Articles in this Issue
Linzhe Liu, Tony Osei, Ph.D., Jerry Hsu, Ph.D., Jonine Greyling, Ph.D.
Abstract:
In vitro dissolution profile is an important requirement for extended release solid dosage forms. Compared to immediate release dissolution, more direct analyst intervention is necessary because of multiple sampling and sample preparation.
Michael Donahue, Edita Botonjic-Sehic, David Wells, Chris W. Brown
Abstract:
Infrared and Raman spectra of different crystalline forms of the same organic compound can be used to identify a pure crystal form and quantify a mixture of two forms.
Lokesh Bhattacharyya, Ph.D.
Introduction
Ionic methods of separation have been used in a variety of applications over several hundreds of years. However, the modern form of ion chromatography (IC) was introduced in 1975 by Small, et al. [1].
Samuel Maldonado M.D., M.P.H., FAAP, Daniel Schaufelberger, Ph.D.
It has long been recognized that the therapeutic needs of children are sufficiently different than those of adults as to require specific studies of medications in children. Since most children are healthy and do not suffer of many diseases as do adults, the market of drug for children is small relative to the market of medications for adults. Market forces continue to be de driver for research and development of new medications.
Michael Lowinger
As a well-established process technology that has been developed and optimized over the past century, hot melt extrusion has become a staple of the plastics and food industries while continuing to gain prominence in the pharmaceutical industry. Melt extrusion has become a popular route for increasing the bioavailability of poorly soluble compounds owing to its role as a process technology used to manufacture solid solutions [1-3].
Barbara J.Potts
Global regulations that apply to the control of adventitious agents in raw materials cover prions, viruses, mycoplasma, bacteria and molds/yeasts. The establishment of a risk assessment concerning these agents should cover the likelihood of contamination, the consequences if a contamination event occurs and the impact on the product safety and availability to the public.
Otilia M. Y. Koo, Ph.D.
Pharmaceutical excipients are defined in United States Pharmacopoeia (USP) 33 as “substances other than the active pharmaceutical ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system”. Excipients are essential components to enable the delivery, manufacturability and stabilization of the API in a formulation.
Scott Sutton, Ph.D.
Background:
In talking with colleagues at various conferences and on the PMFList, it is clear that we all have a remarkably similar experience reporting an OOS (Out of Specification) result from the microbiology lab.
Michael N. Eakins, Ph.D.
National pharmacopeias, for example the U.S. Pharmacopeial Convention (USP), The Japanese Pharmacopoeia (JP), and The European Pharmacopoeia of the Council of Europe (EP), set quality standards for active pharmaceutical ingredients, drug products, excipients, packaging materials, labeling and storage conditions.