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.
Application-related properties of a new fast dispersible excipient
January 1st 2009A new excipient for orally disintegrating tablets not only imparts superior tablet characteristics, but has the added advantage of allowing users to maintain full control over their formulations, manufacturing processes and intellectual property.
Merck Forms Follow-On Biologics Business; Emphasizes Emerging Markets
December 18th 2008At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.
SOCMA Cites Concern Over SVA Requirements for Chemical Facility Security Standards
December 11th 2008The Synthetic Chemical Organic Manufacturers Association (SOCMA) has raised concerns over requirements for security vulnerability assessments (SVA) under the US Department of Homeland Security's (DHS) Chemical Facility Anti-Terrorism Act Standards (CFATS).
Lawmakers Pledge to Move on FDA Reform in the Next Congress
December 4th 2008Reps. John D. Dingell (D-MI), current chairman of the Committee on Energy and Commerce in the US House and Representatives, and Bart Stupak (D-MI), chairman of that committee?s Oversight and Investigations Subcommittee, said that moving the Food and Drug Administration Globalization Act and other measures for drug and food safety will be a key priority for the next Congress.
A novel aid for the preparation of pellets by extrusion/spheronization
December 1st 2008Microcrystalline cellulose is the main excipient used in the industrial manufacture of pellets by extrusion/spheronization, but pellets containing this spheronizing aid do not readily disintegrate and are expensive.
The influence of concomitant use of alcoholic beverages on hypromellose matrix tablets
December 1st 2008Research shows that both drug prescription and alcohol consumption increase within the elderly population. It is, therefore, necessary to fully understand the impact of alcohol consumption on solid oral dosage forms, especially extended release formulations.