Formulation and Evaluation of Gastroresistant Tablet Containing Locally Acting Stimulant Laxative

Ravichandran, J (2012) Formulation and Evaluation of Gastroresistant Tablet Containing Locally Acting Stimulant Laxative. Masters thesis, R.V.S. College of Pharmaceutical Sciences, Coimbatore.


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The present study is to formulate and evaluate Gastro-resistant Tablet of bisacodyl. The present work aims to avoid degradation of drug in acidic environment of stomach. So due to enteric coating drug releases in to the small intestine so that peristaltic movement occurs. Preformulation studies were compared with British pharmacopoeia (BP) specification for Bisacodyl. The physical properties such as Organoleptic characteristics, loss on drying, angle of repose, compressibility, density, solution properties like pH, melting point of the solution were evaluated. Drug excipients compatibility study performed at 25oC /60% RH and 50OC/75% RH for 1month. The physical and chemical compatibility was determined. Lactose monohydrate, Pregelatinized starch are used to prepare a blend for direct compression method. The prepared blends were lubricated with Magnesium stearate. To protect the drug form degradation in acidic environment tablet formulation coated with pH dependant solubility polymers Eudragit L100 & S100 (Enteric coating polymer). Blends were compressed on tablet compression machine by using 5 mm punch. Finally optimized formulation for core tablet i.e. F5 is obtained. It gives all required parameters for core tablet. F5 formulations were selected for seal coating and finally enteric coating with Eudragit having optimized polymer 13% coating. These selected formulations were evaluated for tablet parameters i.e. Weight variation, diameter & thickness, hardness, disintegration in 0.1 M HCl for 120 min and different phosphate buffers was used, pH-7.6 phosphate buffer showed better disintegration of tablet. Assay performed by HPLC method to determine content of drug per tablet and related substance also performed by HPLC method. Alu-P.V.D.C blister strip used as packing material. This finally packed tablet kept for stability at different storage condition. Stability studies were carried out for optimized formulation at 250C /60%RH, 400C /75%RH, 1 Months (Stability Studies) and 500C /75%RH, 1 month (Degradation Study). After completion of time period, assay and related substance for every storage condition was determined. On completion of all the study, selected formulation was decided as a final product which complies with reference product parameters.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Gastroresistant Tablet; Stimulant Laxative
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 27 Sep 2017 11:36
Last Modified: 27 Sep 2017 11:36

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