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Late Appearing Polymorphs: Atorvastatin

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

Late Appearing Polymorphs: Atorvastatin2023-01-27T20:11:03+00:00

Identification of unknown crystals in a Vicks® DayQuil Severe LiquiCap

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

Identification of unknown crystals in a Vicks® DayQuil Severe LiquiCap2022-07-27T15:22:56+00:00

Improved Pharma at AAPS with Posters and Booth

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

Improved Pharma at AAPS with Posters and Booth2022-07-19T14:44:37+00:00

Increasing the Effectiveness of Slurry Experiments to Confirm the Relative Stability of Polymorphs

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

Increasing the Effectiveness of Slurry Experiments to Confirm the Relative Stability of Polymorphs2022-05-03T20:03:00+00:00

Determining the Transition Temperature of Enantiotropic Polymorphs with Slow Transformation Kinetics

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

Determining the Transition Temperature of Enantiotropic Polymorphs with Slow Transformation Kinetics2022-04-11T15:46:52+00:00

Detecting Small Amounts of a Polymorph or Solid Form in Drug Product

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

Detecting Small Amounts of a Polymorph or Solid Form in Drug Product2022-04-01T20:44:24+00:00

Poster Example

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

Poster Example2022-11-18T15:20:32+00:00

Control of Nitrosamine Impurities in Human Drugs

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

Control of Nitrosamine Impurities in Human Drugs2022-01-17T20:27:49+00:00

Excipient Effects on Drug Product Performance

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

Excipient Effects on Drug Product Performance2020-09-21T19:19:30+00:00

Are Polymorphs Obvious?

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

Are Polymorphs Obvious?2022-01-17T20:30:49+00:00
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