The the Method of Random Balance for Studying the Influence of Excipientsʼ Quantities on Technological Parameters of Metformin Orodispersible Tablets

Abstract

Objective: The present investigation was undertaken with an objective of analyzing the influence of excipientsʼ amount on the technological parameters of metformin orodispersible tablets using the method of random balance.
 Methods: The tablets were prepared by using direct compression method. The formulations were designed according to the method of random balance. The technological parameters of metformin orodispersible tablets have been studied as a function of quantitative factors: crospovidone (Polyplasdone XL-10®), magnesium aluminometasilicate (Neusilin US2®), microcrystalline cellulose (MCC Sanaq® burst), lactose monohydrate, magnesium stearate (Tablube® MgSt micronized vegetable) and talc. 
 Results: The flowability results were ranging from excellent to good according to the quantities of Neusilin US2® and Polyplasdone XL-10® crospovidone, which used. Results of bulk density and tapped density of the powder mixtures for pressing depended from the quantities of Neusilin US2® and talc. The obtained tablets had uniform weight from 0.93 to 2.30 %. The increase in the amount of Polyplasdone XL-10® crospovidone and the decrease in the amount of talk improved the uniformity of tablets’ weights. All of the prepared tablets showed acceptable hardness and friability which were improved with decrease in the amount of MCC Sanaq®burst and increase in the amount of Neusilin US2®. The rapid disintegration and wetting time for all formulations of tablets were obtained by using the Polyplasdone XL-10® crospovidone and MCC Sanaq®burst.
 Conclusion: Oral disintegrating tablets of metformin were successfully prepared by direct compression method. The random balance method enabled us to identify the most significant quantitative factors and stabilize them at optimal values.

Application of Response Surface Methodology to Optimize the Technology of Metformin Oral Dissolving Tablets

“…On the basis of the preliminary trials, 2 3 full factorial design was employed to study the effect of independent variables, i.e. quantity of MCC Burst (x1) and quantity of Neusilin US2 (x2) on dependent variables.…”

“…The factors, the central point and range of the factors were selected based on preliminary study [3,4]. The coded values of independent factors are shown in Table I.…”

“…The powder mixture (± 100 g) was poured through the funnel. Time for the powder mixture to fall down through a funnel was used to calculate flowability of the powder [3,19]. Bulk density of the powder mixture was determined by pouring the powder into the graduated cylinder.…”

“…The resistance of tablets to shipping, breakage, under conditions of storage, transportation and handling before usage depends on its hardness. The hardness of each batch of tablets was measured in Newton, where five tablets from each formula were tested through tablet hardness tester (Tianjin Guoming Medicinal Equipment Co., Ltd.), and then average value was documented [3,19].…”

“…The friability test was conducted by placing preweighed tablets in the friabilator (Tianjin Guoming Medicinal Equipment Co., Ltd.); the latter was operated at 25 rpm for 4 min; the dust was brushed off the tablets and reweighed. Tablets should lose not more than 1% of their weight to be acceptable [3,19].…”