PHARMACY DISCIPLINE, KHULNA UNIVERSITY Thesis Proposal Submited By Roll No.

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Thesis Title: Desgn & Evaluation of Delayed Release Tablet of a Proton Pump Inhibitor Background Pantoprazole, proton pump inhibitor (PPI), is indicated for the treatment of erosive esophagitis associated with gastro esophageal reflux disease (GERD). Inhibition of hydrogen -potassium-ATPase by this drug blocks the final step of gastric acid production, leading to inhibition of both basal and stimulated acid secretion. Several characteristics of pantoprazoles pharmacologic profile distinguish it from other PPIs. These include The specific sites of binding within the membrane bound proton pump. Little or non potential to induce or inhibit cytochrome P-450 (CYP-450) enzymes that metabolizes many other drugs. Consistent bioavilability. Long duration of action (-24 hours) and Consistent pharmacokinetic in a wide variety of patient types. Objectives The purpose of this work was to develop Delayed Release (DR) tablets of Pantoprazole. The objectives of the present investigation are: 1. to formulate Delayed Release tablet dosage form of a proton pump inhibitor, Pantoprazole 20mg as Pantoprazole Sodium Sesquihydrate per tablet, using Eneric coating. 2. evaluation of core tablets for physical and chemical parameters. 3. to develop suitable formulae and procedure for the manufacture of Pantoprazole Delayed Release tablets in a relatively economical way. 4. In vitro evaluation of tablets for drug release profile. 5. to subject the most satisfactory formulation(s) based on the above studies for accelerated stability studies.

Methodology Pantoprazole tablets is to be prepared, using direct compression method, utilizing Microcrystalline Cellulose, Sodium Starch Glycolate, Crospovidone, Disodium Hydrogen Phosphate Dihydrate, Colloidal Silicon Dioxide and magnesium stearate in the core formulation. Tablets is to be seal-coated with Opadry 03K 19229 , in a partially perforated coating pan, at 2-3% weight gain, followed by aqueous enteric coating with Eudragit L 30 D 55 (Methacrylic Acid Copolymer), Triethyl Citrate, Purified Talc & Simethicone 30% Emulsion at various weight gain of 8.0 to 12.0 and finally color coating with Opadry II 85G52478 (Yellow). Tablets is to be tested for in-vitro dissolution in 0.1N HCl for 2 hours, followed by phosphate buffer (pH 6.8), using apparatus II at 100 rpm. All the formulations is to be evaluated for their physicochemical parameters like thickness, weight variation, disintegration time, and drug content and dissolution studies. Short-term accelerated stability study of final formulation will be carried out at 40 2C and at 75 5 % RH for six months.