In the early 1990’s SSCI, Inc. began working with Parke-Davis Warner-Lambert by providing X-ray diffraction measurements on samples manufactured at its Holland, Michigan manufacturing facility. One of the compounds under investigation was atorvastatin calcium. Atorvastatin had been synthesized by Bruce Roth at Warner-Lambert and patented in 1987 (US Patent 4,681,893). It was under development as Read more
Crystals were observed growing within a DayQuil Liquicap. This blog post describes the approach taken to isolate and identify the unknown crystals. Vicks® DayQuil™ Severe Cold & Flu provides an over the counter non-drowsy, daytime relief for common cold and flu symptoms. DayQuil™ Severe is formulated to relieve or reduce headache, fever, sore throat, Read more
Come see us at booth 555 and posters T1430-08-45 and T1430-08-46 Improved Pharma will be exhibiting in booth 555, conveniently located next to the 360 Center Stage. Also, Dr. Susan Bogdanowich-Knipp and Dr. Pamela Smith will be presenting posters on Tuesday afternoon from 2:30 – 3:30. The presentations will be held in Forum 8, Read more
Thermodynamic stability and form selection. Form selection of active pharmaceutical ingredients is regarded as an essential part of drug development. The goal of form selection is to identify the most suitable solid form for toxicological studies, drug product development, and eventually commercialization. Determining the order in which solid forms exhibit physical stability is one Read more
Select the polymorph with attributes fit for development. It is well established that polymorphism is common in pharmaceutical active ingredients.1 Bernstein and others present statistics that, when they are appropriately screened up to three in four compounds display polymorphism.2 Because of their distinct physical and chemical property differences, polymorph control becomes an essential task Read more
How to quantitate a solid form in your drug product. A very important aspect of pharmaceutical mixture analysis is detecting and possibly quantitating a specific solid form in a drug product, especially tablets. Chapter 22 of Solid-State Properties of Pharmaceutical Materials by Byrn, Zografi, and Chen (Wiley, 2017) outlines several approaches to mixture analysis. Read more
Utilizing Synchrotron-based analytical and Pair Distribution Function Data, Improved Pharma provides an expert assessment of the current status of your polymorph screening activities. These Synchrotron-based studies provide structural knowledge and also analytical information at/near the lowest possible detection limit. Improved Pharma may suggest additional experiments or approaches to determine which form is most stable. Improved Pharma can also use Read more
In February 2021, the FDA issued a guidance aimed at preventing unacceptable levels of nitrosamine impurities in pharmaceutical products. This guidance required a risk assessment to be completed by March 31, 2021. This is because nitrosamines are genotoxic and are classified as possible or probable carcinogens. The guidance also described conditions under which nitrosamines Read more
Traditionally, excipients utilized for the development of pharmaceutically-marketed drug products have been considered largely inert. Excipients are added to formulations for a variety of reasons that may include assisting processability of the drug product formulation, controlling the disintegration rate to facilitate regional dissolution along the gastrointestinal tract (GIT), bulking up the dosage form to enable Read more
Not according to the United States Court of Appeals, citing Improved Pharma’s CSO Steve Byrn’s early paper on polymorph screening. The United States Court of Appeals for the Federal Circuit is known as the Supreme Court of patents, and its rulings are typically considered as significant landmarks in the patent and innovation field. In Read more
