Pharmaceutical gel and aerosol formulations and methods to...

A - Human Necessities – 61 – K

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A61K 9/12 (2006.01) A61K 9/70 (2006.01) A61K 47/38 (2006.01)

Patent

CA 2394569

Bioadhesive formulations to deliver, for both local and systemic effects, a wide variety of drugs of varying degrees of solubility are described. These formulations can be gels or aerosols and comprise a water-insoluble, pharmaceutically acceptable alkyl cellulose, a solvent system comprising a volatile solvent and water, a solubilizing agent or a dispersing agent, or a mixture thereof, and a pharmaceutical. These formulations can be made bioerodible and release the pharmaceutical in a controlled manner. Formulations further comprising a propellant such as 1,1-difluoroethane are also provided. The delivery can be made to a skin surface or to a mucosal surface. Methods for preparing and administering these formulations are also provided. Several specific examples using the anti-ulcer medication 2-amino-7- (1-methylethyl)-5-oxo-5H-[1]benzopyrano-[2,3-b]-pyridine-3-carboxylic acid are provided.

L'invention concerne des formulations bio-adhésives, à effet à la fois local et systématique, pour réaliser une grande variété de produits thérapeutiques à degrés de solubilité différents. Ces formulations peuvent se présenter sous forme de gels ou d'aérosols et comprennent une alkyle cellulose insoluble à l'eau et pharmaceutiquement acceptable, un système de solvant comprenant un solvant volatil et de l'eau, un agent de solubilisation ou un agent de dispersion ou un mélange des deux, et un médicament. Ces formulations peuvent être bio-érodables et libérer le médicament de manière contrôlée. Selon l'invention, il existe également des formulations contenant un gaz de propulsion tel que le 1,1-difluoroethane. Elles peuvent être appliquées sur la peau ou sur des muqueuses. Ladite invention concerne également des méthodes de préparation et d'administration de ces formulations, et elle donne plusieurs exemples spécifiques utilisant comme médicament anti-ulcéreux l'acide 2-amino-7-(1-méthyléthyle)-5-oxo-5H-[1]benzopyrano-[2,3-b]-pyridine-3-carboxylique.

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