Abstract
In current decade, pharmaceutical industries of Bangladesh are giving much emphasize on the formulation of time release preparation to treat various chronic diseases in order to decrease the frequency of administration and to improve patient compliance. Objectives: The objective of this investigation is to design and evaluate sustained release matrix tablet of Gliclazide by direct compression method employing polymers of hydroxypropylmethyl cellulose (HPMC) derivatives (K15M CR and K4M CR) and to select the optimized formulations and compression process by performing a comparative release kinetic study with a reference product, Diamicron MR (one of the worldwide brand of Gliclazide sustain released tablet manufactured by Servier one of the French pharmaceutical company) tablet. Methods: Release kinetics of Gliclazide matrix tablets were determined using USP paddle method at Phosphate buffer (pH 7.4). The release mechanism was explored and explained with zero order, first order, Higuchi and Korsmeyer model. Result: It is found that formulation with lower polymeric concentration follows Higuchi release kinetics and that the formulation with higher concentration best fits with zero order release kinetics. Among the formulations, F1 and F6 show almost similar dissolution profile with Diamicron MR Tablet, which can be suitable candidates for further in-vivo bioequivalence study. Conclusion: Findings of this investigation suggest that F1 and F6 formulations are potential candidates for further bioequivalence study among other formulations.
Highlights
Matrix systems appear to be a very attractive approach from the economic as well as from the process development and scale-up points of view in modified-release system [1]
Lactose was added with this mixture and the powder mix was lubricated with magnesium stearate
Formulation code F1, F2, F3 represents the gliclazide matrix tablet prepared with Methocel K15M CR and Formulation code F4, F5, F6 represents the gliclazide matrix tablet prepared with Methocel K4M CR
Summary
Matrix systems appear to be a very attractive approach from the economic as well as from the process development and scale-up points of view in modified-release system [1]. Methocel (HPMC) is used frequently as a rate-controlling polymer in matrix tablets and offers some advantages of being non-toxic and relatively inexpensive; it can be compressed directly into matrix and is available in different chemical substitution, hydration rates and viscosity grades [2]. Most of the sustain release matrix tablet manufactured by wet granulation process which is very tedious process and required organic granulation solvent because aqueous solvent make the process more tedious. Use of direct compression technique by using suitable excipients can give desired pharmaceutical and pharmacokinetic properties [3]. Direct compression method is used to produce matrix tablets. Gliclazide is 1-(3-azabicyclo [3, 3, 0]oct-3-yl)-3-p-tolylsulphonylurea (Figure 1) which is a secondgeneration sulfonylurea, oral hypoglycemic drug and widely used in the treatment of non-insulin-dependent diabetes mellitus (NIDDM). The usage of the common formulation of gliclazide can be limited by some kinds of reasons, such as patient’s age and renal impairment etc. [4]
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