ICH

ABSTRACTThe overall objective of this research project was to study the in DPI formulations containing ICH and LABA to achieve efficient drug deposition goals. Hence, this project focused on the formulation development of DPIs and impact of different fill weight or fill volume in performance as well as other physicochemical parameter. The performance mainly APSD of dry powder inhalers containing LABA & ICS was found to be optimum when it is formulated with 30% of fine grade lactose monohydrate. The APSD evaluation was concluded that the deposition of particle of (F8) 12.5 mg is better than (F4) 25 mg. It’s may due to more void space in the 12.5 mg capsule formulation than 25 mg capsule formulation. Due to this good turbulence occurs and separation drug particle form carrier surface is more and give better deposition compared to 25 mg fill weight formulation per capsule. The overall project concluded the 12.5mg formulation (F8) is good. These formulations are advantages over 25 mg formulation such as less carrier residue, cost effective, good therapeutic result. Keywords: Dry powder inhaler, ICH, LABA, lactose monohydrate, 12.5 mg, 25 mg.

A simple and effective RP-HPLC method had been developed for the estimation of vorinostat in capsule, using Apollo C18 (4.6 x 150mm, 5mm), mobile phase 100% methanol, detection wavelength at 247 nm, at flow rate of 1ml/min at retention time 3.43 min for vorinostat. Linearity was obtained in the range of 5µg/ml to 25µg/ml for vorinostat. The correlation coefficient was found to be 0.999. The Recovery studies were performed for vorinostat in the range of 50% - 150 %. The % Assay for vorinostat is 99.85 % .Forced Degradation studies were conducted according to the ICH guidelines and the Drug Product was found to be stable in all conditions. Hence, the method could be successfully applied for routine analysis of vorinostat capsules.