Drug Development

Articles

The manufacturing process used for an API’s production is a crucial factor determining its quality.

APIs: Why EU authority oversight is vital

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

This is a year of change for the Synthetic Organic Chemical Manufacturers Association (SOCMA), the Washington, DC-based trade association representing chemical batch and custom manufacturers. Following the sale of Informex, its flagship trade show, last fall, the association is advancing key programs, most notably its new ChemStewards program, an environmental, health, safety, and security initiative (EHS&S) that its members began implementing last month.

SOCMA Launches ChemStewards Program

Although physicochemical preformulation screening is practised universally within the pharmaceutical industry, physicomechanical screening is applied to a lesser extent and often only where a problem exists.

Effect of raw materials on the formulation of norfloxacin tablets

Applications of adsorption of small drug particles at the surface of large excipients were introduced, and different factors affecting adsorption process were discussed and summarized. Several examples of adsorbing drugs to excipients to increase dissolution rate were exhibited in this article.

Adsorption of small drug particles at the surface of large excipients

Hot melt extrusion (HME) formulation development depends heavily on choosing the appropriate polymers. This article reviews HME process parameters and highlights three polymers in HME: polyethylene oxide, ethylcellulose, and hypromellose.

Hypromellose, Ethylcellulose, and Polyethylene Oxide Use in Hot Melt Extrusion

The survival of Bacillus subtilis spores in dicalcium phosphate, lactose, and corn starch and in their binary mixtures depends on the compressional properties of these materials and on parameters involved during the tableting process, including compression speed.

The Survival of B. Subtilis Spores in Dicalcium Phosphate, Lactose, and Corn Starch and Their Binary Mixtures during Tableting

Fridrun Podczeck is professor of pharmaceutics at Sunderland School of Pharmacy, University of Sunderland, UK

Jittima Chatchawalsaisin is a lecturer at the faculty of pharmaceutical sciences, Chalalangkom University, Bangkok, Thailand

Michael Newton is emeritus professor of pharmaceutics at The School of Pharmacy, University of London

The previous studies on the incorporation of glyceryl monostearate into pellets by extrusion/spheronization has been extended to include a range of grades of this material plus a mixed medium chain partial glyceride and two glycerol esters of hydrogenated natural glycerides as described in this article.

The influence of monoglycerides, mixtures and derivatives on the formation of pellets by extrusion/spheronization

Palatinit's "galenIQ" is line of multifunctional excipients that offer the combined advantages of other bulk excipients.

Multifunctional Excipients

Making active pharmaceutical ingredients (APIs) requires long chains of chemical reactions and large quantities of solvents. Ask API manufacturers how they'd like to improve this process, and the responses are likely to be "make the reactions faster," "make the reactions cheaper," or "make the reactions more efficient." Then after all these economically driven answers, you might here, "make the reactions more environmentally friendly."

Industry Takes Steps Toward Greener API Manufacturing

Chemical purity is the most important quality characteristic of a pharmaceutical substance. This article describes the latest scientific and technological advances to meet recent pharmacopoeial and regulatory requirements regarding the control of organic impurities in synthetically produced active substances. Future developments and suggestions for those working in quality control and raw material selection are discussed.

Ingredients