Bioavailability assessment of vitamin A self-nanoemulsified drug delivery systems in rats: a comparative study.

OBJECTIVES To assess and compare the bioavailability of three different oral dosage forms of vitamin A in rats. The formulations included vitamin A self-nanoemulsified drug delivery (SNEDD) optimized formulation-filled capsule (F1), vitamin A SNEDD optimized formulation compressed tablet (F2) and vitamin A oily solution-filled capsules without any additives (control, F3). MATERIALS AND METHODS Bioavailability was assessed after a single oral dose of the three formulations using three groups of rats, each group comprising 6 rats. Blood samples were collected at baseline and over the next 8 h. Plasma was separated and extracted to obtain the drug, which was measured by HPLC. Statistical data analysis was performed using the Student t test and ANOVA with p < 0.05 as the minimal level of significance. RESULTS From the pharmacokinetic parameters, both F1 and F2 showed improved bioavailability compared to F3. The values of AUC +/- SD were 3,080.7 +/- 190.2, 2,137.1 +/- 130.5 and 1,485.2 +/- 80.1 ng x h/ml for F1, F2 and F3, respectively. The Tmax was 1 h in case of F1 and F2 as compared to 1.5 h for F3. The Cmax +/- SD was 799.5 +/- 48.5, 656.2 +/- 64.4 and 425.8 +/- 33.1 for F1, F2 and F3, respectively. The increase in AUC, Cmax and Tmax was significant (p < 0.05). The bioavailability calculated from the AUC for F1 and F2 relative to F3 was 207.4 and 143.8%, respectively. The bioavailability increased almost twofold and 1.4 times for F1 and F2, respectively. CONCLUSIONS The study showed that the newly developed vitamin A SNEDD formulations increased the rate and extent of drug absorption compared to the oily drug solution. The present investigation demonstrated that vitamin A SNEDD optimized formulations, either as filled capsules or as compressed tablets, were superior to its oily solution with regard to their biopharmaceutical characteristics.