Development

Articles

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.

AstraZeneca’s Combination Diabetes Pill Recommended for Approval in EU

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.

Combo Drugs Require a Complex Design Approach

An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.

Catalent Extends Spray Drying Capabilities in Europe

JÃ©rÃ´me Revel is senior development engineer at Recipharm.

Philippe Gorria is senior director of Pharmaceutical Development at Recipharm.

Modified-release oral dosage forms can offer benefits to both formulation scientists and patients.

Modified-Release Formulations: Improving Efficacy and Patient Compliance

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.


Strategic Screening for Solubility Solutions

Martin Koeberle is head of Analytical Development & Stability Testing, HERMES PHARMA-a division of Hermes Arzneimittel GmbH.

The challenge of achieving sustained delivery of an active ingredient or nutrient can be achieved with extended-release formulations.

A User-Friendly Approach to Developing an Extended-Release Product

Yasvanth Ashokraj works in Integrated Product Development at CIPLA.

Prashant Modak works in Integrated Product Development at CIPLA.

Kalpesh Sawant work in Integrated Product Development at CIPLA.

Praveen Date works in Integrated Product Development at CIPLA.

Swati Laud works in Integrated Product Development at CIPLA.

This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.

Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.

Developing Lipid-Based Formulations

Pharmaceutical companies are developing new strategies to address the ever-increasing development costs for new drug therapies and maximize the value of their existing drug portfolio.

Innovating Lifecycle Management with Data-Driven and Enabling Technologies

Sai V. Nudurupati is assistant director at AbbVie Inc. (North Chicago, IL)

Michael J. Kukulka is senior manager, Global Labeling, Regulatory Affairs, PRA Health Sciences (Deerfield, IL)

Takako Ono is principal scientist, Analytical Development, Pharmaceutical Sciences, Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Haiyan Grady is associate scientific director CMCC, Takeda Development Center Americas, 300 Massachusetts Ave (4274), Cambridge, MA 02139, Tel: 1-224-554-2067, haiyan.grady@takeda.com

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized. 

Formulation and Drug Delivery, Controlled Release