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...

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Bibliographic Details
Published in:European journal of pharmaceutical sciences 2013-01, Vol.48 (1-2), p.181-194
Main Authors: Stegemann, S., Kopp, S., Borchard, G., Shah, V.P., Senel, S., Dubey, R., Urbanetz, N., Cittero, M., Schoubben, A., Hippchen, C., Cade, D., Fuglsang, A., Morais, J., Borgström, L., Farshi, F., Seyfang, K.-H., Hermann, R., van de Putte, A., Klebovich, I., Hincal, A.
Format: Article
Language:English
Subjects:
Administration, Inhalation
Affordable medicines
Bioequivalence
Chronic respiratory disease
Drug Delivery Systems - economics
Dry powder inhalation
Dry Powder Inhalers - economics
Fees, Pharmaceutical
Humans
Inhalation therapy
Orally inhaled products
Pharmaceutical Preparations - administration & dosage
Pharmacokinetics
Therapeutic Equivalency
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Summary: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.
ISSN:0928-0987
1879-0720
DOI:10.1016/j.ejps.2012.10.021