Development and Characterization of Antiasthmatic Bronchodilator Nebuliser Solution

Abstract

The primary aim of the work was to develop & characterized an Antiasthmatic bronchodilator nebulizer solution of strength 2.5 mg/2.5 ml, for the management of Asthma & COPD as the API is selective β2 agonist, long acting drugs which provide fast onset of action & bypass first pass metabolism which minimizes the dose to be administered ultimately which decreases the dosing frequency and hence improve patients compliance and also preferable for management and prevention of attack of asthma and COPD. This formulation is effective and safe product similar to RLD. Bioequivalence is the main principal behind the development of Antiasthmatic nebulizer solution & their bioavailability's have to similar in such degree that their effect can be expected to be essentially the same. The development of generic Antiasthmatic Bronchodilator Nebulizer Solution 2.5 mg/2.5 ml, a generic version of the reference medicinal product (RMP).The Preformulation studies & compatibility studies Was done for drug alone and in combination of excipients. After confirming the compatibility of each excipient with the drug they are selected. By confirming the results of Preformulation, preliminary trials were taken and process optimization was done based on QTTP and critical process parameter which will affect the final quality of drug product. we have optimized unknown process parameters along with its invitro characterization of drug products using NGI and breath simulator for drug dose uniformity, aerodynamic particles size distribution, mean delivered dose, geometric standard deviation, relative standard deviations. At Initial time, QTTP was laid down on basis of drug substance properties, characteristics of the RLD products & characteristics of RMP labelling. QbD concept was used for risk assessment. On basis of patients compliance either safety or efficacy, the CQA was defined which included assay, pH and impurities and was focused throughout the whole process of drug development life cycles.