Objective: The main objective of the present investigation
is to develop combination therapy for Type II Diabetic subjects using bilayer
sustained release formulation of metformin hydrochloride (MFH) and gliclazide
(GLZ) based on monolithic-matrix technology.
Methods: Bilayer tablets were prepared by the wet
granulation method. Initially, metformin HCl layer and gliclazide layers were
optimized using release retardants like Polyox WSR coagulant and different
viscosity grades of hydroxyl propyl methyl cellulose (HPMC) and evaluated for
in vitro dissolution performance and drug excipient studies separately. The
optimized formulations were selected and compressed to bilayer tablets to
achieve the desired sustained release in combination.
Results: Metformin hydrochloride and gliclazide showed
sustained release of drug by diffusion mechanism and followed first-order
kinetics. The best formulation of metformin hydrochloride (M7) and gliclazide
(G8) shows 99.93% and 99.65% of drug release in 24 h respectively. The
similarity factor (f2) was 89.95 for metformin hydrochloride and 83.62 for
gliclazide when compared to the innovator. FTIR studies reveal the absence of
significant interactions indicating drug excipient compatibility.
Conclusion: The monolith diffusion-controlled bilayer
tablets of metformin hydrochloride and gliclazide offer improved patient
compliance and convenience with better postprandial hyperglycemic control with
once-a-day dosing. The sustained release of the drug up to 24 h regulates
antidiabetic activity round the clock with minimal side effects.
Author(s) Details
Rajeswari Aleti
Department of Pharmaceutics, Gokaraju Rangaraju College of Pharmacy,
Hyderabad 500090, India.
Sailaja Gunnam
Department of Pharmaceutics, Gokaraju Rangaraju College of Pharmacy,
Hyderabad 500090, India.
Monika Nijhawan
Department of Pharmaceutics, Gokaraju Rangaraju College of Pharmacy,
Hyderabad 500090, India.
Please see the book here:- https://doi.org/10.9734/bpi/prrat/v4/1115
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