Cirrus Pharmaceuticals, Inc.

Case Studies

Development of Metered Dose Inhaler

Oral Protein Drug Development

DEVELOPMENT OF METERED DOSE INHALER

In working with a mid-size pharmaceutical firm to develop a metered dose inhaler product Cirrus was responsible for:

Analytical method development

Micronization optimization

Salt selection

Formulation development

Packaging component selection

Accelerated stability studies

Process development and technology transfer

Data generation for IND and NDA submissions

This project was initiated in 1999, the NDA submission was filed in mid 2004, and the FDA approved the product after the first round review (just 10 months after filing) an industry record for a metered dose inhaler. The sponsor also filed a patent application based on the formulation developed at Cirrus.

ORAL PROTEIN DRUG DEVELOPMENT

Cirrus was requested to formulate a modified protein as an oral dosage form. The drug was previously administered subcutaneously. Cirrus developed several liquid and solid oral dosage forms of the modified protein drug. In clinical trials, the results obtained with Cirrus' oral formulation were similar to those seen with the subcutaneous injection of the drug. This positive outcome led the client and Cirrus to file a joint patent. This work was pivotal for the client in obtaining a substantial licensing agreement with a major pharmaceutical company.