Polymorphism in the pharmaceutical industry by Rolf Hilfiker

Polymorphism in the pharmaceutical industry Rolf Hilfiker ebook
ISBN: 3527311467, 9783527311460
Format: pdf
Page: 433
Publisher: Wiley-VCH

One third of phar- maceutical drugs are estimated to be polymorphic, and this. Abstract: The polymorphic stability of a drug substance is a very important topic in the pharmaceutical industry. CrystEngComm will publish a themed issue on 'Crystal engineering and crystallography in the pharmaceutical industry' in early 2012 with Guest Editors Dr Magali Hickey, Dr Örn Almarsson and Dr Matt Peterson. Pharmaceutical companies could exclude those people who are known to have a negative response to the drug, from the clinical trials. The knowledge of the effects of polymorphisms of genes for the enzymes is applied in drug discovery and development as well as in clinical use of drugs. Labels: anthony crasto, DRUGS, medicinal chemistry, organic chemistry, POLYMORPHISM INDUSTRY. The knowledge of the effects of polymorphism of genes for the enzymes involved in drug metabolism, like those belonging to the family of cytochrome P450 can be applied in drug delivery, development and the clinical use of drugs. The benefits of pharmacogenomics are numerous. Cost-effective methods for genotyping are being developed and it would For the pharmaceutical companies, segmentation of the market may not leave room for conventional blockbusters but smaller and exclusive markets for personalized medicines would be profitable. The ability to isolate, dif- ferentiate, and characterize individual polymorphs is a major challenge to the pharmaceutical industry. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new drug Traditionally, solid-state polymorphic forms of an API are classified as either crystalline, amorphous, or solvate and hydrate forms, and applicable regulatory schemes for these solid-state polymorphic forms are well-defined. It is well-known that calcium atorvastatin (ATV), C66H68CaF2N4O10•3H2O, presents polymorphism. 8 years experience from pharmaceutical industry within the area of physical characterisation. Lack of control could be due to variation in particle sizes or to changes in crystallinity (i.e. And salt used, pH, and temperature.