Thin-film freeze-dried antibiotic powders for fixed-dose pulmonary delivery

Background

Pulmonary diseases such as nontuberculous mycobacterial infections and chronic obstructive pulmonary disease (COPD) remain major global health challenges, often requiring long-term antibiotic therapy delivered directly to the lungs to achieve effective pathogen clearance.

Inhaled drug delivery provides a promising approach to increase local drug concentration while reducing systemic toxicity, but current dry powder formu­lations suffer from significant limitations. Many antibiotic combinations cannot be co-formulated because of conflicting solubility profiles, and crystalline drug forms often dissolve slowly and deposit inefficiently in the deep lung. Formulations frequently require multiple excipients, adding regulatory burden and potential safety concerns.

These constraints limit the development of effective fixed-dose combinations and reduce the therapeutic impact of inhaled antibiotics for complex respiratory infections.

Technology overview

This technology uses thin-film freeze-drying to produce highly porous, amorphous dry powder formulations of azithro­mycin, amikacin, or precise fixed-dose combinations of both, optimized for delivery via a dry powder inhaler.

By dissolving the drugs in a compatible cosolvent, rapidly freezing the mixture into thin films, and sublimating the solvent, the process overcomes the drugs’ incompatible solubilities and yields powders with aerodynamic diameters under five micrometers and fine particle fractions between 65% and 84%. These properties enable efficient deep lung deposition and rapid dissolution.

The method supports excipient-free formulations or minimal excipients such as leucine to enhance powder porosity, while allowing precise control of drug ratios for combination therapy. The resulting particles exhibit improved dissolution rates, enhanced bioavailability, and targeted delivery to infected lung tissue, making them well suited for treating non­tuberculous myco­bacterial infections, chronic obstructive pulmonary disease (COPD), and other respiratory diseases.

Benefits

• Co-formulates azithromycin and amikacin despite incompatible solubilities
• Produces amorphous, highly porous powders for rapid dissolution
• Generates respirable particle sizes for deep lung deposition
• Supports excipient-free or minimal-excipient formulations
• Enables customizable fixed-dose combinations for optimized therapy

Applications

• Nontuberculous mycobacterial lung disease
• Chronic obstructive pulmonary disease (COPD)
• Inhaled antibiotic therapies
• Combination drug delivery platforms
• Advanced dry powder inhaler formulations

Opportunity

• Addresses major formulation barriers limiting inhaled antibiotic combinations
• Enables scalable manufacturing of high-performance pulmonary powders
• Reduces regulatory complexity through excipient-free options
• Available for exclusive licensing

Intellectual property

U.S. Provisional application serial no. 63/820,618 filed on 06/09/2025