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01 June 2005 : Original article  

Pharmaceutical availability of gliclazide from selected matrix formulation tablets

Tadeusz W. Hermann, Roman Dobrucki, Stefan Piechocki, Matylda Resztak, Robert Reh

Med Sci Monit 2005; 11(6): BR181-188 :: ID: 16492

Abstract

Summary
Background: Immediate release and modifi ed release gliclazide formulation tablets are available on the market. We decided to measure the kinetics of gliclazide release from these tablets, and to propose our own technique for producing gliclazide matrix tablets, comparing their release kinetic profi le with the gliclazide tablets available on the market.
Material/Methods: A BP 2001 dissolution test was performed for selected gliclazide formulation tablets, and the water solubility of authentic gliclazide samples from different manufacturers was determined by UV spectrometry.
Results: Diabezidum (Jelfa) and diabrezide (Molteni) tablets are classic gliclazide oral formulations, releasing the drug very rapidly in vivo and in vitro according to BP 2001 (approximately 99% at 100 min). However, diaprel tablets (Servier) are modifi ed release formulations (67% released in in vitro conditions at 8 h). The matrix tablets (C) produced according to our own formula demonstrated a release profi le similar to diaprel tablets. The MDT, calculated in order to classify the tablets we studied, ranged from 4.6 to 76.4 minutes for immediate release (IR) tablets (diabrezide, diabezidum, I and F), and from 279.6 to 701.2 minutes for sustained-release (SR) tablets (E, G, C, diaprel, J, B,
D, H, K, A).
Conclusions: The dissolution process of immediate release gliclazide formulation tablets (diabrezide, diabezidum, F, I) obeys a fi rst-order equation. However, the process for modifi ed release formulation tablets (diaprel, diaprel MR, A, B, C, D G, H, J, K) proceeds according to a zero-order equation

Keywords: Gliclazide - chemistry, Gliclazide - pharmacokinetics, Administration, Oral, Calibration, Gliclazide - pharmacokinetics, Hydrogen-Ion Concentration, Hypoglycemic Agents - pharmacokinetics, Solubility, Spectrophotometry, Ultraviolet, Tablets

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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750