title: Developing and advancing dry powder inhalation towards enhanced therapeutics.
abstract: 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.
authors.affiliation: Capsugel, Bornem, Belgium. sven.stegemann@capsugel.com
authors.forename: S
authors.initials: S
authors.lastname: Stegemann
authors.forename: S
authors.initials: S
authors.lastname: Kopp
authors.forename: G
authors.initials: G
authors.lastname: Borchard
authors.forename: V P
authors.initials: VP
authors.lastname: Shah
authors.forename: S
authors.initials: S
authors.lastname: Senel
authors.forename: R
authors.initials: R
authors.lastname: Dubey
authors.forename: N
authors.initials: N
authors.lastname: Urbanetz
authors.forename: M
authors.initials: M
authors.lastname: Cittero
authors.forename: A
authors.initials: A
authors.lastname: Schoubben
authors.forename: C
authors.initials: C
authors.lastname: Hippchen
authors.forename: D
authors.initials: D
authors.lastname: Cade
authors.forename: A
authors.initials: A
authors.lastname: Fuglsang
authors.forename: J
authors.initials: J
authors.lastname: Morais
authors.forename: L
authors.initials: L
authors.lastname: Borgström
authors.forename: F
authors.initials: F
authors.lastname: Farshi
authors.forename: K-H
authors.initials: KH
authors.lastname: Seyfang
authors.forename: R
authors.initials: R
authors.lastname: Hermann
authors.forename: A
authors.initials: A
authors.lastname: van de Putte
authors.forename: I
authors.initials: I
authors.lastname: Klebovich
authors.forename: A
authors.initials: A
authors.lastname: Hincal
mesh_terms: D000280:Administration, Inhalation; D016503:Drug Delivery Systems / Q000191:economics; D058995:Dry Powder Inhalers / Q000191:economics; D005252:Fees, Pharmaceutical; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency
chemical_list: D004364:Pharmaceutical Preparations