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Pharmaceutical materials can exist in a crystalline or amorphous state. Figure 1 illustrates the crystalline state as a perfectly ordered solid with molecules (circles) packed in an orderly array.  Figure 1 also illustrates an amorphous material as a disordered material with only short-range order.  Crystalline materials give an X-ray diffraction pattern because Bragg planes Read more

Since the ritonavir crisis in 1998, when a lifesaving HIV protease inhibitor had to be withdrawn from the market for almost a year due to a sudden and unpredictable appearance of a new less soluble polymorph, ritonavir has been of interest to solid state chemists, crystallographers, and drug development scientists.[1-4] After the appearance of Form Read more

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