FORMULATION AND EVALUATION OF FAST DISSOLVING SUBLINGUAL FILM OF PAROXETINE HYDROCHLORIDE FOR TREATMENT OF DEPRESSION
Objective: Oromucosal route could be an alternative over the conventional route for paroxetine hydrochloride (PXH) as it offers direct systemic delivery, by avoiding extensive first-pass metabolism, which results in poor systemic absorption. The film dissolves quickly when placed in mouth without need of water thus helpful in providing rapid onset of action.
Methods: Fast dissolving film of PXH was prepared using Pullulan in various combinations of 32 full factorial design by solvent casting technique. Prepared films were subjected to mechanical, in vitro, and ex vivo characterization.
Results: The physicochemical characteristics such as mass uniformity, thickness, surface pH, and folding endurance were found satisfactory. The formulation (F3) containing 4% w/v Pullulan showed maximum release 94.31% and ex vivo permeation 92.67% through goat oral mucosa in 15 min. Uniform drug loading was observed in all the batches with disintegration time <25 s. Fourier transform infrared spectroscopy study revealed the compatibility of drug with polymer. Scanning electron microscopy revealed that there was uniform mixing of all ingredients. Optimized batch F3 was found to be stable for 1 month as no significant changes were observed in % cumulative drug release and weight of film.
Conclusion: Pullulan a natural biodegradable polymer allocates good physical property to film. Hydrophilic nature of polymer imparts fast disintegrating property to film.
2. Prajapati VD, Chaudhari AM, Gandhi AK, Maheriya P. Pullulan based oral thin film formulation of zolmitriptan: Development and optimization using factorial design. Int J Biol Macromol 2018;107:2075-85.
3. Patel P, Patel J, Patel K, Shah N, Shah S. A review on fast dissolving sublingual film. J Pharm Sci Bio Sci Res 2015;5:279-85.
4. Belzung C, Willner P, Philippot P. Depression: From psychopathology to pathophysiology. Curr Opin Neurobiol 2015;30:24-30.
5. Prajapati PH, Oza M, Shah HM, Patel CB. Formulation and evaluation of sublingual tablet of paroxetine hydrochloride. Int J Pharm Res Bio Sci 2014;3:1019-36.
6. Wadetwar RN, Charde T. Design, development, and characterization of oromucosal wafer of tramadol hydrochloride. Asian J Pharm Clin Res 2018;11:116-22.
7. Patil P, Shrivastava SK. Formulation, evaluation and optimization of fast dissolving oral film of selective antihypertensive drug. World J Pharm Pharm Sci 2014;3:996-1060.
8. Koland M, Sandeep V, Charyulu N. Fast dissolving sublingual films of ondansetron hydrochloride: Effect of additives on in vitro drug release and mucosal permeation. J Young Pharm 2010;2:216-22.
9. Sumitha CH, Varma MV, Sriniwas K. Development of taste masked fast dissolving orally consumable films of seldinafil citrate. IJPIS J Pharm Cosmet 2011;1:1-6.
10. Navamanisubramanian R, Nerella R, Chamundeeswari D, Shanmuganathan S. Use of okra mucilage and chitosan acetate in verapamil hydrochloride buccal patches development; in vitro and ex vivo characterization. J Young Pharm 2017;9:94-9.
11. Nalluri BN, Sravan IB, Saisri AV, Sribramhini R, Maheswari KM. Development and evaluation of mouth dissolving films of sumatriptan succinate for better therapeutic efficacy. J Appl Pharm Sci 2013;3:161-6.
12. Singh S. Drug stability testing and shelf-life determination according to international guidelines. Pharm Tech 1999;23:68-88.
13. Kunte S, Tandale P. Fast dissolving strips: A novel approach for the delivery of verapamil. J Pharm Bioallied Sci 2010;2:325-8.
14. Patel VM, Prajapati BG, Patel MM. Design and characterization of chitosan-containing mucoadhesive buccal patches of propranolol hydrochloride. Acta Pharm 2007;57:61-72.
15. Bhupinder B, Jangra S. Formulation and evaluation of fast dissolving sublingual films of rizatriptan benzoate. Int J Drug Dev Res 2012;4:133-43.
16. Daud A, Peepliwal A, Bonde M, Sapkal N, Gaikwad N. Design and development of Nicotiana tabacum film using factorial design. Int J Pharm Pharm Sci 2016;8:115-23.
17. Ghada EY, Haidy AB. Design and evaluation of fast dissolving oro-dispersible films of metoclopramide hydrochloride using 32 multifactorial designs. Int J Pharm Pharm Sci 2016;8:218-22.
18. Kaur G, Singh D, Brar V. Bioadhesive okra polymer based buccal patches as platform for controlled drug delivery. Int J Biol Macromol 2014;70:408-19.
19. Khanna R, Agarwal SP, Ahuja A. Preparation and evaluation of mucoadhesive buccal films of clotrimazole for oral Candida infections. Indian J Pharm Sci 1997;59:299-305.
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