Thought Leadership, Technical Papers

Article

Making Real-Time Process Analytical Technology in Biomanufacturing a Reality

Automated, aseptic sampling and analysis is a prerequisite for making real-time Process Analytical Technology (PAT) in biomanufacturing a commercial reality.

Developed in collaboration with several leading pharmaceutical companies over an extensive development program, the Modular Automated Sampling Technology (MAST) platform from Capsugel/Bend Research allows direct transfer of aseptically collected bioreactor samples to analytical devices, providing rapid, reliable data for superior bioprocess guidance.

White Paper

Cultivate Your Probiotic Performance: Market Trends and Innovative Solutions

Consumers are quickly adopting supplements to maintain their well-being in an effort to keep their health care costs down. Probiotic supplement use is expected to ride along this wave of growth.

To provide insights into the global probiotics market, this report analyzes regional trends and explores how consumer education, government regulations, probiotic forms, wellness claims and effective delivery systems can help cultivate probiotic performance in the coming years.

Article

How Polymer Science is Changing the Functional Role of Capsules

New developments in polymer science are broadening the role that capsules play in drug delivery, formulation science and medical research. Today options exist to achieve immediate, delayed, controlled, site-specific or colon-targeted release. Specialized capusles can now play a functional role in improving bioavailability, meet the clinical needs for specific plasma time-course profiles, avoid site-specific degradation in the GI tract, and improve drug efficacy for patients.

White Paper

Inhaled PYY(3–36) dry-powder formulation for appetite suppression

Peptide YY3–36 [PYY(3–36)] has shown efficacy in appetite suppression when dosed by injection modalities (intraperitoneal (IP)/subcutaneous). Transitioning to needle-free delivery, towards inhalation, often utilizes systemic pharmacokinetics as a key endpoint to compare different delivery methods and doses. Systemic pharmacokinetics were evaluated for PYY3–36 when delivered by IP, subcutaneous, and inhalation, the systemic pharmacokinetics were then used to select doses in an appetite suppression pharmacodynamic study.

Article

June 21 2016

50 years of oral lipid-based formulations - Provenance, progress and future perspectives

This article was authored by researchers at Monash University, Uppsala University and Capsugel and has been accepted for publication in the journal Advanced Drug Delivery Reviews (ADDR).  It describes 50 years past use of lipid formulations in drug development, primarily to promote the absorption of poorly water-soluble compounds. Also, the article provides detailed insights into the bioavailability enhancing properties of lipid formulations and recent advancements made in in vitro testing of lipid formulations. Download the full article to read more!  

White Paper

Next Generation HPMC Capsules Bioequivalence and Functional Performance

In this executive summary, experts will present the in vitro dissolution and an in vivo bioequivalence study comparing the performance of the identical formulation of three different drugs in Vcaps® Plus capsules to hard gelatin capsules. In addition, the circumstances under which the same API and formulation contained in HGC and Vcaps Plus can be expected to provide equivalent performance will be discussed.

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Poster

AAPS 2015 Poster - Bioavailability Enhancement - R6106 - A Rapid Screening Tool for Assessing the Utility of Amorphous Dispersions for Bioavailability Enhancement

Amorphous dispersions prepared by spray drying or hot melt extrusion can increase oral bioavailability of a wide range of drugs by leading to supersaturation in the upper intestine and sustaining that supersaturation long enough to increase the driving force for permeability. Recent work on amorphous dissolution has demonstrated the ability to readily detect amorphous phase separation in aqueous solutions. Based on this work, we set out to develop a rapid assay for determining amorphous solubility and the ability of polymers and surfactants to prevent crystallization from the supersaturated state in biorelevant media.

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Poster

AAPS 2015 Poster - Bioavailability Enhancement - W5055 - Formulation design and evaluation of self-emulsifying drug delivery systems (SEDDS) for a poorly water-soluble BCS II Compound

Robust SEDDS formulation development is based on in-depth analysis and understanding of a given API’s physicochemical and biological characteristics and, if appropriate, the consequent selection of specific lipid- based excipients known to have physiological effects. The purpose of this study was to leverage internal know-how and methodologies to develop lipid formulations that address solubility and metabolic barriers to the oral bioavailability of a BCS class II API.

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Poster

AAPS 2015 Poster - Modified Release - M1077 - Targeted Monoclonal Antibody Delivery Using Enteric Coated Hard Gelatin Capsules

Proteins and peptides delivered via the oral route can be subject to degradation when exposed to the gastric environment. Through the application of polymeric based coatings, targeted hard capsule rupture can be used to protect gastro- sensitive API’s1. Prior to clinical trial, early pharmacokinetic (PK) studies are often conducted in small animals, such as the mouse or rat. The pH variation within the rat and mouse GI system is not comparable to that of a human2, therefore a suitable enteric coating is required to target appropriate release in the selected animal model.

The purpose of this study was to investigate the in-vivo performance of an anti-inflammatory monoclonal antibody, administered to the mouse model, via the oral route, using an enteric coated hard capsule. The performance of the enteric coated capsule was compared to liquid administration.

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White Paper

Spray-Drying Formulation + Process Development Advances

This white paper provides an overview of inhaled drug delivery and formulation options for DPI delivery using SD technology pioneered by Bend Research, a division of Capsugel Dosage Form Solutions, and specially designed capsules developed by Capsugel. A case study is presented that describes an integrated approach to formulation, process design, and drug-delivery system selection.

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Article

Comparative Human In-Vivo Study of an Immediate Release Tablet Over-Encapsulated by Gelatin and Hydroxypropyl Methyl Cellulose Capsules - Impact Of Dissolution Rate on Bioequivalence

Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolution tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing.

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White Paper

Fundamentals of Spray-Dried Dispersion Technology white paper

A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility. The literature suggests that a significant majority of new drug candidates are in the Biopharmaceutics Classification System (BCS) class II and IV space, which includes compounds that are dissolution rate, solubility or permeability limited to absorption, or all three. As portfolios across the industry are increasingly focused on these compounds, the need for enabling technologies continues to grow.