Drug preparation for oral administration

Details Drug preparation for oral administration Drug preparation for oral administration

1998-01-26

2001-02-13

Travers, Russell (Department: 1617)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Having -c-, wherein x is chalcogen, bonded directly to...

C424S085100, C424S085100

Reexamination Certificate

active

06187803

ABSTRACT:

This Application claims priority from Japanese Patent application No. 31,311/1221 filed Jun. 30, 1997
FIELD OF THE INVENTION
The present invention relates to a drug preparation for oral administration containing histamine-added immunoglobulin as an effective component.
BACKGROUND OF THE INVENTION
A complex of immunoglobulin and histamine has been known as a drug preparation, histamine-added immunoglobulin. It restores histamine fixing ability which is lowered in patients suffering from allergy and asthma. Accordingly, histamine-added immunoglobulin is used as an agent for nonspecific hyposensitizing therapy for bronchial asthma, allergic rhinitis, vasomotor rhinitis, and allergic skin diseases such as urticaria, chronic eczema, atopic dermatitis, etc. Histamine-added immunoglobulin also exhibits suppressive action to liberation of histamine. It does not exhibit side effects exhibited by antihistamines and adrenocortical hormones used as symptomatic remedies. It has therefore been widely used as a pharmaceutical agent with high safety. See pages 463 and 464 of “Drugs in Japan, Ethical Drugs,” edited by Japan Pharmaceutical Information Center; published by Yakugyo Jiho Co., Ltd., Japan in October 1996.
Histamine-added immunoglobulin is administered by a hypodermic injection because it is a proteinic preparation. There has been no report of its pharmaceutical effects by oral administration.
The present inventors have conducted various tests and studies on the pharmacological activity of histamine-added immunoglobulin. As a result, they have unexpectedly found that said histamine-added immunoglobulin has the same pharmacological activity as shown by the conventional hypodermic injection even if it is administered orally whereupon the present invention has been achieved.
The present invention provides a pharmaceutical composition for oral administration containing histamine-added immunoglobulin as an active component. The composition is shelf-stable over an extended period of time and is easily administered by a patient. The histamine-added immunoglobulin may be administered orally for the treatment of allergic diseases such as bronchial asthma, allergic rhinitis, vasomotor rhinitis, urticaria, chronic eczema and atopic dermatitis; autoimmune diseases such as multiple sclerosis, chronic rheumatoid arthritis and systemic lupus erythematodes; various immunodeficiency syndromes; and also eosinophilia or various inflammatory diseases caused by infectious diseases, parasitic diseases, diseases of respiratory organs, autoimmune diseases, malignant tumor, etc.
SUMMARY OF THE INVENTION
An allergic disease, autoimmune disease, immunodeficiency syndrome, inflammatory disease, or eosinophilia may be treated by orally administering to a patient in need of such treatment an orally ingestible, pharmaceutical composition comprising a pharmaceutically effective amount of a histamine-added immunoglobulin and a pharmaceutically acceptable carrier. The pharmaceutical composition is shelf-stable for extended periods of time and is more easily administered orally than by injection. Even though the composition contains a proteinic component, its efficacy is not substantially lost even though it is administered orally and subjected to digestive action of the stomach and intestines.
The histamine-added immunoglobulin may be prepared by dissolving about 1 mg to about 200 mg, preferably about 5 mg to about 50 mg, of immunoglobulin and about 0.01 &mgr;g to about 2 &mgr;g, preferably about 0.05 &mgr;g to about 0.5 &mgr;g, of a histamine component in a suitable pharmaceutically acceptable solution. The solution of histamine-added immunoglobulin may be prepared in a dry state or the solution may be filled in vials or the like followed by freeze-drying. Additives or carriers may be added in pharmaceutically acceptable amounts with one or more binders, disintegrating agents, lubricating agents, bulking agents, moisturizing agents, buffers, preservatives, or perfumes to obtain orally ingestible pharmaceutical compositions in the form of tablets, diluted powders, granules or capsules.
Exemplary of diseases which may be treated by oral administration of the histamine-added immunoglobulin are allergic diseases such as bronchial asthma, allergic rhinitis, vasomotor rhinitis, urticaria, chronic eczema and atopic dermatitis; autoimmune diseases such as multiple sclerosis, chronic rheumatoid arritis and systemic lupus erythematodes; various immunodeficiency syndromes; and also eosinophilia or various inflammatory diseases caused by infectious diseases, parasitic diseases, diseases of respiratory organs, autoimmune diseases, and malignant tumors.


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