title: Dry powder antibiotic aerosol product development: inhaled therapy for tuberculosis.
abstract: Inhaled therapies offer a unique approach to the treatment of tuberculosis (TB) using a relevant target organ system as a route of administration. The number of research reports on this topic has been increasing exponentially in the last decade but studies of clinical efficacy have been rare in recent times. The challenge is to take many research findings and translate them into a strategy for product development. Dry powder inhalers are the dominant drug product under consideration by those interested in the inhaled therapy for TB. A range of factors including candidate drug, formulation, device selection, drug product testing for proof of concept, and preclinical and clinical purposes all demand different considerations. The following review is intended to raise awareness of a growing body of evidence, suggesting that inhaled therapy for TB is possible and desirable. In addition, it is intended to outline key elements of the product-development activity for this particular application that has not been discussed elsewhere in the literature. Hopefully, this will encourage those with development expertise to seriously contemplate the steps required to bring such products forward.
authors: Center for Aerosol and Nanomaterials Engineering, Research Triangle Institute, Research Triangle Park, North Carolina, 27709.
authors: Anthony J
authors: AJ
authors: Hickey
authors: Amit
authors: A
authors: Misra
authors: P Bernard
authors: PB
authors: Fourie
mesh_terms: D000280:Administration, Inhalation; D000818:Animals; D000904:Antibiotics, Antitubercular / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000379:methods; D016503:Drug Delivery Systems / Q000295:instrumentation*; D058995:Dry Powder Inhalers / Q000295:instrumentation*; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000187:drug effects; D014376:Tuberculosis / Q000188:drug therapy*
chemical_list: D000904:Antibiotics, Antitubercular
keywords: anti-infectives; drug delivery systems; factorial design; formulation; global health; multivariate analysis; powder technology; pulmonary drug delivery