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Claims for Patent: 4,225,597

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Claims for Patent: 4,225,597

Title: Beclomethasone dipropionate-hexane solvate and aerosols prepared therefrom
Abstract:A beclomethasone dipropionate-hexane solvate, useful in the preparation of beclomethasone dipropionate aerosols is disclosed herein. The new n-hexane solvate is stable when stored as bulk, and convenient and cheap to prepare. The trichlorofluoromethane solvate prepared by contacting micronized n-hexane solvate with trichlorofluoromethane affords beclomethasone dipropionate-trichlorofluoromethane solvate which retains its small particle size.
Inventor(s): Finckenor; Lawrence E. (Wayne, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:05/728,570
Patent Claims: 1. A solid composition of matter which consists of a beclomethasone dipropionate-n-hexane solvate characterized by an infrared absorption spectra substantially as shown in FIG. 1 and comprising 94-96% by weight beclomethasone dipropionate and 4-5% by weight n-hexane.

2. A method of preparing micronized beclomethasone dipropionate-fluorotrichloromethane solvate which comprises contacting micronized beclomethasone dipropionate-n-hexane solvate of claim 1 with trichlorofluoromethane.

3. A method according to claim 2 wherein the micronized beclomethasone dipropionate-n-hexane solvate is slurried with the trichlorofluoromethane.

4. In a method for preparing a beclomethasone dipropionate-fluorotrichloromethane solvate in an aerosol formulation, the improvement which comprises contacting beclomethasone dipropionate-n-hexane solvate with trichlorofluoromethane in situ.

5. In a method for preparing an aerosol formulation of beclomethasone dipropionate in a suitable aerosol propellant suitable for inhalation therapy, the improvement which comprises utilizing beclomethasone dipropionate-n-hexane solvate.
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