US4448774A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Steroid formulation
Assignee: FISONS INVESTMENTS Inc
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Filing: 1982-12-22
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Granted: 1984-05-15
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Expires: 2002-12-22
Abstract
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.
Inventors
- 👤 Emmett Clemente
- 👤 Ho-Leung Fung
- 👤 Denise Brousseau
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 18:07
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0087; A61K9/0095; A61K31/00; A61K31/56; A61K31/57
Claims Analysis
Total Claims: 22
Claim 1
Independent Claim
70 words
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.
Claim 2
Dependent Claim
70 words
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.
Claim 3
Dependent Claim
14 words
A solution according to claim 1 containing from 0.5 to 5 mg/ml of steroid.
Claim 4
Dependent Claim
14 words
A solution according to claim 2 containing from 0.7 to 2 mg/ml of steroid.
Claim 5
Dependent Claim
9 words
A solution according to claim 1 containing a sugar.
Claim 6
Dependent Claim
10 words
A solution according to claim 4 containing sorbitol or sucrose.
Claim 7
Dependent Claim
14 words
A solution according to claim 5 containing from 10 to 50% w/w of sugar.
Claim 8
Dependent Claim
15 words
A solution according to claim 6 containing from 25 to 45% w/w/ of the sugar.
Claim 9
Dependent Claim
8 words
A solution according to claim 1 containing methyl-hydroxybenzoate.
Claim 10
Dependent Claim
14 words
A solution according to claim 8 containing from 0.01 to 0.08% w/w of methyl-hydroxybenzoate.
Claim 11
Dependent Claim
15 words
A solution according to claim 1 having a pH in the range 6.5 to 7.5.
Claim 12
Dependent Claim
15 words
A solution according to claim 1 containing ethylene diamine tetraacetic acid or a salt thereof.
Claim 13
Dependent Claim
20 words
A solution according to claim 11 containing from 0.01 to 0.1% w/w of a salt of ethylene diamine tetraacetic acid.
Claim 14
Dependent Claim
21 words
A solution according to claim 12 containing from 0.02 to 0.05% w/w of the disodium salt of ethylene diamine tetraacetic acid.
Claim 15
Dependent Claim
10 words
A solution according to claim 1 containing a phosphate buffer.
Claim 16
Dependent Claim
57 words
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.
Claim 17
Dependent Claim
63 words
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.
Claim 18
Dependent Claim
24 words
A method according to claim 16 wherein the patient is a child and from 5 to 60 ml of the solution is administered per
Claim 19
Dependent Claim
20 words
A method according to claim 16 wherein the biological half life of the solution is from 12 to 24 hours.
Claim 20
Dependent Claim
12 words
A solution according to claim 1 containing aspartame as a sweetening agent.
Claim 21
Dependent Claim
115 words
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.
Claim 22
Dependent Claim
115 words
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.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1987-05-15 | 1987-11-14 | 1988-05-15 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-05-15 | 1991-11-14 | 1992-05-15 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-05-15 | 1995-11-14 | 1996-05-15 | $7700.00 | Window Closed / Lapsed |