albuterol inhalational powder (A006 DPI) / Amphastar - LARVOL DELTA

Development and validation of a stability-indicating high-performance liquid chromatography method for the simultaneous determination of albuterol, budesonide, and ipratropium bromide in compounded nebulizer solutions (J AOAC Int) -

An HPLC-UV method to separate and quantitate albuterol, ipratropium bromide, and budesonide in nebulizer solutions is reported;The method was validated, showed good selectivity, and was linear over several orders of magnitude; Significant albuterol -dependent degradation occurred within 5 hours in solutions formulated with the free base of albuterol, while those containing the sulfate salt of albuterol produced no degradation

New diagnostic • Asthma

Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers (clinicaltrials.gov) - P2; N=22; Completed; Sponsor: Amphastar Pharmaceuticals, Inc.; Active, not recruiting -> Completed ; N=18 -> 22

Trial completion • Asthma • Biosimilar • Immunology • Inflammation

Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation (clinicaltrials.gov) - P2; N=24; Recruiting; Sponsor: Amphastar Pharmaceuticals, Inc.

New P2 trial • Asthma • Biosimilar • Immunology