Pharmaceutical Technology-03-02-2002

March 01, 2002

The author discusses three current examples of new ideas in formulating outsourcing arrangments.

March 01, 2002

Adhesives manufacturers can be involved in the development of transdermal drug delivery products by working with pharmaceutical companies on R&D, materials qualification, manufacturing, and other product development tasks.

March 01, 2002

Current security technologies and associated infrastructures are designed to protect information assets and satisfy 21 CFR Part 11 requirements for integrity and privacy of records using authentication and encryption methods.

March 01, 2002

When FDA reviewed PDA's Technical Report No. 34 about isolator systems, significant differences of opinion between the organizations came to light.

March 01, 2002

Semisolid dosage forms are advantageous in terms of their easy application, rapid formulation, and ability to topically deliver a wide variety of drug molecules.

March 01, 2002

FDA wants manufacturers to revise product labeling and packaging and step up adverse-event monitoring to reduce risky product use.

March 01, 2002

The author discusses the use of batch control systems for the collection and management of production data.

March 01, 2002

The authors review their study that aimed to develop a coprocessed, directly compressible, multipurpose adjuvant that could serve as a diluent and built-in disintegrant.

March 01, 2002

Public CROs are creating new ways of operating their outsourcing businesses to remain competitive in difficult economic conditions.

March 01, 2002

This study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.

March 01, 2002

Meeting the challenges of large-scale LC/MS/MS such as elminating carr-over and matrix effects can increase sensitivity and improve turnaround times.

March 01, 2002

The development of a successful powder for injection formulation requires careful study of preformulation parameters, packaging and process parameters, and the elimination of particulate matter.

March 01, 2002

The delivery agent-mediated transport of low moleular weight heparin across Caco-2 cells is accomplished without opening the junctions or adversely affecting the structural integrity of the cell monolayer.

March 01, 2002

This article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.