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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND DEVELOPMENT
May -2009 / Volume - 1 /Issue - 3/ Article No - 1 / Research Article
BILAYER TABLET FORMULATION OF METFORMIN HYDROCHLORIDE AND GLICLAZIDE:
A NOVEL APPROACH IN THE TREATMENT OF DIABETES
Jitendra R. Amrutkar*1, Mohan. G. Kalaskar1,
Varsha.G. Shrivastav2, P. G. Yeole2
BILAYER TABLET FORMULATION OF METFORMIN HYDROCHLORIDE AND GLICLAZIDE:
A NOVEL APPROACH IN THE TREATMENT OF DIABETES
Jitendra R. Amrutkar*1, Mohan. G. Kalaskar1,
Varsha.G. Shrivastav2, P. G. Yeole2
ABSTRACT
Bilayer tablet of Metformin Hydrochloride and Gliclazide was formulated with Metformin as sustained release formulation. In the same sustained release layer of Metformin hydrochloride, an immediate layer of Gliclazide was optimized separately and then constituted in bilayer tablet. Hydrogenated castor oil and HPMC K100 M polymers were used in combination as matrix forming agent for sustaining Metformin release. Effect of these polymers concentration and different diluents were studied. Effect was evaluated by swelling studies and dissolution studies of prepared matrix formulations. f2 value was taken as basis to optimized the sustained release formula. Drug to polymer ratio (125:1:4) with lactose monohydrate as a diluent to showed better performance among all and shows Higuchi model as the best suited. The mechanism of release was found to be anomalous to the model. Sodium starch glycolate at the concentration range of 16 % gives fastest disintegration i.e. in 17 s. Bilayer tablet prepared from optimized formula was found to be best suited method for fixed dose combination of sustained release Metformin HCl and immediate release Gliclazide.
Key Words: Bilayer tablet, Metformin Hydrochloride, Gliclazide, Melt granulation
Bilayer tablet of Metformin Hydrochloride and Gliclazide was formulated with Metformin as sustained release formulation. In the same sustained release layer of Metformin hydrochloride, an immediate layer of Gliclazide was optimized separately and then constituted in bilayer tablet. Hydrogenated castor oil and HPMC K100 M polymers were used in combination as matrix forming agent for sustaining Metformin release. Effect of these polymers concentration and different diluents were studied. Effect was evaluated by swelling studies and dissolution studies of prepared matrix formulations. f2 value was taken as basis to optimized the sustained release formula. Drug to polymer ratio (125:1:4) with lactose monohydrate as a diluent to showed better performance among all and shows Higuchi model as the best suited. The mechanism of release was found to be anomalous to the model. Sodium starch glycolate at the concentration range of 16 % gives fastest disintegration i.e. in 17 s. Bilayer tablet prepared from optimized formula was found to be best suited method for fixed dose combination of sustained release Metformin HCl and immediate release Gliclazide.
Key Words: Bilayer tablet, Metformin Hydrochloride, Gliclazide, Melt granulation
Mr.J.R.Amrutkar
1R. C. Patel Institute of Pharmaceutical Education and Research,
Shirpur - 425 405, Maharashtra, India
2Institute of Pharmaceutical Education and Research,
Borgaon (Meghe), Wardha- 442 001 Maharashtra, India
Shirpur - 425 405, Maharashtra, India
2Institute of Pharmaceutical Education and Research,
Borgaon (Meghe), Wardha- 442 001 Maharashtra, India