OPTIMIZATION BY EXPERIMENTAL DESIGN
OF AN IMMEDIATE RELEASE TABLET
FORMULATION COMPRISING METFORMIN
AND GLIBENCLAMIDE
POTUR ROXANA-GEORGIANA*1,2, MOISUC LĂCRĂMIOARA1,
BOIŢĂ TUDOR1; GAFIŢANU ELIZA2, POTUR MIRCEA-DAN3
1 Pharmaceutical Development Department, Antibiotice S.A., Str. Valea
Lupului nr. 1, 707410, Iaşi, Romania
2 Faculty of Pharmacy, University of Medicine and Pharmacy “Gr. T.
Popa”, Str.Universitatii nr.16 700115 Iasi, Romania.
3Faculty of Automation and Computer Science, Technical University
"Gheorghe Asachi" of Iasi, Str. Prof. Dr. Doc. Demetrius Mangeron,
no. 27, cod 70005, Iasi, Romania
*corresponding author: roxana.potur@yahoo.com
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Abstract:

The association of metformin and glibenclamide presents notable advantages with respect to the administration of the two active ingredients separately, because it significantly improves the compliance in older patients and in patients subjected to polytherapy with other drugs.
The aim of this study consisted in developing a formulation of an immediate
release tablet that contained 500 mg metformin and 2.5 mg glibenclamide and optimizing it in order to attain a similar dissolution profile to the innovator product (Glucovance®). The statistical method employed was Partial Least Squares multilinear regression, using Modde 9.0 Umetrics software. The tablets obtained according to the experimental plan were evaluated regarding the release of metformin hydrochloride and
glibenclamide using validated HPLC methods. The results demonstrated that the optimal formulation corresponded to the specifications of the European Pharmacopoeia 6th edition for immediate release coated
tablets with a very similar dissolution profile to the innovator product (Glucovance®), f2 (similarity factor) showing values of 92.89 for the release of glibenclamide and of 90.98 for the release of metformin.

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