Film-form preparation

Abstract

An object of the present invention is to provide a film-form preparation to be used in desensitization therapy and a method for producing the same. This film-form preparation enables the patient to self-administer an allergen and adjust the dose, has excellent portability, has no residual sensation, provides excellent protection against accidental swallowing, is easy for a caregiver to administer, and can greatly improve the QOL of both patients and caregivers. Additionally, this film-form preparation enables arbitrary control of the dissolution time in the mouth, particularly sublingually and has very little gummy sensation in the mouth and better feeling when touched by the fingers. A film-form preparation including: an allergen; an edible polymer that is soluble in both water and a polar organic solvent; and one or two or more types of particles selected from the group consisting of monosaccharide to hexasaccharide sugars and sugar alcohols thereof that have an average particle size of 0.1 to 100 [mu]m.

Description

technical field [0001] The present invention relates to a film-form preparation that can be easily dissolved in the oral cavity. More specifically, the present invention relates to a film-form preparation suitable for oral or sublingual administration for the purpose of specific desensitization therapy by introducing an allergen at a prescribed Exposure to the patient's oral cavity (for example, in the oral mucosa, especially the sublingual mucosa) and the allergen is administered for a certain period of time, so that the patient acquires immune tolerance. Background technique [0002] As a treatment for allergic diseases such as pollen allergy, at present, it is basically a symptomatic treatment using antihistamines. In recent years, desensitization therapy has attracted attention as a treatment method that can completely cure allergic diseases. [0003] Since desensitization therapy generally requires long-term administration of about 2 to 3 years, it is considered that a...

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Problems solved by technology

[0005] 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.

[0015] Therefore, in the current film-like preparations, by adding sugar and sugar alcohols, especially only a large amount of sugar and sugar alcohols, it is not possible to fully satisfy the sticky feeling when applied in the oral cavity, the sticky feeling when touched by the fingers, and other factors such as high Film properties such as film strength

In addition, since it is difficult to arbitrarily control the dissolution time in the oral cavity, it cannot be said to be the most suitable preparation for desensitization therapy of patients using allergens

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