Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Hyderabad, India
Mahibalan Senthi Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Hyderabad, India. The respected author has specialization in the field of Pharmacy.
Research Article
Development and Validation of Robust Analytical Method to Determine Droplets Size Distribution of Nasal Spray Using Laser Diffraction Technique
Author(s): Mugada Ravi Prasada Rao*, Paul Mogadati, Srinivas Arutla and Mahibalan Senthi
In the recent past, delivery of therapeutic agents through the nasal route becoming a very attractive proposition, especially when rapid absorption and effects are required. The droplets size of a nasal spray dosage form is important for both efficacy and toxicity. In this study, an attempt was made to develop and validate a method to measure the droplets size distribution in Fluticasone nasal spray using Malvern spray tech coupled with automatic actuation station at various angles. Devices were actuated at the force of 6.0 kg, the velocity at 60 mm/s and rate of acceleration at 5000 mm/s2. Data was collected for 150 ms at a height of 6.0 cm from the tip of the device. The method was evaluated for their precision, robustness and impact of different actuation angle on the formation of droplets size. The study revealed that changing the actuation angle from 0° to 45° had no sign.. View more»