TY  - GEN
AU  - Hashem, Hanan M.
AU  - Abdou, Aya R.
TI  - COMPARATIVE  IN VITRO  DISSOLUTION STUDY ON METFORMIN MARKET PRODUCTS USIN G  DIFFERENT DISSOLUTION APPARATUSES 
PY  - 2019///
CY  - M P
PB  - Innovare Academic Sciences Pvt Ltd
KW  - PHARMACEUTICS
N2  - 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®.
UR  - https://innovareacademics.in/journals/index.php/ijpps/article/view/34711/20642
ER  -