Dry Powder Formulation
Pulmonary delivery by oral inhalation. MannKind’s dry powder formulation technology is a versatile drug delivery platform that allows the pulmonary delivery of therapeutic agents by oral inhalation. Our approach can be used to deliver small molecule, peptide, or protein drugs currently requiring administration by injection. MannKind’s formulation technologies offer several competitive advantages over other drug delivery systems.
- Applicability to a wide variety of therapeutic agents
- Very rapid drug absorption
- Avoidance of hepatic metabolism
- Excellent bioavailability
- Administration through simple, patient-friendly, breath-powered inhalers
MannKind’s dry powder formulations. MannKind’s dry powder formulations are based on FDA-approved excipients, including fumaryl diketopiperazine (the excipient used in Technosphere® inhalation powders) and mannitol. Our formulations result in powders that have particles within the consistent and narrow particle size range required for delivery to the deep lung, and without the need for sizing, milling, or blending. The resulting powders have a low density and are readily dispersed from our simple, patient-friendly inhalers. After inhalation, the powders dissolve rapidly at the surface of the deep lung and deliver the drug directly into the arterial circulation, bypassing the liver to provide excellent systemic exposure.
Diverse Compatibility. Our dry powder formulation technology is compatible with a diverse assortment of drugs over a broad range of physicochemical characteristics, including molecular weight (300 – 150,000 Daltons), structure (small molecules to monoclonal antibodies), charge, and hydrophilicity/hydrophobicity. Our dry powders are ideally suited to deliver drugs for local diseases, such asthma and COPD. In addition, the use of our Technosphere technology for systemic conditions was validated by the FDA approval of AFREZZA® (insulin human) inhalation powder, and has also been demonstrated in clinical studies with Technosphere formulations of parathyroid hormone (PTH/Technosphere), salmon calcitonin (sCT/Technosphere), and glucagon-like peptide 1 (GLP-1/Technosphere).