FORMULATION AND EVALUATION OF IN VITRO TRANSDERMAL PATCH DICLOFENAC SODIUM USING CHITOSAN POLYMER AND POLYVINYL ALCOHOL CROSS-LINKED TRIPOLYPHOSPHATE SODIUM
DOI:
https://doi.org/10.22159/ajpcr.2018.v11i8.25145Keywords:
Diclofenac sodium, Chitosan, Polyvinyl alcohol, Tripolyphosphate sodium, Glycerin, Release kineticsAbstract
Objective: The aim of this study was to investigate diclofenac sodium patches using chitosan (Ch) and polyvinyl (PVA) alcohol cross-linked tripolyphosphate sodium (TPP) to increased transdermal permeation of the drug from the matrix system across rabbit skin.
Materials and Methods: The chemical characterization of diclofenac sodium was done by ultraviolet-visible spectrophotometry. Formulation of diclofenac sodium patches using solvent evaporation method with cross-link technique. Evaluation of physical character of the film includes organoleptic observation, weight test, thickness, % moisture absorption, fold resistance, interaction between materials used Fourier transform infrared (FTIR), and active substance levels. The drug release was determined using Franz diffusion cells in phosphate buffer (pH 7.4).
Results: The result of physiochemical parameters of the transdermal patch were found satisfactory. Formula F1, F2, F3, and F4 produce patches with fine texture, F5 and F6 formulas produce patches with coarse texture. Formula F1, F2, F5, and F6 are flexible and fulfill the multiplier test requirements, while the F3 and F4 formulas are not flexible and do not meet the multiplier test requirements. The patch weight, thickness, and drug content were uniform. The release of patches with following the zero-order release. The optimal formula with the total sodium diclofenac released as much as 17.89 μg, the release flux of 89.42 μg/cm²/h of permeation time of 10 h and the moisture absorption rate of 1.07±0.193. The FTIR data of rabbit skin indicated Ch and PVA alcohol cross-linked TPP increase transdermal permeation of diclofenac sodium in the stratum corneum.
Conclusion: The diclofenac sodium can be prepared by cross-linked method, resulted in a better discharge profile.
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References
Agoes G. Sistem Penghantaran Obat Pelepasan Terkendali. 2nd. Bandung: Penerbit ITB; 2008. p. 373.
Agustin R, Ratih H. Dissolution Profile of Sustained Release Tablet of Diclofenac Sodium Using Metolose 90 Sh 4000. J Sains Farm Klin 2015;1:176-83.
Alexander A, Dwivedi S, Ajazuddin, Giri TK, Saraf S, Saraf S, et al. Approaches for breaking the barriers of drug permeation through transdermal drug delivery. J Control Release 2012;164:26-40.
Allen L, Ansel HC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadhelpia: Lippincott Williams & Wilkins; 2013. p. 295.
Ansel HC. Pengantar Bentuk Sediaan Farmasi. Edisi Keempat. Jakarta: UI-Press; 2005. p. 176-81.
Banakar UV, Pharmaceutical Dissolution Testing. New York: Marcel Dekker, Inc. 1991. J Pharm 1992;151:26-32.
Barhate SD, Potdar MB. Formulation of transdermal patch of Carvedilol by using novel polymers. Pharmacia 2012;2:185-9.
Bartosova L, Bajgar J. Transdermal drug delivery in vitro using diffusion cells. Curr Med Chem 2012;19:4671-7.
Bazigha K, Rasool A, Eman F, Fahmy A, Sadan S. Development and evaluation of ibupropen transdermal gel formulation. Trop J Pharm Res 2010;9;355-63.
Bhattarai N, Gunn J, Zhang, M, Chitosan hydrogels for controlled, localized drug delivery. Adv Drug Deliv Syst 2010;62:83-99.
Bhavani PP, Kumar PR, Shankar RK, Santosh T. Formulation and evaluation studies on transdermal dosage forms of diclofenac sodium. World J Pharm Pharm Sci 2015;4:1043-63.
Can AS, Erdal MS, Gungor S, Ozsoy Y. Optimization and characterization of chitosan film for transdermal delivey of ondansentron. Molecules 2013;18:5455-71.
Cheung RC, Ng TB, Wong JH, Chan WY. An update potential biomedical and pharmaceutical application. Mar Drug 2013;13:5156.
Das A, Ahmed AB. Formulation and evaluation of transdermal patch of indomethacin containing of pathcouli oil as natural penetration enhancer. Asian J Pharm Clin Res 2017;10:320-5.
Dash S, Murthy PN, Nath L, Chowdhury P. Kinetic modeling on drug release from controlled drug delivery system. Acta Pol Pharm 2010;67:217-23.
Devissaguet J, Aiache JM. Farmasetika 2 Biofarmasi. 2nd ed. Surabaya: Widji Soerarti. Airlangga University Press; 1993. p. 443-58, 172.
Flyn GL, Stewart B. Percutaneus drug penetration choose candidates for transdermal drug development. Drug Dev Res 1988;13:169-85.
Fox SC. Remington Education Pharmaceutics. London: Pharmaceutical Press; 2014. p. 432-4.
Gadhekar R, Saurabh MK, Thakur GS, Saurabh A. study of formulation, characterisation and wound healing potential of transdrmal patchs curcumin. Asian J Pharm Clin Res 2012;5:225-30.
Giri TK, Thakur A, Alexander A, Badwaik H, Tripathi DK. Modified chitosan hydrogels as drug delivery and tissue engineering system, present status and aplication. Acta Pharm Silaica B 2012;2:439-49.
Goci EN, Haloci EN, Xhulaj SK, Malaj LE. Formulation and in vitro evaluation of diclofenac sodium gel. Int J Pharm Pharm Sci 2014;6:259 61.
Goswami DS, Uppad N, Gloyal S, Mechta N, Gupta AK. Permeation enhancer for transdermal drug delivery from natural and synthetic sources. J Biomed Pharm Res 2013;2:19-29.
Gupta JR, Irchiya R, Garud N, Priyanka T. Formulation evaluation of matrix type transdermal patchs of glibenclamide. Int J Pharm Sci Drug Res 2011;1:46-50.
Jadhav RT, Kasture PV, Gattani SG, Surana SJ. Formulation and evaluation of transdermal films of diclofenac sodium. Int J Pharm Tech Res 2009;1:1507-11.
Jahan L, Ferdaus R, Shabeen SM, Sultan MZ, Mazid MA. In vitro transdermal delivery of metformin from HPMC/PVA based transdermal drug delivery patch et different ph. J Sci Res 2011;3:651-7.
Jatav VS, Jitentra S, Rakesh KJ, Sharma K, Ravindra PS. Recent advances in development of transdermal patchs. Pharmacopore 2011;2:287-97.
Liang S, Liu L, Huang Q, Yam KL, Preparation of single or double network chitosan/poly(Vinyl Alcohol) gel film through selectively cross-linking method. Carbohydrate Polym 2009;77:718-24.
Kouchak M, Ameri A, Naseri B, Boldag SK. Chitosan and polyvinyl alcohol composite film containing nitrofurazone, preparation and evaluation. J Basic Med Sci 2014;17:14-20.
Malji P, Gandhi A, Jena S, Maji N. Preparation and characterization of maleic anhydride cross linked chitosan polyvinil alcohol hydrogel matrix transdermal patch. J Pharm Sci Tech 2013;2:62-7.
Patel H, Bhimani B, Patel G, Transdermal drug delivery system. as prominent dosage form for the highly liphophilic drugs. Int J Pharm Biosci 2012;1:42-65.
Patil SS, Gupta RM, Gupta KS, Doddayya H. Formulation and characterization of tpp cross-linked chitosan microspheres loaded with lornoxicam. J Biomed Pharm Res 2014;3:51-8.
Pouranvari S, Ebrahimi F, Javadi G, Maddah B. Chemical cross-linking of chitosan/polyvinyl alcohol electrospun nanofibers. Original Sci Artcle 2016;50:663.
Raj AR, Formulation evaluation and in vitro permiation studyes of transdermal nifedipine from matrix type patch. Int J Pharm Pharm Sci 2013;6:185-8.
Raza R, Mittal A, Kumar P, Alam S, Prakash S, Chauhan N. Approach and Evaluation Of Transdermal Drug Delivery System. Int J Dev Res 2015;7:222-33.
Rowe RC, Sheskey PJ, Owen SC. Hanbook of Pharmaceutical Excipients. 5th ed. London: The Pharmaceutical Press; 2006. p. 217 611.
Sachan R, Bajpai M. Transdermal drug delivery system a review. Int J Dev Pharm Life Sci 2013;3:748-65.
Saroha K, Yadav B, Sharma, B. Transdermal patc, a discrete dosage form. Int J Curr Pharm Res 2011;3:98-108.
Setyawan EI. Pengaruh Kombinasi HPMC dan MC Terhadap Karakter Fisik dan Pelepasan Ketopropen dari Matrik patch Transdermal. Yogyakarta: Tesis Universitas Gajah Mada; 2013. p. 73.
Sharma K, Singh V, Arora A. Natural biodegradable polymer as matrics in transdermal drug delivery. Int J Drug Dev Res 2011;3:85-103.
Sherwood L. Human Physiology, From Cells to Systems. 6th ed. Belmont, CA: Cencage Learning; 2012. p. 485-6.
Ng SF, Rouse JJ, Sanderson FD, Meidan V, Eccleston GM. Validation of static franz diffusion cell system for in vitro permeation studies. AAPS Pharm Sci Tech 2010;2:1432-41.
Singh I, Sri P. Percutaneus penetration enchanment in transdermal drug delivery. Asian J Pharm 2010;4:92-101.
Sinko PJ. Martin’s Physical Pharmacy and Sciences. 6th ed. Philadelphia: Lippincot William, Philadelphia Pharmaceutical; 2016. p. 223.
Soujanya C, Lakshmi Satya B, Lokesh Reddy M, Manogna K, Ravi Prakash P, Ramesh A. Formulation and in vitro and in vivo evaluation of transdermal patchs of lornoxican using natural permeation enhancers. Int J Pharm Pharm Sci 2014;6:282-6.
Subrata M, Kumar PD, Mukherjee B, Sengupta S, Pattnaik S, Chakraborty S. Optimization of in-vitro permeation pattern of ketorolac tromethamine transdermal patchs. Iran J Pharm Res 2011;10:193-201.
The Board of Trustees. United Sates Pharmacopeia. 27th ed. National Formulary Rockville: The Board of Trustees; 2007.
Varshosaz J, Karimzadeh S. Develpment of cross-linked chitosan for oral mucosal delivery of lidocain. Res Int Pharm Sci 2007;2:43-52.
Wasitaatmaja SM, Penuntun Ilmu Kosmetik dan Medik. Indonesia: Penerbit Universitas Jakarta; 1997. p. 3-5.
Watkinson AC. Transdermal and topical drug delivery today, Transdermal and Topical Drug Delivery. Principles and Practice. Hoboken, NJ, USA: John Wiley Sons Inc.; 2012. p. 357-66.
Wester RC, Maibach HI, Regional Variation in Percutaneus Absorption Drugs, Cosmetic, Mechanism, Methodology. New York: Marcel Dekker; 1997. p. 107.
Wise DL. Handbook of Pharmaceutical Controlled Release Technology. New York: Marcell Dekker; 2000. p. 321.
Wang Q, Du Y, Fan L. Properties of chitosan/poly(vinyl alcohol) film for drug controlled release. J Appl Polim Sci 2004;96:808-13.
Xiong Y, Liu QL, Zhang QG, Zhu AM. Synthesis and characterization of cross-linked quaternized poly(vinyl alcohol)/chitosan composite anion exchange membranes for fuel cells. J Power Sour 2008;183:447 53.
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