FORMULATION AND EVALUATION OF TRANSDERMAL PATCHES OF PANTOPRAZOLE SODIUM
DOI:
https://doi.org/10.22159/ijap.2021v13i5.42175Keywords:
Transdermal patches, Pantoprazole sodium, In vitro release, In vitro skin permeabilityAbstract
Objective: The present study was an attempt to develop an alternative dosage form for the existing conventional oral, parenteral proton pump inhibitor (PPI) as transdermal patches for treating peptic ulcers.
Methods: Transdermal patches of PPI were prepared using HPMC E5 with PVP K 30 and HPMC E5 with Eudragit L100 polymers in different ratios by a solvent evaporation method. All the formulated patches were subjected to various evaluation parameters such as thickness, folding endurance, weight uniformity, content uniformity, swelling index, percentage moisture content, moisture uptake, surface pH and in vitro release studies.
Results: All patches exhibited satisfactory characteristics regarding integrity, flexibility, dispersion of drug, and other quality control parameters. In the in vitro release studies of transdermal patches, formulation F1 showed the prolonged release of drug (98.99 %) for 24 h, which indicates the maximum availability of the drug, and the in vitro skin permeability studies also showed that 96.26 % of drug Pantoprazole sodium permeated through the rat abdominal skin in 24 h. The kinetic studies were carried out and it was found that all the formulations follow zero-order and the release mechanism of drugs was found to be diffusion rate-limited, Non-Fickian mechanism which was confirmed by Korsmeyer–Peppas model.
Conclusion: This suggests the transdermal application of Pantoprazole sodium holds the promised controlled release of the drug for an extended period of time.
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Asbill CS, Michniak BB. Percutaneous penetration enhancers: local versus transdermal activity. Pharm Sci Technol Today 2000;3:36–41.
Balaji P, Thirumal M, Gowri R, Divya V, Ramaswamy V. Design and evaluation of matrix type of transdermal patches of methotrexate. Int J Pharm Chem Biol Sci 2012;2:464–71.
Das PS, Saha P. Design and characterisation of transdermal patches of Phenformin hydrochloride. Int J Curr Pharm Res 2017;9:90–3.
Shivalingam M, Balasubramanian A, Ramalingam K. Non-invasive medicated dermal patch–a review. Int J Pharm Res 2020;12:3018–27.
Shivalingam MR, Balasubramanian A, Ramalingam K. Design and evaluation of medicated dermal patches of proton pump inhibitor-esomeprazole. Int J Pharm Res 2020;12:3038–43.
Funke AP, Schiller R, Motzkus HW, Gunther C, Muller RH, Lipp R. Transdermal delivery of highly lipophilic drugs: in vitro fluxes of antiestrogens, permeation enhancers, and solvents from liquid formulations. Pharm Res 2002;19:661–8.
Guy RH. Current status and future prospects of transdermal drug delivery. Pharm Res 1996;13:1765–9.
Barry BW. Novel mechanisms and devices to enable successful transdermal drug delivery. Eur J Pharm Sci 2001;14:101–14.
Huber R, Hartmann M, Bliesath H, Luhmann R, Steinijans VW, Zech K. Pharmacokinetics of pantoprazole in man. Int J Clin Pharmacol Ther 1996;34:185–94.
Mehdizadeh A, Toliate T, Rouini MR, Abashzadeh S, Dorkoosh F. Design and in vitro evaluation of new drug-in-adhesive formulations of fentanyl transdermal patches. Acta Pharm 2004;54:301–17.
Mukherjee B, Das S, Patra B, Layek B. Nefopam containing transdermal-matrix patches: based on pressure-sensitive adhesive polymers. Pharm Technol 2006;30:146–63.
Chandrashekhar SN. Physicochemical and pharmacokinetic parameters in drug selection and loading for transdermal drug delivery. Indian J Pharm Sci 2008;70:94–6.
Singh A, Bali A. Formulation and characterization of transdermal patches for controlled delivery of duloxetine hydrochloride. J Anal Sci Technol 2016;7:1–13.
Prabhakara P, Koland M, Vijaynarayana K, Harish NM, Shankar G, Ahmed MG, et al. Preparation and evaluation of transdermal patches of papaverine hydrochloride. Int J Res Pharm Sci 2010;1:259–66.
Shivaraj A, Selvam RP, Mani TT, Sivakumar T. Design and evaluation of transdermal drug delivery of ketotifen fumarate. Int J Pharm Biomed Res 2010;1:42–7.
Keleb E, Sharma RK, Mosa EB, Aljahwi A-AZ. Transdermal drug delivery system-design and evaluation. Int J Adv Pharm Sci 2010;1:201–11.
Bangale GS, Rathinaraj BS, Rajesh KS, Shinde GV, Umalkar DG, Rajveer CH, et al. Design and evaluation of transdermal films of atenolol. J Chem Pharm Res 2010;2:593–604.
Lec ST, Yac SH, Kim SW, Berner B. One way membrane for transdermal drug delivery systems/system optimization. Int J Pharm 1991;77:231-7.
Venkateswari Y, Jayachandra Babu R, Sampathkumar D, Mittal N, Pandit JK. Development of a low cost tetracycline strip for long term treatment of periodontal disease. Indian Drugs 1995;32:205–10.
Pandit V, Khanum A, Bhaskaran S, Banu V. Formulation and evaluation of transdermal films for the treatment of overactive bladder. Int J Pharm Tech Res 2009;1:799–804.
Garala KC, Shinde AJ, Shah PH. Formulation and in vitro characterization of monolithic matrix transdermal systems using HPMC/Eudragit S 100 polymer blends. Int J Pharm Pharm Sci 2009;1:108–20.
Nishad KM, Arul B, Rajasekaran S. Design and comparative evaluation of clarithromycin gastric bioadhesive tablets by ex vivo and in vivo methods. Asian J Pharm Clin Res 2018;11:248–56.
Pandey S, Shah RR, Gupta A, Arul B. Design and evaluation of buccoadhesive controlled release formulations of prochlorperazine maleate. Int J Pharm Pharm Sci 2016;8:375–9.
Suksaeree J, Boonme P, Taweepreda W, Ritthidej GC, Pichayakorn W. Characterization, in vitro release and permeation studies of nicotine transdermal patches prepared from deproteinized natural rubber latex blends. Chem Eng Res Des 2012;90:906–14.
Simon A, Amaro MI, Healy AM, Cabral LM, de Sousa VP. Comparative evaluation of rivastigmine permeation from a transdermal system in the Franz cell using synthetic membranes and pig ear skin with in vivo-in vitro correlation. Int J Pharm 2016;512:234–41.
Singh J, Tripathi KP, Sakya TR. Effect of penetration enhancers on the in vitro transport of ephedrine through rat skin and human epidermis from matrix based transdermal formulations. Drug Dev Ind Pharm 1993;19:1623–8.
Hwang BY, Jung BH, Chung SJ, Lee MH, Shim CK. In vitro skin permeation of nicotine from proliposomes. J Controlled Release 1997;49:177–84.
Pongjanyakul T, Prakongpan S, Priprem A. Permeation studies comparing cobra skin with human skin using nicotine transdermal patches. Drug Dev Ind Pharm 2000;26:635–42.
Hardainiyan S, Kumar K, Nandy BC, Saxena R. Design, formulation and in vitro drug release from transdermal patches containing imipramine hydrochloride as model drug. Int J Pharm Pharm Sci 2017;9:220–5.
Hadjiioannou TP, Christian GD KMA. Quantitative calculations in pharmaceutical practices and research. New Delhi: NY-VCH publishers Inc; 1993. p. 345–8.
Higuchi T. Mechanism of sustained action of medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci 1963;52:1145–9.
DW B. Pharmacokinetics. In: Modern Pharmaceutical. 4th ed. Banker GS, Rhodes CT E. editor. New York: Marcel. Dekker Inc; 2002. p. 67–92.
Korsmeyer RW, Gurny R, Doelker E, Buri P PN. Mechanisms of solute release from porous hydrophilic polymers. Int J Pharm 1983;15:25–36.
Gnanasekaran J, Arul B, Kothai R. Development of mucoadhesive tablet of pentoxifylline using a natural polymer from Manilkara zapota Linn. Int J Appl Pharm 2019;11:88–91.
Selvaraj GJ, Balasubramanian A, Ramalingam K. Application of novel natural mucoadhesive polymer in the development of pentoxifylline mucoadhesive tablets. Int J Appl Pharm 2019;11:37–41.
Firoz SG, Kothai R, Arul B. Novel approaches for pulsatile drug delivery system. J Crit Rev 2020;7:2282–9.
Cojocariu A, Porfire L, Cheaburu C, Vasile C. Chitosan/montmorillonite composites as matrices for prolonged delivery of some novel nitric oxide donor compounds based on theophylline and paracetamol. Cell Chem Technol 2012;46:35-8.
Mishra MK, Ray D, Barik BB. Microcapsules and transdermal patch: a comparative approach for improved delivery of antidiabetic drug. AAPS PharmSciTech 2009;10:928–34.
Jain P, Dubey D, Mishra M. Formulation and evaluation of transdermal patch of benazepril hydrochloride using acryl coat L100 and acryl coat S100. Int J Pharm Chem Res 2016;2:167-79.
Mutalik S, Udupa N. Formulation development, in vitro and in vivo evaluation of membrane controlled transdermal systems of glibenclamide. J Pharm Pharm Sci Publ Can Soc Pharm Sci Soc Can des Sci Pharm 2005;8:26–38.
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