.

"The Licaps market is growing by leaps and bounds. Development of the 000 size is an enormous extension of this extremely popular liquid delivery form," Whitelaw said.

"While the 000 is available to all dietary supplement markets, this new size is especially good news for the fish oil segment and the sports nutrition segment - both of which are popular and booming. Fish oil supplements commonly are sold in 1 gram dosages and can benefit from a Licaps capsule that will effectively mask taste and smell. The sports nutrition segment is looking for bigger and more potent dosages in one big package - delivered by size 000 Licaps with plenty of options for custom color and branding."

In addition to delivering standard products in the 000 Licaps, Capsugel will also help customers customize liquid-fill formulas for this largest Licaps size.

To learn more about Licaps capsules, click here.

Capsugel $17 Million Expansion to Add 45 Jobs in Greenwood, SC

March 7, 2007 - Following close on the heels of a 2006 expansion to its Licaps manufacturing center in Greenwood, South Carolina, and a state-of-the-art Formulation Center at SC Bio in the Greenwood Genetics Center, Capsugel has announced a $17 million dollar investment in its North Emerald campus that will add 45 new jobs. According to Capsugel's Deborah Morrison, Liquids Director, Americas, "With the growth of Licaps this expansion will add the necessary capacity to manufacture new product options for our customers and give the Licaps operation continued room to grow in the future."

The exclusively patented Licaps process fills and seals liquid in a traditional hard capsule shell and is popular in the growing sports nutrition and Neutraceutical markets. Since its beginning in Greenwood four years ago, sales of the product have increased over 60% per year.

"Celebrating its 40th anniversary in Greenwood is not the only milestone that Capsugel marks in 2007. It is another year of growth for the Pfizer subsidiary and a demonstration of the company's continued commitment to Greenwood," said Greenwood County Councilman Gonza Bryant.

"Capsugel is one of the jewels in Greenwood's manufacturing crown," added County Council Dee Compton. The company is not only a subsidiary of a Fortune 100 giant, but a name that immediately grabs the attention of prospects we try to recruit to the area. News like this announcement supports the county's strategic plan to not only recruit new industry, but aid our long-forgotten, but loyal existing industries."

Greenwood Partnership Alliance CEO Jeff Fowler added, "We are, of course, pleased with Capsugel's continued faith in the future of Greenwood County, but also very thankful for the continuing support by the Partnership's Chairman of the Board and Capsugel Director of Manufacturing, Phil Vickery.

For additional information, please contact Jeff Fowler at (864) 388-1250.

Capsugel Launches Pearlcaps, an Alluring Pearlescent Capsule Effect

January 22, 2007 -- Capsugel today announced the introduction of Pearlcaps, a pearled effect that gives two-piece capsule shells a glamorous pearlescent look in a multitude of color options in the dietary supplement industry. The pearled effect is not an added coloring but results from the unique combination of a hard capsule made from plant-based HPMC or gelatin with a light-reflecting pigment. A world leader in capsule manufacturing, Capsugel is the first capsule manufacturer to produce a pearled two-piece capsule.

The use of all-natural Candurin^®, made of light-reflecting pigment composed of natural mica and titanium dioxide, creates the pearled effect. Candurin can be used alone to produce a striking pearl white or with other DS-approved dyes to create a palette of pearled colors of pink, green, turquoise, purple, powder blue, orange, charcoal, and various two-color combinations as well as metallic colors previously unavailable in capsules such as bronze, silver, and gold.

"In addition to offering new color possibilities, this aesthetic and eye-catching pearled effect can add sophistication to products. It helps make visually bland formulations more attractive. The use of shiny or metallic colors can fashion distinctive looks to differentiate brands," said Bob Whitelaw, Capsugel's Director of Marketing, Sales, and Business Development.

He added that Pearlcaps products have been well received in two markets in particular: oral cosmetic products and sports nutrition products. "The pearlescent look can complement and capitalize on the trend toward "beauty from within" and powerful presentations in both industries. The use of reflecting pigments in products is growing fast. Shiny, iridescent packaging and displays are in vogue and now the product can look as distinctive."

Previously used in topical applications and tablet coatings, the mica-based pearlescent pigment was approved for use in food and supplements by the Federal Drug Administration on July 20, 2006.

For more information, contact Missy Lowery at 864-942-3063.

Capsugel Launches an Improved Laboratory-Scale Liquid Capsule Filling and Sealing (CFS) Machine

LONDON, October 09, 2006 /PRNewswire-FirstCall/ -- Capsugel, the leading supplier of capsules for the pharmaceutical and dietary supplement industries, today announced the launch of the CFS1200, an improved version of its laboratory-scale Capsule Filling and Sealing system.

This updated machine offers R&D laboratories several significant improvements over its predecessor, the CFS1000, which is currently used extensively by pharmaceutical development scientists to fill and seal capsules with liquid formulations. The CFS1200 utilizes Capsugel's patented LEMS (Liquid Encapsulation Micro-Spray) Technology.

The CFS1200 employs a unique micro-dosing technology, which offers automated capsule filling and sealing for preparation of early stage clinical trial supplies. Specifically designed to allow formulation scientists a better ability to exploit the potential of lipid based or poorly soluble compounds, the CFS1200 helps accelerate the development timeframe and achieve 'Faster Time to First in Man(TM)', or the critical go/no go decision point for new molecules within the pharmaceutical development process.

David Edwards, Capsugel's Director of Pharmaceutical Technology, said "While the CFS1000 has been widely accepted in the industry, our market research and dialogue with customers has identified the need for additional features. The CFS1200 has been developed directly as a result of this feedback, particularly in respect of a higher throughput rate, improved capsule handling and sealing, more accurate temperature control and better cleanability. All of these features are included in the new product".

Keith Hutchison, Vice President of R&D at Capsugel said "Going forward, a key part of Capsugel's strategy is to focus more on providing integrated solutions to customer's problems. The new CFS1200 enables Pharmaceutical R&D departments to overcome some major Formulation Development challenges such as those of poorly soluble drugs and highly potent new molecules. We see the CFS1200 as a key part of our strategy in this area."

The new CFS1200 will be on display on the Capsugel Booth 829, Hall C at the AAPS Exposition in San Antonio, Texas, USA, October 29th- November 2nd 2006.

DSEA SupplySide East Fundraising Dinner a Roaring Success

Sponsorships by Capsugel and The Vitamin Shoppe Allow All Proceeds to Go to DSEA Initiatives

SECAUCUS, NJ – The Dietary Supplement Education Alliance (DSEA) fundraising dinner at SupplySide East, which was held on Tuesday, May 2, 2006 in the renowned Park & Orchard Restaurant, was quite possibly the group’s most successful fundraising event to-date, and without a doubt the most fun. The dinner, which was co-sponsored by Capsugel and The Vitamin Shoppe, culminated in the attendees bidding ferociously, and uproariously, for prizes and perks.

A lively auction, led by Elliott Balbert, founder of Natrol, began with two tickets to a Yankees/Sox game donated by The Ullman Shapiro Ullman law firm. This touched off a flurry of bidding that reached its peak with NBTY and VSI battling it out. NBTY ultimately scored. Next, EuroPharma jumped in with Green Bay Packers tickets, with New Hope and Capsugel splitting the prize after heated bidding. Trish Balbert, a holistic health care practitioner in New York City, donated three months of healthy lifestyle counseling, which set off another round of competitive bidding, ultimately won by Virgo Publishing. The outpouring of support for DSEA included additional donations from Inverness Medical, Herbalife, EuroPharma, Zila, NBTY, The Shelton Group, TABS Media, and many others. The fundraising culminated in the Vitamin Shoppe offering to match other dinner donations.

"While we expected the dinner to be another sell-out, we didn’t anticipate the overwhelming generosity in support for our initiatives" said Jon Benninger, president of DSEA. "Clearly our programs are having an effect, and industry sees that supporting our efforts is good for their businesses. And judging from how hard everyone was laughing, it was a very fun dinner."

The money raised will fund DSEA's initiatives, including the third Lewin Group Health Impact Report. This report focuses on the health status of diabetes patients who take supplements. In addition, attendees received the advance release of the new DSEA Field Guide to Herbs. This guide, a handy reference to help legislators, media and consumers feel confident about the safety and efficacy of herbal products will be widely distributed.

The generous co-sponsorship from Capsugel and The Vitamin Shoppe ensured that 100 percent of the proceeds from the $250 per person dinner will benefit DSEA education and communications initiatives.

DSEA, formed in 2001 to communicate the benefits of dietary supplements, is a not for profit organization supported by over 100 companies within the dietary supplement industry. Board members include: Elliott Balbert, Natrol (NTOL); Valerie Bell, Canadian Health Food Association (CHFA); Jon Benninger, Virgo Publishing; Fred Linder, New Hope Natural Media; Michael McGuffin, American Herbal Products Association (AHPA); David Morrison, The Vitamin Shoppe; Marlene Ross, Nature’s Bounty (NBTY); David Seckman, National Nutritional Foods Association (NNFA), and Bob Whitelaw, Capsugel.

For more information, contact Deb Knowles at (941) 349-9044 or debknowles@supplementinfo.org.

Clinical Trial Materials: Outsourcing Provides Niche Expertise

Reprint of article from Tablets and Capsules Magazine - March, 2006. Copyright, CSC Publishing.

Pharmaceutical companies outsource the preparation of clinical trial materials (CTMs) to pharmaceutical development organizations (PDOs) for many reasons. Sometimes, a company (called a sponsor) seeks to avoid investing in specialized equipment or personnel. Sometimes, the PDOs have a desirable niche expertise. But in almost all cases, time is the driving force.
See rest of article.

The World's Most Advanced Capsule Plant Opens in China

The new plant of Suzhou Capsugel Ltd., a division of Pfizer Inc, officially opened on October 28th 2005, marking it the most advanced capsule production plant based in China.

With more than a century of experience in capsule manufacturing, Capsugel is the largest manufacturer of hard gelatin capsules in the world, with over 50% of global market share. Suzhou Capsugel Ltd. (SCL), the joint venture set up by Capsugel in 1988, has grown into the number one capsule manufacturer in the country.

Every stage of the capsule production process in SCL's new plant is controlled by highly-automated computer systems, ensuring reliable and consistent product quality. Furthermore, SCL has invested in employment of Statistical Process Control (SPC) techniques and is the first capsule manufacturer in China to formally launch a 6-sigma Quality Initiative, further enhancing quality consistency and reliability of its products.

In addition to quality manufacturing processes and industry leading standards of cleanliness, SCL's use of superior raw materials means that there is no use of harmful preservatives, which other capsule manufacturers in China do use.

Suzhou Capsugel Ltd. has been honored as one of the top 10 JVs in China for its market success and significant contribution to the country's capsule industry. The launch of the new plant will no doubt bring a new breeze to the industry.

Mr. Charles Danjaut, Pfizer, Capsugel Division Vice President, and SCL Chairman, ascribes the popularity of SCL products to their high quality: The high machineability and low defect ratio mean great profit margin for the customers, while the application of quality gelatin materials and preservative free process enables SCL to achieve a product safety level that no other domestic counterparts can equal.

As GMP certification on drug makers is drawing to an end, the government reportedly is considering the initiation of GMP certification on pharmaceutical excipients. Invited by SFDA, SCL participated in the GMP standard drafting for China's pharmaceutical excipient industry. The industry insiders believe that a quality-driven capsule market will lead this dynamic industry in the future, and that's the reason CAPSUGEL is confident to invest more in the local market.

Capsugel Opens Laboratory in America to Create Liquid-fill Formulas for
Dietary Supplements

Scientific protocols used to develop effective, safe, marketable products

December 1, 2005 (Greenwood, SC) - Capsugel, a global leader in capsule manufacturing, announced today the opening of its Americas Region Formulation Center, a laboratory with state-of-the art, world-class capabilities that will service the $21-billion dietary supplement markets in North and South America.* It will distinctively use pharmaceutical-based scientific development protocols to formulate dietary supplement ingredients into a liquid dosage form.

Using proprietary software "expert" systems and cutting-edge equipment, skilled formulators will test ingredients (for purity, density, and combination compatibility) and analyze formulas (for density, particle size, and viscosity) to ensure fast-to-market delivery of high-quality final formulations, including those customized for optimum bioavailability. They will work in a laboratory housed at SC Bio, a biotech incubator for development and entrepreneurial ventures in the heart of Greenwood in upstate South Carolina, a fast-growing nutraceutical hub.

"We have made a significant investment in a new Formulation Center because we have tremendous faith in our knowledge, resources, and development processes and great confidence in our liquid Licaps^® dosage form to meet the demands of the growing encapsulated liquids market," said Deborah L. Morrison, director of Liquids, Americas.

"We also are committed to helping to advance dietary supplements as a part of a credible, science-based industry," Morrison added. "With our quality development, we can create products that consumers want, meet and exceed regulatory requirements, and our customers can sell to address current and future health platform needs."

The scientific protocols are technologies transferred from Capsugel's successful formulation center in Colmar, France, which has been operating since June 2002 and develops both pharmaceutical and dietary supplement products. Colmar formulators developed a specially formulated CoQ10 that, in one study, delivers 30% higher bioavailability than other tested dosage forms of the ingredient.

The scientific development protocols will shorten formulation time and facilitate quality manufacturing quickly, for a rapid market launch for customers vying in a fast-paced competitive industry. They also will help to produce fast-acting, potent formulations with increased bioavailability, key advantages of encapsulated liquid products that are in ever-growing demand by savvy consumers who are increasingly accepting more responsibility for their own health and wellness.

Consumer research reveals a growing preference for liquid-filled capsules and Capsugel's Licaps^® brand can help meet that consumer preference. "Licaps^® liquids are a new technology that can satisfy consumer desire for a dosage form that is convenient to take, easy to swallow and has no unpleasant taste or smell," said Mark Vieceli, manager of Business Development.

The Americas Region Formulation Center will be at the "beck and call" of customers for customized products using Licaps^® technologies, said J. Croft Hollingsworth, manager of new product development for Liquids, Americas. "We are like an extension of their R & D departments - or in some cases, we can be their primary R & D or formulation resource."

To aid in its ongoing search for expert knowledge and viable solutions, Capsugel can draw upon its associations with the biotech region's other distinguished industrial, technological, scientific, and academic resources, including SC Bio, Greenwood Genetic Center, Clemson University's Institute for Nutraceutical Research and the Biosystems Research Complex, and the SC Nutrition Research Consortium.

The capabilities of Americas Region Formulation Center complement Capsugel's menu of services available for customers to facilitate rapid launches.

After development and testing of a formula is completed, the liquid-fills can be encapsulated quickly and cost-effectively, in small and large lots, at the newly expanded Licaps^® manufacturing factory on Capsugel's campus, the world's largest capsule manufacturing plant. The Greenwood facility features machinery that embodies Capsugel proprietary technology to precisely seal two-piece hard gelatin and vegetable-based capsules. Marketing support also is available in areas such as trade advertising, web site links, market research, product positioning, graphics packaging, and retailer education.

"We offer multiple products and services and a ready-made network of capabilities," Morrison said. "Everything is together in Greenwood."

*Source: Nutrition Business Journal, May/June 2005 and Nicholas Hall & Company, Yearbook 2004.

Capsugel Launches Online Nutritional Supplements Bibliography

Internet tool offers technical, clinical and market information

GREENWOOD, SC - January 2, 2006 - Capsugel, the world's leading supplier of empty two piece capsules, has launched an online Nutritional Supplements Bibliography. The bibliography, available on Capsugel's website, is a comprehensive database focused on research that supports alternative treatments. The tool was designed to assist dietary supplement formulators and marketers with essential scientific evidence information needs.

The Nutritional Supplements Bibliography offers convenient access to technical, clinical and market information, to assist the user in new product development, product positioning and marketing communications initiatives. By utilizing a simple database navigation function, the user is able to easily access supplement ingredient information, including:

• The latest evidence-based information on herbs and supplement ingredients developed and reviewed by a team of physicians and pharmacologists
• Over 12,000 double blind, placebo controlled and other scientific studies cited, with new studies added regularly
• More than 200 articles on medical conditions, related therapies and scientific evidence for use
• Critical interaction data between drugs and herbs/supplements

"The need for convenient access to scientific information on dietary supplement ingredients and uses has never been greater," states Scott Marsi, Global Product Manager of Liquids at Capsugel. "Market needs and trends are clear: the industry needs to improve consumer confidence. A more stringent regulatory environment is developing; trends show that sustained growth in the industry will continue to be generated by science-supported products that are well communicated to the consumer. Capsugel has a long tradition of supporting the responsible development of this market, and the Nutritional Supplements Bibliography service continues that tradition. Use of this valuable tool will help product developers and marketers make good development and product positioning decisions more quickly."

Capsugel is offering annual subscriptions to the Nutritional Supplements Bibliography as well as a free two week trail offer for each organization.

We take great pleasure today in announcing Pfizer's acquisition of Bharti Healthcare Ltd. The operation, located in Dharuhera, India, about 50 miles outside Delhi, will be managed by Capsugel. Bharti Healthcare, established in 1985, manufactures and markets empty hard gelatin capsules.

Capsugel, a division of Pfizer, with 2,500 colleagues and 9 facilities around the world is recognized as a world leader in supplying innovative and quality capsules for the pharmaceutical and dietary supplement industries.

As the new owner of Bharti Healthcare Ltd, Capsugel is committed to ensuring the continuity of the business and continuing to provide customers with the high level and professionalism for which Bharti is known.

Through this acquisition, Capsugel is very pleased to establish a manufacturing presence in India. In considering opportunities to enter the Indian market, Pfizer selected Bharti Healthcare Ltd based on the strong results and reputation established by the leadership of Bharti.

Americas Region Formulation Center Meets Call for Fast-to-Market Delivery of Quality Liquid Supplements

Complete services, scientific protocols, experienced formulators offer competitive advantage

Greenwood, SC - In the $21-billion dietary supplement industry in North and South America, today's savvy consumers desire effective, superior products, with a growing preference for fast-absorbent liquid supplements. Suppliers aim to be the first to meet this demand with new and better liquid dosages.

Capsugel's Liquid Formulation Center for the Americas Region in Greenwood, SC, steps up to the plate to meet market demand for liquid supplements in both North and South America.

It creates and customizes dietary supplement formulas specifically for the Licaps^® brand, a proprietary liquid-fill capsule technology. And it does so quickly - from concept to finished product formula ready for full-scale manufacturing at the plant on Capsugel's campus headquarters.

"Our formulators use our state-of-the-art, world-class laboratory to actively create products backed by science. The laboratory's full range of grade-A services and scientific processes shortens the time needed to develop new formulations, which in turn allows Capsugel customers to rapidly launch new products into a fast-paced competitive market," said Mark Vieceli, manager of business development for dietary supplements at Capsugel, a global leader in capsule manufacturing.

"We can be your formulation center headquarters."

Specifically, Capsugel and its Liquid Formulation Center for the Americas Region offer:

• Full range of existing Licaps^® products
• Breadth of inventive formulation services
• Pharmaceutical-based scientific development protocols using cutting-edge equipment
• World-class formulation talent and experience
• Ongoing innovative thinking fed by access to premier regional biotech institutions
• Dedicated manufacturing facility for fast-to-market delivery

Wide Range of Existing Licaps^® Products

Customers can buy and market under their brands dozens of Capsugel's existing liquid-fill Licaps^® products. Many raw materials have been screened and selected with formulations previously optimized for prompt availability. Licaps products serve various health platforms, among them heart health, women's health, and weight management. The Licaps^® line includes specialty oils, herbal suspensions, and combination products. (See Licaps^® Line insert for complete list.)

Array of Inventive Formulation Services

The capabilities of the Liquid Formulation Center for the Americas Region make possible other options:

• Take a customer's formula and create a liquid-fill product
• Improve upon a customer's formula, such as making it more bioavailable to speed up effectiveness or making it more stable for a longer shelf life
• Create and customize entirely new formulas, such as combination products or patentable products

A major goal: "proactive" development. "We want to develop new products that we can bring to our customers," said J. Croft Hollingsworth, manager of new product development for Liquids, Americas and manager of the Greenwood Formulation Center.

Development time, from the concept to manufacturability, can vary depending on a host of factors. "It can be as fast as two days to two weeks for creating liquid-fills from a customer's formula, based on the nature and availability of the raw materials. Or it could take longer if we are modifying a customer's formula or creating an entirely new formula," Hollingsworth said.

Development Processes: Scientific Protocols Using Cutting-Edge Equipment

The Liquid Formulation Center for the Americas Region draws upon the protocols used at Capsugel's successful development center in Colmar, France, which formulates and evaluates dietary supplement products and pharmaceutical products.

The processes check for ingredient quality, formulation feasibility, and manufacturing ease, as follows:

• The laboratory tests incoming raw ingredients for potency and identity. Does the ingredient exist as labeled - or is it an entirely different substance? Is it a high or inferior grade? Does it have the right viscosity? Do particles need further milling or micronizing before being suitable for production?
• Formulators analyze proposed formulations by consulting complete information databases of "bibliographic combinations." Are the materials compatible or incompatible?
• The laboratory combines raw materials and then analyzes the blends to better understand their characteristics. This allows formulators to see how the formulas are interacting with other ingredients and the excipient system used, an important process as the market moves toward combinational dietary supplements. Regarding density, is the material packed evenly? How are particle sizes of liquids and suspension in a liquid format distributed? What are the rates of sedimentation for particles, which affect shelf life? Is the water content low enough?
• Last, the materials are tested to ensure they can be manufactured with the current equipment used. Is the material moving smoothly through the capsule filling machine?

The use of sophisticated, analytical equipment utilized in pharmaceutical laboratories enhances the power of these protocols.

"We can analyze the chemical and physical properties of a material on the spot," said Jeff Taylor, product development/senior formulation scientist at Americas Region Formulation Center. "This helps to shorten formulation time and allows for manufacturing quickly in quality form so customers can get their unique formulation to the market fast."

Key cutting-edge equipment:

• Coulter® LS 13 320 Laser Diffraction Particle Size Analyzer - The most versatile and sophisticated analyzer that allows for accurate testing of particle sizes of liquids and suspension in a liquid format
• CFS 1000™ (Rheometer) - Invented by Capsugel, a high-precision, cGMP- compliant, development-scale bench-top machine that automatically fills and seals two-piece capsules with liquid formulations used to test formulations for manufacturability, in particular, difficult-to-produce liquids

Innovative Thinking: World-Class Formulation Talent and Biotech Associations

Formulators draw upon several decades of combined experience in dietary supplement development to offer creative solutions to challenging formulations.

Based on their tenures at Capsugel's Colmar formulation center, where they worked on drug development as well as dietary supplement formulation, Capsugel formulators are skilled in the field of microemulsions. This ability to solubilize some compounds that aren't easily solubilized is critical to creating lipid-based formulations in which fats and amino acids are broken down, or emulsified, into minute particles for improved bioavailability.

The chemical process is common in pharmaceutical development but uncommon in dietary supplement development. "We are borrowing science from the pharmaceutical drug environment to 'bioadvance' nutraceuticals - essentially enhance the chemical constituents in plant substances and nutraceuticals," said Taylor.

Because the laboratory is housed in Greenwood's SC Bio, a biotech incubator for development and entrepreneurial ventures viable in the marketplace, "We will have an opportunity to exchange ideas with forward-thinking colleagues as a matter of course - as we lunch or walk down the hallways together," Hollingsworth said.

In the same building - nestled in a 50-acre, pine tree-filled medical community campus - is the Greenwood Genetic Center, founded and currently directed by Dr. Roger E. Stevenson, who discovered the importance of folic acid in preventing birth defects, in particular, spina bifida. Other key nearby resources include the Institute for Nutraceutical Research and the Biosystems Research Complex at Clemson University in South Carolina.

Competitive Advantage: Fast-to-Market Development & Dedicated Manufacturing of Superior Product

What are the bottom line advantages of the Americas Region Formulation Center's services - in particular, the scientific protocols that test for substance accuracy and viability?

"Shorten time to market, drive overall unit costs down, and increase quality," Hollingsworth said. "There is increased productivity in the manufacturing cycle. There is no trial and error in manufacturing. Without laboratory testing, development is being done in manufacturing facilities. Development in real time is not efficient and places raw materials at risk for waste. When we manufacture, we have already tested the product viability so our yields are improved."

The icing on the cake for complete, fast-to-market delivery: convenient manufacturing at the laboratory's adjacent Licaps^® plant, newly expanded on the Greenwood campus of Capsugel's Americas Region headquarters.

Key Personnel for Americas Region Formulation Center

Deborah L. Morrison, Director of Liquids, Americas -- Morrison directs the Liquids, Americas group, which includes the Licaps^® brand, the Americas Region Formulation Center, and the Licaps^® manufacturing facility in Greenwood. Since joining Capsugel in 1985, she has directed and managed several engineering and technology systems departments and projects involving finished goods, hard-capsule machines, processing equipment, manufacturing scheduling systems, and business intelligence software. Before joining Capsugel, Morrison was a production manager for Midland Ross' Grimes Division's plant in Greenwood, SC, and set up manufacturing operations and supervised production engineering for Rockwell International's Missile Systems Division in Duluth, GA. She received a bachelor's degree in electrical engineering from the Georgia Institute of Technology in Atlanta.

Mark J. Vieceli, Manager of Business Development, Dietary Supplements -- Vieceli identifies and evaluates future growth opportunities in the dietary supplement business at Capsugel. He bridges the gap between existing and non-traditional markets to create a landscape for future growth and assists in regulatory efforts. Before joining Capsugel in 2003, Vieceli was director of sales of food/dietary supplement ingredients for E&J Gallo's Dry Creek Nutrition in Modesto, CA. He received a bachelor's degree in science and chemistry from the University of Nebraska in Lincoln.

J. Croft Hollingsworth, Manager of Liquids Product Development -- Managing all scientific development of the Formulation Center, Hollingsworth works closely with customers from product development through manufacturing and leads design and execution to meet Food cGMP conditions. Since joining Capsugel in 1995, Hollingsworth has been the business manager for Licaps^®; automation and strategic planning manager for all operations, including coordination with R&D projects; and a manufacturing support services manager for expansion projects such as the Gel Prep area. He earned a master's degree in business administration and a bachelor's degree in mechanical engineering from South Carolina's Clemson University.

Jeff Taylor, Product Development/Senior Formulation Scientist -- Taylor develops liquid-based formulations for Licaps^® and new liquid-based technologies at the Americas Region Formulation Center, services he performed for Capsugel's Formulation Center in Colmar, France, since joining Capsugel in June 2003. His product development experience in the dietary supplement industry includes tenures at Nutricia, Inc. (formerly General Nutrition Products), in Greenville, SC, as a senior scientist/group leader, and at Nature's Sunshine Products, Inc., in Spanish Fork, UT, as R&D research scientist and manager. Taylor received a master's degree in business administration from Clemson University and a bachelor's degree of science in botany, with an emphasis in biotechnology and biochemistry, from Brigham Young University in Provo, UT.

Licaps® Distinctive Technology Yields Distinctive Benefits in Liquid Market

Liquid preference, oxygen protection, and potent bioavailability are key competitive advantages

Greenwood, SC - As the demand for encapsulated liquid products in the dietary supplement industry grows, the Licaps^® brand stands out, according to executives of Capsugel, inventor of this unique proprietary liquid-fill delivery technology.

Introduced in 2002, Licaps^® is a distinctive "new technology" that helps, depending on formulation, to preserve bioavailability and potency of the liquid fills because of unique protection from oxidation that can degrade the formulas.

How so? First, the capsule is filled with the liquid formulation and then it is flushed with nitrogen to eliminate all oxygen from the final product, evidenced by the nitrogen bubble visible through the transparent capsule. Second, through the fusion process, the capsule itself provides an effective barrier to oxygen. A robust seal is created by fusing the outer shells, using a precision microspray process (LEMS™), resulting in no need for banding and no leakage.

Both are accomplished in a newly expanded, dedicated manufacturing plant located on the campus of Capsugel's Americas Region headquarters in Greenwood, SC.

"As a global leader in capsule manufacturing, we have a reputation for quality. We bring this same commitment to quality to the Licaps^® brand for dietary supplements," said Deborah L. Morrison, director of Liquids, Americas. "We provide consumers a product that works well. We give customers a full menu of diverse products that they can sell under their own brand because of Licaps' competitive commercial advantages. And we deliver an exceptional product that meets regulatory standards within the dietary supplement industry."

Consumer Benefits

Licaps^® delivers the advantages that draw consumers to liquid supplements, plus additional values for which they have shown a willingness to pay more, as follows:

• Consumers prefer Licaps^® because they are easier to swallow than tablets
• Because the capsule is less permeable than softgels to oxygen, it effectively masks tastes and unpleasant odors
• Protect against oxidation and subsequent degradation of the liquid
• Convenient to carry and take for those with fast-paced lifestyles
• Supports the vegetarian lifestyle
• Clear view of liquid through transparent capsule, depending on formula

Commercial Advantages

While all of the consumer benefits make Licaps^® extremely marketable, the brand has other qualities that can give customers an edge in the encapsulated liquids marketplace.

• Available in hypromellose (HPMC), the vegetarian capsule, appealing to a potential market of 70 million Americans alone who make vegetarian choices, of which 69 percent deem supplements beneficial.
• A versatile delivery system; any supplement product category can be delivered and protected from oxidation and gas permeation in liquid form.
• Precision Liquid Encapsulation Microspray Sealing (LEMS™) process creates robust seal to eliminate need for banding and prevent leakage
• Fast-to-market launch capabilities with low investment requirements
  • More than 45 standard products are immediately available with raw materials already screened and selected, formulations already optimized, and safety and stability tests completed. These include specialty oils, herbal suspensions, and combination products in a variety of health platforms.
  • Prompt turnaround of custom-formulated products through the services of the Americas Region Formulation Center in Greenwood, SC.
• Visually appealing liquid formulation, including capsule color selection and custom logo printing for product differentiation opportunities and packaging and promotional initiatives
• Marketing support through Capsugel industry promotion

Regulation Quality

Using protocols developed in the pharmaceutical industry, Capsugel is careful to follow high-caliber guidelines across the board for all its products, including the Licaps^® brand, as follows:

• Test incoming raw materials for identity, quality, and potency
• Manufacture to Food cGMP's (certified good manufacturing practices) standards
• Meet rigorous quality assurance standards
• Provide Certificate of Analysis with every production batch

Capsugel Formulators Create One-of-a-Kind Licaps^® Products with Competitive Edge

Americas Region Formulation Center taps on "heritage of success" of laboratory in Colmar, France

Although the actual physical laboratory of the Americas Region Formulation Center in Greenwood, SC, is new, its formulators draw upon a history of Licaps^® formulation projects from Capsugel's formulation center in Colmar, France, to serve the dietary supplement markets in North and South America.

Operating since June 2002, the Colmar laboratory develops both pharmaceutical and dietary supplement products. "There is a heritage of success for outstanding formulations," said J. Croft Hollingsworth, manager of liquids product development at the Americas Region Formulation Center. "We will build on this tradition to continue to invent formulas and products that will stand out in the dietary supplement marketplace."

Following are some of Colmar's specially formulated Licaps^® products with exceptional performance advantages or meriting patent status

Red Wine Extract

The powerful polyphenol found in red wine and the red skins of grapes, red wine extract is an antioxidant associated with healthy lifestyles. As a dietary supplement, red wine extract can have bioavailability problems because the compound dissolves only in certain solvents, including alcohol. It also is highly susceptible to oxygen degradation. Formulated into a Licaps^®, however, it is protected from oxidation, can maintain potency, and offers the benefits of a liquid form. In a 2002 study conducted by the brand holder, among 14 red wine extract dietary supplements of equal concentrations, the Licaps^® form showed a six-times greater biological activity than the next-best red wine extract supplement, with a number of other red wine supplements having barely measurable biological activity.¹ Furthermore, the Licaps^® technology has exhibited shelf-life stability.

CoQ10

A critical nutrient involved in the production of energy within cells, CoQ10 has been a popular dietary supplement among many health-wise consumer groups. In a 2004 study conducted by Pharmaceutical Standards, a respected clinical research laboratory, the patented CoQ10 Licaps^® (28.1 mg/unit) delivered 30% higher bioavailability than other popular forms of equivalent dosage (softgel, powder-filled hard-shell capsules, and effervescent tablet). ²

SAMe

SAMe is an antioxidant that helps raise the brain's serotonin levels. A patent-pending formulation, Licaps^® SAMe is the first liquid-stable product in a non-animal capsule on the market and the only one of its kind. Based on a Capsugel study, it has demonstrated at least one-year of stability.²

L-Carnitine

L-Carnitine is an amino acid that impacts the muscular system. A patent-pending formulation, Licaps^® L-Carnitine is the only liquid-pure and -stable L-Carnitine on the global market. A 100% pure L-Carnitine base (without salts Fumarate and Tartrate that shield from moisture and preserve potency) is unstable, but a Capsugel study has shown the Licaps^® formula maintains at least one year of stability.² The Licaps^® form also does not use D-Carnitine, which is not recognized by the body.

¹ Independent laboratory study conducted at Biomol International, Plymouth Meeting, PA in June 2004.

² Capsugel data on file.

Capsugel Takes Over Excipient-free Capsule Technology

Reprint of article from in-Pharma Technologist.com on 9/8/2005
(http://www.in-pharmatechnologist.com/news/ng.asp?id=61803).

9/08/2005 - Capsugel, the gelatin capsule manufacturing subsidiary of number one drugmaker Pfizer, has expanded its equipment product offering to its pharmaceutical customers by buying the powder micro-dosing technology Xcelodose from Meridica.

The handover of the technology comes in the wake of Pfizer's acquisition of Meridica in September 2003, which brought a range of inhaler and intranasal delivery technologies into the drug giant's portfolio.

Xcelodose, an automated and programmable tool for the precise metering of drugs into capsules and other solid dosage form containers, was always somewhat outside Meridica's core focus, and it is no surprise that it has been transferred to Capsugel, which offers a range of encapsulation machinery and formulation services.

Xcelodose is particularly targeted for preparation of early stage clinical trial supplies, and can handle drug compounds without bulking agent or excipients. The system can fill up to several hundred capsules per hour with programmable weights, from 100 micrograms to several hundreds of milligrams. The increased speed comes with other benefits, including reduced waste and improved accuracy (2 per cent standard deviation), according to Meridica.

Xcelodose is also small enough to operate in a normal laboratory environment or within a laminar flow or other containment enclosure, but has a production capacity that could be suitable even for small scale commercial manufacture.

In April, Meridica supplied its first Xcelodose system to North American contract research company MDS Pharma Services, which said it would use the system to help its customers start clinical trials of candidate drugs more quickly, as it does away with the need for excipient compatibility, stability and preformulation studies.

Meridica's David Edwards will continue as director responsible for the Xcelodose business and will be located at Capsugel's UK offices in Cambridge.