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Saving Time & Money with Small Scale Formulation Development

Mon, 06/03/2013 - 10:25am
Michael Gamlen, Gamlen Tableting Ltd, Biocity Nottingham, UK

Under the Quality by Deign (QbD) paradigm, new pharma product must be correctly designed to take into account the disease and its impact on the patient; the patient population; the drug properties; the preferred route of administration (from a clinical and a marketing perspective); and the requirements of the organization manufacturing the product.  The preferred dosage form will usually be an oral solid dosage form (OSD), usually a tablet, which are relatively cheap to manufacture and administer, and can be produced with a wide range of release profiles.

Drug substance properties must be taken into account when developing the product formulation and manufacturing process. Selection of a sub-optimal process or formula may result in considerable extra costs and delays, and even failure.

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