Abstract

Formulation and development of aspirin / extended release dipyridamole capsules

Aspirin plus extended-release Dipyridamole was superior to Clopidogrel in the prevention of recurrent stroke. Granular grade of Aspirin was used for product development. Opadry white YS-17027 was used to seal coat the Aspirin. Sugar is used for sugar coating purpose. Tartaric acid is an organic acid, is used as starter pellets of Dipyridamole for maintaining microenvironmental acidic pH for the drugs, Hypromellose was used as a film forming Polymers. Eudragit S100 is a Methacrylic acid copolymer, used for enteric coating. Aggrenox® (A1) Capsules marketed by Boehringer Ingelheim Pharma USA was selected as Innovator’s Drug product. In vitro dissolution of Aspirin and Dipyridamole was carried out in 0.1N HCl followed by phosphate buffer pH5.5 using USP XXI basket apparatus. Increase in quantity of HPMC HP55, Eudragit S100 and Traicetine retard the release of Dipyridamole. Optimised formulation of Aspirin/Extended release Dipyridamole capsules were packed in a High wall thickness HDPE bottle with induction seal and with 9g silica gel and Medium wall thickness round HDPE bottle with cap containing Desiccant and additional desiccant 6g for conducting the laboratory stability studies


Author(s): Pavan K. Rawat, Arun K. Pandey, Prakash B. Mote, Bhushan S. Gulecha, Vivek B. Rajendra, Swaroop R. Lahoti

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