Formulation and Evaluation of Delayed Release Tablets of Rabeprazole Sodium

Vijayanand, M (2017) Formulation and Evaluation of Delayed Release Tablets of Rabeprazole Sodium. Masters thesis, Sankaralingam Bhuvaneswari College of Pharmacy, Sivakasi.

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AIM AND OBJECTIVE: The aim of the present investigation was to prepare delayed release i.e., enteric coated tablets of Rabeprazole sodium by using Methacrylic acid copolymer and to optimize coating process parameters by Direct compression method. Rabepeazole sodium is used in the treatment of acid related gastro duodenal disorders by reducing gastric acid secretion. Proton pump inhibitors are substituted benzimidazoles and all share a similar core structure and mode of action, but differ in substituent groups.SUMMARY: Formulation and evaluation of delayed release tablets of Rabeprazole sodium was carried out by performing the preformulation studies, formulation of Rabeprazole sodium delayed release tablets, evaluation parameters, in vitro drug release studies and stability studies. The preformulation studies of API and drug excipients compatibility studies were carried out. IR spectroscopic analysis of drug with excipients was showed that the drug was compatible with excipients which were used in the formulation. Rabeprazole delayed release tablets were prepared by direct compression method and coated with Protectab Enteric M1 as coating polymer in different concentrations. The prepared powder blend was evaluated for precompression parameters like angle of repose, bulk density, tapped density, compressibility index and Hausner ratio. The obtained results indicated that it has good flow property for direct compression method. The prepared tablets were evaluated for hardness, thickness, weight variation, friability, assay and disintegration time. All these parameters were found to be within the pharmacopoeial limits in F-VII formulation. In vitro dissolution study was carried out for F-VII formulation. The drug release was found to be 99.98 ± 0.12% at 45 mins. Comparative in vitro dissolution study of F-VII formulation showed better drug release than the marketed product. The accelerated stability studies of F-VII formulation at 40oC/75% RH for a period of 3 months indicated that there was no significant change in description, disintegration time, drug content and in vitro dissolution profiles. The result shows that the F-VII formulation was stable. CONCLUSION: Formulation and evaluation of Delayed release tablets of Rabeprazole sodium for the effective treatment of duodenal ulcer was successfully carried out. The preformulation studies, formulation of Rabeprazole sodium delayed release tablets, selection of the best formulation based on disintegration time and in vitro studies for delayed release tablets and stability studies were performed. The final product was correlated with the marketed product. From all the above observations it was concluded that the F-VII formulation was better one compared to the other formulations. Thus the study concluded that delayed release tablets of Rabeprazole sodium prepared by direct compression method. The tablets were coated with Protectab Enteric M1 as a polymer for the effective therapy for duodenal ulcer. Delayed release dosage form is best formulations which are used for drugs that are destroyed in the gastric fluids, or cause gastric irritation, or are absorbed preferentially in the intestine. Such preparations contain an alkaline core material comprising the active substance, a separating layer and enteric coating layer.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Delayed Release Tablets ; Rabeprazole Sodium
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 19 Dec 2017 09:25
Last Modified: 19 Dec 2017 09:25

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