Mallikarjuna Reddy, Kalam (2011) Formulation and Evaluation of Omeprazole and Domperidone Bilayer Tablets. Masters thesis, The Erode College of Pharmacy and Research Institute, Erode.
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Abstract
The present work is to develop and evaluate bilaye tablet containing compressed Multiparticulate delayed release Omeprazole layer and Domperidone Sustained release layer. Objectives: The main objective of the present work is to develop poly therapy for the treatment of Gastroesophageal reflux disease (GERD) by using Omeprazole and Domperidone. To achieve FDC in simplest manner of Drug Delivery System. To prepare Bilayer tablets by using compressible enteric coated granules of omeprazole and sustained release granules of Domperidone. To evaluate the resistance to rupture of different enteric coating polymers to compression force. To maintain the drug concentration in blood for a longer time. To study the stability of dosage form and compare with the standard specifications.In this present study nine formulations of enteric coated Omeprazole granules and Domperidone are formulated into a bilayer tablet. The Omeprazole compressible enteric coated granules were prepared by using different enteric coated polymers such as HPMC Phthalate, Eutragit NE30D and Kollicoat MAE30DP with different ratios and plasticized with PEG. The Omeprazole granules which are coated with 8% Eutragit and plasticized with 2%PEG meet the USP criteria in drug release. From the above data it is evident that the formulation F7 shows satisfactory drug release both on acid phase and buffer phase and complies with all the pharmacopoeial limits before and after the stability studies and is the most suitable composition for the delayed release of Omeprazole. Two different grades of HPMC polymer are used to study the release retarding activity. Different concentrations of polymer are used in the sustained release layer and their effect on the release of Domperidone is explored. The formulation F7 is found to be the best formulation since it meets the USP criteria in the drug release. HPMC of grade K4M and K15M at a concentration of 20% and 10% releases the drug as per the USP specifications. The cumulative drug release at the end of twelfth hour is 100%.From the above data it is evident that the formulation F7 shows atisfactory sustained release and complies with all the pharmacopoeial limits before and after the stability studies and is the most suitable composition for the sustained release of Domperidone. Finally I conclude that F7 formulation shows the best release in both the layers (Omeprazole and Domperidone) and that may fulfils the objective of the study. The stability studies were performed according to in-house specifications for the optimized formulation. The tablets were kept at accelerated condition (40±2º C/ 75±5% RH) for a period of three months. The obtained results were within the specifications.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Omeprazole; Domperidone; Bilayer Tablets; Gastroesophageal reflux disease |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 11 Aug 2017 05:39 |
| Last Modified: | 11 Aug 2017 05:39 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/2501 |
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