Innovation and optimization of Rizatriptan Benzoate Oromucosal Tablets by Using Design of Experiment (DoE)
Abstract
The present study deals with the formulation and study of oromucosal tablets of Rizatriptan Benzoate (RB) using different bioahdesive polymer. Nine formulations were prepared by using direct compression method. Hydroxypropyl methyl cellulose (HPMC K4M), Gum acacia and Sodium Alginate were used as buccal mucoadhesive polymer. Ethyl cellulose (EC) used as an impermeable backing layer. FTIR Studies showed no interaction with drug, polymer and excipients. 32 full factorial design was used to optimize the effect of independent variable such as concentration of HPMC K4M (X1) and concentration of Sodium Alginate (X2) on dependent variables such as % drug release (Y1), Mucoadhesive strength (Y2), Swelling Index (Y3). The prepared buccal mucoadhesive tablets were evaluated for weight variation, Hardness, Surface pH and drug content, content uniformity, swelling index, In-vitro drug release study and mucoadhesive strength. In-vitro drug release study showed sustained drug released for 9 hours. The In-vitro release kinetics reveals that formulation DE5 follows Higuchi model for drug release.
Keywords: Buccal Mucoadhesion, HPMC K4M, Sodium alginate, Design of experiments.
Keywords:
Buccal Mucoadhesion, HPMC K4M, Sodium alginate, Design of experimentsDOI
https://doi.org/10.22270/jddt.v12i2.5308References
Ratnaparakhi MP, Gupta JP,”Sustained Release Oral Drug Delivery System-An Overview”, IJPRR, 2013; 2(3):11-21
Shaik S, Himabindu S, Sathish D. “Formulation and Ex Vivo Evaluation of Buccal Tablet of Electriptan Hydrobromide.” AJPTR. 2012; 2(3):919- 930.
Fatima S, Panda N, Reddy V A, Fatima S. “Buccal Mucoadhesive tables of Sumatriptan Succinate for Treatment of Sustainable Migraine: Design Formulation and In Vitro Evaluation.” IJPRAS. 2015; 4(3):114 – 126.
Bobade NN, Atram SC, Wankhade VP, Dr. Pande SD, Dr. Tapar KK.” A Review on Buccal Drug Delivery System”, IJPSR.2013; 3(1):35-40 DOI:10.13040/IJPSR.0975-8232.2 (6)0.1303-21
Haranath C, K Arshad Ahmed Khan, Reddy Surya Prakash C, Pradeep Kumar B, V Veera Bhadrappa K. “Formulation and In-vitro Evaluation of Mucoadhesive Buccal tablet of Antimigrain drug”. Inventi Rapid: NDDS. 2015; (4):1- 10
Sellappan V, P Srinivas. “Formulation and Evaluation of Losartan Potassium Mucoadhesive Buccal Tablets”, AJPCR. 2013; 6(3):125-130
M Kanchan Mandal, Dr. Patel D B, “Formulation and Evaluation of Buccal Tablets of Rizatriptan Benzoate”, WJPR. 2019; 8(12):1311-1353
Kundal A, Kumar P, Chaudhary A, “A Review of Mucoadhesive Buccal Tablets Prepared Using Natural and Synthetic Polymers.” WJPPS. 2015; 4(7):475-500
Reddy CP, Chaitanya KSC, Rao M Y, “A Review on Bioadhesive Buccal Drug Delivery Systems: Current Status of Formulation and Evaluation Methods”. DARU: JPS. 2011; 19(6):385-403
Gilhotra R M, Ikram Mohd, Srivastava S, Gilhotra N A. “Clinical Perspective on Mucoadnesive Buccal Drug Delivery System”. JBR. 2014; 28(2):81- 97
Steiner T J, Stovner L J, Birbeck G L. “Migraine the seventh disabler,” JHP, 2013; 14;1 https://doi.org/10.1186/1129-2377-14-1
Burch R C, Buse D C, Lipton R B. “Migraine: Epidemiology Burden and Comorbidity,” NC. 2019; 37(4):631-649 https://doi.org/10.1016/j.ncl.2019.06.001
Scott A.K., “Sumatriptan Clinical Pharmacokinetics,” CP. 1994; 27(5):337-344. https://doi.org/10.2165/00003088-199427050-00002
Vyas KP, Halpin RA, Geer LA, Ellis JD, Liu L, Cheng H, Chavez-Eng C, Matuszewski B K, Varga SL, Guiblin AR, Rogers JD, ”Disposition and pharmacokinetics of the antimigraine drug, rizatriptan in humans”. DMD. 2000; 28(1):89-95
Fakuda I M, Pinto C F F, Moreira CS, Saviano A M, Lourenco F R, “Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design. (QbD)” BJPS. 2018:54 https://doi.org/10.1590/s2175-97902018000001006
Paithankar M, Bhalekar M, “Quality by Design Enabled Development and optimization of the Nanoparticulate system of Carbazitaxel” IJPSDR. 2022; 14(1):112-121
Manogna K, Nagaveni P, Thyagaraju K. “A Review on Mucoadhesive Bilayer Buccal Tablets”. AJPTR. 2018; 8(1):101-115 https://doi.org/10.46624/ajptr.2018.v8.i1.007
Shinkar D M, Shaikh T A and Saudagar R B. “Design, Optimization and Evaluation of Mucoadhesive Buccal Tablets of Valsartan”, IJPSR. 2020, 11(5):2093-2103
S D Naidu S D, Deepthi B S, Rao M P, Mogil R K, Rao V N. “Formulation and Evaluction of Mucoadhesive Buccal Tablet of Naratriptan Hydrochloride,” IJPCR. 2015; 1(1):46-54
Saleem M A, Pange S S, Shaikh AU, Singh VK. “Development and Evaluation of Mucoadhesive Buccal Tablets of Sumatriptan Succinct using Natural Gums.” RJT. 2011; 4(7):1140-1146
Krishna M S, P John, Syed J M. “Formulation and Invitro Evaluation of Mucoahesivd Buccal Tablets of Atrovastatin Calcium”, IJDD. 2014; 6(2):140-150
Siju P. Paun J, Soniwala M, Chavda J. “Design, Development and Evaluation of Unidirectional Buccal Tablets of Rizatriptan Benzoate.” EJPMR. 2018; 5(1):223 - 234.
Wable A J, Thokal S B, Mittal S S, Shirsat A E, Bhingare C L, Ingle P L1. “Effect of Formulation Parameters on Sumatriptan Succinate Buccal Mucoadhesive Tablet: Quality by Design approach”. JAPS. 2013; 4(4):103-111.
Ramani V D, Sailor G U , Patel M M , Parmar G R, Seth A K. “Experimental Design Approach for the Formulation of Controlled Release Buccal Bilayer Tablets of Carvedilol”.JIHS 2018; (6)2: 53-59. https://doi.org/10.4103/JIHS.JIHS_19_18
Gouda R, Baishya H, Qing Z, “Application of Mathematical models in Drug Release Kinetics of Carbidopa and Levodopa ER Tablet. JDD, 2017; 6(2) https://doi.org/10.4172/2329-6631.1000171
Paarakh P M, Jose P A, Setty C M, Christopher G V P, “Release Kinetics-Concepts and Applications.” IJPRT, 2018; (8). https://doi.org/10.4172/2329-6631.1000171
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