The Development and Validation of a Dissolution …

16 DissolutionTechnologies| AUGUST 2004 The Development and Validation of a Dissolution Method for Clomipramine Solid Dosage FormsMehdi Ansari 1,3, Maryam Kazemipour 2, Javad Talebnia1email: IntroductionDrug absorption from solid dosage forms after oraladministration depends on the release of the drugsubstance from the drug product, the Dissolution orsolubilization of the drug under physiological conditions,and the permeability across the gastrointestinal of the critical nature of the first two of these steps,in vitro Dissolution may be relevant to the prediction of invivo performance. Based on this general consideration, invitro Dissolution tests for immediate release solid oraldosage forms are used: (a) to assess the lot-to-lot quality ofa drug product; (b) to assess the stability of the drug prod-uct; (c) to ensure continuing product quality and perfor-mance after certain changes, such as changes in the formu-lation, the manufacturing process, the site of manufacture,and the scale-up of the manufacturing process; and (d) todevelop new formulations.

20 Dissolution Technologies| AUGUST 2004 Consequently,the in-house development of a precise,vali-dated,and reliable dissolution method for clomipramine solid oral dosage forms was necessary in order to support

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