Dosage Forms

Reshaping Dosage Forms

Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Frontrunners in Bispecific Antibodies

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Determination of Dermal PDE for Pharmaceutical Products

January 02, 2018

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.

Auromedics Pharma Recalls Linezolid Injection Due to Mold Contamination

December 28, 2017

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

Federal Circuit Decides in Favor of Novartis in Biosimilars Patent Dispute with Amgen

December 18, 2017

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

FDA Approves Pfizer Biosimilar to J&J’s Remicade

December 14, 2017

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

New Immunotherapy for Pediatric Brain Cancer Targets Mutated Protein

December 14, 2017

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

FDA Approves Sanofi’s Follow-On Insulin

December 13, 2017

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

An Innovative Excipient System for Film Coating

December 08, 2017

The low viscosity of Colorcon’s Opadry QX, even at solid levels as high as 35%, reduces coating and preparation time compared to traditional hydroxypropyl methylcellulose-based coatings.

Manufacturing Microparticles in a Single Step

December 06, 2017

Equipment and Processing Report

Orbis Biosciences’ Optimµm Platform delivers microparticulate dosage forms with controlled-release and taste-masked properties in a single manufacturing step.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

December 05, 2017

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

FDA Approves First Biosimilar to Roche’s Herceptin

December 04, 2017

FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.