FORMULATION AND EVALUATION OF CONTROLLED RELEASE MUCOADHESSIVE MATRIX TABLETS OF LEVAMISOLE: ASSEMENT OF PURIFIED FRUIT PULP POLYSACCHARIDE ISOLATED FROM AEGLE MARMELOS AS MUCOADHESIVE EXCIPIENT

Authors

  • Jashabir Chakraborty
  • Suvakanta Dash
  • Biswajit Das

Abstract

ABSTRACT
Objective: Mucoadhesive tablets have been developed for Levamisole using natural mucoadhesive material such as purified polysaccharide isolated from
the ripe fruit pulp of Aegle marmelos. Lin (AMPS) and evaluate in-vitro, in-vivo mucoadhesive properties to assess its efficacy as mucoadhesive agent.
Method: The tablets were formulated with AMPS in different concentration employing wet granulation method. Pre-compression tests, tablet
parametric tests, swelling index and In-vitro drug release kinetics were performed. Optimization of formulation was done on the basis of controlled
and maximum amount of drug release with respect to time. In-vitro, ex-vivo evaluation of mucoadhesion was performed with all prepared formulation
but in-vivo evaluation was done by X-ray with optimized formulation (F40) in rabbit. Stability studies were carried out according to ICH guide line
with optimized formulation.
Results: The tensile strength, mucoadhesive strength and swelling index increase as the natural polymer concentration increase. The release
Kinetics and mechanism of release were calculated by fitting in-vitro release data in various models demonstrating that release. In vitro drug release
of the optimized batch (F40) was best fitted and explained by Korsemeyer–Peppas and zero order drug release; (Rp=0.9891) and (Ro=0.9842)
showed highest linearity and n value 0.97>0.5<1. Hence, pattern of drug release by non-Fickian erosion controlled release. Studies of the optimized
formulation demonstrate no significant change in the tensile strength, mucoadhesive strength and drug assay.
Conclusion: These research outcomes clearly specify the potential of the AMPS to be used as mucoadhesive, release retardent natural material in
tablet formulation
Keywords: Polysaccharide, Acrylamidopropylmethane sulfonic acid, Aegle marmelos, Levamisole, Mucoadhessive.

Downloads

Download data is not yet available.

References

REFERENCES

Morris GA. Polysaccharide drug delivery systems based on pectin and chitosan. Biotechnol Genet Eng Rev 2010;27:257-83.

Andrews GP, Laverty TP, Jones DS. Mucoadhesive polymeric platforms for controlled drug delivery. Eur J Pharm Biopharm 2009;71(3):505-18.

Morkhade DM, Fulzele SV, Satturwar PM, Joshi SB. Gum copal and gum damar: Novel matrix forming materials for sustained drug delivery. Indian J Pharm Sci 2006;68(1):53-8.

Jindal M, Kumar V, Ranaa V, Tiwarya AK. Aegle marmelos fruit pectin for food and pharmaceuticals: Physico-chemical, rheological and functional performance. Carbohydr Polym 2013;93(2):386-94.

Patil DN, Kulkarni AR, Patil BS. Fruit gum of Aegle marmelos as pharmaceutical aid. Int J Pharmacol 2010;6(1):68-71.

Vandamme TF, Demoustier M, Rollmann B. Quantitation of levamisole in plasma using high performance liquid chromatography. Eur J Drug Metab Pharmacokinet 1995;20(2):145-9.

Koyma K, Oshi T, Ishii A, Deguchi T. Levamisole: Metabolic fate of levamisole in rats, dogs and monkey. Oyo Yakuri 1983;26:869-76.

Adams JG. Pharmacokinetics of levamisole. J Rheumatol Suppl 1978;4:137-42.

Barker SA. The formation of aminorex in racehorses following levamisole administration. A quantitative and chiral analysis following synthetic aminorex or levamisole administration vs. aminorex-positive samples from the field: A preliminary report. J Vet Pharmacol Ther 2009;32(2):160-6.

Kumar MK, Suseela M. Phytochemical investigation and acute toxicity study of methanol extract of Bambusa vulgaris leaves. J Pharm Res 2011;4(2):403-5.

Singh AV, Nath LK. Evaluation of chemically modified hydrophobic sago starch as a carrier for controlled drug delivery. Saudi Pharm J 2013;21(2):193-200.

IP. Indian Pharmacopoeia. The Indian Pharmacopoeia Commission, Central Indian Pharmacopoeia Laboratory, Ministry of Health and Family Welfare, Govt. of India, Sector 23, Raj Nagar, Ghaziabad 201 002, India; 2007. p. 1516-7.

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):1264-71.

Manivannan R, Balasubramaniam A, Prem DC, Sandeep G, Rajkumar N. Formulation and in-vitro evaluation of mucoadhesive buccal tablets of diltiazem hydrochloride. Res J Pharm Technol 2008;1(4):478-80.

Sriamornsak P, Thirawong N, Weerapol Y, Nunthanid J, Sungthongjeen S. Swelling and erosion of pectin matrix tablets and their impact on drug release behavior. Eur J Pharm Biopharm 2007;67(1):211-9.

Ghosal K, Chakrabarty S, Nanda A. Hydroxypropyl methylcellulose in drug delivery. Pelagia Res Libr 2011;2(2):152-68.

Dash S, Murthy PN, Nath LK, Chowdhury P. Kinetic modelling on drug release from controlled drug delivery systems. Acta Pol Pharm 2010;67(3):217-23.

Lehr CM, Joke L, Schacht EH, Junginger H E. In vitro evaluation of mucoadhesive properties of chitosan and some other natural polymers. Int J Pharm 1992;78(1):43-8.

Teng CL, Ho NF. Mechanistic studies in the simultaneous flow and adsorption of polymer-Coated latex particle on intestinal mucus. J Cont Release 1987;6(1):133-49.

Rao R, Buri KV. A novel in situ method to test polymers and coated micro particles for bioadhesion. Int J Pharm 1989;52:265-70.

Singh SK, Bothara SB, Singh S, Patel R, Dodia R. Formulation and evaluation of mucoadhesive tablet: Influece of some hydrophilic polymers on the release rate and in vitro evaluation. Intern J Pharm Sci Nanotechnol 2010;3(3):1111-21.

Jain SK, Agrawal GP, Jain NK. A novel calcium silicate based microspheres of repaglinide: In vivo investigations. J Control Release 2006;113(2):111-6.

Jinsixiaozao CV, Li J, Fan L, Ding S. Isolation, purification and structure of a new water soluble polysaccharide from Zizyphus jujube. Carbohydr Polym 2011;83:477-82.

Säkkinen M, Marvola J, Kanerva H, Lindevall K, Ahonen A, Marvola M. Are chitosan formulations mucoadhesive in the human small intestine? An evaluation based on gamma scintigraphy. Int J Pharm 2006;307(2):285-91.

Abrahamsson B, Alpsten M, Bake B, Larsson A, Sjögren J. In vitro and in vivo erosion of two different hydrophilic gel matrix tablets. Eur J Pharm Biopharm 1998;46(1):69-75.

Al-Taani BM, Tashtoush BM. Effect of microenvironment pH of swellable and erodable buffered matrices on the release characteristics of diclofenac sodium. AAPS PharmSciTech 2003;4(3):E43.

Hancock BC, Parks M. What is the true solubility advantage for amorphous pharmaceuticals? Pharm Res 2000;17(4):397-404.

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

Singh B, Chakkal SK, Ahuja N. Formulation and optimization of controlled release mucoadhesive tablets of atenolol using response surface methodology. AAPS PharmSciTech 2006;7(1):E3.

Ponchel G, Touchard F, Duchene D, Peppas NA. Bioadhesive analysis of controlled systems. I. fracture and interpenetration analysis in poly (acrylic acid) containing systems. J Cont Release 1987;5:129-41.

Singh B, Ahuja N. Development of controlled release bucoadhesive hydrophilic matrices of diltiazem hydrochloride: Optimization of bioadhesive, dissolution and diffusion parameters. Drug Dev Ind Pharm 2002;28(4):431-42.

Abrahamsson B, Alpsten M, Bake B, Larsson A, Sjögren J. In vitro and in vivo erosion of two different hydrophilic gel matrix tablets. Eur J Pharm Biopharm 1998;46(1):69-75.

Mughal MA, Iqbal Z, Neau SH. Guar gum, xanthan gum, and HPMC can define release mechanisms and sustain release of propranolol hydrochloride. AAPS PharmSciTech 2011;12(1):77-87.

Leung SH, Robinson JR. Polymer structure features contributing to mucoadhesion II. J Cont Release 1990;12:187-94.

Arora G, Malik K, Singh I, Arora S, Formulation and evaluation of controlled release mucoadhesive matrix tablets: Assessment of myrrh oleo gum resin as a natural pharmaceutical excipient. Int J Pharm Sci Drug Res 2011;3(2):84-8.

Published

01-07-2015

How to Cite

Chakraborty, J., S. Dash, and B. Das. “FORMULATION AND EVALUATION OF CONTROLLED RELEASE MUCOADHESSIVE MATRIX TABLETS OF LEVAMISOLE: ASSEMENT OF PURIFIED FRUIT PULP POLYSACCHARIDE ISOLATED FROM AEGLE MARMELOS AS MUCOADHESIVE EXCIPIENT”. Asian Journal of Pharmaceutical and Clinical Research, vol. 8, no. 4, July 2015, pp. 262-9, https://journals.innovareacademics.in/index.php/ajpcr/article/view/6641.

Issue

Section

Original Article(s)