Pharmaceutical evaluation of metformin hcl products available

Abstract EN

Five brands of metformin HCl tablets that are commercially available in the Jordanian market were subjected to analysis according to the British Pharmacopoea (2007) monograph.

The tested criteria of the preparations included identification, assay and dissolution performance.

The obtained results indicated that all of the examined products were in accordance with the pharmacopeal specifications.

However, dissolution profile comparisons, which are not required by British Pharmacopoea, revealed potentially serious differences in the performance of the studied products.

According to similarity factor calculations, only one generic product was found to have similar dissolution profile to the originator (similarity factor (74.3).

The other products showed similarity factors less than 50.

Therefore only one generic can be said to be exchangeable with the originator.

Further investigation might be conducted to confirm such results.

Keywords: Metformin, Dissolution, Quality control, Pharmaceutical tablets.