August 8th 2024
Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.
FDA Panel Rejects OTC Status for Merck’s “Mevacor”
December 28th 2007The US Food and Drug Administration's joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending approval of the over-the-counter use of Merck & Co.'s “Mevacor” (lovastatin) 20 mg.
Preparation and Characterization of Meloxicam–Myrj-52 Granules Obtained by Melt Granulation
December 2nd 2007Various manufacturing techniques can improve a drug's solubility, thus increasing its bioavailability. The authors examined whether melt granulation can enhance drug solubility using meloxicam as the drug substance and myrj-52 as the binder.
Enhancing Topical Delivery Using Prodrugs
December 1st 2007The permeation of drugs through the skin is compromised by the presence of polar functional groups such as thiols, alcohols, phenols, imides or amides. By transiently masking these polar functional groups as prodrugs the permeability of drugs containing these functional groups through the skin can be improved.
Topical delivery of oily actives using solid lipid particles
December 1st 2007Lipid-based drug delivery systems - such as liposomes, micro-and nanoemulsions, self-emulsified drug delivery systems, and solid lipid micro-and nanoparticles - are becoming more popular because lipid materials are easily characterized, contain a high range of well-defined/tolerated surfactant molecules and can be developed for several administration routes.
Global Pharmaceutical Industry Growth to Slow in 2008
November 21st 2007Growth in the global pharmaceutical industry is expected to slow in 2008, marked by slowing growth in the United States and other major markets. At the same time, pharmaceutical industry growth in emerging markets is expected to reach double-digits, although these markets still represent a small percentage of global pharmaceutical sales.
SOCMA Offers Recommendations To Better Foreign Inspection Process
November 16th 2007The Bulk Pharmaceuticals Task Force, an affiliate of the Synthetic Organic Chemical Manufacturers Association (SOCMA) weighed in on the Congressional debate concerning the US Food and Drug Administration?s inspection process of foreign drug- manufacturing facilities.
FDA Commissioner Testifies Before Congress on Foreign Inspection Process
November 8th 2007US Food and Drug Administration Commissioner Andrew C. von Eschenbach testified before Congress last week to outline the agency’s inspection process for foreign drug manufacturers and efforts to improve the agency’s information technology systems.
Congress Focuses on FDA Inspections of Foreign Drug Facilities
November 8th 2007The US Food and Drug Administration’s effectiveness in regulating the manufacture of pharmaceutical products and active pharmaceutical ingredients at foreign facilities was questioned at a Congressional hearing last week. Congress, industry, and government officials weighed in on the issue.