Methods
Determination of Solubility of Rosuvastatin calcium
Excess amount of ROC was added to 20 ml of distilled water. The suspensions were equilibrated on a mechanical shaker for 24 h at ambient temperature and resulting suspensions were filtered through 0.5 µm whatman filter paper. The 0.1 ml of filtrate was diluted with 10 ml of distilled water to determine dissolved amount of ROC using UV visible spectrophotometer at 241 nm (Jasco V-505, Japan).
Solubility determination of Rosuvastatin calcium in different oils, surfactants and co-surfactants
Excess amount of ROC was added to 3 ml of different oils (Sefsol 228, HCO 40, Maisine 35-1, LAS, Ethyl oleate, Olive oil, Castor oil, Capryol 90, Gelucire 44/14), surfactants (Tween 20, Lauroglycol,…show more content… L-SMEDDS was added drop wise onto aerosil-200 in a porcelain dish to get uniform distribution of drug and dried at room temperature.
Evaluation of L-SMEDDS and S-SMEDDS
Drug content
L-SMEDDS ( L 1 to L 4) and S-SMEDDS ( S 1 and S 2) equivalent to 10 mg were dissolved in 10 ml of methanol in 10 ml volumetric flask separately and suitably diluted with methanol to determine ROC content at 241 nm spectrophotometerically.
Percentage transmittance and reconstitution
L-SMEDDS (L 1 to L 4) and S-SMEDDS (S 1 and S 2) formulations (equivalent to 10 mg of ROC) were diluted with 100 ml of distilled water and percentage transmittance was measured spectrophotometrically at 638.2 nm using distilled water as blank by using U.V. Spectrophotometer and reconstitution property is visualized simultaneously.
Assessment of Self-emulsification and precipitation
It was performed by drop wise addition of pre-concentrate (L-SMEDDS), One ml of formulation was added to 250 ml of distilled water maintained at 37 ± 0.5°C with stirring of 50 rpm. Precipitation was evaluated by visual inspection of resulting emulsion after 24 h. Based on precipitation study; formulations were categorized as Grade A Clear (transparent or transparent with bluish tinge), Grade B non clear (turbid), Grade C Stable (no precipitation at the end of 24 hours), Grade D Unstable (showing precipitation within 24…show more content… The single injection of triton (100 mg/kg i.p.) elevated TC, TG, LDL and V-LDL levels by 2 folds respectively while comparing with untreated group, whereas high density lipoprotein level is decreased up to 50 % in all groups when compared to an untreated control group (Table 2).
At end of 24 h of dosing, reduction in TC, TG, LDL and V-LDL levels was observed in all groups except normal group. Formulations containing LAS as oil showed better reduction in elevated level of TC, TG, LDL and VLDL as compared to formulation containing Maisine 35-1: Capryol 90 as oil system.
Statistically significant difference were observed (p 0.05) in comparison with test groups. Test formulations containing LAS as oil ( L 4 and S 1) showed significant reduction in TC, TG, LDL, VLDL level as compared to control group (p <0.001;
Discussion
All four formulations of liquid and solid nanoemulsifying system without ROC gave stable clear micro emulsion