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Current Applied Polymer Science

Editor-in-Chief

ISSN (Print): 2452-2716
ISSN (Online): 2452-2724

Research Article

Design, Development and Optimization of Glibenclamide Sustained Release Matrix Tablet by Using Natural Polymers

Author(s): Kuldeep H. Ramteke*, Dipika E. Ghadge, Savita A. Palve and Sachin S. Gaikwad

Volume 3, Issue 3, 2019

Page: [197 - 211] Pages: 15

DOI: 10.2174/2452271603666191104151057

Abstract

Background: Tablets being the conventional dosage forms can be modified for providing the desired therapeutic effect to the patients. The network of matrix in the tablet allows the drug release to be slowed down considerably.

Objective: The prime objective of the study was to formulate sustained release glibenclamide matrix tablets using locust bean gum and karaya gum as a matrix polymer.

Methods: Tablets were formulated by optimization using 32 factorial designs by direct compression method using different drug: polymer concentrations. The dependent variables selected were % cumulative drug release (Y1) and % drug content (Y2). The independent variables are the amount of locust bean gum (X1) and karayagum (X2). Drug-polymer compatibility studies were confirmed by FTIR and DSC. The pre-compression properties of powder were assessed indicating a good flow property. The evaluation results of the tablets were found to be within the Indian Pharmacopoeial limit. In this work, the effect of diluents type and polymer type was studied on the drug release with its increase in concentration.

Results: All the formulations showed retarded drug release as the concentration of the polymer was increased. Formulation F8 was selected as the best-optimized formulation with about 100.56% drug release within 12 h. Release kinetics was carried out and it was found to be zero-order release and from assay, drug content was found to be in limits.

Conclusion: ANOVA analysis indicated that the studied variables affected the response variables significantly. The optimized formulation was stable. Hence, it is concluded that the Glibenclamide sustained release matrix tablet containing natural polymers were successfully formulated by using 32 factorial design.

Keywords: ANOVA analysis, DSC, karaya gum, locust bean gum, matrix tablet, P-XRD.

Graphical Abstract
[1]
Ponchel G, Irache J. Specific and non-specific bioadhesive particulate systems for oral delivery to the gastrointestinal tract. Adv Drug Deliv Rev 1998; 34(2-3): 191-219.
[http://dx.doi.org/10.1016/S0169-409X(98)00040-4] [PMID: 10837678]
[2]
Furlanetto S, Cirri M, Maestrelli F, Corti G, Mura P. Study of formulation variables influencing the drug release rate from matrix tablets by experimental design. Eur J Pharm Biopharm 2006; 62(1): 77-84.
[http://dx.doi.org/10.1016/j.ejpb.2005.07.001] [PMID: 16154333]
[3]
Patel MP, Patel MM, Patel KN, Patel DR, Patel UI. Formulation and evaluation of transdermal patches of glibenclamide. Int J Pham Res 2009; 1(2): 34-42.
[4]
Wei H, Löbenberg R. Biorelevant dissolution media as a predictive tool for glyburide a class II drug. Eur J Pharm Sci 2006; 29(1): 45-52.
[http://dx.doi.org/10.1016/j.ejps.2006.05.004] [PMID: 16815694]
[5]
Löbenberg R, Krämer J, Shah VP, Amidon GL, Dressman JB. Dissolution testing as a prognostic tool for oral drug absorption: dissolution behavior of glibenclamide. Pharm Res 2000; 17(4): 439-44.
[http://dx.doi.org/10.1023/A:1007529020774] [PMID: 10870988]
[6]
Kaity S, Ghosh A. Facile preparation of acrylamide grafted locust bean gum poly(vinyl alcohol)interpenetrating polymer network microspheres for controlled oral drug delivery. J Drug Del. Sci Tech (Paris) 2016; 33: 1-12.
[7]
Picout DR, Ross-Murphy SB, Jumel K, Harding SE. Pressure cell assisted solution characterization of polysaccharides. 2. Locust bean gum and tara gum. Biomacromolecules 2002; 3(4): 761-7.
[http://dx.doi.org/10.1021/bm025517c] [PMID: 12099820]
[8]
Davidson RL. Handbook of water soluble gums and resins. 1980.
[9]
Munday DL, Cox PJ. Compressed xanthan and karaya gum matrices: Hydration, erosion and drug release mechanisms. Int J Pharm 2000; 203(1-2): 179-92.
[http://dx.doi.org/10.1016/S0378-5173(00)00444-0] [PMID: 10967440]
[10]
Reddy SC, Shivakumar HG, Shyami MM, Narendra C. Karaya and ghatti gum as a novel polymer blend in preparation of extended release tablets: Optimization by factorial design.J Drug Del. Sci Tech (Paris) 2014; 24(5): 525-32.
[http://dx.doi.org/10.1016/S1773-2247(14)50099-8]
[11]
United States Pharmacopoeia and National Formulary (USP29- NF24) Supplement 1. New York: United States pharmacopeial convention. 2006.
[12]
The Pharmacopoeia of India. New Delhi: Government of India Ministry of Health and Family Welfare 1996.
[13]
Kompellaa SD, Bharathia A, Sowjanyaa K. Formulation and in-vitro evaluation of sustain release matrix tablet of losartan potassium using natural gum. J Drug Del Res 2014; 2(4): 17-33.
[14]
Moin A, Shivakumar HG. Formulation of sustained-release diltiazem matrix tablets using hydrophilic gum blend. Trop J Pharm Res 2010; 9(3): 283-91.
[http://dx.doi.org/10.4314/tjpr.v9i3.56291]
[15]
Deb N, Kulkarni SV, Kumar P. Feasibility of using natural gums for development of sustained release matrix tablet of itopride. Der Pharmacia Lettre 2015; 7(3): 114-23.
[16]
Deshmukh VN, Singh SP, Sakarkar D. Formulation and evaluation of sustained release metoprolol succinate tablet using hydrophilic gums as release modifiers. Int J Pharm Tech Res 2009; 1(2): 159-63.
[17]
Bakshi P, Sadhukhan S, Maiti S. Design of modified xanthan mini-matrices for monitoring oral discharge of highly soluble Soluplus®-glibenclamide dispersion. Mater Sci Eng C 2015; 54(1): 169-75.
[http://dx.doi.org/10.1016/j.msec.2015.05.014] [PMID: 26046280]
[18]
Ahad AH, Reddy AB, Chandra Shekar A, Ravindra BV. Development and in Vitro evaluation of glibenclamide aloe barbadensis miller leaves mucilage controlled release matrix tablets. Int J Pharm Tech Res 2010; 2(2): 1018-21.
[19]
Costa P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 2001; 13(2): 123-33.
[http://dx.doi.org/10.1016/S0928-0987(01)00095-1] [PMID: 11297896]
[20]
Stability testing of new drug substances and products note for guidance on stability testing: Stability testing of new drug substances and products European Medicines Evaluation Agency (EMEA) (CPMP/ICH/2736/99). 2003.
[21]
Ahad AH, Meghana M, Navya K, Mallika B. Designing and evaluation of glibenclamideazadirachtaindicamucilage based controlled release matrix tablets. Der Pharmacia Lettre 2010; 2(1): 117-21.
[22]
Jayaswal SR, Felix JV, Viswanath BA. Formulation and evaluation of sustained release matrix tablets of Glibenclamide. Int J Pharm Teach 2014; 6(2): 6572-86.
[23]
Pawan P, Kumar N. Formulation, evaluation and comparison of sustained release matrix tablet of diclofenac sodium using natural polymer. Int J Res Pharm Biomed Sci 2013; 4(1): 367-79.
[24]
Maity S, Sa B. Ca-carboxymethyl xanthan gum mini-matrices: Swelling, erosion and their impact on drug release mechanism. Int J Biol Macromol 2014; 68: 78-85.
[http://dx.doi.org/10.1016/j.ijbiomac.2014.04.036] [PMID: 24768968]
[25]
Sharma J, Nagpal M, Arora S. Glibenclamide solubility enhancement by modified natural gum carriers using the solid dispersion technique. Farmacia 2012; 60(6): 822-39.
[26]
Garad SV, Jangme CM, Somnathe ND. Application of rheological synergism between hydrophilic gums in the development of sustained release matrix tablets. World J Pharm Pharm Sci 2015; 4(3): 503-12.
[27]
Martins JT, Cerqueira MA, Bourbon AI, Pinheiro AC, Souza BWS, Vicente AA. Synergistic effects between k-carrageenan and locust bean gum on physicochemical properties of edible films made thereof. Food Hydrocoll 2012; 29(2): 280-9.
[http://dx.doi.org/10.1016/j.foodhyd.2012.03.004]

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