Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization.

Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization. Research Abstract Details 

Research Abstract Table of Contents

Jump to the:

Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization. Abstract Text:

Catherine H Richardson,Marcel de Matas,Harold Hosker,Rahul Mukherjee,Ian Wong,Henry Chrystyn,

PURPOSE: The relative lung bioavailability of salbutamol sulfate particles produced using supercritical fluids (SEDS) and delivered by dry powder inhaler (DPI) was compared with the performance of a conventional micronized drug DPI using the same device design (Clickhaler, Innovata Biomed). MATERIALS AND METHODS: Twelve healthy volunteers and 11 mild asthmatic patients completed separate four-way randomised cross-over studies, assessing the relative bioavailability of salbutamol sulfate (urinary excretion method), formulated as SEDS particles (three batches) and micronized particles (Asmasal inhaler, UCB Pharma Ltd). Post-treatment improvements in patient lung function were assessed by measuring FEV(1). Physicochemical evaluation of the three SEDS batches revealed inter-batch differences in particle size and shape. RESULTS: There was no significant difference in the relative lung bioavailability of salbutamol and its bronchodilator response between the best performing SEDS formulation and the Asmasal inhaler in volunteers and patients, respectively. SEDS salbutamol sulfate showing wafer like morphology gave greater fine particle dose, relative lung bioavailability and enhanced bronchodilation compared to other SEDS batches containing elongated particles. CONCLUSIONS: Active Pharmaceutical Ingredient (API) manufactured using supercritical fluids and delivered by DPI can provide similar lung bioavailability and clinical effect to the conventional micronized commercial product. Product performance is however notably influenced by inter-batch differences in particle characteristics.

Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization. Publishing Authors By Initials

CH Richardson,M de Matas,H Hosker,R Mukherjee,I Wong,H Chrystyn,

For similar natural sciences: chemistry: chemistry, physical: particle size research abstracts see: natural sciences: chemistry: chemistry, physical: particle size research

PUBMED ID PMID:

MEDLINE DATE:

Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: Pharmaceutical research

VOLUME: 24

Page Numbers: 2008-17

Journal Abbreviation: Pharm. Res.

ISSN: 0724-8741

DAY: 18

MONTH: 05

YEAR: 2007

Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 8406521

Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization. Keywords Mesh Terms:

KEYWORDS: Particle Size

MESH TERMS: metabolism

Chemical & Substance for Abstract: Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization. Information

Substance Name: Albuterol

Registry Number: 18559-94-9

Grant and Affiliation Information for Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization.

AFFILIATION: Institute of Pharmaceutical Innovation, University of Bradford, Bradford, BD7 1DP, UK.

Country: United States

AGENCY:

GRANT:

ACRONYM:

MEDLINETA: Pharm Res

REFSOURCE:

DATABASENAME:

ACCESSION NUMBER:

Number Hits: 0

Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization Related Publications

• Can all patients with COPD use the correct inhalation flow with all inhalers and does training help?
• Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization.
• Evaluation of an in vitro in vivo correlation for nebulizer delivery using artificial neural networks.
• Evaluation of in vitro in vivo correlations for dry powder inhaler delivery using artificial neural networks.
• Relative lung deposition of salbutamol following inhalation from a spacer and a Sidestream jet nebulizer following an acute exacerbation.
• The Diskus: a review of its position among dry powder inhaler devices.