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Stabilized pharmaceutical composition, liquid preparation of stabilized pharmaceutical composition, film-form preparation, and method for producing film-form preparation

A technology of composition and stabilizer, applied in the directions of drug combination, carbohydrate active ingredients, drug delivery, etc., can solve the problems of pain, refrigerated storage, frequent visits to the hospital, etc.

Inactive Publication Date: 2011-10-05
NITTO DENKO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, in the specific desensitization therapy based on subcutaneous injection, there are problems in the risk of anaphylactic shock, the need for administration by medical personnel, the need for frequent visits to the hospital for a long time, the pain caused by the injection, the need for Refrigerated storage, etc.
As a result, existing allergen-containing film-form preparations cannot meet the requirements of sufficient film strength, reduction of sticky feeling caused by water-soluble polymers in the oral cavity, and tactile sensation when touched by fingers.

Method used

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  • Stabilized pharmaceutical composition, liquid preparation of stabilized pharmaceutical composition, film-form preparation, and method for producing film-form preparation
  • Stabilized pharmaceutical composition, liquid preparation of stabilized pharmaceutical composition, film-form preparation, and method for producing film-form preparation
  • Stabilized pharmaceutical composition, liquid preparation of stabilized pharmaceutical composition, film-form preparation, and method for producing film-form preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0125] To 100.0 parts by weight of D-sorbitol, 55.0 parts by weight of standardized allergen treatment extract "TORII" cedar tree pollen 2000 JAU / mL (manufactured by Torii Pharmaceutical Co., Ltd.) was added, stirred and dissolved, and a water content of 17.7% by weight was prepared. Stabilized pharmaceutical compositions. In addition, the standardized allergen treatment extract "TORII" cedar pollen 2000JAU / mL contains 50% by weight of water.

[0126] This stabilized pharmaceutical composition was stored at 30±2° C. for 2 weeks, and the allergen activity was measured 1 week later and 2 weeks later. The results are shown in Table 10.

Embodiment 2～4

[0128] A stabilized pharmaceutical composition was prepared in the same manner as in Example 1, except that the composition shown in Table 1 was used. The obtained stabilized pharmaceutical composition was stored at 30±2° C. for 2 weeks, and the allergen activity was measured 1 week later and 2 weeks later. The results are shown in Table 10.

experiment example 1

[0130] To 100.0 parts by weight of erythritol, 55.0 parts by weight of standardized allergen treatment extract "TORII" cedar tree pollen 2000 JAU / mL (manufactured by Torii Pharmaceutical Co., Ltd.) was added and dissolved with stirring to prepare a drug composition with a water content of 17.7% by weight things.

[0131] This pharmaceutical composition was stored at 30±2° C. for 2 weeks, and the allergenic activity was measured 1 week later and 2 weeks later. The results are shown in Table 10.

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Abstract

The present invention provides a stabilized pharmaceutical composition that enables the production of a preparation for desensitization therapy useful as an agent for the prevention or treatment of allergic diseases such as pollen hypersensitivity, has outstanding allergen protein stability, and is useful for storage and transfer. More specifically, the present invention provides a stabilized pharmaceutical composition containing an allergen protein and at least one type of stabilizer selected from the group consisting of sugars, sugar alcohols, and sugar fatty acids.

Description

technical field [0001] The present invention relates to a stabilized pharmaceutical composition suitable for desensitization therapy, which is useful as a preventive or therapeutic agent for hay fever and the like. In particular, the present invention relates to a stabilized pharmaceutical composition having excellent stability of cedar pollen allergen protein and excellent convenience in storage and handling. Background technique [0002] In recent years, due to changes in lifestyle and living environment, the number of patients suffering from allergic diseases has increased, and in particular, the number of patients suffering from allergic diseases such as pollen allergy has increased rapidly. [0003] In formulation of such biopharmaceuticals for allergic diseases, it is necessary to stably preserve proteins used as pharmaceuticals, that is, to minimize the loss of biological activity. [0004] However, in pharmaceutical compositions used in conventional formulations of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/36A61K9/70A61K47/10A61K47/14A61K47/26A61K47/38A61P37/08
CPCA61K9/0056A61K9/006A61K39/36A61K9/0095A61K9/7007A61K39/35A61P27/14A61P37/08A61K9/70A61K31/70
Inventor 浅利大介堀光彦宍户卓矢
Owner NITTO DENKO CORP