Abstract

FORMULATION & EVALUATION OMEPRAZOLE DELAYED RELEASE TABLETS

K. Venkata Gopaiah*, Dr. P. V. Rao, D. Narasimha, G. Soni, L. Bhavani Ranjitha, Dr. CH. Gopala Krishna

Abstract

Introduction:- Delayed release dosage forms are designed to provide spatial placement or temporal targeted delivery of a drug to the distal human gut. Spatial placement relates to targeting a drug to a specific organ or tissue, while temporal delivery refers to desired rate of drug release to target tissue over a specified period of treatment. Materials & Methods:- By using Direct Compression Method & Sift the ingredients like Omeprazole sodium, mannitol, heavy magnesium oxide, L-HPC-LH 21, HPC, Cross povidone through sieve # 40. Results & Discussion:- By observing dissolution profiles, SE6 was failed in pH8.0 buffer. So next trail (SE7) was proceeded by increasing enteric buildup but fails in first time point release in buffer. SE8 (2+22) was formulated by further increasing enteric buildup then passed in pH 8.0 buffer but when the same formulation was observed in discriminative media (pH6.5 phosphate buffer) it was found to be lower side as compared to innovator (Omesec). After that randomly selected coated batches evaluated for dissolution studies. SE9 (S.C+E.C(3+20)) and SE11(5+16) was observed for drug release in media but results were found to be not satisfactory. So next trails were proceeded by increasing sub coat and decreasing enteric coating. Based on results SE10 formulation was passed in official media pH8.0 buffer but the same formulation was lower side in discriminative media as compared to innovator (Omesec). In-vitro dissolution profile of SE10 & SE12 with innovator in pH 6.5 phosphate buffer -20 0 20 40 60 80 100, 0 10 20 30 40 50 60 Time (min) % cumulative drug release AcipHex SE10 (4+18) SE12 (6+14). Based on results SE12 formulation was found to be satisfactory in both medias. So, finally SE12 (6+14) was found to be best formula for formulation of Omeprazole sodium delayed release. Conclusion:- Based on the above data it was concluded that drug release from SE12 was same as that of innovator product (Omesec).

Keywords: Omeprazole, pH, Buffer, Compression.