Thought Leadership, Technical Papers

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.

White Paper

Implementing true PAT in bioreactor operations

Gaining optimized cell-level “observability” and data-driven process “guidance” by leveraging on-line technologies such as dielectric spectroscopy and at-line tools such as the modular automated sampling technology (MAST™) platform.

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Article

Advances in manufacturing liquid-filled hard capsules for delivery of difficult API's

Capsules filled with liquids or semi-solids offer a greater range of formulation options than other dosage forms do, particularly when the API is lipophilic, poorly bioavailable, or highly potent. This article highlights advances in the design and production of liquid-filled hard capsules and summarizes how they perform compared to liquid-filled soft gelatin capsules.

Poster

Development of a Sustained Release Dosage Form for Phenylephrine Hydrochloride using Solid Lipid Pellets

The purpose of this work was to demonstrate proof-of-concept for a stable sustained release dosage form containing phenylephrine hydrochloride (PE HCI) using Capsugel's Solid Lipid Pellets (SLP) technology.

Poster

New Cellulosic Excipients for Solubilization of Active Pharmaceutical Ingredients

The goal of this work to demonstrate the potential utility of exploring a broad space of HPMCAS succinoyl and acetyl contents to maximize solubilization performance and bioavailability of specific active compounds.