Objective:
This study was proposed to evaluate and compare the
in vitro
dissolution profiles of six Metformin Hydrochlorid
e (MH) market products.
Methods:
Different dissolution apparatuses (USP apparatus II
, IV and beaker method) were used to evaluate the d
issolution profiles (in phosphate
buffer, pH 6.8) of two immediate release (IR) generi
c products of Metformin Hydrochloride (MH): Cidopha
ge® 1000 mg (G1, Egyptian market) and
Metformin arrow® 1000 mg (G2, French market) with r
espect to the reference products named Glucophage®
850 mg (R1, Egyptian market and R2,
French market). In addition to a generic controlled
-release (CR) product; Cidophage Retard® 850 mg (G3
) versus the reference product;
Glucophage XR® 1000 mg (R3) (both from Egyptian mar
ket). Dissolution efficiency (D. E.) and the simila
rity factor (
f
2
) were calculated. Weight
uniformity, hardness, tablet dimensions and MH conte
nt were measured.
Results:
Results of the three apparatuses showed that MH IR p
roducts studied (reference and generics) did not me
et the 75% USP 30 specifications
for MH dissolved at 30 min. For MH CR products, Gluco
phage XR® did not fulfill the USP release criteria,
while Cidophage Retard® did. USP
apparatus IV revealed the highest sensitivity and d
iscriminative capability.
Conclusion:
Generally, MH IR generics (G1 and G2) might be inter
changeable with the innovator product (Glucophage®)
. However, Cidophage
Retard® might not be interchangeable with Glucophag
e XR®.