TITLE OF THE PROJECT Gastroretentive drug delivery for the treatment of H.

pylori infection

Abstract: Drugs that are easily absorbed from gastrointestinal tract (GIT) and have short halflives are eliminated quickly from the systemic circulation. Frequent dosing of these drugs is required to achieve suitable therapeutic activity. To avoid this limitation, the development of oral sustained-controlled release formulations is an attempt to release the drug slowly into the gastrointestinal tract (GIT) and maintain an effective drug concentration in the systemic circulation for a long time. After oral administration, such a drug delivery would be retained in the stomach and release the drug in a controlled manner, so that the drug could be supplied continuously to its absorption sites in the gastrointestinal tract (GIT). Helicobacter pylorus (H. pylori) is a gram-negative, motile, microaerophilic spiral bacterium. Helicobacter species is the causative organism for peptic ulcer. Gastric (mainly peptic) ulcer is one of the major ailments affecting about 60% of human adults and nearly 80% of child population, all H. pylori species cause some degree of persistent inflammation. Treatment of it remain a challenge although it is highly sensitive to most antibiotics, eradication of it from patient is difficult, even with the current best therapies. Conventional tablets and capsules are used for eradication therapy; do not remain in stomach for a long time. The various floating preparations such as micro balloons, granules, powders, capsules, tablets, and laminated films has been attempted. The main objective of the present study is to retain the dosage form in the stomach for longer period their by achieving local action for longer period of time.

References: 1. Deshpande AA, Shah N, Rhodes CT, Malik W. Development of a novel controlled-release system for gastric retention. Pharm Res 1997; 14: pp.815-19. 2. Santus G, Lazzarini G, Bottoni G, Sandefer EP, Page RC, Doll WJ, Ryo UY, Digenis GA. An in vitro- in vivo investigation of oral bioadhesive controlled release furosemide formulations. Eur J Pharm Biopharm 1997; 44: pp.39-52. 3. Streubel A, Siepmann J, Bodmeier R. Multiple unit Gastroretentive drug delivery: a new preparation method for low density microparticles. J Microencapsul 2003; 20: pp.329-47. 4. Shrma S. and Pawar A. Low density multiparticulate system for pulsatile release of meloxicam. Int J Pharm 2006; 313: pp.150-58. 5. Deshpande AA, Shah N, Rhodes CT, Malik W. Development of a novel controlled-release system for gastric retention. Pharm Res 1997; 14: pp.815-19.

1. Submission of status report at the end of first phase for IDC (inetrnal departmental committe) approval Phase 1: literature survey and preformulation studies -30/1/2012 to 4/2/2012 2. Submission of status report at the end of second phase for IDC approval Phase 2: formulation and characterization -19/3/2012 to 24/3/2012 3. Submission of status report at the end of third phase for IDC approval Phase 3: invitro & in vivo studies -14/5/2012 to 19/5/2012 4. Presubmission seminar -2/7/2012 to 7/7/2012 5. Final thesis submission

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