Formulated allergen preparation and its use

Drug – bio-affecting and body treating compositions – Identification or warning feature – Taste or smell or chemical irritation to the eye – nose – or...

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424 21, 424 88, 424 89, 424 91, 424 92, 514456, A61K 924, A61K 3900

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active

046422323

DESCRIPTION:

BRIEF SUMMARY
The present invention is concerned with a novel formulated preparation containing an immunotherapeutically active amount of at least one allergen. The invention comprises also a method of treating allergic conditions by oral administration of the formulated preparation.
Allergic disorders may arise when the body is exposed to foreign substances, for instance due to inhaling of such substances or due to their contacting the skin or mucous membranes, or due to their reaching the body via the food ingested. Hypersensitivity reactions may occur, resulting from stimulation of immunological or other mechanisms.
The term "allergen" is used here and subsequently to mean a substance which, when exposed to a mammal, will be able to mount an immune response resulting in antibodies of the IgE-class and which also will be able to trigger an allergic reaction when the mammal later on is exposed to the substance. Allergens are chemically a very heterogenous class of compounds and they may consist of protein, a lipid, a carbohydrate or a combination thereof such as a glycoprotein, a proteoglucan, a lipoprotein etc.
Some compounds eliciting allergenic activity have to combine with biopolymers in vivo in order to mount the immune response or to trigger the allergic reaction in question.
Among immunologically-based disorders, the most dramatic one is the so-called atopic or IgE mediated allergic reaction which in its most severe form may result in a so-called anaphylactic shock which is potentially fatal. This disorder is characterized by the presence of antibodies of the immunoglobulin E class (IgE) which are capable of binding just that foreign substance (allergen) to which the individual is hypersensitive. These IgE antibodies moreover have the property of binding to the surface of certain cell types in the body. One such cell type is the mast cell which is present abundantly in the skin and in the mucosae of e.g. the nose, eyes, trachea and intestine.
When IgE antibody coated mast cells are exposed to the allergen that had originally "raised" the antibody, the mast cells are stimulated to release so-called mediators. All these mediators, for example histamine, SRS-A (leucotrienes), PAF (platelet activating factor) and a number of chemotactic factors and enzymes, contribute to the typical allergic inflammation which is characterized by (i) an early phase starting immediately with edema, contraction of smooth muscles and increased secretion, and (ii) a late phase with infiltration of phagocytic cells.
There are different ways of alleviating an allergic condition. Two of these are utilized in accordance with the present invention, viz.:
(1) Immunotherapy, also called hyposensitization, whereby the aforesaid stimulation of the mast cell may be prevented, probably due to a combined effect of developing immunological tolerance (inhibiting IgE antibody formation) and forming so-called blocking antibodies which belong to other classes of immunoglobulins.
(2) Pharmacotherapy, by which allergic symptoms may be averted or mitigated. Averting of the symptoms may be obtained by means of mediator release inhibition (for instance by administration of antiallergic substances such as e.g. disodium cromoglycate (DSCG) or other substances which applied locally are apt to decrease or prevent mediator formation or release, such as e.g. calcium antagonists, substances increasing the CAMP level or substances interfering with leucotriene synthesis). Mitigation of the symptoms may be obtained by inhibition of the effect of the mediators (for instance by administration of antihistamine or of antagonists to other mediators or of substances having opposite effects such as e.g. adrenergics, anticholinergics or xanthine derivatives).
An antiallergic substance of the DSCG type is believed to locally affect the mast cell so as to inhibit release of histamine and other mediators of the immediate allergic reaction. To be effective the drug has to reach the mast cell prior to the exposure to allergen. Ever since the discovery of DSCG, attempts have been m

REFERENCES:
patent: 3224942 (1965-12-01), Martin
patent: 4158705 (1979-06-01), Malley
patent: 4215036 (1980-07-01), Malley
patent: 4314993 (1982-02-01), Wijnendaele
patent: 4409237 (1983-10-01), Cairns et al.
patent: 4457913 (1984-07-01), Kokubu
patent: 4473548 (1984-09-01), Frenkel
Stemmann et al--Prax. Pneumol., vol. 33, (1979) pp. 302-304.
Roitt--Essential Immunology-4th edit., (1980) Blackwell Science Publicat., pp. 217-252.

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