DEVELOPMENT AND EVALUATION OF ASYMMETRIC MEMBRANE CAPSULE OF KETOROLAC TROMETHAMINE
Objective: Osmotic systems for moderate to low water soluble drugs are limited because of the more thick coatings impede the permeability. To overcome this problem, asymmetric membrane osmotic drug delivery systems have been developed.
Method: In present investigation asymmetric membrane capsules (AMC), having in-situ pores for achieving the osmotic controlled release of ketorolac tromethamine, were successfully designed by using cellulose acetate (CA 398-10) as semi-permeable membrane forming polymer and glycerol, PEG-400 as pore forming agent andÂ osmotic agents viz. sodium chloride, fructose and mannitol.
Result: The prepared AM capsules were physically evaluated for various parameters such as length, weight variation, thickness, elongation at break, tensile strength, void volume determination and surface characterization. Results of SEM studies inveterate the formation of pores in the asymmetric membranes after coming into contact with the aqueous environment. in- vitro release profile of ketorolac tromethamine were investigated. It is evident from results that the percent of drug released with glycerol was fund to be highest, followed by PEG-400. No significant change was observed in stability study of AMC.
Conclusion: It was concluded that the drug release rate increase with the amount of osmogent due to increase in water uptake hence increased driving force for drug release. The percent drug released at the end of dissolution time from the control capsule (containing drug only) was lower as compared to capsules filled with various proportion of drug/osmogents.
Keywords: of ketorolac tromethamine, asymmetric membrane capsules, cellulose acetate, osmotically controlled gastroretentive delivery
Theeuwes F. Elementary osmotic pump. J Pharm Sci 1975;64:1987-91.
Danadagi PM, Koradia NV, Gadad AP, M Mastiholimath VS, Sanghvi MM. Oral osmotic drug delivery system: an update. Int J Res Pharm Sci 2011;2:225-36.
Thakor R, Majmudar F, Patel J, Patel B. Formulation and evaluation of monolithic osmotic tablets for controlled delivery of nifedipine. Int J Pharm Sci Res 2010;1:58-66.
Kuczynski AL, Ayer AD, Wong Patrick LS. A delivery system for administration blood-glucose-lowering drug. US Patent 5091190; 1992.
Tripathi KD. 6th edn. Essentials of pharmacology, Jaypee Publishers (P) Ltd. New Delhi; 2013. p. 186-9.
Banker, Rhodes. 2nd edn. Modern pharmaceutics, Macel Dekker, Inc; 1990. p. 635-71.
Chauhan CS, Ranawat MS, choudhary PK. Fabrication and evaluation of asymmetric membrane osmotic pump. Indian J Pharm Sci 2007;69:748-52.
Chandy A, Jharia M, Manigauha A. fabrication and evaluation of osmotic capsular pump for controlled drug delivery. Int J Pharm Pharm Sci 2010;1:99-103.
Baker RW, Brooke JW. Pharmaceutical delivery system, US Patent 4687660; 1987. p. 18.
Kidane A, Ray SK, Bhatt PP, Bryan Jr, Jones W. Osmotic delivery of therapeutic compounds by solubility enhancement; US Patent 20050053653; 2005.
Waterman KC. Pharmaceutical tablet and process for making thereof; US Patent 20030143272; 2003.
Theeuwes, Bayne WF. Method for the management of intraocular pressure; US Patent 4305927; 1981.
Lacy CF, Armstrong LL, Goldman MP, Lance LL. 14th edn. Drug information handbook international. Lexi-cmp-inc; 2006. p. 898-9.
Ghosh T, Ghosh A. Drug delivery through the osmotic systems-an overview. J Appl Pharm Sci 2011:1:38-49.
Patel GM, Patel JD. Single core osmotic pump (SCOP): development of single layer osmotic controlled release tablet for poorly soluble drug. J Pharm Technol Drug Res 2012:1-5. Doi.org/10.7243/2050-120x-1-1. [Article in Press]
Ning M, Zhou Y, Chen G, Mei X. Preparation and in vitro/in vivo evaluation of vinpocetine elementary osmotic pump system. Adv Pharmacol Sci 2011;1-11. Doi.org/10.1155/2011/385469. [Article in Press]
Peterson LL, Maruyama FH, Dehnad H, Hom L, Sly KS, Davis CR, et al. Osmotic delivery system flow modulator apparatus and method: US Patent 20080071253; 2008.
Alessi TR, Desjardin MA, Lam S, Lautenbach SD, Zamora PC. Osmotic delivery system and piston assemblies for use therein: US Patent 20110166554; 2011.
Siepmann J. Modeling of drug release from delivery system based on hydroxypropyl methylcellulose (HPMC). Adv Drug Delivery Rev 2001;48:139-57.
Dash S, Murthy PS, Nath L, Chawdhury P. Kinetic modeling on drug release from controlled drug delivery systems. Acta Poloniae Pharm Drug Res 2010:67;217-23.
Anderson RC. Osmotic intraosseous drug delivery system. US Patent 20070005043; 2007.
Shah VP, Yi T, Sathe P, Williams RL. In vitro dissolution profile comparison-Statistics and analysis of the similarity factor, f2. Pharm Res 1998;15:886-9.
United States Pharmacopoeia. Rockville MD: USP convention INC. 32 revision, NF; 2009. p. 27.