Formulation Taste Masked Orodispersible Tablet of Pregabalin

Inderjeet singh Gurbachan singh Huda, Sanjay S. Toshniwal

Abstract


In the present work, orodispersible tablets of Pregabalin were designed by preparing tasteless complexes of Pregabalin with weak cation ion exchange resins (KYRON T 134). The ion exchange complexes were prepared by the batch process using activated Kyron T 134 with a drug: resin ratios 1:1, 1:2, 1:3 and 1:4 (% w/w). IR analysis, assay content and decomplexation studies confirmed complex formation. It was found that maximum complexation of drug with resin was noted between pH range 5.5-7, while activation of ion exchange resin does not affects the percent drug loading. Drug release from drug: resin complex in salivary pH was insufficient to impart bitter taste. A study on super-disintegrants along with directly compressible diluents is studied and its effect on disintegration time and enhance mouth feel. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity and in vitro dispersion time. Based on in vitro disintegration time (approximately 30 s), formulations were tested for in vitro drug release pattern (in 0.06 N HCl),

Keywords


Orodispersible Tablet; Pregabalin; Ion exchange Resin; Kyron T 134.

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References


Seager H. Drug-delivery products and the Zydis fast-dissolving dosage form. J Pharm Pharmacol. 1998; Apr 50(4):375-82.

Sastry SV, Nyshadham JR, Fix JA. Recent technological advances in oral drug delivery: A review. Pharm Sci Technol Today. 2000; 3:138-45.

Mallet L. Caring for the Elderly Patient. J. Am. Pharm. Assoc, 1996;36(11): 628-635

Habib W, Khankari R, Hontz J. Fast-dissolve drug delivery systems. Crit. Rev. Ther. Drug. Carrier Syst. 2000;17:61-72

Laboratoire L.Lefon, Maisons-Alfort, France, (1985) European Patent 0159 237.

Green R., Kearney P. Process for preparing fast dispersing oral solid dosage forms, US Patent 5 976 577, 1999.

Cousin G, Bruna E, Gendrot E. Rapidly disintegratable multiparticulate tablet, US Patent 5,464, 632, 1995.

Dobetti L. Fast-Melting Tablets: Developments and Technologies. Pharm. Technol., Drug delivery supplement. 2001; 44-50.

Morita Y, Tsushima Y, Termoz R, Ajioka J, Takayama K. “Evaluation of disintegration time of rapidly disintegrating tablets via a novel method utilizing a CCD camera.” Chem Pharm Bull (Tokyo). 2002;50:1181-1186.

Bi Y, Sunanda H, Yonezawa Y, Danjo K, Otsuka A, Iida K. Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity. Chem. Pharm. Bul (Tokyo) 1996; 44: 2121-2127.

Watanabe Y, Yamamoti Y, Fujii M, Kondoh M, Shibata Y. “A novel method for predicting disintegration time in the mouth of rapid disintegrating tablet by compaction analysis using Tab AII”, Chem Pharm Bull (Tokyo). 2004;52:1394-1395

Warner-Lambert Company (Northwestern University) (1996) US patent 5563175.

Borodkin S, Sundberg DP. “Polycarboxylic acid ion-exchange resin adsorbates for taste coverage in chewable tablets”, J Pharm Sci. 1971;60:1523–1527.

Swarbrick, J., Boylan, J.C., editors. Encyclopedia of Pharmaceutical Technology. Marcel Dekker., New York, 1993. p 203– 16

Notari, RE. “Biopharmaceutics and Clinical Pharmacokinetics” Marcel Dekker., 4th ed. New York.; 1987

Borodkin, S. and Yunker, M. H. Interaction of amine drugs with a polycarboxylic acid ion-exchange resin. J. Pharm. Sci. 1970;59:481–486.

Bhise, K., Shaikh, S. & Bora, D. Taste mask, design and evaluation of an oral formulation using ion exchange resin. AAPS PharmSciTech. 2008;9(2):557-62

Agrawal R, Mittal R, Singh A.“Studies of Ion-Exchange Resin Complex of Chloroquine Phosphate.” Drug Dev Ind Pahrm., 2000;26:773-776.

“United States pharmacopoeia 24/ National Formulary 19”, The Official Compendia of Standards. Asian ed. Rockville, MD, p. 1913-14.

Martin, A. (2001) “Physical Pharmacy” Lippincott Williams & Wilkins 5th ed. Philadelphia, PA.

Wells, J. (2002) “Pharmaceutical preformulation: The physiochemical properties of drug substances”, In : Aulton, M. E. ed. Pharmaceutics the science of dosage form design. London: Churchill Livingstone. p. 247.

Rajinder Singh G, Sk Manirul Haque and Sanjeev Kumar. “A novel method for the determination of pregabalin in bulk pharmaceutical formulations and human urine samples.” Afr. J. Pharm. Pharmacol., 2009; 3(6):327-334.


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