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PHARMACEUTICAL INDUSTRY

PHARMACEUTICAL INDUSTRY

The pharmaceutical industry is forecast to achieve worldwide prescription drug sales of over one trillion dollars by 2020, with an average growth of 5.1% per year from 2013 to 2020. After two years of actual sales stagnation, it is a much improved growth outlook.

The pharmaceutical industry market place is however still transitioning from the blockbuster era, the ‘patent cliff’ and the rapid growth of the generics. The FDA approved 27 New Molecular Entities (NME) in 2013 — down from the 39 in 2012. A third of the 27 NMEs were for rare diseases and niche medical conditions, the new medicines which do not fall under the traditional blockbuster drug category.

Drug Discovery & Development

The small-molecule drug discovery process is complex, time consuming and costly. Medicinal chemists synthesize an average of 10,000 New Chemical Entities (NCE) for subsequent screening of potential drug candidates to undergo pharmacological and safety testing. Only 10% of the NCEs will be approved for clinical trials. Currently, most new small-molecule drugs and those under development are chiral. Therefore, chirality in many pharmacologically active drugs is of crucial importance.

Use of enantioselective chromatography is widely adopted by many pharmaceutical companies to screen and rapidly identify single-enantiomer drug candidates for further testing. The chromatography of enantiomers relies on the availability of chiral stationary phases specifically designed to separate chiral molecules since their enantiomers have the same physical and chemical properties but different spatial orientations. Chiral Technologies CSPs are the most widely employed stationary phases to isolate pure enantiomers. Furthermore, the immobilized polysaccharide-derived CSPs exhibit a new level of robustness leading to a higher success rate and longer column life time.

Generics Drug Analysis

Standard-Setting Chiral Stationary Phases for Generic Drug Analysis

The generics industry has exhibited significant growth in the last decade due to the expiration of patent protection for a large number of branded medicines, and currently accounts for 70% – 80% of all pharmaceuticals sold in the West. With this increase in generic drugs has come the need for reliable methods of analysis, both for the end products, as well as intermediates and raw materials.

The FDA requires generic drugs to have the same quality and performance as branded drugs. Upon approval, generic drugs meet the established standards with respect to identity, potency, quality and purity. When drugs are mass produced, variations in purity, strength and other parameters may occur. The FDA has strict guidelines for drug manufacturers on how much variability is acceptable.

The US Pharmacopeia (USP) is a scientific nonprofit organization that helps secure the quality of the American drug supply. The USP sets standards for the identity, potency, quality and purity of drugs, food ingredients and dietary supplements manufactured and distributed globally. The USP drug standards are enforceable in the US by the FDA and are utilized globally. The compilation of these standards in USP Monographs serves as a well-known and well-respected source for established analytical methods.

The USP is part of the Pharmacopeial Discussion Group (PDG) to work on pharmacopeial harmonization topics. The PDG includes representatives from the European Pharmacopoeia (EP) and the Japanese Pharmacopoeia (JP). The goal of the PDG is to harmonize analytical methods, which yield the same results for the quality and purity of drugs.

The USP provides The Chromatographic Columns online database that is a compilation of the chromatographic columns used to validate the chromatographic procedures. A number of USP, EP and JP monographs list Daicel Chiral Technologies’ chiral stationary phases (CSPs) to measure Enantiomeric Purity of chiral drugs.

Furthermore, Chiral Technologies strives to improve the existing analytical procedures by developing new methods that provide faster and more efficient analyses. An Application Note describes an improved method, developed by Daicel Chiral Technologies India, to measure Enantiomeric Purity of atorvastatin.

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