Formulation and Evaluation of Mouth Dispersible Tablets of Simvastatin By Direct Compression Technique

T.V. Rao and S. Vidhyadhara

Abstract: New era is an area of novel drug delivery systems, formulation research is oriented towards increasing safety and efficacy of existing drug molecule through novel concept of drug delivery. In the present investigation was under taken with a view to develop a fast dissolving tablet of simvastatin by directcompression with moisture activation technique i.e., exposed in humidity chamber 75% RH at 300C for 1 hr, which offers a new range of product having desired characterstics and intended benefits. Fast dissolving tablets of simvastatin were prepared by using effervescent mixture i.e., sodium bicarbonate and citric acid, mannital, spray dried lactose, M.S and BHT obtained tablets were subjected for moisture activation. All the formulations were evaluated for hardness, friability, weightvariation, mouth feel, test for dispersibility, absorption ratio, in vitro dispersion time and in vitro drug release studies. An effective pleasant tasting and stable formulation F4 containing sodium bicarbonate and citric acid was found to have hardness 3.8 Kg/cm2, in vitro dispersion time was 10 sec, and maximum amount of drug was released with in 5 mins, than other prepared and marketed formulation.

Recent developments in technology have presented viable dosage alternatives for paediatric, geriatric, bedridden, nauseous or non compliment patients. Traditional tablets and capsules administered with 250ml of water may be inconvenient or impractical for such patients. Hence fast dissolving/disintegrating tablets (FDTs) are a perfect fit for them. FDTs dissolve or more commonly disintegrate rapidly in the saliva with out the aid of water. Also this dosage form offers an advantage of convenience of administration while traveling where there may not be an access to water. Moreover this dosage form combines the advantage of both liquid and tablet formulation. Simvastatin is a hypolipidemic drug. It is a powerful lipid-lowering that can decrease low density lipoprotein levels by upto 50%, having half life 3 hrs, it is sparingly soluble in water and bland taste makes it an ideal candidate for fast dissolving tablets by direct compression with moisture activation technique, with regards to palatability. The present investigation deals with the development of an effective and stable FDTs of simvastatin by moisture activation technique having adequate hardness, low dispersion time and pleasant taste.

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