Formulation and Evaluation of Pitavastatin Nanosuspension

AIMS: The aim of this work is to formulate and develop nanosuspensions containing a hypercholesterolemia drug and carrier’s urea, PVP 30, β-cyclodextrin and Tween 80 & SLS. OBJECTIVES: The main objective of the present study is to carry out formulation and evaluation of nanosuspensions of hypercholesterolemia by using suitable polymers to improve its bioavailability. The objectives of the present study as follows 1. Preformulation studies for selection of suitable excipients to develop the dosage form based on physicochemical properties of drug and excipients. 2. Screening of excipients for compatibility and efficacy for developing the formulation. 3. Carry out Preformulation study of Pitavastatin drug. 4. Preparation of nanosuspensions drug delivery system for enhancing the solubility and thus bioavailability of drug. 5. Evaluation of nanosuspensions drug delivery system, in vitro. 6. Optimize the formulation using experimental design technique regarding particle size, particle size distribution, zeta potential, stability, release profile, etc. 7. Evaluation of formulated product and identification of defects. 8. Study the stability of the formulation following ICH guidelines. CONCLUSION: The results of the present study demonstrate that nanoprecipitation technique was employed to produce nanoparticles of pitavastatin, a poorly water-soluble drug, for the improvement of solubility and dissolution velocity. In this process, the particle size of pitavastatin can be obtained in the nano-size ranges, by adjusting the operation parameters. The best nanosuspension of pitavastatin can be obtained by 10mg, β-cyclodextrin 30mg, and 0.2% w/v Tween 80. Thus it can be concluded that the dissolution of pitavastatin is significantly increased when it is nanosized and thus the bioavailability can be increased compared with the pure pitavastatin