• Publication Date: 12/01/2021
  • Author(s):
    Berg, Carolyn
  • Organization(s):
    Catalent Pharma Solutions
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Product Development/Formulation, Respiratory Medicine

The Pulmonary Fibrosis Foundation maintains a database of molecules and clinical programs in development for IPF. As of June 2021, while it may not be comprehensive, it listed 33 programs, yet shows only five via the inhaled route. Why then, given the availability of the technology and manufacturing knowledge, and the inherent medical advantages of inhaled drugs, are manufacturers pursuing conventional oral and IV formulations?

Idiopathic pulmonary fibrosis (IPF) is a debilitating, progressive disease with a poor prognosis. The two approved pharmacological therapies have shown to slow disease progression, but do not stabilize or reverse fibrosis, yet cause noteworthy side effects in many patients. Therefore, there is a real and urgent need for disease-modifying therapies for IPF patients. Inhalable formulations may provide considerable advantages for patient care, access, administration and distribution compared to intravenous formulations. There remain significant opportunities for pharmaceutical developers to pursue inhaled formulations of drugs, especially those for indications that have high unmet needs such as IPF, PAH, cystic fibrosis and other rare lung diseases and thereby provide safer, more tolerable and more efficacious products.

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