Compositions of Bedaquiline, Combinations Comprising Them, Processes for Their Preparation, Uses and Methods of Treatment Comprising Them

A system for use in providing antibiotic activity when treating or providing prophylaxis against a pulmonary infection caused by mycobacteria or other gram-positive bacteria, wherein the system comprises:

• a nebulized pharmaceutical formulation comprising:
• a therapeutically effective dose of bedaquiline;
• a nonionic surfactant with an Hydrophilic-Lipophilic Balance value of greater than 10;
• and
• an aqueous liquid carrier selected from water, isotonic saline, buffered saline and aqueous electrolyte solutions and
• a nebulizer, wherein the bedaquiline is present in the form of a suspension, and wherein the aerosol particles produced by the system have a mass median aerodynamic diameter of 1 to 5 μm.

A system for use in providing antibiotic activity when treating or providing prophylaxis against a pulmonary infection caused by mycobacteria or other gram-positive bacteria, wherein the system comprises:

• a dry powder pharmaceutical formulation comprising
• a) a therapeutically effective dose of bedaquiline,
• b) one or more excipients selected from sugars, amino acids, and phospholipids, and combinations thereof,
• a container for the formulation selected from a capsule or blister package, and
• a dry powder inhaler,
• wherein the bedaquiline is present in the form of a dry powder, and wherein the bedaquiline containing particles have a mass median diameter of 1 to 5 μm.