Development

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.


Contamination Drives a More Concerted Approach to Genotoxins

Mannitol has been shown to improve patient perceptions of tablet flavor and mouthfeel, but its use can add to tableting challenges. SPI Pharma has developed new grades of material designed to make it easier to manufacture in patient-centered formulations.

Enhancing Mannitol’s Excipient Properties

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

Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another. 

Characterizing APIs is Essential for Combo Drug Formulations

Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.

The Search for Transparency in Excipient Sourcing

FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.

US Maintains Lead in Drug Development Despite Fewer Approvals in 2019

The key is to ensure that excipients only interact with APIs via desired mechanisms.

Managing Excipient Interactions

The new API for hypothyroidism treatment will replace the hormones that are ineffectively produced by the human thyroid gland.

Bioiberica Introduces New API for Hypothyroidism

Gayatri C.Patel, M.Pharm, PhD, is associate professor in the Department of Pharmaceutics & Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy at the Charotar University of Science and Technology, Changa Campus, Changa- 388 421, Anand, Gujarat, India, gayatripatel.ph@charusat.ac.in, +91 2697 265162.

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis. 


Optimizing Compression Coating for Pulsatile Release Tablets

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Adapting APIs for Specialty Dosage Forms

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

APIs and Excipients