FORMULATION AND EVALUATION OF CILNIDIPINE MUCOADHESIVE BUCCAL FILM BY SOLVENT CASTING TECHNIQUE FOR THE TREATMENT OF HYPERTENSION
Keywords:Buccal film, Cilnidipine, Solvent-casting, HPMC, Mucoadhesive
Objective: Buccal drug delivery is the most suited route for local as well as systemic delivery of drugs. Cilnidipine is an L/N type dihydropyridine 4th generation calcium channel blocker (CCB), which decreases hypertension by blocking the N-type calcium channel to attenuate vascular sympathetic neurotransmission. It has high first-pass metabolism leading to low bioavailability. Hence the present research work was undertaken to formulate mucoadhesive buccal film of Cilnidipine with an objective to enhance therapeutic efficacy, bioavailability and was developed to administer into the unconscious and less-co-operative patients.
Methods: Cilnidipine buccal films were prepared by a solvent-casting technique using various concentrations of mucoadhesive-polymers such as Hydroxyl propyl methylcellulose (HPMC) E15 and K4M and ethyl-cellulose as backing-layer, which acts like a patch providing unidirectional drug release. Prepared films were evaluated for their weight variation, thickness, surface-pH, swelling-index, drug content uniformity, in vitro residence time, folding endurance, tensile strength, in vitro release and permeability studies.
Results: The infra-red (IR) spectra showed no interaction, and Physico-chemical characteristics were found within the limit. Swelling of the film increases with increasing concentration of polymers and %drug content of all formulations found to be in the range of 92.13%±0.94% to 97.92%±0.35%. The formulation F5, showed a promising tensile strength, folding endurance and in vitro drug release of about 95.18±0.03%, thus can be selected as an optimized formulation of mucoadhesive buccal film.
Conclusion: The formulation of Cilnidipine mucoadhesive buccal film was found to be satisfactory and reasonable.
Chien YW. Novel drug delivery systems. 2nd ed. Marcel Dekker, New York, Revised and expanded; 1982. p. 197-228.
Indira MY, Kumari SK. Mucoadhesive buccal films of glibenclamide: development and evaluation. Int J Pham Investigation 2011;1:42-7.
Arun JL, Rani S, Kumar MP. Buccal drug delivery system: history and recent developments. Asian J Pharm Clin Res 2016;9:36-42.
Madhavi RB, Murthy VSN, Rani PA, Gattu DK. Buccal film drug delivery system-an innovative and emerging technology. J Mol Pharm Org Process Res 2013;1:100-107.
Smalt A, Semalty M, Nautiyal U. Formulation and evaluation of mucoadhesive buccal films of enalapril maleate. Indian J Pharm Sci 2010;72:571-5.
Sudhakar Y, Kuotsu K, Bandyopadhyay AK. Buccal bioadhesive drug delivery-a promising option for orally less efficient drugs. J Controlled Release 2006;114:15-40.
Haju S, Yadav S, Baig R, Sawant G. Buccal film: a novel approach for oral mucosal drug delivery system. Asian J Pharm Clin Res 2021;14:27-35.
Bhati R, Nagarajan RK. A detailed review on oral mucosal drug delivery system. Int J Pharm Sci Res 2011;3:659-81.
Bhalerao A, Choudhari P. Formulation of solid lipid nanoparticle of cilnidipine for treatment of hypertension. J Drug Delivery Ther 2019;9:212-21.
Yelave A, Bhagwat G. Mucoadhesive buccal films: a novel approach for the delivery of anti-hypertensive drugs. Asian J Pharm Clin Res 2021;14:12-21.
Patel Z, Bhura R, Shah S. Formulation optimization and evaluation of mouth dissolving film of ramosteron hydrochloride. Int J Curr Pharm Res 2020;12:99-106.
Jagtap VD. Buccal film-a review on novel drug delivery system. Int J Res Rev 2020;7:17-28.
Al-Dhubiab BE, Nair AB, Kumria R, Attimarad M, Sree H. Development and evaluation of buccal films impregnated with selegiline-loaded nanosphere. Drug Delivery 2016;23:2154-62.
Nair AB, Kumari R, Harsha S, Attimarad M, Al-Dhubiab BE, Alhaider IA. In vitro techniques to evaluate buccal films. J Controlled Release 2013;166:10-21.
Lodhi M, Dubey A, Narayan R, Prabhu P, Sneh P. Formulation and evaluation of buccal film of invbradine hydrochloride for the treatment of stable angina pectoris. Int J Pharm Ivestig 2013;3:47-53.
Alagusundaram M, Chetty CM, Dhachinamoorthi D. Development and evaluation of novel-trans-buccoadhesive films of famotidine. J Adv Pharm Technol Res 2011;2:17-23.
Surini S, Gotalia F, Putri KSS. Formulation of mucoadhesive buccal films using pregelatinized cassava starch phthalate as a film-forming polymer. Int J Appl Pharm 2018;10:225-9.
Raghavendra Rao NG, Suryakar VB. Formulation and evaluation of montelukast sodium mucoadhesive buccal patches for chronic asthma attacks. Int J Pharm Bio Sci 2010;1:1-14.
Salehi S, Boddohi S. New formulation and approach for mucoadhesive buccal film of rizatriptan benzoate. Prog Biomater 2017;6:175-87.
Morales JO, McConville JT. Manufacture and characterization of mucoadhesive buccal films. Eur J Pharm Biopharm 2011;77:187-99.
Suvarna DS, Koland M, Prabhu A, Sindhoor SM. Mucoadhesive polymeric films of acyclovir proniosomes for buccal administration. Int J Appl Pharm 2021;13:135-43.
Kumar BV, Kumar AA, Sudheer B, Kumar SK, Rao SV, Kirtinidhi K, et al. Formulation design, in vitro evaluation and stability studies on mucoadhesive buccal films of anti-anginal calcium channel blocker. J Appl Pharm Sci 2011;1:136-42.
Prajapati ST, Maheshwari PD, Patel CN. Formulation and evaluation of orodispersible tablets of cilnidipine by spray drying techniques. World J Pharm Pharm Sci 2015;5:1526-39.
Hanif M, Zaman M, Chaurasiya V. Polymers used in buccal film: a review. Design Monomers Polymers 2015;18:105-11.
Mishra SK, Guard N, Singh R. Development and evaluation of mucoadhesive buccal patch of flurbiprofen. Pharma Technol 2011;68 Suppl 6:955-64.
Lohani A, Prasad N, Rajeshwar KKA. Formulation and characterization of mucoadhesive buccal films of ranitidine hydrochloride. Int J Pharm Sci 2011;2:2547-462.
Nair AB, Al-Dhubiab BE, Shah J, Jacob S, Saraiya V, Attimardd M, et al. Mucoadhesive buccal film of amlotriptan improved therapeutic delivery in rabbit model. Saudi Pharm J 2020;28:201-9.
Patel VM, Prajapati BG, Patel MM. Design and characterization of chitosan-containing mucoadhesive buccal patches of propranolol hydrochloride. Acta Pharm 2007;57:61-72.
Peh KK, Wong CF. Polymeric films as a vehicle for buccal delivery: swelling, mechanical and bioadhesive properties. Int J Pharm Pharm Sci 1999;2:53-61.
Malpure DR, Deore SL. Development and characterization of buccal film of candesartan. Pharm Methods 2016;7:75-88.
Nappinnai M, Chandanbala R, Balajirajan R. Formulation and evaluation of nitrendipine buccal films. Indian J Pharm Sci 2008;70:631-5.
Augusthy AR, Vipin KV, Chandran S, Thushara MV, Muhammed STK. Formulation and evaluation of mucoadhesive buccal film of lisnopril. Res Rev J Pharm Nanotechnol 2014;2:45-51.
Mane PP, Bushetti SS, Keshavshetti GG. Development and in vitro evaluation of mucoadhesive buccal film of nebivolol. Indian J Pharm Sci 2014;76:166-9.
Nafee NA, Ismail FA, Boraie NA, Mortada LM. Mucoadhesive buccal patches of miconazole nitrate: in vitro/in vivo performance and effect of ageing. Int J Pharm 2003;264 Suppl 1-2:1-14.
El Sharawy AM, Shur MH, Elshafeey AH. Formulation and optimization of duloxetine hydrochloride buccal films: in vitro and in vivo evaluation. Drug Delivery 2017;24:1762-9.
Sharma D, Sharma A, Garg R. Design, development and in vitro/ex-vivo evaluation of mucoadhesive buccal film of benzydamine hydrochloride for the effective treatment of aphthous stomatitis. Recent Pat Drug Delivery Formul 2018;12 Suppl 4:277-94.
Gorle A, Patil P, Bhaskar R, Ola M. Development and evaluation of buccal film containing antihypertensive agent. Pharm Innova J 2015;4:53-60.
How to Cite
Copyright (c) 2021 SHIFA SHAUKAT HAJU, SHEELA YADAV
This work is licensed under a Creative Commons Attribution 4.0 International License.