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

Reshaping Dosage Forms

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

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

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

Frontrunners in Bispecific Antibodies

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Articles

This study examines the effect and interaction of variations in hypromellose physicochemical properties.

Applying Quality by Design for Extended Release Hydrophilic Matrix Tablets

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.

New Era for Generic Drugs

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.

EMA Aims to Facilitate Biosimilars Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The physical form of an API is an important consideration in formulation development. Particle-engineering technologies, such as crystal design for controlling crystallisation and producing cocrystals, particle-size reduction and amorphous solid dispersions, help to optimise delivery of a drug.

Seeking Solutions in Solid-State Chemistry

Orphan drugs achieved blockbuster status in 2011, generating over $50 billion, and have the potential to generate as much lifetime revenue as drugs used for more common health conditions, according to a report from Thomson Reuters’ IP & Science division.

Study ‘Confirms Economic Viability’ of Orphan Drugs

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

CDER to Expand Office of Generic Drugs

Andreas Gryczke is the technical marketing manager of technology commercialization at Evonik RÃ¶hm GmbH.

The advantages and disadvantages of hot-melt extrusion in solid dispersion formulations.

Solid Dispersions by Hot-Melt Extrusion

The authors investigate the tablet-coating process using a combination of different simulation techniques.

Peer Reviewed: Numerical Simulation of Tablet Coating

The authors describe a solid form technology platform used to optimize salt selection, cocrystallization identification and modification, or the development of a free form.

Developing the Optimal Solid Form

Pfizer has two manufacturing facilities in Germany for high-potency manufacturing, respectively in Freiburg and Illertissen. Pharmaceutical Technology's Executive Editor Patricia Van Arnum visited the facilities and spoke to the company about the design and operation of these facilities.