Formulation and Evaluation of Ora-Solv Tablets of Pantoprazole Sodium

Pantoprazole is a potent and selective proton pump inhibitor. It is an effective agent in the treatment of Peptic ulcers, Gastro-oesophageal reflux disease (GERD), Oesophagitis, Zollinger-Ellison syndrome and other GI hypersecretory disorders. It provides rapid symptoms relief up to 85-90% of Ulcer patients within 1 hour of treatment. It has mediocre bioavailability of 50% and poor aqueous solubility and thus makes its absorption and dissolution rate limited, delaying its onset of action to certain extent. Pantoprazole is available as conventional tablet in the market and many patients find it difficult to swallow these, especially paediatric and geriatric subjects which results in high incidence of non-compliance and ineffective therapy. In this present study, an effort has been made to formulate fast disintegrating and rapid release tablets, also called as Ora-Solv tablets, of Pantoprazole using two different Superdisintegrants viz. Croscarmellose sodium and Sodium starch glycollate (SSG) by direct compression method. Evaluation of the tablets showed that all the tablets were found to be within official limits and the disintegration time for the formulations ranged from 15 s to 25 s. From the overall observations, formulation F6 containing 15% w/w concentration of SSG was considered to be the optimized formulation which releases up to 100.70% of the drug in 15 minutes. The formulated OST’s have potential advantages over conventional marketed tablets with their improved patient compliance, both in geriatrics and paediatrics, ease of administration and bio-availability.