Quickly soluble film preparations

Abstract

A rapidly soluble film-shaped preparation containing a drug and an edible polymer, wherein the breaking strength of a film thereof is from 200 to 3,000 g / phi7 mm, the tensile strength of the film is from 200 to 3,000 g / 15 mm, the water disintegration time Y [sec] is within 300 seconds (Y<=300), and when the reciprocal [mg / mm2] of the specific surface area [mm2 / mg] of the film is taken as X (X>=0), the relationship of water disintegration time Y [sec] >=7500X2 is satisfied, and the rapidly soluble film-shaped preparation comprising one drug-containing layer, or having a support layer on one side or both sides of the drug-containing layer, wherein the edible polymer is hydroxypropyl cellulose and / or hydroxypropylmethyl cellulose, the compounding ratio of the drug is from 0.01 to 40% by weight based on the whole preparation, and that of the edible polymer is from 40 to 99.99% by weight based on the whole preparation.

Description

technical field [0001] The invention relates to an oral dissolving film preparation which can be taken without water, and the preparation contains useful drugs for disease treatment or diagnosis. More specifically, the oral dissolving film of the present invention contains medicine and edible macromolecular substances, and when put into the oral cavity, the preparation will be rapidly dissolved (within about 60 seconds) by the moisture in the oral cavity. Background technique [0002] The previous oral dosage forms refer to oral dissolving preparations including tablets, chewable tablets, sublingual tablets, capsules, pills, buccal tablets, oral liquids, and intraoral mucosal patches. It is the most widely used, and capsules, oral liquids, etc. are also being widely used. [0003] Furthermore, the following types are generally known for oral dissolving type preparations. (1) It is composed of excipients, plasticizers and binders to form a sheet-shaped edible shaped product...

AI Technical Summary

Problems solved by technology

In addition, the strength of the film is not described in this patent document 3, and the breaking strength and tensile strength of the film formed with such a low proportion of the film forming agent are all low, and the product becomes brittle and difficult to use.

Also, the product is not "instant"

[0018] As mentioned above, the conventional oral dissolving preparations are too thick, have a foreign body sensation, have disadvantages such as low strength and brittleness, and low drug content.

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