Study of comparative bioavailability of omeprazole pellets.

The objective of this study was to assess the bioequivalence between the omeprazole laboratory based formulation and the commercial formulation, Zimor Rubio, Spain, considered as reference formulation. The experiment was carried out according to a 2-period, 2-sequence crossover design with a two week washout period. A validated high performance liquid chromatographic method was applied for in vivo experiments. It was observed that omeprazole contents were comparable in all formulations. To establish bioequivalence, 90% confidence intervals (CI) for the differences of total AUCs of the test and reference formulations were calculated. The 95% CI ratio of the AUC within 0.80 to 1.25 was considered as bioequivalent. The carryout effect was investigated prior to assessing the bioequivalence of the two formulations. The test formulation of omeprazole was found to be comparable with the reference formulation (Zimor) with regard to bioavailability.

Development and evaluation of omeprazole pellets fabricated by sieving-spheronization and extrusion - spheronization process.

Pelletized dosage forms can be prepared by different methods which, in general, are time consuming and labor intensive. The current study was carried out to investigate the feasibility of preparing the spherical pellets of omeprazole by sieving-spheronization. An optimized formulation was also prepared by extrusion-spheronization process to compare the physical parameters between these two methods. The omeprazole pellets were consisted of microcrystalline cellulose, polyvinylpyrrolidone K 30, sodium lauryl sulphate and polyethylene glycol 6000. The omeprazole delay release system was developed by coating the prepared pellets with aqueous dispersion of Kollicoat 30 DP. The moisture content, spheronization speed and residence time found to influence the final properties of omeprazole pellets prepared by extrusion-spheronization and sieving-spheronization. The Mann-Whitney test revealed that both methods produced closely similar characteristics of the pellets in terms of, friability (p=0.553), flowability (p=0.677), hardness (p=0.103) and density (bulk, p=0.514, tapped, p=0.149) except particle size distribution (p=0.004). The percent drug release from the coated formulation prepared by sieving-spheronization and extrusion spheronization was observed to be 84.12 ± 1.10% and 82.67 ± 0.96%, respectively. Dissolution profiles of both formulations were similar as indicated by values of f1 and f2, 1.52 and 89.38, respectively. The coated formulation prepared by sieving-spheronization and commercial reference product, Zimore ® also showed similar dissolution profiles (f1=1.22, f2=91.52). The pellets could be prepared using sieving-spheronization. The process is simple, easy, less time- and labor-consuming and economical as compared to extrusion-spheronization process.

Haruan (Channa striatus) incorporated palm-oil creams : formulation and stability studies.

Topical emulsions stabilized with non-ionic emulsifiers have been an attractive alternative as vehicles for drug delivery, particularly for the patients suffering from dermatological problems. Haruan (a natural wound healer) creams were formulated with different types of emulsifiers (Tween 80 and Span 80) using different grades of Malaysian Palm-oleins (DFPL 56, 60, 62 and 65). The stability (at room temperature and accelerated stability testing) of the various creams was evaluated at different temperatures (5, 25 and 45 degrees C) for a period of 6 months by measuring changes in droplet size, viscosity and percentage oil separation. The emulsifier type and concentration showed pronounced effect on the physicochemical properties of the cream, whereas storage time did not. This study suggested that the choice of emulsifiers and concentration of haruan extract are the most important factors in the stability of the haruan creams.