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Sheet-form preparation and method for producing the same

A preparation and tablet technology, applied in the field of tablet preparations, can solve problems such as difficulty in arbitrarily controlling dissolution time, anaphylactic shock pain, refrigerated storage, long time for dissolution, etc.

Inactive Publication Date: 2012-07-11
NITTO DENKO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the specific desensitization therapy by subcutaneous injection has the following problems: the risk of anaphylactic shock, the need for administration by a medical worker, the need for long-term frequent hospital visits, pain caused by injection, cold storage, etc.
[0007] Conventional film preparations use a water-soluble polymer as a base material, so a large amount of saliva is required to dissolve in the oral cavity, and it may take a long time to dissolve
In addition, as a preparation method of such a conventional film preparation, a method of dissolving a water-soluble polymer using water as a solvent, dispersing or solventing plant pollen therein, and performing heat drying has been disclosed. In the case of pollen dispersion of especially heat-labile plants, the activity of plant pollen may be reduced by heating
In addition, when the plant pollen is a liquid extract, the film-form preparation may dissolve, so it may be difficult to maintain a constant shape
Moreover, it is also difficult to arbitrarily control the dissolution time in the oral cavity, so further improvement is required for use in desensitization therapy for patients with allergic diseases.

Method used

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  • Sheet-form preparation and method for producing the same
  • Sheet-form preparation and method for producing the same
  • Sheet-form preparation and method for producing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] 1 part by weight of crystalline cellulose was added to 29 parts by weight of purified water, and ultrasonic dissolution and dispersion were performed. 10 parts by weight of water-soluble gelatin (average molecular weight about 100,000, hydroxyproline amount about 8.6 mol%) derived from fish (tilapia) was added thereto, and it was dissolved at a temperature of 30 to 50° C. Vibration was applied at a constant temperature of ~32°C to prepare a gelatin solution.

[0109] In addition, take 50 parts by weight of the standard allergen extract of cedar pollen 2000JAU / mL for treatment, dissolve 7 parts by weight of D-sorbitol and 3 parts by weight of PEG4000 at 2-8°C, and heat to After the temperature of 25~30℃, add all to the pre-prepared gelatin solution, mix quickly at 28~32℃, and distribute 2.2g per portion to 5cm 2 Plastic blisters (Cryomold (square) No. 3, manufactured by Sakura Finetek Japan Co., Ltd.) were cooled and solidified at 2 to 8°C for 1 day and night to obtain ...

Embodiment 2、3

[0111] Except having adopted the composition shown in Table 1, it operated in the same procedure as Example 1, and obtained the sheet-form preparation.

[0112] Use gelatin (fish origin) (average molecular weight about 100,000, hydroxyproline amount about 8.6 mol%) in embodiment 2, use gelatin (pig origin) A (average molecular weight about 85,000, hydroxyproline amount 8.6 mol%) in embodiment 3 The amount is about 9.2 mole %).

Embodiment 4

[0117] 1 part by weight of crystalline cellulose was added to 29 parts by weight of purified water, and ultrasonic dissolution and dispersion were performed. Add 10 parts by weight of alkali-treated gelatin (porcine origin) (average molecular weight: 180,000, hydroxyproline content about 9.2 mol%), dissolve it at a temperature of 70 to 80°C, and apply it at a constant temperature of 40°C Shake to make a gelatin solution.

[0118] In addition, take 50 parts by weight of the standard allergen extract of cedar pollen 2000JAU / mL for treatment, dissolve 7 parts by weight of D-sorbitol and 3 parts by weight of PEG4000 at 2-8°C, and heat to After a temperature of 40°C, add all to the pre-prepared gelatin solution, mix quickly at 40°C, and dispense 2.2g per portion into 5cm 2 The plastic blister (Cryomold (square) No. 3, manufactured by Sakura Finetek Japan Co., Ltd.) was cooled and solidified at 2 to 8°C for 1 day and night to obtain a sheet-like preparation.

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Abstract

The present invention provides a sheet-form preparation that can be easily dissolved in the mouth, allows the dissolution time thereof to be easily controlled, and can stably contain an allergenic protein from cedar pollen. The sheet-form preparation is characterized by containing water, gelatin, an allergenic protein from cedar pollen, and a stabilizing agent of the allergenic protein from cedar pollen.

Description

technical field [0001] The present invention relates to a sheet preparation containing cedar pollen allergenic protein. More specifically, it relates to a tablet preparation that can be easily dissolved in the oral cavity in desensitization therapy for cedar hay fever, and a method for producing the tablet preparation. Background technique [0002] The current treatment of allergic diseases such as pollen allergy is basically symptomatic therapy using antihistamines, but in recent years, desensitization therapy has attracted attention as a treatment method that can radically cure allergic diseases. [0003] Since desensitization therapy generally requires long-term administration for about 2 to 3 years, it must be a dosage form that further improves the QOL (quality of life) of caregivers and patients. [0004] At present, most of the dosage forms used in specific desensitization therapy are injections for subcutaneous injection. [0005] However, the specific desensitizat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/42A61K38/00A61K39/00A61P37/08
CPCA61K47/42A61K2039/54A61K47/26A61K9/0056A61K39/36A61K9/7007A61P37/08A61K9/70A61K47/30A61K47/36
Inventor 浅利大介宍户卓矢堀光彦冈崎俊彦小西达也
Owner NITTO DENKO CORP
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