FORMULATION AND EVALUATION OF SUBLINGUAL TABLETS OF POORLY SOLUBLE DRUG ATORVASTATIN USING SUPERDISINTEGRANTS

Atorvastatin belongs to the group of medications known as HMG-CoA reductase inhibitors (statins). Sublingual tablets, which disintegrate in the oral cavity beneath the tongue in less than a minute, are solid dosage forms that have the benefit of avoiding first pass metabolism. The need for Sublingual has increased over the past ten years, particularly among the elderly and kids who have swallowing issues. In order to achieve rapid disintegration in gastric pH and quick action to lower cholesterol and triglyceride (fat) levels in the blood, the current study's goal was to create sublingual tablets of atorvastatin using various concentrations of starch (soluble), AC-Di-Sol and polyplasdone-XL as superdisintegrants. There are twelve different Atorvastatin Sublingual tablet formulations that were created using wet granulation technology. There is no interaction between the medications and the numerous excipients employed in the formulation, according to FTIR technology studies on the compatibility of drugs and excipients. When compared to the pharmacopoeia, the outcomes of the various precompression and after compression characterizations of tablets were satisfactory. Using a USP II paddle type dissolution equipment, in vitro release experiments for a number of formulations were carried out. Formulation AST₁₁, which contains 2% AC-Di-Sol and 4% Polyplasdone-XL, demonstrated complete drug release in less than 30 minutes (>99%), establishing itself as an optimised formulation. Using both superdisintegrants in tandem also demonstrated an improved drug release profile. However, when compared to the commonly marketed formulation, the formulation AST₈ with 4% Polyplasdone-XL exhibits the highest similarity factor and the lowest difference factor; therefore, it is regarded as the best formulation from the perspective of the dissolving profile. The zero-order kinetic model was the best formulation. Accelerated stability studies for improved formulation were done to confirm the stability of dose forms.

Key words: Atorvastatin, Sublingual tablet, AC-Di-Sol, Polyplasdone- XL, anticholesteremic.