FABRICATION AND EVALUATION OF MOUTH-DISSOLVING FILMS OF DOMPERIDONE
Keywords:Mouth dissolving film, Domperidone, β cyclodextrin, Solvent casting method, HPMC
Objective: The objective of present research work was to fabricate and evaluate mouth-dissolving films of domperidone by solvent casting method using hydroxypropyl methyl cellulose as polymer for rapid release of drug.
Methods: Domperidone (DMP) is specific blocker of dopamine receptors (D2 and D3) and is widely used to treat emesis. Since domperidone solubility is less, domperidone solid dispersion (DMP SD’s) were prepared with β-cyclodextrine inclusion complexes in different ratio (1:1, 1:2, 1:3 and 1:4) by kneading method to increase the solubility. The DMP mouth dissolving films (MDF) were developed using DMP SD’s by solvent casting method. Hydroxypropyl methyl cellulose (HPMC) was used as film forming agent and glycerine was used as plasticizer. Nine formulations were fabricated and were evaluated for their various physico-mechanical properties, in vitro disintegration time and in vitro dissolution characteristics.
Results: The solid dispersion SD3 increased the solubility of drug compared to pure drug. FTIR studies revealed the integrity of the drug in its pure form in both drug-βcyclodextrine complex and finished MDF. The thickness uniformity, weight uniformity, folding endurance, surface pH and drug content of mouth dissolving films were uniform and reproducible. Formulation F1 released highest percentage of drug i.e., 100% of drug in 16 min compared to other formulations in in vitro release studies and disintegrated within 2.5 min and hence was considered as optimized formulation. The mechanism of drug release of prepared mouth dissolving films was Non-Fickian diffusion controlled kinetics.
Conclusion: Complexation by Kneading technique was found satisfactory for solid dispersion of domperidone. Solvent casting method was successfully used to obtain uniform mouth dissolving films containing drug-β cyclodextrine solid dispersion. Mouth dissolving films containing domperidone could be successfully developed and optimised.
Arya A, Chandra A, Sharma V, Pathak K. Fast dissolving oral films: an innovative drug delivery system and dosage form. Int J ChemTech Res. 2010 Jan;2(1):576-83.
Rao NR, Shravani B, Reddy MS. Overview on buccal drug delivery systems. J Pharm Sci Res. 2013 Apr 1;5(4):80-8.
Reddy RJ, Anjum M, Hussain MA. A comprehensive review on buccal drug delivery system. Am J Advan Drug Deliv. 2013;1:300-12.
Almeida NMG, Lima R, Alves TFR, Rebelo MdA, Severino P, Chaud MV. A novel dosage form for buccal administration of bupropion. Braz J Pharm Sci. 2015 Jan;51(1):91-100. doi: 10.1590/S1984-82502015000100010.
Aboutaleb AE, Abdel Rahman SI, Ahmed MO, Younis MA. Design and evaluation of domperidone sublingual tablets. Int J Pharm Pharm Sci. 2016;8(6):195-201.
Mandeep K, Rana A, Nimrata S. Fast dissolving films: an innovative drug delivery system. Int J of Pharm Res and All Sci. 2013;2(1):14-24.
Junmahasathien T, Panraksa P, Protiarn P, Hormdee D, Noisombut R, Kantrong N. Preparation and evaluation of metronidazole-loaded pectin films for potentially targeting a microbial infection associated with periodontal disease. Polymers. 2018 Sep 13;10(9):1021-33. doi: 10.3390/polym10091021, PMID 30960947.
Siddiqui MN, Garg G, Sharma PK. A novel approach in oral fast dissolving drug delivery system and their patents. Adv Biol Res. 2011;5(6):291-303.
Bhura N, Sanghvi K, Patel U, Parmar B, Patel D. A review on fast dissolving film. IJPRBS. 2012;1(3):66-89.
Pathare YS, Hastak VS, Bajaj AN. Polymers used for fast disintegrating oral films: a review. Int J Pharm Sci Res. 2013 Jul;21(1):169-78.
Teodorescu M, Poly BM (vinylpyrrolidone)–a versatile polymer for biomedical and beyond medical applications. Polym Plast Technol Eng. 2015 Jun 23;54(9):923-43.
Helmy SA, El Bedaiwy HM. Pharmacokinetics and comparative bioavailability of domperidone suspension and tablet formulations in healthy adult subjects. Clin Pharmacol Drug Dev. 2014 Mar;3(2):126-31. doi: 10.1002/cpdd.43, PMID 27128456.
Athukuri BL, Neerati P. Enhanced oral bioavailability of domperidone with piperine in male Wistar rats: involvement of CYP3A1 and P-gp inhibition. J Pharm Pharm Sci. 2017 Jan 24;20:28-37. doi: 10.18433/J3MK72, PMID 28459658.
Chaturvedi S. Solubility and dissolution enhancement of domperidone using 2-hydroxypropyl-β-cyclodextrin by kneading method. Asian J Pharm. 2017 Sep 9;11(03):168-75.
Joshi P, Patel H, Patel V, Panchal R. Formulation development and evaluation of mouth dissolving film of domperidone. J Pharm Bioallied Sci. 2012;4(Suppl 1):S108-9. doi: 10.4103/0975-7406.94159, PMID 23066181.
Thorat KV, Khade P, Kakade S, Bhosale A. Formulation and evaluation of fast dissolving mouth film of domperdone. World J Pharm Res. 2021;10(12):2104-21.
Zayed GM, Rasoul SA, Ibrahim MA, Saddik MS, Alshora DH. In vitro and in vivo characterization of domperidone-loaded fast dissolving buccal films. Saudi Pharm J. 2020 Mar 1;28(3):266-73. doi: 10.1016/j.jsps.2020.01.005, PMID 32194327.
Bala R, Khanna S, Pawar P. Design optimization and in vitro-in vivo evaluation of orally dissolving strips of clobazam. J Drug Deliv. 2014;2014:392783. doi: 10.1155/2014/392783, PMID 25328709.
Abdelbary A, Bendas ER, Ramadan AA, Mostafa DA. Pharmaceutical and pharmacokinetic evaluation of a novel fast dissolving film formulation of flupentixol dihydrochloride. AAPS PharmSciTech. 2014 Dec;15(6):1603-10. doi: 10.1208/s12249-014-0186-8, PMID 25142820.
Higuchi T. Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci. 1963 Dec;52:1145-9. doi: 10.1002/jps.2600521210, PMID 14088963.
Reza MS, Quadir MA, Haider SS. Comparative evaluation of plastic, hydrophobic and hydrophilic polymers as matrices for controlled-release drug delivery. J Pharm Pharm Sci. 2003 May 1;6(2):282-91. PMID 12935440.
http://www.ich.org/FileAdmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf [Last accessed on 21 Aug 2022].
Saokham P, Muankaew C, Jansook P, Loftsson T. Solubility of cyclodextrins and drug/cyclodextrin complexes. Molecules. 2018 May 11;23(5):1161. doi: 10.3390/molecules23051161, PMID 29751694.
How to Cite
Copyright (c) 2023 SARFARAZ MD, SUSHIL KUMAR, H. DODDAYYA
This work is licensed under a Creative Commons Attribution 4.0 International License.