Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Utility Patent
1996-03-28
2001-01-02
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S844000
Utility Patent
active
06169069
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field of the Invention
The present invention relates to the formulation of an antagonist of CGRP (peptide derived from the calcitonin gene: Calcitonin Gene Related Peptide, or “CGRP”) into pharmaceutical compositions, in particular for topical application, for the treatment of ocular and/or palpebral pruritus and/or pain and/or dysaesthesias.
This invention also relates to the formulation of a CGRP antagonist into cosmetic compositions intended for making up or caring for the eyes or eyelids, as well as to a regimen for making up and/or caring for sensitive eyes.
2. Description of the Prior Art
It is known to this art that certain patients suffer from ocular and/or palpebral pain following operations or blows received to the eye. Moreover, and although the precise cause is not known, certain individuals very often experience sensations of itching or pruritus and dysaesthesic sensations around the eyes and eyelids. These may also be pruritus or dysaesthesic sensations of allergic origin.
By the term “dysaesthesic sensations” are intended sensations of burning or heating, stinging, tingling, discomfort and tightness. These sensations may be combined with redness.
All of these ophthalmic indications may, moreover, be combined with rosacea and possibly with conjunctivitis.
Among the factors triggering ophthalmic or palpebral pruriginous or dysaesthesic afflictions, exemplary thereof are rapid temperature variations, heat and in particular exposure to ultraviolet or infrared radiation, low relative humidity, exposure to violent winds or to currents of air (blowing machine, conditioned air), the application of surfactants, exposure to toxic or irritant vapors (solvents) or to dusts, irritant ophthalmological drops or topical products, irritant dermatological or cosmetic palpebral topical products (alpha-hydroxy acids, retinoids) or the use of certain cosmetics, even when these are not known to be particularly irritating.
Other factors triggering ocular or palpebral pruriginous or dysaesthesic afflictions which should also be included are allergens such as, in particular, pollen, animal hairs, acarians and molds.
Hitherto, the pathological mechanism of these signs was very poorly understood and ocular and/or palpebral dysaesthesias were treated with corticoids and also local antiseptics as an ophthalmic ointment or as drops.
Although corticoids are relatively effective at alleviating the above symptoms, they unfortunately have side effects which are often very severe, such as atrophies. Furthermore, they sensitize towards mycotic or bacterial infections and their kinetics are often slow (several minutes to a few hours). Moreover, their chronic use may lead to a pharmacodependency.
Thus, serious need continues to exist in this art for a treatment of the aforesaid ocular and palpebral dysaesthesias, pains and pruritus which does not have the above drawbacks/disadvantages.
SUMMARY OF THE INVENTION
A major object of the present invention is the administration of one or more CGRP antagonists to a mammalian, notably human patient, for treating the disease states indicated above.
CGRP is a polypeptide chemical species produced and released by a nerve ending. CGRP is involved, in particular, in respiratory and inflammatory diseases, in allergic diseases and in certain dermatological diseases such as eczema and prurigo.
It has now unexpectedly been determined that it is possible to treat ocular and/or palpebral pruritus and/or ocular and/or palpebral pain and/or ocular and/or palpebral dysaesthesias by preventing the synthesis and/or the release and/or the binding of CGRP.
Thus, the present invention features the formulation of at least one CGRP antagonist into a pharmaceutical or dermatological composition for treating ocular and/or palpebral pruritus and/or ocular and/or palpebral pain and/or ocular and/or palpebral dysaesthesias.
This invention also features the application of compositions containing one or more CGRP antagonists to the eyes or the eyelids to effect a marked reduction or even complete disappearance of the ophthalmic pruritus, dysaesthesic sensations and pain; a preventive and curative, calming and soothing effect on the eyes and eyelids is very rapidly attained, and in any event much more rapidly than with corticoids. In addition, no pharmacodependency results.
Too, this invention also features formulating these CGRP antagonists into cosmetic compositions for sensitive eyes and, in particular, lotions for cleansing or removing makeup from the eyes, and into makeup products for sensitive eyes and, especially, eye shadows, mascaras, eye pencils or eyeliners for sensitive eyes.
Thus, the present invention features the formulation of at least one CGRP antagonist into a cosmetic composition containing a cosmetically acceptable medium, such composition being intended for sensitive eyes.
The present invention accordingly features a regimen for making up or caring for sensitive eyes, comprising topically applying a cosmetic composition containing at least one CGRP antagonist, in a cosmetically acceptable medium, to the eyelids, the eyelashes and/or under the eyes.
This invention also features cosmetic, dermatological and/or pharmaceutical compositions for sensitive eyes, comprising an effective amount of at least one CGRP antagonist, in a cosmetically, pharmaceutically or dermatologically acceptable medium.
DETAILED DESCRIPTION OF BEST MODE AND SPECIFIC/PREFERRED EMBODIMENTS OF THE INVENTION
More particularly according to the present invention, the subject compositions comprise a cosmetically, pharmaceutically or dermatologically acceptable medium (vehicle, carrier or diluent), namely, a medium which is compatible with the skin and the eyes. The compositions containing the CGRP antagonist or antagonists are preferably administered via topical application. They may also be ingested or injected (systemic administration).
By “CGRP antagonist” is intended any molecule, whether organic or inorganic, which is capable of effecting inhibition of the receptor binding of CGRP or of effecting an inhibition of the synthesis and/or of the release of CGRP by sensitive nerve fibers.
In order for a chemical species to be recognized as a CGRP antagonist, it must in particular satisfy the following characteristic: it must have a CGRP antagonist pharmacological activity, i.e., induce a coherent pharmacological response, in particular in one of the following tests:
(a) the antagonist species must reduce the vasodilation induced by capsaicin, and/or
(b) the antagonist species must induce an inhibition of the release of CGRP by sensitive nerve fibers, and/or
(c) the antagonist species must reduce inhibition of the contraction of vas deferens smooth muscle induced by CGRP.
In addition, the antagonist may have an affinity for the CGRP receptors.
Hitherto, a link between CGRP and sensitive eyes had not been established.
CGRP 8-37 and anti-CGRP antibodies are suitable CGRP antagonists according to the invention.
In the compositions according to the invention, the CGRP antagonist is preferably employed in an amount ranging from 0.000001% to 10% by weight relative to the total weight of the composition, and in particular in an amount ranging from 0.0001% to 5% by weight relative to the total weight of the composition.
The CGRP antagonist may advantageously be combined with one or more antagonists of another neuropeptide such as substance P antagonists and/or one or more inflammation mediator antagonists such as histamine antagonists, interleukin 1 (IL1) antagonists and Tumor Necrosis Factor alpha (TNF alpha) antagonists.
The substance P antagonists are preferably receptor antagonists.
The substance P antagonists which are particularly well suited according to this invention are those described in published French patent application 94/05537, filed May 5, 1994 and assigned to the assignee hereof. Exemplary substance P antagonists include sendide and spantide II.
By way of example, the substance P antagonists and the inflammation mediator antagonists may be formulated i
Breton Lionel
De Lacharriere Olivier
Burns Doane Swecker & Mathis L.L.P.
Fay Zohreh
Societe L'Oreal S.A.
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