Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing
Reexamination Certificate
2001-06-15
2003-06-17
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
C424S078050, C128S200140, C514S861000, C514S871000, C514S863000, C514S887000, C514S886000
Reexamination Certificate
active
06579512
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a pharmaceutical composition of the treatment of inflammatory skin conditions, and a therapeutic method for treating inflammatory skin conditions using the pharmaceutical composition.
Topical corticosteroids are a powerful tool for treating skin disease. Understanding the correct use of these agents will result in the successful management of a variety of skin problems. There are many products available, and new ones appear almost monthly. Pharmaceutical companies have responded to the great demand for these agents with an increasing number of products, but all of these preparations have basically the same antiinflamatory properties. They differ only in strength, base and price.
The antiinflammatory properties of topical corticosteroids result in part from their ability to induce vasoconstriction of the small blood vessels in the upper dermis. This property is used in an assay procedure to determine the strength of each new product. These products are subsequently tabulated in seven groups, with group I the strongest and group VII the weakest (see the Formulary below).
Group No.
Generic Name
I
Clobetasol propionate
II
Fluocinonide
III
Triamcinolone acetonide
IV
Fluocinolone acetonide
V
Hydrocortisone valerate
VI
Desonide
VII
Hydrocortisone
The treatment recommends topical steroids by group number rather than by generic or brand name because the agents in each group are essentially equivalent in strength. When a new topical corticosteroid appears on the market, ask to which group it belongs and add it to the list in the Formulary.
Guidelines for choosing the appropriate strength of topical steroid are presented in the chart below.
SUGGESTED STRENGTH OF TOPICAL STEROIDS
TO INITIATE TREATMENT*
GROUPS I-II
GROUPS III-V
GROUPS VI-VII
Psoriasis
Atopic dermatitis
Dermatitis (eyelids)
Lichen planus
Nummular eczema
Dermatitis (diaper area)
Discoid lupus†
Asteatotic eczema
Mild dermatitis (face)
Severe hand eczema
Stasis dermatitis
Mild anal inflammation
Poison ivy (severe)
Seborrheid dermatitis
Mild intertrigo
Lichen simplex
Lichen sclerosis
chronicus
et atrophicus (vulva)
Hyperkeratotic eczema
Intertrigo
(brief course)
Chapped feet
Tinea (brief course to
control inflammation)
Lichen sclerosis
Scabies (after
et atrophicus (skin)
scabicide)
Alopecia areata
Intertrigo
(severe cases)
Nummular eczema
Anal inflammation
(severe)
(severe cases)
Atopic dermatitis
Severe dermatitis
(resistant adult cases)
(face)
*Stop treatment, change to less potent agent, or use intermittent treatment once inflammation is controlled.
†Use on the face may be justified.
The best results are obtained when preparations of adequate strength are used for a specified length of time. Weaker, “safer” strengths often fail to provide adequate control. Patients who do not respond after 1 to 4 weeks of treatment should be reevaluated.
Additionally, topical preparations of the steroid clobetasol propionate are indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatosis. See, for example, Maloney, et.al., “Clobetasol Propionate Emollient 0.05% in the Treatment of Atopic Dermatitis”, International J. of Dermatology, 1998, 37, 128-144.
In the past, it has been found that clobetasol propionate is most effective in the treating of inflammatory skin conditions when combined with zinc pyrithione and undecylenic acid. For example, Seidel (U.S. Pat. No. 5,972,920) discloses the use of clobetasol propionate in combination with either zinc pyrithione, undecylenic acid, or both. Applicant Crutchfield also noted the requirement for zinc pyrithione in Crutchfield, et.al., “The Effective Use of Topical Zinc Pyrithione in the Treatment of Psoriasis: a Report of Three Cases”, J. Geriatr. Dermatol. 1997; 5(1):21-4.
Surprisingly, the applicants have found that zinc pyrithione and undecylenic acid are not necessary for the optimal effectiveness of clobetasol propionate.
Studies have also indicated that some sort of surfactant, such as sodium lauryl sulfate, is necessary for the optimal effectiveness of clobetasol propionate, whether alone or combined with zinc pyrithione and undecylenic acid. Again, Seidel '920 discloses the use of an anionic surfactant (sodium lauryl sulfate) in conjunction with clobetasol propionate, zinc pyrithione, and undecylenic acid.
Surprisingly, the applicants have found that no surfactant is necessary for the optimal effectiveness of clobetasol propionate.
Applicants have also found that the composition is most effective and easily tolerated by patients when administered in a spray form by means of a propellant. In contrast, Seidel '920 teaches away from the use of a spray as being highly evaporative and producing a painful freezing sensation to the skin and that some propellants are explosive.
SUMMARY OF THE INVENTION
A pharmaceutical topical spray composition of corticosteroid, an alcohol, a propelant, and isopropyl myristate. A method for treating an inflammatory skin condition using the administration to the skin of a mammal of the pharmaceutical composition. The pharmaceutical composition is effective in the treatment of inflammatory skin conditions without the need for zinc pyrithione, undecylenic acid, or a detergent.
REFERENCES:
patent: 5972920 (1999-10-01), Seidel
patent: 6096326 (2000-08-01), Wikholm
The Merck Index, Ninth Edithion, Merck & Co, Inc, 1976.*
Product information for Cormax 0.05% Cream (Clobetasol Propionate Cream USP), Jul., 1988 (2 pgs.).
Article entitled “The Effective Use of Topical Zinc Pyrithione in the Treatment of Psoriasis: A Report of Three Cases”, vol. 5, No. 1, Jan./Feb. 1997, (pp. 21-24).
Product information entitled “Dermalogix Partners, Inc., The New #1 Psoriasis Treatment, Mirror Image of Skin Cap”, vol. 7, No. 12, Dec. 1999 (2 pgs.).
NOVA Medical Laboratories' advertisement appearing in Cosmetic Dermatology, Dec., 1995 (2 pgs.).
Information entitled “Triamcinolone Acetonide Spray (Reformulated) in the Treatment of Topical Steroid-Responsive Dermatoses”, Ronald Goldner, M.D. (pp. 659-661).
Product Information, Glaxo Wellcome (pp. 1277-1282).
Article entitled “The Journal of Investigative Dermatology”, presented by Westwood Squibb (3 pgs.).
Dermatology Online Journal, vol. 3, No. 1, Mar. 1997 (8 pgs.).
Briggs and Morgan
Capes Nelson R.
Dees Jose′ G.
Haghighatian Mina
Helget Gerald E.
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