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Claims for Patent: 4,448,774

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Claims for Patent: 4,448,774

Title: Steroid formulation
Abstract:There is described an aqueous pharmaceutical solution comprising a steroid selected from prednisolone, prednisolone sodium phosphate, prednisone and methyl prednisolone, the steroid being present at a concentration of at least 0.3 mg/ml., the pH of the formulation between 5 and 8 and the formulation containing a pharmaceutically acceptable preservative, a pharmaceutically acceptable chelating agent, and being substantially free of ethanol. There is also described a method of treatment of a variety of conditions, particularly in children, using the solution.
Inventor(s): Clemente; Emmett (Manchester, MA), Fung; Ho-Leung (Getzville, NY), Brousseau; Denise (Andover, MA)
Assignee: Fisons Corporation (Bedford, MA)
Application Number:06/452,294
Patent Claims: 1. An aqueous pharmaceutical solution suitable for oral administration comprising as an active ingredient a steroid selected from the group consisting of prednisolone, prednisolone sodium phosphate, prednisone and methyl prednisolone, the steroid being present at a concentration of at least 0.3 mg/ml, the pH of the formulation being between 5 and 8 and the formulation containing a pharmaceutically acceptable preservative, a pharmaceutically acceptable chelating agent, and being substantially free of ethanol.

2. A solution according to claim 1 containing from 0.5 to 5 mg/ml of steroid.

3. A solution according to claim 2 containing from 0.7 to 2 mg/ml of steroid.

4. A solution according to claim 1 containing a sugar.

5. A solution according to claim 4 containing sorbitol or sucrose.

6. A solution according to claim 5 containing from 10 to 50% w/w of sugar.

7. A solution according to claim 6 containing from 25 to 45% w/w/ of the sugar.

8. A solution according to claim 1 containing methyl-hydroxybenzoate.

9. A solution according to claim 8 containing from 0.01 to 0.08% w/w of methyl-hydroxybenzoate.

10. A solution according to claim 1 having a pH in the range 6.5 to 7.5.

11. A solution according to claim 1 containing ethylene diamine tetraacetic acid or a salt thereof.

12. A solution according to claim 11 containing from 0.01 to 0.1% w/w of a salt of ethylene diamine tetraacetic acid.

13. A solution according to claim 12 containing from 0.02 to 0.05% w/w of the disodium salt of ethylene diamine tetraacetic acid.

14. A solution according to claim 1 containing a phosphate buffer.

15. A solution according to claim 1 containing prednisolone sodium phosphate in an amount of from 0.7 to 2 mg/ml, methyl-hydroxybenzoate in an amount of from 0.01 to 0.08% w/w, the disodium salt of ethylene diamine tetraacetic acid in an amount of from 0.02 to 0.05% w/w and sorbitol in an amount of from 25 to 45% w/w.

16. A method of treatment of a patient suffering from an endocrine disorder, a rheumatic disorder, a collagen disease, a dermatologic disease, an allergic state, an ophthalmic disease, a respiratory disease, a haematologic disorder, a neoplastic disease, an edematous state, a gastrointestinal disease or a nervous disease, which conprises administration of an effective amount of a solution according to claim 1 to the patient.

17. A method according to claim 16 wherein the patient is a child and from 5 to 60 ml of the solution is administered per

18. A method according to claim 16 wherein the biological half life of the solution is from 12 to 24 hours.

19. A solution according to claim 1 containing aspartame as a sweetening agent.

20. An aqueous pharmaceutical solution suitable for oral administration to a patient comprising:

(a) as an active ingredient a steroid selected from the group consisting of prednisolone, prednisolone sodium phosphate, prednisone and methyl prednisolone;

(b) methyl-hydroxybenzoate as a perservative in an amount of from about 0.01 to 0.08% w/w;

(c) ethylene diamine tetraacetic acid or a pharmaceutically acceptable salt thereof as a chelating agent in an amount of from about 0.01 to 0.2% w/w;

(d) sorbitol or sucrose as a sweetening agent in an amount of from about 10 to 50% w/w; and

(e) a phosphate buffer, the pH of the formulation being between about 6.5 and 7.5 and the solution being substantially free of ethanol.
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