The US FDA has awarded a grant to Cirrus Pharmaceuticals for a study titled “Comprehensive Evaluation of Formulation Effects on Metered Dose Inhaler Performance,” the company has announced. According to Cirrus, the study will “investigate the effects of excipient concentrations and API particle size on the aerosolization performance of metered dose inhaler (MDI) formulations and . . . evaluate the sensitivity of in-vitro methods in detecting those changes.”
Cirrus Senior Director for Inhalation & Analytical Testing Jay Holt commented, “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.”
The company, which was acquired by Kemwell Biopharma in July 2013, offers numerous analytical and product development services for MDIs, DPIs, nasal sprays and inhalation solutions.
Read the Cirrus press release.
