Process Validation of Pantoprazole 40mg Tablets
Journal Title: The Pharma Innovation - Year 2012, Vol 1, Issue 5
Abstract
Renata P. Raffin, Have done Sodium Pantoprazole-Loaded Enteric Micro particles Prepared by Spray Drying: Effect of the Scale of Production and Process Validation. Pantoprazole is a prodrug used in the treatment of acid related disorders and Helicobacter pylori infections. The purpose of this study was to investigate the physical characteristics of enteric pantoprazole-loaded micro particles prepared by spray drying using a blend of Eudragit and HPMC. At pilot scale, among the four sets of micro particles prepared varying the atomization and the air pressure, in three of them free micro particles were obtained. The micro particles prepared with rotating disc atomizer or two fluid atomizer and mixed flow presented either crystals on the particle surface or very high polydispersity, respectively. Using two fluid nozzle and air pressure of 49 kPa (N1-microparticles) the product obtained was not adequate because it presented strings in the powder. Using the same atomizer but air pressure of 196 kPa (N2-microparticles) the micro particles presented high encapsulation efficiency and the highest stabilization of formulation in acid medium. N2-microparticles were chosen for the pilot scale evaluation. The three batches of pantoprazole-loaded micro particles prepared to validate the process showed reproducible diameter, polydispersity, densities, encapsulation efficiency and gastro-resistance profile. T. Scholten, G. Gatz, Once-Daily Pantoprazole 40 mg and Esomeprazole 40 mg Have Equivalent Overall Efficacy in Relieving GERD-Related Symptoms.
Authors and Affiliations
Raveendranath Thaduvai , Bodavula Samba Siva Rao , M. Jeybaskaran
Keywords
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