Formulation and Drug Delivery

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

Fixed-dose combination drug therapies give rise to innovation in solid-dosage formulations and manufacturing.

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.

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

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.

A roundup of the latest developments for drug delivery of parenteral drugs.

Researchers have developed injectable, reformable, and spreadable hydrogels capable of delivering sustained release of the proteins they contain for up to six months.

Advances in targeted drug delivery and customized release profiles are key industry goals.

Development of viable dosage forms for poorly water-soluble compounds continues to be a significant challenge for formulation scientists, and insufficient bioavailability of such compounds may result in development delays or failures.

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.

A Q&A with BASF moderated by Patricia Van Arnum.

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 Q&A with Babu Padmanabhan, Managing Director and Chief Knowledge Officer of STEER Engineering, on recent industry trends.

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.

Enhancing bioavailability can be achieved through hot-melt extrusion or spray drying. Patricia Van Arnum interviews Bend Research to find out more about when to use each technique.

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.

Nanolipogels for anticancer drug delivery, inhalable and thermo-responsive, fat-encased nanoparticles for targeted drug delivery, and calcium carbonate microspheres are some recent developments.

Dedong Wu, senior scientist at AstraZeneca, explains how nanoparticle engineering and crystal engineering can aid solubility.

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.