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Formulation of sustained release metformin hydrochloride pellets

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 Thuy Nguyen Hanh, Thao Trinh Phuong, Chien Nguyen Ngoc

 ABSTRACT

A sustained release formulation of metformin hydrochloride pellets was developed using a combination of extrusion and spheronization method and pellet-coating method to prolong the gastro-intestinal retention and reduce the dose frequency and improve patient compliance.

Objectives

The main purpose of this research was to formulate a sustained release pellet of metformin hydrochloride using aqueous film coating suspension of Eudragit® polymers.

Methods

Metformin hydrochloride pellets were prepared by extrusion and spheronization method using microcrystallization cellulose (MCC) PH 101, lactose monohydrate, hydroxypropyl methyl cellulose E6, talc, and magnesium stearate. Then, metformin hydrochloride pellets were coated with a controlled release film using an aqueous suspension of methylmethacrylate polymers (Eudragit® RL100 and Eudragit®RS100). Several properties of pellets such as morphology, friability, drug dissolution and mechanism release were evaluated.

Results

The results showed that amounts of triethyl citrate (TEC), talc, the ratio of Eudragit® RL100 and Eudragit® RS100, and the weight gain have significant effects on drug release from pellets. The obtained pellets were coated by 35% weight gain of coating formulation, which contained 15% TEC, 50% talc (compared with the amount of polymers) and a mixture of Eudragit® RL100 and Eudragit® RS100 at the ratio 5:95. The drug release was sustained upto 8 hours and the dissolution profile of obtained formulation was similar to that of the reference product (Glucophage SR 500mg).

Conclusion

The results indicated that the aqueous suspension of methylmethaacrylate polymers could be applied to prolong release of metformin hydrochloride from pellet upto 8 hours and produce a similar in vitro profile release compared with the reference product.

Keywords

Pellets, metformin hydrochloride, sustained release, Eudragit® RL100, Eudragit® RS100

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