Main Article Content
respectively.The phase solubility study with Î²CD suggested BS type of curve with a possibility of 1:1 inclusion complex.The solid systems were characterized by in vitro release studies, DSC, and SEM.The results of solid state studies revealed that AC was completely dissolved in the carrier matrix in case of the melt-solvent method, which suggested the possible formation of solid solution with AC to be existed in an amorphous state. All the binary systems exhibited improved dissolution as compared to pure drug. However, the best dissolution enhancement was achieved with the binary system AC: PEG 6000 in 1:2 weight ratio using the melt-solvent method which was subjected to tablet preparation by direct compression.The tablets so compressed complied with in-house and compendial specifications. The in vitro dissolution test was carried out for the
formulated tablets and three popular marketed brands of conventional AC tablets. None of the commercial brands showed complete drug release but the formulated tablets exhibited almost complete drug release within 50 min.The dissolution data
were further characterized using model-independent parameters DP30, DE50, t50%, similarity factor f2 and difference factor f1. The tablets formulated incorporating the AC: PEG 6000 (1:2) binary system displayed significantly improved dissolution profile as compared to existing immediate release commercial tablets.
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.
Sweetman SC. Martindale: the complete drug reference. Great Britain:
The Pharmaceutical Press; 2002. p. 11.
Suhagia BN, Patel HM, Shah SA, Rathod I, Parmar VK. Preparation
and characterization of etoricoxib-polyethylene glycol 4000 plus
polyvinylpyrrolidone K30 solid dispersions. Acta Pharm 2006;56:285-98.
Serajuddin AT. Solid dispersion of poorly water soluble drugs: early
promises, susbsequent problems, and recent breakthroughs. J Pharm
Serajuddin AT, Sheen PC, Augustine MA. Improved dissolution of a
poorly water-soluble drug from solid dispersions in polyethylene glycol:
polysorbate 80 mixtures. J Pharm Sci 1990;79:463-4.
Betageri GV, Makarla KR. Enhancement of dissolution of glyburide
by solid dispersion and lyophilization techniques. Int J Pharm
Higuchi T, Connors KA. Phase solubility techniques. In: Reilly CN,
editor. Advances in analytical chemistry instrumentation. New York:
Interscience; 1965. p. 117-212.
Chutimaworapan S, Ritthidej GC, Yonemochi E, Oguchi T, Yamamoto
K. Effect of water soluble carriers on dissolution characteristics of
nifedipine solid dispersions. Drug Dev Ind Pharm 2000;26:1141-50.
Fernandez M, Rodriguez IC, Margarit MV, Cerezo A. Characterization of
solid dispersions of piroxicam/poly(ethylene glycol) 4000. Int J Pharm
United States Pharmacopoeia 27, NF 18. Rockville: The USP Convention
Peck GE, Baley GJ, Mc Curdy VE, Banker GS. Tablet formulation and
design. In: Lieberman HA, Lachman L, Schwartz B. Pharmaceutical
Dosage Forms: Tablets Vol 1, 2nd ed. revised and expanded. New York:
Marcel Dekker Inc; 1989. p. 109.
Christoher R, Eleftheria N. Analysis of dissolution data. In: Dressman, JB,
Lennernas H, editors. Oral Drug Absortion: prediction and Assessment.
New York: Marcel Dekker Inc; 2000. p. 241-2.
Kulkarni GT, Gowthamraja K, Suresh B. Stability testing of pharmaceutical products: an overview. Ind J Pharm Edu 2004;38:194-202.
Ozdemir N, Ordu S. Improvement of dissolution properties of
furosemide by complexation with beta-cyclodextrin. Drug Dev Ind
Guidance for industry: Dissolution testing of Immediate Release Solid
Dosage forms, United States Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research
(CDER) 1997. p. 1-17.
Leuner C, Dressman J. Improving drug solubility for oral delivery using
solid dispersions. Eur J Pharm Biopharm 2000;50:47-60.
Craig DQ. The mechanism of solid dispersions in water soluble
polymers. Int J Pharm 2002;231:131-44.
Khan KA. The concept of dissolution efficiency. J Pharm Pharmacol
Costa P, Lobo JMS. Modeling and comparison of dissolution profiles.
Eur J Pharm Sci 2001;13:123-33.