Design, Formulation and Physicochemical Evaluation of Clotrimazole Chewing Gum
Abstract
Background: Oral candidiasis is widespread in the patients with immunodeficiency diseases. Chewing gums are considered as mobile drug delivery systems that affected locally or systemically via the oral cavity. This study aimed to develop and evaluate the formulation of clotrimazole chewing gums for patients having oral candidiasis. Materials and Methods: Fourteen formulations (F) were designed by Design-Expert, version 7. These formulations were different in the amount of gum bases and sweeteners. Gum bases of elvasti, 487, stick, and fruit C were heated up to 70°C. Clotrimazole powder, sugar, liquid glucose, glycerin, mannitol, xylitol, and maltitol as well as different flavoring agents were added to the gum bases at 40°C. Content and weight uniformity, organoleptic properties evaluation, releasing the active ingredient in the phosphate buffer pH, 6.8, and taste evaluation were analyzed by Latin square analysis. Also, the mechanical test was done on F13 and F14 formulations. Results: F14 was the best formulation in terms of organoleptic properties. This formulation had suitable size, hardness, softness, and lack of adhesion to teeth. F14 formulation released 89% and 97% of clotrimazole after 30 and 45 minutes, respectively. F14 content uniformity and weight variations were 9.83±0.086 mg and 1.14±0.09 g, respectively. F14 evaluation of mechanical properties showed Young’s modulus about 0.32 MPa, and yield point occurred at the stress of 0.599 MPa and strain of 4.1%. Conclusion: F14 was chosen according to its physicochemical and organoleptic properties. F14 had adequate hardness, lack of adhesion to the teeth, suitable size, and best drug release. Tutti Frutti was a proper flavoring agent for clotrimazole gum formulations.[GMJ.2021;10:e1084]References
Salerno C, Pascale M, Contaldo M, Esposito V, Busciolano M. Candida-associated denture stomatitis. Med Oral Patol Oral Cir Bucal. 2011;1(16):139-43.
https://doi.org/10.4317/medoral.16.e139
PMid:20711156
Jafari M, Khalojini M, Falahati M , Ghadimipoor H R , Bigvand P , Tavakoli S . The frequency of candida albicans in the oral cavity of patients with major thalassemia and normal individuals. MLJ. 2011;5(1):24-30.
Katiraee F, Khosravi A, Khalaj V, Hajiabdolbaghi M, Khaksar A, Rasoulinejad M. In vitro antifungal susceptibility of oral candida species from Iranian HIV infected patients. Tehran Univ Med J. 2012;70(2):96-103.
Wen Y, Li C, Pei J, Bai J, Yang X, Duan K. The incidence of oral candidiasis in patients with human immunodeficiency virus infection/acquired immunodeficiency syndrome from Yunnan, China. Zhonghua Kou Qiang Yi Xue Za Zhi. 2014;49(8):454-8.
Scully C, El-Kabir M. Candida and Oral Candidosis: A Review. Crit Rev Oral Biol Med. 1994;5(2):125-57.
https://doi.org/10.1177/10454411940050020101
PMid:7858080
Phaechamud T, Tuntarawongsa S. Clotrimazole soft lozenges fabricated with melting and mold technique. Res J Pharm Biol Chem Sci. 2010;1(4):579-86.
Wang J, Jia L, Kuang Z, Wu T, Hong Y. The in vitro and In vivo antitumor effects of clotrimazole on oral squamous cell carcinoma. PLoS One. 2014;9(6).
https://doi.org/10.1371/journal.pone.0098885
PMid:24892421 PMCid:PMC4043897
Crowley PD, Gallagher HC. Clotrimazole as a pharmaceutical: past, present and future. J Appl Microbiol. 2014;117(3):611-17.
https://doi.org/10.1111/jam.12554
PMid:24863842
Ellepola ANB, Samaranayake LP. Oral candidal infections and antimycotics. Crit Rev Oral Biol Med. 2000;11(2):172-98.
https://doi.org/10.1177/10454411000110020301
PMid:12002814
Bhaskar DI, Amit SD, Unmesh MJ, Kailash RB. Chewing Gum: Mobile drug delivery system. Int. J Pharm Sci Rev Res. 2012;14(2):106-14.
Gadhavi A, Patel B, Patel D, Patel C. Medicated chewing gum- a 21st century drug delivery system. Int. J Pharm Sci Rev Res. 2011;2(8):1961-74.
https://doi.org/10.4103/0975-8453.86290
Anand S, Surana. Chewing gum: a friendly oral mucosal drug delivery system. Int. J Pharm Sci Rev Res. 2010;4(2):68-71.
Madhav N, Shakya A, Shakya P, Singh K. Orotransmucosal drug delivery systems: A review. J Control Release. 2009;140(1):2-11.
https://doi.org/10.1016/j.jconrel.2009.07.016
PMid:19665039
Aslani A, Rostami F. Medicated chewing gum, a novel drug delivery system. J Res Med Sci. 2015;20(4):403-11.
Prashant K, Pagare, Chandrakant S, Satpute, Varsha M. Medicated Chewing Gum: A Novel Drug Delivery System. J Appl Pharm Sci. 2012;2(6):40-54.
https://doi.org/10.7324/JAPS.2012.2706
Aslani A, Rafiei R. Design, Formulation and evaluation of nicotine medicated chewing gum. Adv Biomed Res. 2012;1:57.
https://doi.org/10.4103/2277-9175.100175
PMid:23326788 PMCid:PMC3544094
Sameja K, Raval V, Asodiya H, Patadiya D. Chewing Gum: A modern approach to oral mucosal drug delivery. IJPRD. 2011;4(3):1-16.
Pandey S, Goyani M, Devmurari V. evelopment, in-vitro evaluation and physical characterization of medicated chewing gum: Chlorhexidine gluconate. Der Pharmacia Lettre. 2009;1:286-92.
Aslani A, Ghannadi A, Rostami F. Design, formulation, and evaluation of ginger medicated chewing gum. Adv Biomed Res. 2016;5(30):130.
https://doi.org/10.4103/2277-9175.187011
PMid:27563640 PMCid:PMC4976530
Nagaich U, Chaudhary V, Karki R, Yadav A, Sharma P. Formulation of medicated chewing gum of ondansetron hydrochloride and its pharmacokinetic evaluations. IJPSR. 2010;1(2):32-40.
Aslani A, Ghannadi A, Raddanipour R. Design,formulation and evaluation of Aloe vera chewing gum. Adv Biomed Res. 2015; 31(4):175.
Aslani A, Jalilian F. Design, formulation and evaluation of caffeine chewing gum. Adv Biomed Res. 2013;2:72.
https://doi.org/10.4103/2277-9175.115806
PMid:24223387 PMCid:PMC3814650
Aslani A, Ghannadi A, Khalafi Z. Design, formulation and evaluation of green tea chewing gum. Adv Biomed Res 2014;3:142.
https://doi.org/10.4103/2277-9175.135159
PMid:25161989 PMCid:PMC4139976

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