CRITICAL ROLES PLAY OF MAGNESIUM STEARATE IN FORMULATION DEVELOPMENT OF A HIGHLY SOLUBLE DRUG METFORMIN HYDROCHLORIDEAbstract
This article is giving emphasis on the decisive role of particle size of highly hydrophobic lubricant i.e. Magnesium Stearate, its concentration and lubrication time to establish the desired quality attributes of formulation containing highly soluble model drug Metformin Hydrochloride. Magnesium Stearate from two sources with different Particle size distribution (PSD) range was selected. It was observed that the Magnesium Stearate with a designed PSD is controlling the drug release profile of Metformin hydrochloride Tablets, which can replace the use of excess quantity of Magnesium Stearate or addition of a rate controlling polymer like hydroxy propyl methyl cellulose in the formulation design.
Meenakshi Shadangi, Saurabh Seth* and Deepak Senapati
Ajanta Pharma Limited, Kandivali (W), Mumbai, Maharashtra, India
10 January, 2012
16 March, 2012
28 March, 2012
01 April, 2012