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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE ANNEXURE – II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION MAHESH R KALYANPUR. K.L.E.S’s COLLEGE OF PHARMACY 2nd BLOCK, RAJAJINAGAR, P.B.NO. 1062, BANGALORE-560 010 1. Name of the candidate and address PERMANENT ADDRESS: NEAR GUN GUNI SCHOOL. ROYAL STREET, HONAVAR. KARWAR DIST. KARNATAKA – 581 334. 2. Name of the Institution K.L.E.S’s COLLEGE OF PHARMACY, 2nd BLOCK, RAJAJINAGAR, P.B.NO. 1062, BANGALORE-560 010 3. Course of study and subject MASTER OF PHARMACYPHARMACEUTICAL TECHNOLOGY 4. Date of admission 13-06-2008. 5. Title of the Topic "DESIGN AND CHARECTERIZATION OF RITODRINE HYDROCHLORIDE TRANSDERMAL DELIVERY BY PASSIVE DIFFUSION AND IONTOPHORESIS." 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 NEED FOR THE STUDY: Transdermal Drug delivery systems (TDDS) by virtue of its rate limiting property of stratum corneum offer many benefits over conventional drug therapy. It can decrease fluctuation in plasma drug concentrations and increase bioavailability by bypassing the hepatic first pass metabolism. Lower incidence of adverse effects and higher patient compliance is also expected from TDDS.1 Ritodrine, a selective β-2 adrenergic agonist (sympathomimetic), is used as tocolytic agent in the treatment of premature labor. Treatment is normally done by IV loading followed by repeated administrations of oral dose for a prolonged period of time (Up to 35 weeks).2 As the drug has got short half life it needs to be administered every 2 hrs. High oral dose of ritodrine is avoided because of its potential to cause significant side effects and post-natal complications. Maintenance of the plasma concentration at a fixed (effective) level is desirable for the therapy. As transdermal drug delivery can offer the advantages of intravenous infusion, 2 the drug appears to be a good candidate for transdermal drug delivery systems (TDDS). So far no work has been done on ritodrine hydrochloride to assess its suitability for transdermal drug delivery. The present study aims to bridge that gap. Ritodrine is available as the hydrochloride salt and is extremely watersoluble. As stratum corneum offers high resistance to the permeation of hydrophilic moieties iontophoresis seems to be a better option for transdermal administration of ritodrine hydrochloride. 6.2 REVIEW OF LITERATURE: So far no work has been done on ritodrine hydrochloride to assess its suitability for transdermal drug delivery. However, Iontophoresis has been carried out on different drugs with similar physicochemical properties.3-4 Buspirone hydrochloride was studied for iontophoretic delivery.5 Iontophoresis at 0.5 mA/cm2, could achieve a steady state flux of buspirone hydrochloride (350 µg/cm2/h), which was thought to be therapeutically effective if clinically duplicated. Importantly, 24 h of iontophoresis at 0.5 mA/cm2 did not affect skin morphology and after the current was switched off, the skin’s permeability to buspirone hydrochloride rapidly reverted to its pre-iontophoretic level. The effect of the stratum corneum on skin permeability of triprolidine hydrochloride was evaluated by studying the skin permeation through a stripped mouse skin using a side-by-side diffusion cell.6 The permeation rate of triprolidine hydrochloride in the stripped skin was greatly larger than that in the whole skin. Thus it showed that the stratum corneum acts as a barrier of skin permeation. Novel combination strategies, where iontophoresis was used with other devices have been reported to enable successful transdermal drug delivery systems7 6.3 OBJECTIVE OF THE STUDY: The aim of the present study is to screen ritodrine hydrochloride transdermal delivery by passive diffusion and iontophoresis. To achieve this objective the work will be divided under these headings: 1. Evaluation the physicochemical parameters of the drug for the Transdermal drug delivery systems. 2. Evaluation the solubility of in the donor and receptor fluids. 3. Evaluation of the in-vitro passive permeability studies of the drug through porcine ear skin using Franz diffusion cell. 4. Evaluation of the effects of constant current of 0.5mA/cm2 on the permeability of drug for iontophoretic delivery. 5. Evaluation of the permeation effects the drug under interrupted current 6. If the permeation is found to be inadequate a permeation studies will be carried out using a combination of enhancers and iontophoresis. 7. Statistical analysis of the data. 7. MATERIALS AND METHODS: 7.1 SOURCE OF DATA: The reported data on Pharmacokinetic and Pharmacodynamic parameter will be collected from internet web, research papers, Journals. The experimental data will be generated in the laboratory of K.L.E.S’s COLLEGE OF PHARMACY. 7.2 METHOD: Study of research articles. Laboratory investigation that includes: PHYSICO-CHEMICAL PROPERTIES: Data on physicochemical properties (solubility, partition co-efficient, pKa etc.) will be generated using standard procedure and phase solubility study will be carried out. PASSIVE PERMEATION STUDY: This experiment will be carried out using Franz diffusion cell. The hydrated porcine skin sample will be sandwiched between the donor and receiver compartment with subcutaneous layer facing the donor compartment. The drug in the form of solution will be placed in the donor compartment and the receptor compartment will be filled with 0.9% NaCl or other suitable buffer. The sample will be withdrawn at predetermined intervals and will be assayed using spectrophotometer. IONTOPHORETIC STUDY OF RITODRINE: Iontophoresis can be defined as permeation of ionized drug molecules across biological membranes under the influence of electrical current. This study will be carried out by using iontophoretic apparatus associated with the constant current power supply (DC) using Ag/AgCl electrodes, the sample will be withdrawn at predetermined intervals and assayed using spectrophotometer. Similarly for interrupted current study. The current will be applied to initial hours and passive permeation will be allowed for the rest of the period.8 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY. NO. 7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3? NOT APPLICABLE. 8. LIST OF REFERENCES: 1. Jurgen D, Remy M and Ulla T, et al. Pharmacokinetics and pharmacodynamics of a new transdermal delivery system for Bopindolol. Journal of Clinical Pharmacology 1991; 31: 671-676. 2. Holleboom CAG, Merkus JMWM and Van ELWM. A loading-dose infusion scheme for intravenous tocolysis with Ritodrine: a pilot study. European Journal of Obstetrics & Gynecology and Reproductive Biology 1987; 26 (2):119-126. 3. Singh G, Ghosh B, Dave K and Somashekar V. Transdermal delivery of Vanlafaxine hydrochloride: passive diffusion and iontophoresis. AAPS Pharm Sci Tech DOI 2008; 1208/s 12249-008:911-3. 4. Anroop B, Ghosh B, Parcha V, Khanam J. Comparative Skin permeability of Metoprolol tartrate and its ester prodrugs by passive permeation and iontophoresis. Asian Journal of Pharmaceutical Sciences 2008; 3:1-11. 5. Victor M, Mohammad MAK, Michniak BB. Enhanced iontophoretic delivery of Buspirone hydrochloride across human skin using chemical enhancers. International Journal of Pharmaceutics 2003; 264: 73–83. 6. Sang-Chul Shin, Lee Hyun-Jin. Enhanced transdermal delivery of Triprolidine hydrochloride from the ethylene-vinyl acetate matrix. European Journal of Pharmaceutics and Biopharmaceutics 2002; 54: 325–328. 7. Wang Y, Thakur R, Fan Q, Michniak BB. Transdermal iontophoresis: Combination strategies to improve transdermal iontophoretic drug delivery. European Journal of Pharmaceutics and Biopharmaceutics 2005; 60920: 179-91. 8. Langer R. Transdermal drug delivery: past progress, current status, and future prospects. Advances in Drug Delivery Review 2004;56:557-58. 9. Signature of the candidate 10. Remarks of the guide 11.1 Name and Designation of the guide Recommended Dr. Bijaya Ghosh Dept. of Pharmaceutical Technology, K.L.E.S’s College of Pharmacy, Rajajinagar, Bangalore-560010. 11.2 Signature 11. 11.3 Head of the Department Dr. Bijaya Ghosh Head of the Department Dept. of Pharmaceutical Technology, K.L.E.S’s College of Pharmacy, Rajajinagar, Bangalore-560010 11.4 Signature 12.1 Remarks of the Chairman and Principal Recommended for registration 12.2 Principal Dr. Purnima Ashok Principal K.L.E.S’s College of Pharmacy, 2nd block, Rajajinagar, Bangalore-560010 12 12.3 Signature