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.
Highlights
Diabetes is an important public health problem, one of the major causes of morbidity and mortality in the world [1, 2]
The materials which we used for this study comprise metformin hydrochloride (Harman Finochem Limited, India), crospovidone (Polyplasdone XL-10®) (Ashland Specialty Chemical, USA), magnesium aluminometasilicate (Neusilin US2®) (Fuji Chemical Industry Co., LTD, Japan), microcrystalline cellulose (MCC Sanaq® burst) (Pharmatrans Sanaq AG, Switzerland), lactose monohydrate (Alpavit Kaserei Champignon Hofmeister GMBH and CO Ltd, Germany), magnesium stearate (Tablube® Magnesium stearate (MgSt) micronized vegetable)
Technological parameters of metformin orodispersible tablets (ODT) have been studied as a function of 6 quantitative factors
Summary
Diabetes is an important public health problem, one of the major causes of morbidity and mortality in the world [1, 2]. According to the data International Diabetes Federation (IDF) Diabetes Atlas, [3] there are 425 million people with diabetes in the world. Type 2 diabetes mellitus (T2DM) is the most common form of diabetes, which has increased alongside cultural and societal changes. Around 90 % of patients with diabetes have T2DM. There is an increasing tendency in the number of patients with T2DM. The most common objectives of T2DM are overweight and obesity rates, lifestyle and dietary changes, and an aging population. There are many clinical practice guidelines to manage T2DM. All the guidelines recommend metformin as the first choice for initiating pharmacological treatment of people with T2DM [4,5,6]
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