Formulation and In-vitro Evaluation of Pantoprazole Sodium Delayed Release Tablets

A. Gowramma¹*, M. Ramu², P. Mounika^3
1Dept. of Pharmaceutics, Sri Padmavathi School of Pharmacy, Tiruchanoor, Tirupati, A.P, India
²Dept. of Pharmaceutics, Santhi ram college of pharmacy, Nandyal, Kurnool, A.P, India
³Dept of Pharmaceutical Analysis, Sree Vidyanikethan College of Pharmacy, Rangampet, Tirupati, A.P, India

A B S T R A C T
Pantoprazole is a category of proton pump inhibitor, belongs to group of benzimidazole derivative used for the treatment of gastric and duodenal ulcers. Pantoprazole is undergoes degradation in acidic media of stomach. In the present study was attempted to formulate and evaluate pantoprazole sodium as enteric coated tablet. The pre-compression parameter of blend was performed includes FT-IR studies, DSC and constructs the calibration curve of pantoprazole sodium. The delayed release tablets of pantoprazole sodium were prepared by dry granulation method using PVPk30 as binder, Mannitol as diluent, and HPMC as a sub-coating material. The prepared sub coated tablets were evaluated for Weight variation, thickness, hardness, friability, disintegration time and it was found that obtaining results was comply with official standards. The prepared tablets were coated by using enteric coating polymers such as Eudragit L30D55 and HPMCP HP55 by using pan coater (spray technique). The prepared enteric coated tablets were subjected for the physical and chemical evaluation. The in-vitro drug release studies were performed by using acidic buffer (pH 1.2) and phosphate buffer (pH 6.8). The in-vitro drug release study there is no loss during acidic phase (2 hrs). In phosphate buffer the in-vitro drug release was observed and it gives highest % drug release (96.81) in F7 (60 min) and also it reaches the innovator product (92.78). Accelarated stability studies were indicated that the prepared enteric coated tablets were stable and maintain their pharmaceutical properties at 40⁰C/75% RH for a period of 3 months.
Keywords: Pantoprazole sodium, HPMC, EudragitL30D55, HPMCP HP55, Dry granulation, in-vitro drug release.