Specialty Dosage Forms

Inhalation & Nasal Dosage Forms

Covar’s Management Team possess a rich experience in inhalation and nasal dosage form development, including successfully bringing numerous NCEs to market, including blockbuster products. Our team harnesses our deep understanding of development and scale up requirements to provide development services for specialty dosage forms for various actives (e.g. steroids, bronchodilators) and indications (e.g. seasonal rhinitis, asthma, COPD).

The primary challenge in inhalation & nasal dosage form development is achieving a correct respiratory fraction based on spray characteristics of the powder/liquid. In practice, this requires sufficient aerosolization to fluidize the material in air and suitable aerodynamic particle size to actuate effectively to reach the lungs (as little as 15% of some powders reach the lungs) with sufficiently uniform droplet size (for liquid products) throughout the dose.

Other challenges can include dose uniformity to assure sufficient administration to the lungs for each dose out, suspendability (e.g steroids), etc. Device robustness, priming, and in-use stability are also important considerations, as is preservative selection for liquid dosage forms due to their pH 7 requirement.