Cirrus-Kemwell Receives FDA Grant to Evaluate Formulation Effects Under QbD Paradigm

Nov 05, 2013

PR Newswire

Cirrus Pharmaceuticals has been awarded a grant by the FDA entitled "Comprehensive Evaluation of Formulation Effects on Metered Dose Inhaler Performance." The goals of the program 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 paradigm," said Dr. Jay Holt, Sr. Director for Inhalation & Analytical Testing, Cirrus Pharmaceuticals.

Read the press release

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