Drug – bio-affecting and body treating compositions – Identification or warning feature – Taste or smell or chemical irritation to the eye – nose – or...
Patent
1982-05-25
1985-05-14
Rose, Shep K.
Drug, bio-affecting and body treating compositions
Identification or warning feature
Taste or smell or chemical irritation to the eye, nose, or...
424 28, A61L 1503, A61F 1300, A61K 970
Patent
active
045171734
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
The present invention relates to a preparation which is applied to a mucous membrane and more particularly it relates to a mucous membrane-adhering film preparation which is placed on and adheres onto a mucous membrane part or an inflammed body portion of a mucous membrane to obtain general or local curing effects, and to a process for its preparation.
BRIEF DESCRIPTION OF THE PRIOR ART
Preparations used for applying onto a mucous membrane have become particularly attractive in recent years and give the expectation of quick curing effects by reason of a high concentration of a pharmaceutical agent being absorbed by the mucous membrane and carried directly to the whole body by the body circulatory system, and, these preparations have a lesser loss of the pharmaceutically effective component where the loss occurs by decomposition and chemical or microorganism reactions of the pharmaceutically effective component with the pH condition, digestive juices and microorganisms in the gastric and intestinal organs, such as generally used oral drugs of which the pharmaceutical effective component is absorbed by a gastric wall and the intestinal organs and carried to the whole body after passing through the portal veins and heptic organ.
Troches, buccal tablets, and tongue tablets as preparations for being applied to a mucous membrane in the oral cavity, a suppository, vaginal suppository for use in the rectum and vagina, and an ointment and an adhering tablet as an external preparation applied directly to the inflammed portion are well known as preparations to be applied to the mucous membrane.
However, taking preparations for external use as an example, it is difficult to coat the desired body part alone with the ointment, particularly in the buccal cavity, the staying time of the pharmaceutical component on an ulcerated body part is short because of saliva and the movement of the tongue and cheeks, and the pharmaceutical effect is small in comparison with the amount of dosage and this is a serious drawback. Further, the adhering tablet applied to a larger ulcer stimulates and increases contact pain and furthermore in the event of applying the tablet to several ulcerated parts, several pieces of adhering tablets must be placed on these ulcerated parts and thereby a high pressure of extraneous material is felt on the body parts.
As preparations to overcome these drawbacks, a preparation of the type to adhere to the mucous membrane in the oral cavity or nasal cavity was proposed at the 99th annual meeting of the Japan Pharmaceutical Society (Aug. 28, 1979) and disclosed in the Public Bulletin of Japan Open Patent Publication No. 100714/1981 in which the base agent of the ointment is eccentrically placed in a mucous membrane-adhering coating layer such as cellulose ether.
This preparation has an improved soft flexibility as compared with the conventional adhering tablet, but the size of the preparation is limited.
The present inventors carried out research as to preparations to be applied to the mucous membrane and as a result they have discovered a film preparation which comprises at least two layers: (a) a water-soluble layer containing a pharmaceutical agent, and (b) a poor water-soluble layer; and, wherein the water-soluble layer is to be adhered onto the mucous membrane, and thus, the present invention came into being.
OBJECTS OF THE INVENTION
Therefore, an object of the present invention is to provide a mucous membrane-adhering film preparation which is improved over the defects of the prior art.
Another object of the invention is to provide a process for producing this film preparation.
SUMMARY OF THE INVENTION
Generally speaking, the present invention contemplates a mucous membrane-adhering film preparation which is to be adhered at the side of a pharmaceutical layer onto a mucous membrane, which consists of two layers: (a) a pharmaceutical layer, and (b) a poor water-soluble layer. The pharmaceutical layer (a) consists mainly of pharmaceutical agents and water-soluble high
REFERENCES:
patent: 4136162 (1979-01-01), Fuchs et al.
patent: 4210633 (1980-07-01), Takruri
patent: 4292299 (1981-09-01), Suzuki et al.
Fujiyama Norimasa
Ito Akinori
Kizawa Hidenori
Kobayashi Jitsuo
Nippon Soda Co. Ltd.
Oujevolk George B.
Rose Shep K.
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