Development and evaluation of extended release matrix tablets containing Metformin HCl (850mg)

RUBIO S, ; CIANCHINO V,; SAIDMAN E,; BERROA GOMEZ L ; ALVAREZ M

CORDOBA

Congreso; 3° REUNION INTERNACIONAL DE CIENCIAS FARMACEUTICAS 2014; 2014

Facultad de Ciencias Quimicas Universidad Nacional de Còrdoba

Diabetes is one of the major causes of death and disability in the world. Metformin HCl (MHCl) is an oral antidiabetic drug in the biguanide class. It is the first-line drug of choice for the treatment of 2 diabetes type, in particular, in overweight and obese people and those with normal kidney function. Hydrophilic matrices represent a popular and widely used approach for extended release drug delivery. The purpose of the study was to formulate MHCl (850 mg) sustained release matrix tablets, to analyzing the influence of hydrophilic polymers in the rheological properties of the granules and sustained release of the active ingredient. Granules of MHCl were prepared using the wet granulation method. Two granulates different were obtained from 30% w/w of RetaLac (Meggle) or Hypromellose (HPMC K100M), used as matrix former,named MHCl-R and MHCl-H, respectively. Granules were evaluated for loose bulk density, tapped density, compressibility index, hausner ratio and angle of repose. All the granules were lubricated and compressed using 14 mm flat-faced punches. The matrix tablets were evaluated for uniformity of weight, friability, hardness and in vitro dissolution. The drug delivery was analyzed according to USP XXX. Theamount off drug release was measurer for 24 h at one hour interval and was them determined spectrophotometrically at λ 233 nm (UV- 1603, Shimadzu, Japan).The evaluation of granules showed in both formulations that the powder mixture had good flow properties.Physico-chemical evaluation of tablets: Both formulations showed uniformity of weight. MHCl-R showed friability 2.6%, while the MHCl-H was 0.3%. The hardness of tablets from all formulation was between 5 and 6 kg/cm2. The dissolution release profile of formulation made with HPMC was comparable with the market formulation. Hence MHCl-H formulation was found to be the best formulation to accomplish the aim of this study.