Stable pharmaceutical drug aerosols

Details Stable pharmaceutical drug aerosols Stable pharmaceutical drug aerosols

A - Human Necessities

61

K

A61K 9/00 (2006.01) A61K 9/12 (2006.01) A61K 31/58 (2006.01)

Patent

CA 2677347

Various aspects of the present invention provide for methods of manufacturing a pharmaceutical drug product, which include storing a container at a temperature greater than ambient conditions for at least about seven days and conducting release testing on the container after storing. Products manufactured by this method have a more consistent fine particle size distribution (FSD) and fine particle fraction (FPF) at ambient conditions and at accelerated stability conditions over the life of the drug product. Advantageously, such products may more reliably and regularly pass testing requirements as required for an approved drug product by regulatory authorities such as the United States Food and Drug Administration (USFDA).

Divers aspects de la présente invention ont pour objet un procédé de fabrication d'un produit médicamenteux pharmaceutique, lequel comprend le stockage d'un récipient à une température supérieure aux conditions ambiantes pendant au moins environ sept jours et l'analyse de la libération du récipient après le stockage. Les produits fabriqués par ce procédé présentent une distribution de la taille des particules fines et une fraction des particules fines plus uniforme aux conditions ambiantes et à des conditions de stabilité accélérées pendant la durée de vie du produit médicamenteux. De manière avantageuse, de tels produits peuvent répondre de manière plus fiable et régulière aux exigences requises pour un produit médicamenteux approuvé par les autorités réglementaires telles que l'USFDA (United States Food and Drug Administration).

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