Developing and advancing dry powder inhalation towards enhanced therapeutics.

Enhanced therapeutics are drug products derived from existing generic drugs that provide additional benefits to the patients and the healthcare system. Enhanced therapeutics are considered to be an important and relatively low risk source of innovation. Pulmonary drug delivery is the major delivery route to treat chronic respiratory diseases and has been proven as a potential delivery route for complex drugs that cannot be delivered orally. Development of dry powder inhalation systems targets the delivery of fine drug particles to the deep lung surface by a combination of drug formulation, primary packaging and a device, whereby each contributes to the overall performance. Various methodologies for the non-clinical and clinical performance testing of orally inhaled products have been proposed and applied with variable success. Regulatory pathways have been developed and applied since. Considerable efforts have been made during the past decade to understand and optimize pulmonary drug delivery including their efficient commercial manufacturing. Pulmonary drug delivery remains an area of future innovation in the effective treatment of pulmonary diseases as well as the systemic delivery of systemically active complex drugs.

In-vivo studies in the treatment of oral ulcers with liposomal dexamethasone sodium phosphate.

Liposomes are man-made organelles composed of bimolecular lipid layers enclosing aqueous compartments. Dexamethasone Sodium Phosphate (DSP) was encapsulated in MLV liposomes and served as the test solution. DSP in solution served as control. Both were labeled with 99mTc. The rats were divided into three groups: typical application group, intramucosal injection and control group. Oral mucosal ulcers were produced by silver nitrate and was monofocal. Rats were killed at three and 24 h, respectively, after application. Ulcerated mucosa, intact adjacent mucosa and distant mucosa were excised. Biodistribution was determined by radiotracer technique in the three mucosal parts as well as in the blood, liver, spleen and brain. Liposomes increase local and decrease systemic drug concentration. Another finding was that liposomes localize the drug in the ulcerated area. In conclusion, liposomes may be useful in the treatment of oral ulcers.