Topical cromolyn formulations
View Patent ↗The present invention provides a topical composition comprising (a) at least one delivery agent compound and (b) a cromoglycic acid compound. Methods of treatment, and methods of preparing the topical composition are also provided.
1. A topical administration composition comprising:
(A) a cromolyn component selected from the group consisting of cromolyn and pharmaceutically acceptable salts thereof;
(B) a delivery agent selected from the group consisting of N-(8-[2-hydroxybenzoyl]-amino)caprylic acid, 8-(2-hydroxybenzoylamino)-octanoic acid 2-{2-[2-(2-{2-[2-(2-methoxyethoxy)ethoxy]ethoxy}ethoxy)ethoxy]ethyoxy}ethyl ester, and pharmaceutically acceptable salts thereof;
(C) a semi-aqueous vehicle which is unconjugated PEG/water; and
(D) (a) an excipient,
(b) a cream,
(c) an ointment base,
(d) a viscosity building agent,
(e) a moisturizer,
(f) a preservative,
(g) a formulation vehicle, or
(h) any combination thereof,
wherein the topical administration composition provides a higher epidermal layer concentration of the cromolyn component over 8 hrs or 48 hrs after a single administration than a similar topical composition without the delivery agent compound.
2. The topical administration composition of claim 1 , wherein the cromolyn component is disodium cromoglycate.
3. The topical administration composition of claim 1 , wherein the delivery agent is monosodium N-(8-[2-hydroxybenzoyl]-amino)caprylate.
4. The topical administration composition of claim 1 , wherein the delivery agent is 8-(2-hydroxybenzoylamino)-octanoic acid 2-{2-[2-(2-{2-[2-(2-methoxyethoxy)ethoxy]ethoxy}-ethoxy)ethoxy]-ethyoxy}ethyl ester.
5. The topical administration composition of claim 1 , in the form of a cream, ointment, gel, suspension, or solution.
6. The topical administration composition of claim 1 , further comprising an anti-allergic medication, a glucocorticoid, or a corticosteroid.
7. A method for administering an effective amount of a cromolyn component to a patient in need of thereof, comprising the step of topically administering the composition of claim 1 .
8. A method of treating a skin condition in a patient in need thereof, comprising the step of topically administering to the patient an effective amount of the composition of claim 1 .
9. The method of claim 8 , wherein the skin condition is atopic dermatitis.
10. The topical pharmaceutical composition of claim 1 , wherein the composition comprises from about 0.01 to about 7.0 percent by weight of the cromolyn component.
11. The topical pharmaceutical composition of claim 1 , wherein the composition comprises from about 0.5 to about 4.0 percent by weight of the cromolyn component.
12. The topical pharmaceutical composition of claim 1 , wherein the composition comprises about 3.0 percent by weight of the cromolyn component.