Drug Development

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C-H silylation reactions.

Advances in Heterocyclic Chemistry for API Synthesis

FDA’s inactive ingredients database (IID) has been under development for several years, as a way to allow generic and name-brand pharmaceutical manufacturers to check on the safety and performance of specific inactive ingredients.

IPEC-America Suggests Improvements to FDA’s Inactive Ingredients Database

Croda Chocques SAS' excipient facility in France has received EXCiPACT certification from SGS ICS, making it the 24th manufacturing site to be certified to the scheme, which verifies that manufacturing of pharmaceutical-grade excipients meets current good manufacturing practices (cGMPs).  It is the third Croda site in Europe to receive this certification in the past year. Certification reflects a rigorous assessment program, both for the auditor and the audited, and the auditor's report had to be verified by an independent certification board.

Croda's French Facility Receives EXCiPACT Certification

Dow introduces solvent-free productivity technology for coating barrier membranes.

Dow Pharma Launches Polymer for Coating Barrier Membranes

EMD Millipore, the life-science division of Merck KGaA, has introduced Parteck SRP 80, a new functional excipient for oral sustained-release formulations. The excipient is polyvinyl alcohol (PVA)-based and fully synthetic-according to EMD Millipore, this feature ensures batch-to-batch and performance consistency and facilitates quality by design (QbD) and validation processes.

EMD Millipore Presents New Sustained-Release Excipient for Oral Dosage Forms

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards

Boai NKY Pharmaceuticals becomes first Chinese supplier to get EXCiPACT certification

Athenex will build two facilities for high-potency, oncology API ingredients in Chongqing, China.

Athenex Expands API Manufacturing in China

Hovione is investing in specialized formulation capabilities, beginning with the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal, the company announced on Oct. 19, 2015. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

Hovione Expands Formulation Capabilities

At CPhI Worldwide 2015, The Dow Chemical Company announced the global commercial availability of AFFINISOL HPMC HME, a new generation of cellulosic polymer for drug solubilization. The polymer is designed for use by pharmaceutical companies looking to enhance the solubilization and inhibit the recrystallization of APIs in hot-melt extrusion (HME) formulations.

Dow’s New Excipient Is Designed for Hot-Melt Extrusion

The new sugars are touted to increase the efficacy of active pharmaceutical ingredients and improve cell culture yield.

APIs and Excipients