Formulation Development of Atorvastatin CalciumTablets by Gel Liquisolid Compact Technique forimproving Solid State Stability and Dissolution Profile

Background: BCS class II and IV drugs, which have low solubility, provide a number of challenges for formulation scientists working on oral delivery of drugs. Aims: The aim and purpose of the present work was to design a gel liquisolid tablets for Atorvastatin calcium a water insoluble drug to increase its dissolution rate there by its bioavailability. Materials and Methods: The preformulation studies like solubility studies of API in different non-volatile solvents, optimization of gelling agent and adsorbent quantity were performed. Gel liquisolid compacts (GLS1-GLS10) and directly compressible tablets (DCT 1 and DCT 2) of Atorvastatin calcium were prepared and evaluated for flow properties, post compression parameters and in vitro dissolution studies. Structural analysis of GLS was done using differential scanning calorimetry (DSC) and Xray powder diffraction (XRD) techniques. Finally, the ideal batches (GLS1 and DCT 1) were subjected for in vivo bioavailability studies. Results: The solubility was found to be highest in propylene glycol (150.05 ± 0.4278 mg/mL). In vitro dissolution studies of the prepared GLS had shown maximum dissolution within one hour when compared to that of prepared DCT tablets. DSC and XRD studies revealed that the drug in the GLS had been solubilized. From the obtained pharmacokinetic data such as AUC, tmax and Cmax through in vivo bioavailability studies it was established that GLS have shown better bioavailability compared to that of prepared DCT tablets. Conclusion: This study confirms that Atorvastatin calcium prepared by GLS have better dissolution and bioavailability compare to conventional DCT dosage form and therefore GLS could be a promising drug delivery for Atorvastatin calcium.