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The aim of this study was to prepare taste-masked drug-resin complex using ion exchange resin Kyron T-134.

Development of Taste-Masked Oral Reconstitutable Suspension of Cetirizine Dihydrochloride

This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.

Approaches to Reduced Sampling and Testing for Starting Materials

Gayatri C.Patel, M.Pharm, PhD, is associate professor in the Department of Pharmaceutics & Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy at the Charotar University of Science and Technology, Changa Campus, Changa- 388 421, Anand, Gujarat, India, gayatripatel.ph@charusat.ac.in, +91 2697 265162.

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis. 


Optimizing Compression Coating for Pulsatile Release Tablets

Chintan Patel is researcher at Cadila Healthcare Ltd.’s Zydus Research Center in Ahmedabad, Gujarat, India

Gayatri Patel is associate professor of pharmaceutics and pharmaceutical technology at Charotar University of Science and Technology, Changa, Gujarat, India

Sanjay Bandyopadhyay is vice president at Cadila Healthcare Ltd.’s Zydus Research Center in Ahmedabad, Gujarat, India;

Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.

Optimizing Manufacturing Based on the Storage Stability of Pegylated Products

Research compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.

Inhalation Drug Delivery: The Impact of Particle Size Reduction

Mark Witcher is senior consultant at Brevitas Consulting, witchermf@aol.com

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures. 

Improving Prospective Product Development Methods Derived from Management-Based Regulatory Guidelines

Orlando LÃ³pez is a senior consultant at McNeil Consumer Healthcare, a J&J company.

Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.

Defining and Managing Raw Manufacturing Data

Andrew Johnson is analytical specialist with Gaylord Chemical Co, LLC.

Ashley Jones is analytical chemist with Gaylord Chemical Co, LLC.

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

Testing for Water in DMSO: Exploring Alternatives to Volumetric Karl Fischer Analysis

Chintan Patel is a researcher in the Department of Biotechnology, Zydus Research Centre, Cadila Healthcare Ltd., Ahmedabad, Gujarat, India. 

Sanjay Bandyopadhyay, PhD, is vice-president in the Department of Biotechnology, Zydus Research Centre, Cadila Healthcare Ltd., Ahmedabad, Gujarat, India

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution. 

Degradation Pathways: A Case Study with Pegylated L-Asparaginase

Johannes G. Khinast is professor at the Institute of Process and Particle Engineering, Graz University of Technology, Austria

Stephan Sacher is senior scientist at the Research Center for Pharmaceutical Engineering GmbH in Graz, Austria.

Elen Gartshein is senior manager at Pfizer Global Supply, Peapack, NJ, USA.

Matthias Wolfgang is scientist at the Research Center for Pharmaceutical Engineering GmbH in Graz, Austria.

Patrick Wahl is senior scientist at the Research Center for Pharmaceutical Engineering GmbH, Graz, Austria.

Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.

Peer-Reviewed Research