Abstract
Moisture plays an important role in the individual stages of preformulation studies for solid dosage forms. Examples are given to demonstrate thisThe first stage involves chemical tests with the pure active substance using a reliable storage scheme. Then compatibility testing between active and inactive substances is performed. Under the general heading of sorption tests, the determination of sorption isotherms using special apparatus and their correlation with the physical and chemical changes which occur in the samples are discussed. With the results of these tests it is often possible to influence the sorption properties of the finished dosage form, for example by selection of the excipients and the salt form of the active substance, or by deferring the point of ansorptionFinally, as an example of special tests used in pre-formulation, the development of compound preparations is described and the galenical pre-stages are discussed
Published Version
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