Cirrus Pharmaceuticals has been awarded a grant by the US Food and Drug Administration for evaluating formulation effects on MDI performance.
The grant is called ‘Comprehensive Evaluation of Formulation Effects on Metered Dose Inhaler Performance’.
The goals of the programme are to investigate the effects of excipient concentrations and API particle size on the aerosolization performance of metered dose inhaler (MDI) formulations and to evaluate the sensitivity of in-vitro methods in detecting those changes.
"We are very excited to collaborate with the FDA to add to the scientific knowledge base in this area and to enhance the agency’s reviewing process under the quality by design (QbD) paradigm," said Dr Jay Holt, senior director for inhalation and analytical testing, Cirrus Pharmaceuticals.
Cirrus has a long tradition of providing services in the highly specialized field of respiratory product development. In addition to MDIs, Cirrus provides development services for dry powder inhalers (DPIs), nebulized solutions and suspensions, and nasal sprays.
Cirrus was acquired by Kemwell in July 2013 to give the best geographical advantage to the customer from cutting-edge development in the US to cost-effective manufacturing in India.