Problem
Clofazimine is highly active against a multitude of bacteria that affect the lungs; however, oral delivery of this drug is hindered by the unpredictable bioavailability and pharmacokinetics of clofazimine. Orally administered clofazimine can cause systemic toxicity, with undesirable side effects including GI complications and hyperpigmentation of the skin. Oral administration of clofazimine requires at least 30 days of continued dosing to reach steady-state concentrations; to overcome this, large loading doses may be given, which increases the chance for side effects.
Solution
Dr. Smyth and his team have developed a process to deliver clofazimine to the lungs via a dry powder inhaler. The delivered clofazimine effectively aerosolizes at low and high flow rates without the use of additional excipients or expensive particle engineering techniques. The clofazimine produced by this invention is delivered directly to the lungs, avoiding the unpredictable bioavailability that can occur with oral dosing, and allowing rapid sequestration of clofazimine in lung cells. The dry powder formulation is stable and does not require cold storage, allowing this formulation to be administered in low-resource regions.
About the inventor
Dr. Hugh Smyth is the Alcon Centennial Professor for the College of Pharmacy at The University of Texas at Austin and an Adjunct Associate Scientist at the Lovelace Respiratory Research Institute in Albuquerque, New Mexico. Dr. Smyth has published over 150 peer-reviewed publications, is an editor of three books, and has obtained more than 20 patents or patent applications. The focus of his work has broad applicability in the medical sector, including research and development focused on novel drug delivery devices for respiratory, nasal, ophthalmic, transdermal, and topical systems.
