Steroid formulation
DCFirst Claim
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.
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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.
21 Citations
20 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.
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20. An aqueous pharmaceutical solution suitable for oral administration to a patient comprising:
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(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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Specification