Formulation and Evaluation of Naproxen and Pantoprazole Multilayered Tablets

Naproxen, a non-steroidal anti-inflammatory drug suggested for the long term treatment of disease conditions such as Rheumatoid Arthritis and Osteoarthritis poses an immediate risk of stomach ulceration. To avoid this risk, a proton pump inhibitor is often prescribed along with it. In the present study, Naproxen (500mg) is prepared in combination with Pantoprazole, a proton pump inhibitor as a multi-layer coated tablet. First, Naproxen is prepared as core tablet by wet granulation method. Then it is enteric coated to assist its delayed-release. Over this enteric coated tablet, Pantoprazole (20mg) drug layer is applied to get combination product. The prepared tablets were evaluated for physicochemical properties such as weight variation, hardness, friability, disintegration and drug content. The invitro drug release studies were conducted for Naproxen core tablets, Naproxen enteric coated tablets and multi-layered tablets in 0.1N HCl and 7.4 pH phosphate buffer. The analytical results obtained at several stages of preparation of the product were found to be satisfactory. The in-vitro drug release studies of Naproxen and Pantoprazole from multilayered tablets in 0.1N HCl and 7.4 pH phosphate buffer has shown that the release of drugs follow zero order kinetics. INTRODUCTION: Oral drug delivery is the most widely utilized route of administration among all the routes that have been explored for the systemic delivery of drugs via various pharmaceutical products of different dosage forms. Pharmaceutical products designed for oral delivery are mostly the immediate-release type. Because of their clinical advantages over immediate-release pharmaceutical products containing the same drugs, delayedrelease pharmaceutical products have gradually gained medical acceptance and popularity since their introduction into the market place. QUICK RESPONSE CODE DOI: 10.13040/IJPSR.0975-8232.8(11).4777-87 Article can be accessed online on: www.ijpsr.com DOI link: http://dx.doi.org/10.13040/IJPSR.0975-8232.8 (11).4777-87 Recently, a new generation of combination pharmaceutical products with one immediaterelease component and one delayed-release component have received regulatory approval for marketing 1, 2 . Through such dosage forms several advantages are seen but still some problems arise in preparation of this kind of dosage form such as physical incompatibility, chemical incompatibility etc. Therefore, the bilayer and multilayer tablets are known as a novel drug delivery system. Arthritis is an inflammation of the joints. It can affect one joint or multiple joints. There are more than 100 different types of arthritis, with different causes and treatment methods. Two of the most common types are osteoarthritis (OA) and rheumatoid arthritis (RA). The most well-known therapy for Arthritis is the use of nonsteroidal antiinflammatory drugs (NSAIDs) 3, 4 .