Deep lung pulmonary delivery of treprostinil

A technology of treprostinil and lung deposition, applied in the field of lung delivery, can solve the problem of not providing sustained drug release, and achieve the effect of increasing efficacy

A technology of treprostinil and lung deposition, applied in the field of lung delivery, can solve the problem of not providing sustained drug release, and achieve the effect of increasing efficacy

CN102164487AInactive Publication Date: 2011-08-24ARADIGM
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  • Deep lung pulmonary delivery of treprostinil
  • Deep lung pulmonary delivery of treprostinil
  • Deep lung pulmonary delivery of treprostinil

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] 9. Research plan

[0074] 9.1 General study design and plan

[0075] This was a single-centre, open-label study using a randomized two-way crossover design. Sixteen healthy adult male subjects participated and received study treatment. After providing written informed consent, each study candidate underwent a pre-study assessment and screening to determine eligibility for participation.

[0076] Subjects were instructed and trained in the proper use of the Nebu-Tec Optineb Nebulizer and the use of the drug-free AERx Essence System.

[0077] On each of the two dosing days, eligible subjects administered either the AERx Essence System or the Nebu-Tec Optineb Nebulizer 99m Administration of Tc-labeled treprostinil sodium. Following the initial study dose, subjects underwent a washout period of approximately 48 hours before completing the second (crossover) study dose.

[0078] Following each study dose, subjects underwent gamma scintigraphy and multiple venous blood s...

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Abstract

Administration of aerosolized Treprostinil formulations may provide a more homogeneous lung deposition of treprostinil, whereby making deep lung delivery possible.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Patent Application Serial No. 61 / 100,017, filed September 25, 2009, which is incorporated herein by reference. technical field [0003] The present application relates generally to methods of treatment and, in particular, to methods of treatment which may include pulmonary delivery of inhaled compounds. Such pulmonary delivery can reduce dosage, side effect spectrum and / or frequency of administration. Additionally, such delivery may provide a depot effect in the peripheral lung and an associated extended release into the systemic circulation. Background technique [0004] Most medications can generally be administered by some type of injection. While injecting medication can offer many advantages, it can sometimes be inconvenient and / or painful for some patients. One class of drugs typically administered by injection is prostacyclins and their analogs, eg Treprostin...

Claims

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Application Information

Patent Timeline
24 Aug 2011
Publication
CN102164487A
IPC
A01N37/10; A01K31/19
CPC
A61K9/0078; A61K31/191; A61P11/00; A61P11/08; A61P13/12; A61P15/00; A61P17/00; A61P17/06
Inventors
戴维·C··奇波拉; 伊戈尔·贡达