Film-shaped preparations with improved chemical stability containing active substances and method for the production thereof
First Claim
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1. A film-like, active substance-containing preparation for application in the oral cavity or for transmucosal application, wherein said preparation has a maximum peroxide number of 40.
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Abstract
A film-like, active substance-containing preparation for application in the oral cavity or for transmucosal application. The preparation has a maximum peroxide number that is 40.
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29 Claims
- 1. A film-like, active substance-containing preparation for application in the oral cavity or for transmucosal application, wherein said preparation has a maximum peroxide number of 40.
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15. A process for the production of a film-like active substance-containing preparation for application in the oral cavity or for transmucosal application, comprising the steps of:
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Determining the peroxide number of every formulation component provided for making the preparation of a film-like, active substance-containing preparation for application in the oral cavity or for transmucosal applications wherein the preparation has a maximum peroxide number of 40;
selecting the formulation components wherein the maximum sum of the peroxide numbers of the individual formulation components is 40, with the peroxide number of each formulation component being weighted according to the percentage of these components in the preparation;
preparing a solution, dispersion or melt containing the selected formulation components and at least one active substance to be released;
coating the solution, dispersion or melt onto an inert support using doctor-knife application, roll application, spraying or extrusion methods; and
drying or cooling said preparation to form a film layer. - View Dependent Claims (16, 17, 18, 27, 28, 29)
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Specification