Dosage Forms

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.

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.

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

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

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

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

Rob Blanchard and Clive Roberts discuss the issues surrounding tablet sticking.

Pfizer and Mylan have agreed to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

A look at elastomer changeout times shows how industry knowledge improves operations and cost.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Meticulous system configuration can prevent machines from taking over.

An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars.

MedImmune, the global biologics arm of AstraZeneca, announced that it is restructuring its infectious disease and vaccines R&D and operations. This will result in the closure of MedImmune's sites in Mountain View and Santa Clara, California.

Sandoz announced it has completed the acquisition of Fougera Pharmaceuticals, a maker of generic dermatology products, for $1.5 billion.

GSK Extends Deadline for Tender Offer to Acquire Human Genome Services; Sartorius Opens New Filter, Aseptic-Bag Production Facility in Puerto Rico; and More.

Holistic open learning networks offer a new drug R&D model for improving research outcomes.

Industry experts share their insight on solid-dosage and sterile manufacturing.

Companies roll out expansions in manufacturing high-potency APIs and finished products.

Developments in hot-melt extrusion using twin-screw extruders to make solid-dosage drug forms.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2012 edition from EMD Millipore and Meissner Filtration Products.

Novartis, GlaxoSmithKline, and Lonza are among those participating in newly formed consortiums for developing and producing medical countermeasures.

Basilea, Stiefel Enter into Hand-Eczema Pact; Sandoz Recalls Generic Oral Contraceptive Drug; and More.

In addition to the established coating systems (like the BFC and the BFC TriPan), Bohle developed a new coater to face the market needs, the Bohle-Tablet-Coater BTC.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

How to avoid invisible and airborne contamination.

Partnerships between industry and academic medical centers are expanding to meet R&D needs.

New coating technologies achieve high uniformity and reduce waste through mixing system advances and pan and airflow configuration.

Does global development have to entail multiple comparability studies?