Introduction:The objective of the present study was to design ferrous fumarate (FF) sustained release (SR) pellets using of cow ghee (CG) as an important hot-melt coating (HMC) agent.Materials and Methods:The pellets were coated by HMC technique using CG and ethyl cellulose composition by conventional coating pan without the use of spray system. FF formulated as pellets and characterized with regard to the drug content and physico-chemical properties. Stability studies were carried out on the optimized formulation for a period of 6 months at 40 ± 2°C and 75 ± 5% relative humidity.Results:Pellets with good surface morphology and smooth texture confirmed by stereo micrographs. HMC is easy, efficient, rapid and simple method since virtually no agglomeration seen during coating. In-vitro release from pellets at a given level of coating and for present pellet size was dependent upon the physico-chemical property of the drug and mostly aqueous solubility of the drug. The selection of optimized FF formulation was confirmed by comparing percent cumulative drug release with theoretical release profile. Formulation F2 had difference factor (f1) and similarity factor (f2) values was found to be 5 and 66 respectively. F2 showed SR of drug for 8 h with cumulative per cent release of 98.03 ± 4.49%. Release kinetics indicates approximately zero order release pattern. HMC pellets were stable during the course of stability study.Conclusions:By means of HMC using CG and ethyl cellulose, SR pellets containing FF were successfully prepared.

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The objective of present investigation was to synthesize and assess sub-acute toxicity of novel rosin esters using Swiss Albino mice. Assessment of the safety and toxicity of rosin esters is very important step before its use in pharmaceuticals. The solutions of rosin esters were prepared in corn oil to perform acute (28d) oral toxicity study in Swiss Albino mice as animal model of both sexes. The oral administration of rosin esters at the dose of 25 mg/kg of body weight and constant volume was administered to the mice. One group of mice was kept as a control group. Toxicity of the rosin esters was assessed by using various tests like behavioral changes, clinical signs, mortality and morbidity, biochemical tests, haematological tests, relative organ weights and histopathology tests. The body weights and food-water consumption by mice were recorded on weekly basis. The study results revealed that, there were no signs and incidences of toxicity or mortality in mice during the study period. No significant difference between treated (rosin ester administered) and control group of mice were recorded in the observations of different tests, body weights and food-water consumption. The histopathological examination of organs from the mice treated with rosin esters for 28d does not show any signs of toxic effects when compared with the control group. Therefore, the present investigation confirmed the non-toxic nature of novel rosin ester at 25mg/kg daily dose of body weight after oral administration in both the sexes.

Aim: The objective of the present investigation was to design curcumin suppositories for the effective treatment of vaginal candidiasis to eliminate side effects that are caused by existing antifungal drugs. Materials and Methods: Curcumin has promising antifungal activity in comparison with the existing azole antifungal drugs. Curcumin suppositories were prepared by fusion method with cow ghee (CG) and combinations of CG and polyethylene glycol 6000 in different ratios. The suppositories were evaluated for their visual, physicochemical, and in vitro release characteristics as well as in vitro antifungal activity. Results and Discussion: Formulation F6 showed all the results within the pharmacopeial and in-house specifications. The antifungal activity of the F6 formulation has demonstrated a significant effect against Candida albicans. Conclusion: The study indicates the possible and effective use of curcumin suppositories for vaginal candidiasis as a promising approach for natural antifungal treatment.

Aim: The objective of the present investigation involves the design of modified release multiunit drug delivery system for the effective treatment of gastroesophageal diseases (GEDs) using hot-melt coating (HMC) technique. Materials and Methods: Ranitidine hydrochloride (R.HCL) pellets were prepared using extrusion-spheronization and coated with different levels of hydrogenated castor oil (HCO) as HMC agent using pan pour method. To achieve the desirable release profile, R.HCL pellets were coated with a hybrid of HCO and sodium lauryl sulfate as a pore former. The pellets were evaluated for micromeritic properties, physicochemical properties, in vitro buoyancy study, dissolution study, and stability study. Optimized formulation was selected by comparison of the drug release profiles with theoretical release profile (TRP). Results: Formulation R6 with low floating lag time, floating time >12 h, and the drug release profile similar to TRP. Therefore, R6 was selected as optimized formulation and molded into unit dosage form by filling the pellets in hard gelatin capsules. The R6 formulation shows significant performance in vitro. Optimized formulation was showed no significant difference in their micromeritic properties, physicochemical properties, in vitro buoyancy, and dissolution release after storing under 40°C ± 2°C temperature and 75% ± 5% relative humidity for 3 months. Conclusion: This study confirms the modified release potential of HCO by successfully designing of modified multiparticulate drug delivery system of R.HCL using HMC technique. This drug delivery system may prove effective for the treatment of GEDs by sustained drug release in absorption window for prolong period.