Development and characterization of Antiemetic patch comprising Granisetron
Keywords:
Transdermal drug delivery, penetration enhancers, hydrophilic and hydrophobic polymers, Granisetron HClAbstract
The skin can be used as the site for drug administration for continuous transdermal drug infusion into the systemic circulation. For the continuous diffusion/penetration of the drugs through the intact skin surface membrane-moderated systems, matrix dispersion type systems, adhesive diffusion controlled systems and micro reservoir systems have been developed. Various penetration enhancers are used for the drug diffusion through skin. In matrix dispersion type systems, the drug is dispersed in the solvent along with the polymers and solvent allowed to evaporate forming a homogeneous drug-polymer matrix. Matrix type systems were developed in the present study. In the present work, an attempt has been made to develop a matrix-type transdermal therapeutic system comprising of Granisetron -HCl with different ratios of hydrophilic and hydrophobic polymeric combinations using solvent evaporation technique. The physicochemical compatibility of the drug and the polymers was studied by infrared spectroscopy. The results obtained showed no physical-chemical incompatibility between the drug and the polymers. The patches were further subjected to various physical evaluations along with the in-vitro permeation studies using rat skin. On the basis of results obtained form the in-vitro study and physical evaluation the patches containing hydrophilic polymers i.e. polyvinyl alcohol and poly vinyl pyrrolidone, with oleic acid as the penetration enhancer(5%) were considered as suitable for large scale manufacturing with a backing layer and a suitable adhesive membrane.
References
Chien Y.W. “Novel Drug Delivery Systems”, 2nd Edition, Drugs and Pharmaceutical Sciences, Volume-50, Marcel Dekker, Inc.
Finnin B C, Morgan T M, Trasndermal penetration. J Pharm Sci. Oct 1999;88 (10):955-958.
Allen L V, Popovich N G, Ansel H C, Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems, 8th Edition, Lippincott Williams & wilkins, 2005:298-315.
Barry B. Transdermal Drug Delivery. In Ed: Aulton M E, Pharmaceutics: The Science of Dosage Form Design, Churchill Livingston. 2002:499-533
Cleary G W, Transdermal controlled release systems. Medical Applications of Controlled Release. 1:203-251.
Vyas S P, Khar R K, Controlled Drug Delivery: Concepts and Advances, Vallabh Prakashan, 1st Edition. 2002:411-447.
Tortora G, Grabowski S. The Integumentary system. In: Principles of Anatomy and Physiology. 9th edition. John Wiley and Sons Inc. 150-151.
Wilson K J W, Waugh A. Eds, “Ross And Wilson: Anatomy And Physiology In Health And Illness”, 8th Edition, Churchill Livingstone. 1996:360-366.
Barry B W; “Dermatological Formulations: Percutaneous Absorption”, Drugs and pharmaceutical sciences, Volume – 18, Marcel Dekker, INC. 1983:1-39.
United States Patent: 6,673,363 Issued: January 6, 2004 Title: Transdermal and topical administration of local anesthetic agents using basic enhancers Inventors: Luo; Eric C. (Plano, TX); Gricenko; Nicole T. (San Diego, CA); Hsu; Tsung-Min (San Diego, CA).
Funke AP, Gunther C, Muller RH, Lipp R. In-vitro release and transdermal fluxes of a highly lipophilic drug and of enhancers from matrix TDS. J Control Release.2002 Jul;18;82(1):63-70.
Akimoto T, Nagase Y. Novel transdermal drug penetration enhancer: synthesis and enhancing effect of alkyldisiloxane compounds containing glucopyranosyl group. J Control Release. 2003 Mar 7;88(2):243-52.
Hirvonen J, Murtomaki L, Kontturi K. Effect of diffusion potential, osmosis and ionexchange on transdermal drug delivery: theory and experiments. J Control Release. 1998 Dec 4;56(1-3):33-9.
Fang JY, Lin HH, Chen HI, Tsai YH. Development and evaluation on transdermal delivery of enoxacin via chemical enhancers and physical iontophoresis. J Control Release. 1998 Aug 14;54(3):293-304.
Oh SY, Jeong SY, Park TG, Lee JH. Enhanced transdermal delivery of AZT (Zidovudine) using iontophoresis and penetration enhancer. J Control Release. 1998 Feb 12;51(2-3):161-8.
Fang JY, Sung KC, Lin HH, Fang CL. Transdermal iontophoretic delivery of enoxacin from various liposome-encapsulated formulations. J Control Release. 1999 Jun 28;60(1):1-10.
Pillai O, Panchagnula R. Transdermal iontophoresis of insulin. V. Effect of terpenes. J Control Release. 2003 Mar 7;88(2):287-96.
Vanbever R, Langers G, Montmayeur S, Preat V. Transdermal delivery of fentanyl: rapid onset of analgesia using skin electroporation. J Control Release. 1998 Jan 2;50(1-3):225- 35.
Denet AR, Preat V. Transdermal delivery of timolol by electroporation through human skin J Control Release. 2003 Mar 7; 88(2):253-62.
Bose S, Ravis WR, Lin YJ, Zhang L, Hofmann GA, Banga AK. Electricallyassisted transdermal delivery of buprenorphine. J Control Release. 2001 Jun 15;73(2-3):197 203.
Kikwai L, Kanikkannan N, Babu RJ, Singh M. Effect of vehicles on the transdermal delivery of melatonin across porcine skin in vitro. J Control Release. 2002 Oct 4;83(2):307-11.
http://medical-dictionary.thefreedictionary.com/ondansetron+hydrochloride.
Handbook of pharmaceutical excipients. USA: American pharmaceutical association; 1986
http//en.wikipedia.org/wiki/dibutyl_pthalate.
http//en.wikipedia.org/wiki/oleic_acid.
Gattani SG, Gaud RS, Chaturvedi SC. Formulation and evaluation of transdermal films of ondansetron hydrochloride. Indian Drugs. 2006;43(3):245-9.
Gwak H S, Oh IS, Chun I K, In-vitro percutaneous absorption of ondansetron hydrochloride from pressure-sensitive adhesive matrices through hairless mouse skin, Arch Pharm Res, 26 (8), 2003, 644-8.
Gwak H S, Oh IS, Chun I K, transdermal delivery of ondansetron hydrochloride: effects of vehicles and penetration enhancers, Drug Dev Ind Pharm, 30, (2), Feb 2004, 187-94.
Calpena A C, Blanes C, Moreno J, Obach R, Domenech J, A comparative in vitro study of transdermal absorption of antiemetics, J Pharm Sci, 83 (1), 1994, 29-33.
Agrawal SS, Munjal P. Permeation studies of atenolol and metoprolol tartarate form three different polymer matrices for transdermal delivery. Ind J Pharm Sci. 2007: 535-9. 31.
Sankar V, Sivanand V, Ravichandran V. Design and evaluation of nifedipine transdermal patches. Ind J Pharm Sci. 2003;65(5):510-5.
Gattani SG, Gaud RS, Chaturvedi SC. Formulation and evaluation of transdermal films of chlorpheniramine maleate. Indian Drugs. 2007;44(1):27-33.
Manvi FV, Dandagi PM, Gadad AP. Formulation of a transdermal drug delivery system of ketotifen fumarate. Ind J Pharm Sci. 2003;65(3):239-43.
Saxena M, Mutalik S, Reddy MS. Formulation and evaluation of transdermal patches of metoclopramide hydrochloride. Ind drugs. 2006;43(9):740-5.
Ubaidulla U, Reddy MV, Ruckmani K. Transdermal therapeutic system of Carvedilol: effect of hydrophilic and hydrophobic matrix on in vitro and in Vivo characteristics. AAPS Pharmsci Tech. 2007;8(1):Article 2.
Patra S, Choudhury A. A, Kar R. K and Barik B. B. Spectrophotometric method Ondansetron HCl. Ind J. Pharm. Sci. 2007; 69(6): 840-1.
Murthy S N, Sateesh M, Hamsa V, Drug release from terbutaline sulphate transdermal films across human cadaver skin, Indain J Pharm Sci. 59(2);75-76.
M. Aqil and Asgar Ali. Monolithic matrix type transdermal drug delivery systems of pinacidil monohydrate: in vitro characterization. European Journal of Pharmaceutics and Biopharmaceutics. 2002;54:161–164.
Murthy S N, Shoba Rani, Hiremath R, Formulation and evaluation of controlled release transdermal patches of theophylline-salbutamol sulphate, Drug Dev Ind Pharm, Online published 30/09/2001, 1057-62.
Evaluation of free films. Indian drugs. 1985; 23(1):45-7.
www.priory.com/pharmmol/transdermal/pdf
Prashant M, satturwar S, Fulzele V and avinash K. dorle evaluation of polymerized rosin for the formulation and development transdermal drug delivery systems. AAPS Pharmscitech. 2005; 6(4):48-53.
Carmelo Puglia and Francesco Bonina. Effect of Polyunsaturated Fatty Acids and some conventional Penetration Enhancers on Transdermal Delivery of Atenolol. Drug Delivery. 2008; 15: 107–112.