Pharmaceutical Technology-03-02-2002

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

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.

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.

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

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

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

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

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.

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

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.

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

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.

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.

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.