Abstract
Objective: The objective of the present work was to prepare an optimized, fast dissolving tablet (FDT) of Pitavastatin to increase its dissolution by applying 32full factorial design.
 Methods: Nine formulations (PF1 to PF9) with all possible combinations according to 32full factorial design by selecting two factors i.e. concentration of super disintegrant, Indion414 (5-15%) (A) and sublimating agent, camphor (40-60%) (B) as independent variables at three levels of-1, 0 and 1. The effect of these two variables on three dependent parameters, water absorption ratio (Y1), disintegration time (Y2) and in vitro drug release (Y3) was studied. All the powder blends were evaluated for precompression parameters, and the tablets were prepared by direct compression method which were further evaluated for post-compression parameters. The effect of change in concentration of two selected factors on dependent parameters was studied through 3D surface response plots and polynomial equations using Design expert software version11. Optimized formula was obtained by desirability and overlay plots for which compatibility stability was assessed.
 Results: Precompression and post-compression parameters were satisfactorily within acceptable limits. Optimized formulation was prepared to prove the validity of the evolved mathematical model, which contained 6.75 mg of indion414(0.9) and 54 mg of camphor(0.9) with a disintegration time of 21 sec., water absorption ratio of 113 and 93% of drug release within 12 min. The compatibility between drugs and excipients was proved. The dissolution profiles of optimized formulation and commercially available conventional film-coated tablets of Pitavastatin were compared.
 Conclusion: The optimized formulation showed significantly (P>0.05) increased drug release compared to commercially available film-coated tablets. No changes in disintegration time, drug content and in in vitro drug release from optimized formulation on storage for 3months at 40 °C±2 °C/75% RH±5% RH were observed during stability studies which confirmed the stability of the optimized formulation.
Highlights
Nutritional and lifestyle changes in recent decades lead to many chronic diseases such as dyslipidemia
Pitavastatin was obtained as a gift sample from Aizant pharm labs (Hyderabad, India) Indion414 was purchased from Balaji drugs (Gujarat, India), microcrystalline cellulose, mannitol, magnesium stearate and aerosil were obtained from SD fine chemicals
A total of nine formulations of fast dissolving tablet (FDT) of Pitavastatin was prepared by the direct compression method as per the composition shown in table 2
Summary
Nutritional and lifestyle changes in recent decades lead to many chronic diseases such as dyslipidemia. All statins are available in conventional tablet formulations with very limited bioavailability. Pitavastatin comparatively novel derivative of statin family, it has unique pharmacological benefits in the reduction of low-density lipoprotein–cholesterol (LDL-C) and improvement of high-density lipoprotein-cholesterol (HDL-C) which is used in the treatment of many cardiovascular diseases [2]. Pitavastatin offered in film-coated tablets that cannot be crushed or chewed or swallowed by patients and is not available as liquid dosage forms. Pitavastatin is not useful in emergency clinical conditions of cardiovascular disease because of low solubility and slow onset of action. As there is an increased use of statins for the pediatric and geriatric population, there is a need to develop fast dissolving tablets of Pitavastatin for easy swallowing and fast onset of action
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