Development and evaluation of carbamazepine fast dissolving tablets prepared with a complex by direct compression technique
Main Article Content
Abstract
sodium, crospovidone and sodium starch glycolate. Carbamazepine is used to control different types of seizures in the treatment of epilepsy. Poor solubility in biological fluids is the major problem with this drug as also its poor bioavailability
after oral administration.The rate of absorption and/or the extent of bioavailability for such a poor soluble drug is controlled by rate of dissolution in gastrointestinal fluids. Hence, to enhance the solubility of the drug, a complex of carbamazepine was prepared with β-cyclodextrin and this complex was compressed into tablets. The prepared tablets were evaluated for
hardness, friability, drug content, weight variation, disintegrating time, wetting time, in vitro dissolution studies, etc. The prepared tablets were characterized by DSC, Fourier transform infrared spectroscopy (FTIR) and stability studies.The different formulations showed disintegration times between the ranges of 26.86 and 58.54 s. Drug release showed time between the ranges of 4 and 12 min. Among all the formulations, B8 showed 99.89% drug release within 4 min.Thus, B8 was considered as the best among the other formulations. No chemical interaction between the drug and the excipients was confirmed by
DSC and FTIR studies. The stability study was conducted as per the ICH guidelines and the formulations were found to be stable, with insignificant changes in hardness, drug content and disintegration time.These results revealed that fast dissolving tablets of the poorly soluble drug, carbamazepine, showing enhanced dissolution and, hence, better patient compliance.
Downloads
Article Details
This is an Open Access article distributed under the terms of the Attribution-Noncommercial 4.0 International License [CC BY-NC 4.0], which requires that reusers give credit to the creator. It allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, for noncommercial purposes only.
References
Reynolds JE, editor. In: Martindale; The Extra Pharmacopoeia. 29th ed.
London: The Royal Pharmaceutical Society of Great Britain; 1993. p. 295.
McNaman JO, Hardman JG, Limbird LE, Molinoff PB, Ruddon RW.
editors. The Pharmacological Basis of Therapeutics: 9th ed. New York:
Mc Graw- Hill; 1996. p. 46.
Martin A, editor. Physical pharmacy. 4th ed. Philadelphia: Lippincott
Williams and Wilkins; 1993. p. 324-62.
Schiermeier S, Schmidt PC. Fast dispersible ibuprofen tablets. Eur J
Pharm Sci 2002;15:295-305.
Mizumoto T, Masuda Y, Yamamoto T, Yonemochi E, Tarada K.
Formulation design of a novel fast-disintegrating tablet. Int J Pharm
;306:83-90.
Virley P, Yarwood R. Zydis. A novel fast dissolving dosage form. Manuf
Chem 1990;61:22-9.
Dobetti L. Fast-melting tablets: Developments and technologies. Pharm
Technol Eur 2000;12:32-42.
Bi Y, Sunada H, Yonezawa Y, Danjo K, Otsuka A, Iida K. Preparation and
evaluation of a compressed tablet rapidly disintegrating in the oral
cavity. Chem Pharm Bull 1996;44:2121-7.
Patrick K, Sang KW. Method of making freeze-dried dosage form. US
Patent 1997;5:631-23.
Chang RK, Guo X, Burnside B, Couch R. Fast dissolving tablets. Pharm
Technol 2000;24:52-8.
Takao M, Yoshinori M, Muneo F. Intrabuccally dissolving compressed
mouldings and production process thereof. US patent 1996;5:576-14.
Zhao N, Augsburger LL. Functionality comparison of 3 classes of
superdisintegrants in promoting aspirin tablet disintegration and
dissolution. AAPS Pharm Sci Tech 2005;6:E634-40.
Amin P, Prabhu N, Wadhwani A. Indion – 414 as a superdisintegrant
in the formulation of mouth dissolving tablets. Ind J Pharm Sci
;68:117-14.
Wen X, Tan F, Jing Z, Liu Z. Preparation and study the 1:2 inclusion
complex of carvedilol with beta-cyclodextrin. J Pharm Biomed Anal
;34:517-23.
Rockville. MD, United States Pharmacopoeia: 27 th revision. USP
Convention, Inc. 2004. 2302.
Sunada H, Bi YX, Yonezawa Y, Danjo K. Preparation, evaluation
and optimization of rapidly disintegrating tablets. Powder Technol
;122:188-98.
Indian Pharmacopoeia. 4 th ed. India, New Delhi: Controller of
publications; 1996. p. A-80,82.
Bolhuis GK, Zuurman K, te Wierik GH. Improvement of dissolution of
poorly soluble drugs by solid deposition on a superdisintegrant: II, The
choice of superdisintegrants and effect of granulation. Eur J Pharm Sci
;5:63.
Rowe RC, Sheskey PJ, Weeler PJ, editors. Handbook of pharmaceutical
excipients. 4th ed. London and Washington DC: The Pharmaceutical
Press; 2003.