Development and Statistical optimization of mucoadhesive drug delivery system of famotidine using Hibiscus esculentus polysaccharide

Pulak Deb, Suvakanta Dash, Padala Narsimha Murthy

Abstract


The presentstudy was aimed to formulate and evaluate oral mucoadhesive drug deliverysystem of purified Hibiscus esculentusL polysaccharide (HEP) using famotidine as model drug. A centralcomposite design for 2 factors at 3 levels each was employed to evaluate theeffect of critical variables i.e. concentration of HEP and PVP K30 on drugrelease and mucoadhesive properties of the formulated tablets. FT-IRspectroscopy and Differential Scanning Calorimetry was carried out to evaluatedrug polymer interaction. Formulated tablets were evaluated for physicalproperties, drug release characteristic and physical stability. Ex-vivo mucoadhesion study using goatgastric mucosa was carried out to ascertain the mucoadhesion potential offormulated tablets.The responsesurface analysis clearly indicated the dominating effect of HEP on mucoadhesivestrength, mucoadhesion time and dissolution half life, while PVP K30 has anadditive effect on all afore mentioned responses. The drug release from thematrix tablets was highly affected by the concentration of release retardantspolysaccharide. The kinetics of drug release was found to be first order in lowconcentration but with increase in polymer concentration the release patternshifted towards zero order and is governed by both Higuchi and Hixson-Crowelequation indicating a coupling effect of diffusion and erosion. The result ofthe study suggests that, HEP can be optimistically explored as excellentmucoadhesive agent with controlled release characteristics.

Keywords


Hibiscus esculentus polysaccharide, Mucoadhesive drug delivery system, Mucoadhesive strength, central composite design (CCD), Texture analysis.

Full Text:

PDF

References


Rouge N, Allemann E, Gex-Fabry M, Balant L, Cole ET, Buri P, Doelker E. Comparative pharmacokinetic study of a floating multiple-unit capsule, a high density multipleunit capsule and an immediate-release tablet containing 25 mg atenolol. Pharm Acta Helbetiae, 1998; 73: 81 – 87.

Streubel A, Siepmann J, Bodmeier R. Multiple unit Gastroretentive drug delivery: a new preparation method for low density microparticles. J Microencapsul, 2003; 20: 329 – 347.

Santus G, Lazzarini G, Bottoni G, Sandefer EP, Page RC, Doll WJ, Ryo UY Digenis GA. An in vitro- in vivo investigation of oral bioadhesive controlled release furosemide formulations. Eur J Pharm Biopharm, 1997; 44: 39 – 52.

Deshpande AA, Shah N, Rhodes CT Malik W. Development of a novel controlled-release system for gastric retention, Pharm Res, 1997: 14: 815 – 819.

Park K. Enzyme-digestible swelling as platforms for long term oral drug delivery: synthesis and characterization. Biomaterials, 1988; 9: 435.

Fujimori J, Machida Y, Nagai T. Preparation of a magnetically-responsive tablet and configuration of its gastric residence in beagle dogs, STP Pharma Sci, 1994; 4: 425 – 430.

Khutoryanskiy VV. Advances in mucoadhesion and mucoadhesive polymers, Macromol. Biosci, 2011; 11: 748 – 764.

Bodea A, Leucuta SE. Optimization of propranolol hydrochloride sustained release pellets using box-behnken design and desirability function. Drug Dev. Ind. Pharm. 1998; 24: 145-155.

Kramar A, Turk S, Vrecer F. Statistical optimisation of diclofenac sustained release pellets coated with polymethacrylic films, Int. J. Pharm. 2003; 256, 43-52.

Gohel MC, Jani GK, Patel NK, Gondaliya DP. Optimization of hydrophilic matrix tablet formulation of diclofenac sodium using a mixture design. Pharm. Pharmacol. Commun. 1998; 4: 433-438.

Ladani RK, Patel MJ, Patel RP, Bhatt TV. Modern optimization techniques in field of pharmacy. Res J Pharm Bio Chem Sci, 2010; 1(2): 148-157.

Available at: http://www.rjpbcs.com/pdf/Old%20files/23.pdf

Mathure DM, Bhalekar MR, Mathure DM, Padalkar RR, Dawane BS, Chobe SS. Formulation and statistical optimization of controlled release pellets of cetrizine dihydrochloride. Der Pharmacia Lettre, 2011; 3(3): 443-452

Available at: http://scholarsresearchlibrary.com/DPL-vol3-iss3/DPL-2011-3-3-443-452.pdf

Akhgari A, Garekani HA, Sadeghi F, Azimaie M. Statistical optimization of indomethacin pellets coated with pH-dependent methacrylic polymers for possible colonic drug delivery, Int J Pharmaceu., 2005; 305: 22-30.

Mandal U, Gowda V, Ghosh A, Selvan S, Solomon S, Pal TK. Formulation and optimization of sustained release matrix tablet of metformin HCl 500mg using response surface methodology. Yakugaku Zasshi, 2007; 127(8): 1282 – 1290.

Available at: http://yakushi.pharm.or.jp/FULL_TEXT/127_8/pdf/1281.pdf

Sahoo BK, Mishra AK, Pal TK. Optimization and validation of modulated release formulation of ranitidine hcl by response surface methodology. Int JPharm Sci Drug Res, 2011; 3(1): 13-18

Available at: http://jbsr.pharmainfo.in/documents/vol2issue2/2010020202.pdf

Howden CW, Tytgat GNJ. The tolerability and safely profile of famotidine, Clin. Therapeut., 1996; 18: 36.

Al-Omar MA, Abdullah M, Al-Mohizea AM. Chapter: 3, Famotidine, in Profiles of Drug Substances, Excipients, and Related Methodology, Vol. 34, Academic Press, Burlington; 2009: 115-151.

Jaimini M, Rana AC, Tanwar YS. Formulation and evaluation of famotidine floating tablets. Current Drug Delivery, 2007; 4: 51 – 55.

Dash S, Murthy PN, Deb P, Chakraborty J, Das B. Optimization and characterization of purified polysaccharide from Musa sapientum L. as a pharmaceutical excipient. Food Chem. 2014; 149: 76 – 83.

Verma RK, Garg S. Selection of excipients for extended release formulations of glipizide through drug–excipient compatibility testing. J Pharma Biomed Ana. 2005; 38: 633–644.

Arora G, Malik K, Singh I. Formulation and evaluation of mucoadhesive matrix tablet of taro gum: optimization using response surface methodology. Pol Medy, 2011; 41(2): 23-34.

Available at: www.ncbi.nlm.nih.gov/pubmed/21866794

Umarunnisha AM, Palanichamy S, Rajesh M, Jeganath S, Thangathirupathi A. Formulation and evaluation of matrix tablets of Famotidine using hydrophilic polymer. Arch Appl Sci Res, 2010; 2(3): 212 – 220.

Senthil V, Sureshkumar R, Lavanya K, Rathi V, Venkatesh DN, Ganesh GNK, Jawahar, N, Gowthamarajan K. In vitro and in vivo evaluations of Theophylline Gastroretentive Mucoadhesive tablets preparedby using natural gums. J Pharm Res, 2010; 3(8): 1961-1966.

Zeenath S, Gannu R, Bandari S, Rao YM. Development of gastroretentive systems for famotidine: in vitro characterization. Acta Pharmaceutica Sciencia, 2010; 52: 495-504.

Varelas CG, Dixon DG, Steiner CA. Zero-order release from biphasic polymer hydrogels. J Control Rel. 1995; 34: 185-192.

Mulye NV, Turco SJ. A Simple Model Based on First Order Kinetics to Explain Release of Highly Water Soluble Drugs from Porous Dicalcium Phosphate Dihydrate Matrices. Drug Dev Ind Pharm. 1995; 21: 943-953.

Wagner JG. Interpretation of percent dissolved-time plots derived from in vitro testing of conventional tablets and capsules. J Pharm Sci. 1969; 58: 1253-1257.

Higuchi T. Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci. 1963; 52: 1145-1149.

Katzhendler I, Hoffman A, Goldberger A, Friedman M. Modeling of drug release from erodible tablets. J Pharm Sci. 1997; 86: 110-115.

Korsmeyer RW, Gurny R, Doelker E, Buri P, Peppas NA. Mechanisms of solute release from porous hydrophilic polymers. Int J Pharm. 1983; 15: 25-35.

Ritger PL, Peppas NA. A simple equation for description of solute release II. Fickian and anomalous release from swellable devices. J Control Rel. 1987; 5: 37-42.

Arora G, Malik K, Rana V, and Singh I. Gum Ghatti – A pharmaceutical excipient: Development and optimization of sustained release mucoadhesive matrix tablets of domeperidone. Acta Pol Pharma – Drug Res, 2012; 69(4): 725-729.

Shaikh DM, Shende MA, Shaikh AM. Formulation Development and Evaluation of Gastro Retentive Mucoadhesive Tablets Using Synthetic Polymers. Int. J Res Pharm Biomed Sci. 2013; 4(4): 1264-1271.

Mathews BR. Regulatory aspects of stability testing in Europe, Drug Dev. Ind. Pharm, 1999; 25: 831–856.

Raval JA, Patel MM. Design and development of a swellable andmucoadhesive gastroretentive tablet of amoxicillin, Asian J Pharm Sci, 2011; 6(3): 141-150.

Abrahamsson B, Alpsten M, Bake B, Larsson A, Sjogren J. In vitro and in vivo erosion of two different hydrophilic gel matrix tablets. Eur J Pharm Biopharm, 1998; 46: 69-75.

Rajamma AJ, Yogesha HN, Sateesha SB. Natural gums as sustained release carriers: development of gastroretentive drug delivery system of ziprasidone HCl. DARU J Pharm Sci, 2012; 20: 58.

Al-Tanni BM, Tashtoush BM. Effect of microenvironment pH of swellable and erodable buffered matrices on the release characteristics of diclofenac sodium. AAPS Pharmsci Tech, 2003; 4(3): 43.

Ye CL, Jiang Y. Optimization of extraction process of crude polysaccharide from Plantagoasitica L by response surface methodology. Carbohy Polym, 2011; 84: 495-502.


Refbacks

  • There are currently no refbacks.




Copyright (c)

               AR Journals

18K, Street 1st, Gaytri Vihar, Pinto Park, Gwalior, M.P. India

Copyright@arjournals.org (Design) 2009-2021

 

Follow @arjournals on Twitter