Aclidinium bromide is a long-acting, inhaled muscarinic antagonist approved in the United States in July 2012 as a maintenance treatment for chronic obstructive pulmonary disease. Evidence shows that it can improve quality of life and prevent hospitalizations. Pharmacologically it is a selective M3 receptor antagonist that produces sustained bronchodilation with clinical onset within minutes and a duration that supports twice daily dosing. The commercially available formulation is delivered as an inhalation powder from a dry powder inhaler at a nominal dose of 400 micrograms per actuation, producing minimal systemic anticholinergic effects because aclidinium undergoes rapid plasma hydrolysis to inactive metabolites. Key properties relevant to formulation and quality control include its quaternary ammonium structure, stability profile under accelerated humidity and temperature stress, and routine quantitation by validated HPLC or LC-MS methods in both drug substance and drug product.
Parent: Aclidinium Bromide
Parent: Aclidinium Bromide
Parent: Aclidinium Bromide
Parent: Aclidinium Bromide
Typical quality specifications for aclidinium bromide control both identified related compounds and unspecified impurities using validated chromatographic assays; representative release limits used by manufacturers and in regulatory filings commonly specify individual identified degradation or related compounds such as the de-esterification hydrolysis product (carboxylic acid metabolite) not more than 0.20 percent by area, the N-oxide impurity not more than 0.10 percent, the desmethyl impurity not more than 0.05 percent, and any other single unspecified impurity not more than 0.10 to 0.20 percent. Total impurities are typically limited to not more than 0.5 to 1.0 percent by area. Identification and quantitation are performed by stability-indicating HPLC with orthogonal confirmation by LC-MS when required for structural assignment. Impurity control strategy emphasizes prevention of ester hydrolysis during manufacturing and storage and qualification of any impurity observed above identification and qualification thresholds.
Aclidinium bromide is used as a maintenance bronchodilator to reduce symptoms and exacerbations in patients with chronic obstructive pulmonary disease.
The commonly prescribed brand name for aclidinium bromide in the United States is Tudorza Pressair.
Yes, aclidinium bromide was approved by the U.S. Food and Drug Administration in July 2012 for maintenance treatment of chronic obstructive pulmonary disease.
Aclidinium bromide is a LAMA, a long acting muscarinic antagonist.
