Capsugel® Zephyr™
Dry-Powder Inhalation Capsule Portfolio
Dry-powder inhalation (DPI) technology offers a favorable drug development opportunity for respiratory or systemic drug delivery. Delivering a uniform dose in a portable, easy-to-use system, capsule-based DPI devices are a simple and cost-effective way to deliver inhalable medication.
Capsugel® Zephyr™ is Lonza’s customizable dry-powder inhalation capsule portfolio that is optimized to provide superior performance and compatibility between the capsule/device and capsule/formulation.
Our dry-powder inhalation capsule portfolio offers:
- Consistent powder release
- A customized approach to optimize performance of the end product
- Compatibility with a large selection of device principles and opening systems
- Ideal puncturing and cutting performance
- Availability in gelatin (Coni-Snap® Gelatin or Coni-Snap® Gelatin PEG) and HPMC (Vcaps® or Vcaps® Plus) capsules
- R&D and regulatory support throughout the development including QbD approach
CUSTOMIZED APPROACH FOR EACH APPLICATION
Lonza partners with its customers to closely match specific requirements and leverages a wide range of customization services for its DPI capsule portfolio. To ensure optimal performance for the required device, Lonza:
- Adheres to strict microbial limits to comply with all major DPI regulatory guidelines globally
- Applies strict manufacturing conditions and In Process Controls to achieve consistency in dose delivery to the patient
- Selects and modifies the final capsule to the desired stability and custom weight tolerances for low-dose APIs
- Recommends capsules to optimize puncturing and cutting performance
- Provides a variety of options for capsule branding
- Offers a secure supply chain, including packaging, to maintain integrity of low-moisture compounds
Given patient convenience and compatibility with a range of formulations and doses, capsule-based dry-powder inhalation (DPI) technology is becoming the specialists preferred DPI drug delivery platform for respiratory and systemic applications.
OVER 3+ BILLION DPI DOSES DELIVERED WORLDWIDE
FORMULATION DEVELOPMENT SERVICES
At Lonza, we provide expertise in spray dry processing and jet-milling for optimized particle engineering – which is crucial to successful respiratory product design. Lonza has facilities that are recognized for spray-dried dispersion technology and particle engineering with fast-track programs for new chemical entities. From common to very complex inhalation development, our scientists can select a lactose-free, spray-dried dispersion-based approach based on the API characteristics and target product profile – from large to small molecules.
The Capsugel® brand offers more than 20 years experience and billions of capsules delivered for inhaled drug delivery systems. The Capsugel® portfolio of DPI capsules is well known for its world-class quality that helps ensure dose uniformity and reproducibility, as well as high-performance machinability.
We have developed customized capsule solutions for a number of drugs that have become the gold standard in the treatment of major respiratory diseases. Global supply chain, security of supply and technical and regulatory support accompany every capsule sold. Customized DPI capsules and encapsulation are core competencies, with dedicated equipment in place for efficient, phase-appropriate capsule filling.
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Step 1: Product Target Profile |
Project synopsis: Reference product, targeted market, regulatory route |
Targeted patients: Characteristics and needs |
Device selections supports characterization |
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Step 2: Setting DPI Capsule Specifications |
Active principle ingredient (API) profiling: Formulation approach discussion |
Support to QbD approach: On critical capsule parameters |
Rapid supply of R&D capsule quantities: For preliminary test |
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Step 3: Support throughout validation and dossier filling |
Capsule branding: Color matching, custom color and print development |
Rapid supply of customized DPI capsules : For validation / clinical batches |
QA & regulatory support: Required statements for dossier filling, support on questions from agencies |
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Water Activity Testing |
Device Compatibility Testing |
Powder Retention with Standard Lactose Blend |
Impact of storage condition on performance |
A range of solutions, based on your needs
Coni-Snap® Gelatin DPI
Coni-Snap® Gelatin DPI capsules are the standard gelatin component of the Capsugel® Zephyr™ portfolio of dry-powder inhalation products.
Coni-Snap® Gelatin DPI is a high-quality capsule solution based on gelatin polymer. It is a robust capsule with a LOD (loss on drying) range between 13% and 16%. They offer a wide range of customizable color combinations (transparent or opaque) and print options. Coni-Snap® Gelatin DPI offers a narrow weight distribution and is a cost-effective solution for less challenging formulations.
Coni-Snap® Gelatin-PEG DPI
Coni-Snap® Gelatin-PEG DPI capsules are the robust gelatin component of the Capsugel® Zephyr™ portfolio of dry-powder inhalation products.
Coni-Snap® Gelatin-PEG DPI capsules are a high-quality capsule solution based on gelatin polymer blended with a plasticizer. These robust capsules have a glossy surface and a tailored LOD (loss on drying). Coni-Snap® Gelatin-PEG DPI capsules offer a wide range of customizable color combinations and print options. The standard offer is available in narrow weight distribution. Coni-Snap® Gelatin-PEG DPI capsules are available in two levels of PEG, which is determined by the end product.
Vcaps® Plus DPI
Vcaps® Plus DPI capsules are a unique, plant-based solution within the Capsugel® Zephyr™ portfolio of dry-powder inhalation capsules.
Vcaps® Plus DPI capsules are the only Capsugel® Zephyr™ portfolio HPMC offering with no gelling agents available on the market. They are a high-quality capsule solution with a glossy surface and optimal transparency. Vcaps® Plus DPI capsules are robust capsules with a LOD (loss on drying) below 9% or up to less than 2.2% LWA (low water activity). The standard offering is available with narrow weight distribution and a range of customizable color and print options.
Vcaps® DPI
An integral player within the Capsugel® Zephyr™ portfolio of capsules, Capsugel® Vcaps® DPI capsules offer unique attributes for the dry-powder inhalation industry.
Capsugel® Vcaps® DPI capsules are a high-quality solution based on HPMC polymer with a gelling system. They are available with a wide range of customizable color combinations (transparent or opaque) and print options. Capsugel® Vcaps® DPI capsules are robust with LOD below 9% or up to less than 2.2% LWA (low water activity). They have a very low powder retention profile, matte surface and are available in sizes 3 and 00.