The present study aimed to develop Ketoconazole -loaded ethosomal gel intended to be applied topically for treating skin infections. Ethosomes were prepared using the cold method. The formulation variables were optimized using 33 factorial design and Design Expert® software for analyzing the data statistically and graphically using response surface plots. Phospholipid (X1) and ethanol (X2) and propylene glycol (X3) were chosen as the independent variables, while the dependent variables comprised entrapment efficiency (Y1), vesicles size (Y2) and zeta potential (Y3). Ultra-centrifugation was used to assess the encapsulated medication after confirming the presence and size of vesicles. There was a greater increase in value (79.62%) in sonicated particles containing 30% w/w ethanol. The optimized ethosomes were subsequently incorporated into Carbopol® 940 gel and characterized for rheological behaviour, in-vitro release, ex-vivo skin permeation and deposition. Morphologically, the produced ethosome formulations were consistent when examined by SEM. All of the vesicles met or exceeded the criteria for nanotechnology in terms of size (less than 200nm), polydispersity index (PDI), and entrapment efficiency (of the intended medication). The percentage of Ketoconazole released after 24 hours was significantly decreased (p 0.05) when the ethosomes were included into a variety of gel bases. By contrast, ethosomal gel showed considerably greater anthralin penetration than the other tested preparations (p<0.05). Compared to the ethosomal gel, the drug solution in receptor medium, and the drug hydroalcoholic solution, the total quantity of drug penetrated from the ethosomal gel was around 2.5-, 3.5- and 4.5-fold greater (p<0.05). Stability studies displayed that after 2 months, all of the gels' physicochemical characteristics, including viscosity and color, remained unchanged, passing the tests.
CH. Saibabu*, K. Karthik, A. Kishore, Lakshmi Devi, D. S. V. L. Narasimha, K. N. S. V. Sesha Sai Sri, M. Srilakshmi, SK. Anwar Basha.
Oral Disintegrating Tablets (ODTs) are solid dosage forms containing medicinal substances which disintegrate rapidly, usually in a matter of seconds, when placed on the tongue. Objective of the present study is to design and formulate oral disintegrating tablets of Rizatriptan comparable to the marketed formulation with better stability, high production feasibility and excellent patient acceptability. Direct compression technique was choosen to develop a finished pharmaceutical product of the envisaged form. Various formulation trials (F1-F11) were taken. In these trials, Drug: Excipient ratio was varied and the effect of Diluent, Superdisintegrant and lubricant on the performance of both blend as well as tablets was studied. Based on the results obtained it was concluded that the formulation F11, the reproducibility batch of F4 was finalized as the optimized formula. When subjected to accelerated stability studies the tablets were found to be stable. Thus, the work resulted in the development of a ODT of Rizatriptan comparable to inventor’s product.