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Oral film formulation

A technology of oral film and reducing agent, which is applied in drug delivery, sheet delivery, pharmaceutical formulation, etc., and can solve the problems of unsatisfactory chemical stability, ineffectiveness, and hindering the quality of triptan-containing pharmaceutical compositions, etc.

Inactive Publication Date: 2013-02-27
LABTEC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The inventors of the present invention have now found that the chemical stability of triptans in oral films is generally unsatisfactory
In particular, it has been observed that in oral films, triptans are degraded or metabolized to some extent to their N-oxides or other deleterious degradation products, which are pharmacologically ineffective
These degradation products or metabolites hamper the quality of triptan-containing pharmaceutical compositions

Method used

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Embodiment Construction

[0031] As stated above, the present invention relates to triptan-containing pharmaceutical compositions with increased triptan stability, ie reduced levels of triptan degradation products. The stability of triptans is increased due to the presence of thiol-containing substances. In one embodiment of the present invention, the concentration of the thiol-containing substance in the pharmaceutical composition is about 0.01 to about 7 wt%. Preferably, the mercapto-containing species is present at 0.07 to 6 wt%. In a more preferred embodiment, the concentration of the thiol-containing reducing agent is 0.2 to 1.0 wt%. In one embodiment, the concentration does not exceed 0.5 wt%.

[0032]According to the present invention, the relative amount of degradation products of triptans to the total amount of initial triptans can be reduced to a maximum of about 1%, that is, at least 99% of triptans can be recovered. This applies after the pharmaceutical composition has been "stress teste...

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Abstract

Pharmaceutical composition comprising at least one triptan and at least one thiol-group containing reducing agent.

Description

field of invention [0001] The present invention relates to oral film formulations comprising indole serotonin receptor antagonists (triptans), their preparation and use for the treatment of headaches. Background of the invention [0002] Pharmaceutical dosage forms, such as orally dissolvable film formulations, which dissolve rapidly in the mouth, are advantageous in a variety of ways; in particular they facilitate the oral administration of drugs to patients who have swallowing problems or suffer from nausea and vomiting. Swallowing conventional oral administration forms such as film-coated tablets is often difficult for these patients. Due to the rapid disintegration of film formulations in the oral cavity, active ingredients from film formulations can be incorporated into the oral or gastric mucosal layer. Accordingly, these films can be designed to effectuate or support gastrointestinal or buccal absorption of the active ingredient. [0003] Headaches are a common symp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/70A61K31/422A61K47/18A61K47/20
CPCA61K9/006A61K31/422A61K9/0056A61K9/7007
Inventor A·布赖滕巴驰N·施维尔
Owner LABTEC
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