| RESEARCH PAPER |
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| Year : 2011 | Volume
: 73
| Issue : 5 | Page : 491-496 |
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Formulation design and optimization of fast dissolving clonazepam tablets by sublimation method
SB Shirsand1, Sarasija Suresh2, V Kusumdevi2, PV Swamy1
1 Department of Pharmaceutics, H. K. E. Society's College of Pharmacy, Sedam Road, Gulbarga-585 105, India
2 Department of Pharmaceutics, Al-Ameen College of Pharmacy, Near Lal Bagh Main Gate, Hosur Road, Bangalore-560 027, India
Correspondence Address:
Sarasija Suresh
Department of Pharmaceutics, Al-Ameen College of Pharmacy, Near Lal Bagh Main Gate, Hosur Road, Bangalore-560 027
India
DOI: 10.4103/0250-474X.98984
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Fast dissolving tablets of clonazepam were prepared by sublimation method with a view to enhance patient compliance. A 3² full factorial design was applied to investigate the combined effect of two formulation variables: amount of croscarmellose sodium and camphor. Croscarmellose sodium (2-8% w/w) was used as superdisintegrant and camphor (20-40% w/w) was used as subliming agent, to increase the porosity of the tablets, since it helps water to penetrate into the tablets, along with directly compressible mannitol to enhance mouth feel. The tablets were evaluated for hardness, friability, thickness, drug content uniformity, in vitro dispersion time, wetting time and water absorption ratio. Based on in vitro dispersion time (approximately 11 s); the formulation containing 5% w/w croscarmellose sodium and 40% w/w camphor was found to be promising and tested for in vitro drug release pattern (in pH 6.8 phosphate buffer). Short-term stability (at 40°/75% relative humidity for 3 mo) and drug-excipient interaction. Surface response plots are presented to graphically represent the effect of independent variables on the in vitro dispersion time. The validity of the generated mathematical model was tested by preparing two extra-design checkpoints. The optimized tablet formulation was compared with conventional commercial tablet formulation for drug release profiles. This formulation showed nearly nine-fold faster drug release (t 50% 1.8 min) compared to the conventional commercial tablet formulation (t 50% 16.4 min). Short-term stability studies on the formulation indicated that there are no significant changes in drug content and in vitro dispersion time (P<0.05). |
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