Preparation and Evaluation of Rapidly Disintegrating Glimepiride Tablets
DOI:
https://doi.org/10.37285/ijpsn.2010.3.4.7Abstract
The objective of this work was to prepare Glimepiride (1 mg) rapidly disintegrating tablets (RDT) by direct compression, and also, to evaluate Pharmaburst™ as a newly introduced diluent for this type of tablets, either alone or in combination with other well known tablet excipients. Another goal was to study the stability, as well as, the in vivo effects of selected formulations. Orange flavor was the most preferred flavor for the prepared rapidly disintegrating tablets containing Pharmaburst™ as a single diluent. Pharmaburst™ alone is sufficient to produce rapidly (orally) disintegrating tablets of Glimepiride with good physical characteristics, better compactability and shorter in-vivo and in-vitro disintegration time. The prepared Glimepiride RDT were found to have faster onset of action than the conventional Glimepiride tablets. Also, they were effective in lowering fasting blood glucose levels (FBG) in rabbits. Glimepiride RDT containing Pharmaburst™ alone were found to be stable when subjected to accelerated stability conditions (40 °C / 75 % relative humidity) for at least 3 months. Packaging the prepared Glimepiride RDT in 40 CC high density polyethylene (HDPE) bottles with 2 grams silica gel desiccant canisters and rayon had provided sufficient protection for the tablets. The used packaging system is believed to be very practical and convenient for elderly diabetic patients. It is also assumed to be preferred by the manufacturers.
Downloads
Metrics
Keywords:
Glimepiride, Pharmaburst, Superdisintegrant, Rapidly disintegrating tabletsDownloads
Published
How to Cite
Issue
Section
References
P., and Piccerelle, P., Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration. International Journal of Pharmaceutics. 292, 29-41(2005).
Abdelbary, G., Prinderre, P., Eouani, C., Joachiom, J., Reynier, J. P., and Piccerelle, P., The preparation of orally disintegrating tablets using a hydrophilic waxy binder. International Journal of Pharmaceutics. 278, 423-433(2004).
Aly AM, Semreen M., and. Qato MK. Superdisintegrants for Solid Dispersion to produce Rapidly Disintegrating Tenoxicam Tablets via Camphor Sublimation; Pharmaceutical Technology,29(1):68-75,(2005).
Aly AM., Preparation of Rapidly Disintegrating Ketorolac Tromethamine Tablets by Direct compression and Lyophilizaion, Arab Journal of Pharmaceutical Sciences, 2 (4):47-60 (2003).
Chue P., Welch R., and Binder C., Acceptability and disintegration rates of orally disintegrating Risperidone tablets in patients with Schizophrenia or Schizoeffective disorder. Canadian Journal of Psychiatry. 49 (10): 701-703(2004).
Fukami J., Yonemochi E., Yoshihashi Y., and Terada K., Evaluation of rapidly disintegrating tablets containing glycine and carboxymethylcellulose, International Journal of Pharmaceutics, 310 (1):101-109(2006).
Ishikawa T., Watanabey Y., Utoguchi N.and Matsumoto M. Preparation and evaluation of tablets rapidly disintegrating in saliva containing bitter-taste-masked granules by the compression method. Chem Pharm Bull, 47(10): 1451-1454(1999).
Ito A. and Sugihara M. Development of oral dosage form for elderly patients: use of agar as base of rapidly disintegrating oral tablets. Chem Pharm Bull, 44(11):2132-2136(1996).
Katzung BG., Basic & Clinical Pharmacology. Eighth edition (International edition). New York: Lange Medical Books / McGraw-Hill Companies, Inc., Medical Publishing Division. (2001).
Koizumi KI., Watanabe Y., Morita K., Utoguchi N., and Matsumoto M..New method of preparing high- porosity rapidly saliva soluble compressed tablets using mannitol with camphor, a subliming material. International Journal of Pharmaceutics, 152: 127-131(1997).
Mallet L. Caring for the elderly patient. J Am Pharm Assoc, 36(11): 628 (1996).
Mishra DN, Bindal M., Singh SK., and Vijaya Kumar SG., Spray Dried Excipient Base: A Novel Technique for the Formulation of Orally Disintegrating Tablets. Chemical and Pharmaceutical Bulletin. 54 (1):99–102 (2006).
Oshima T., Sonoda R., Ohkuma M., Sunada H. Preparation of rapidly disintegrating tablets containing itraconazole solid dispersions. Chemical & pharmaceutical bulletin, 55 (11):1557-1562(2007).
Rathbone M., Hadgraft J., and Robert M., Modified-release Drug Delivery Technology. Marcel Dekker Inc., New York and Basel (2003).
Sallam E., Ibrahim H.,. Dahab RA, Shubair M., and Khalil E. Evaluation of fast disintegrants in terfenadine tablets containing a gas-evolving disintegrant. Drug Dev Ind Pharm, 24(6):501- 507 (1998).
Shu T., Suzuki H., Hironaka K., and Ito K. Studies of rapidly disintegrating tablets in the oral cavity using co-ground mixtures of mannitol with crospovidone. Chemical & pharmaceutical bulletin, 50 (2):193-198 (2002).
Sugihara M.. New oral dosage form for elderly patient. Chem Pharm Bull, 43(12): 1853-1861(1995).
Sunada H.., and Bi Y., Preparation, evaluation and optimization of rapidly disintegrating tablets. Powder Technology. 122: 188–198(2002)