Patent US2269963A successfully refreshed from Google Patents.
US4533542A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Pharmaceutical compositions for storage in plastic containers and process therefor
Assignee: Eli Lilly and Co
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Filing: 1983-08-22
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Granted: 1985-08-06
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Expires: 2003-08-22
Abstract
Abstract The instant invention is a pharmaceutical composition suitable for storage in plastic containers which comprises a pharmaceutical compound in powder form coated with a surfactant. A second aspect of the invention is a method for making the composition. This method encompasses applying a solution of a surfactant to the surface of a pharmaceutical compound in powder form and then drying the composition.
Inventors
- 👤 Harry C. Buddenbaum
- 👤 Robert L. Robison
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 00:41
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/33; A61K31/395; A61K31/54; A61K31/542; A61K31/545; A61K9/00; A61K9/48; A61K9/50
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
28 words
A pharmaceutical composition in a plastic container in which haze tends to form upon re-constitution, said composition cconstitution essentially of cefazolin in powder form coated with a surfactant.
Claim 2
Dependent Claim
28 words
A pharmaceutical composition in a plastic container in which haze tends to form upon re-constitution, said composition cconstitution essentially of cefazolin in powder form coated with a surfactant.
Claim 3
Dependent Claim
97 words
A pharmaceutical composition of claim 1, wherein the surfactant is chosen from a group consisting of sucrose dioleate, polyoxyethylene glycol (200) monooleate, sorbitan monolaurate, polyoxyethylene (4) lauryl ether, polyoxyethylene (4) sorbitan monostearate, polyoxyethylene (6) cetyl ether, polyoxyethylene (20) sorbitan monooleate, poly(ethylene glycol)-30 castor oil, poly(ethylene glycol)-40 castor oil, poloxamer 188, polyoxyethylene (20) sorbitan tristearate, polyoxyethylene glycol (400) monooleate, polyoxyethylene glycol (400) monostearate, polyoxyethylene (9) nonyl phenol, polyoxyethylene glycol (400) monolaurate, polyoxyethylene (4) sorbitan monolaurate, polyoxyethylene (20) oleyl ether, polyoxyethylene (20) sorbitan monopalmitate, polyoxyethylene (20) cetyl ether, polyoxyethylene (40) stearate, sodium oleate, polyoxyethylene (100) stearate and potassium oleate.
Claim 4
Dependent Claim
21 words
A pharmaceutical composition of claim 2 wherein the surfactant is polyoxyethylene (20) sorbitan monooleate, poly(ethylene glycol)-40 castor oil, or poloxamer 188.
Claim 5
Dependent Claim
27 words
A pharmaceutical composition of claim 3, wherein the surfactant coating is present in the concentration from between about 10 ppm to about 5000 ppm of pharmaceutical compound.
Claim 6
Dependent Claim
14 words
A pharmaceutical composition of claim 4, wherein an injectable form of cefazolin is used.
Claim 7
Dependent Claim
14 words
A pharmaceutical composition of claim 5, wherein the surfactant is polyoxyethylene (20) sorbitan monooleate.
Claim 8
Dependent Claim
24 words
A pharmaceutical composition of claim 6, wherein the surfactant coating is present in the concentration from between about 100 ppm to about 1000 ppm.
Claim 9
Independent Claim
75 words
A method for substantially reducing or eliminating the formation of haze in reconstituted pharmaceutical compositions of cefazolin stored in plastic containers which comprises the steps of (a) applying a solution of surfactant to cefazolin in powder form wherein said solution is formed with a solvent in which said compound is substantially insoluble; and (b) drying the resultant pharmaceutical composition, (c) placing said composition in a plastic container in which haze tends to form upon reconstitution.
Claim 10
Independent Claim
75 words
A method for substantially reducing or eliminating the formation of haze in reconstituted pharmaceutical compositions of cefazolin stored in plastic containers which comprises the steps of (a) applying a solution of surfactant to cefazolin in powder form wherein said solution is formed with a solvent in which said compound is substantially insoluble; and (b) drying the resultant pharmaceutical composition, (c) placing said composition in a plastic container in which haze tends to form upon reconstitution.
Claim 11
Dependent Claim
96 words
A method of claim 8, wherein the surfactant is chosen from the group consisting of sucrose dioleate, polyoxyethylene glycol (200) monooleate, sorbitan monolaurate, polyoxyethylene (4) lauryl ether, polyoxyethylene (4) sorbitan monostearate, polyoxyethylene (6) cetyl ether, polyoxyethylene (20) sorbitan monooleate, poly(ethylene glycol)-30 castor oil, poly(ethylene glycol)-40 castor oil, poloxamer 188, polyoxyethylene (20) sorbitan tristearate, polyoxyethylene glycol (400) monooleate, polyoxyethylene glycol (400) monostearate, polyoxyethylene (9) nonyl phenol, polyoxyethylene glycol (400) monolaurate, polyoxyethylene (4) sorbitan monolaurate, polyoxyethylene (20) oleyl ether, polyoxyethylene (20) sorbitan monopalmitate, polyoxyethylene (20) cetyl ether, polyoxyethylene (40) stearate, sodium oleate, polyoxyethylene (100) stearate and potassium oleate.
Claim 12
Dependent Claim
20 words
A method of claim 9, wherein the surfactant is polyoxyethylene (20) sorbitan monooleate, poly(ethylene glycol)-40 castor oil, or poloxamer 188.
Claim 13
Dependent Claim
30 words
A method of claim 10, wherein the surfactant is applied to cefazolin in a concentration range of between about 10 ppm to about 5000 ppm per amount of cefazolin present.
Claim 14
Dependent Claim
13 words
A method of claim 11, wherein an injectable form of cefazolin is used.
Claim 15
Dependent Claim
13 words
A method of claim 12, wherein the surfactant is polyoxyethylene (20) sorbitan monooleate.
Claim 16
Dependent Claim
28 words
A method of claim 13, wherein the surfactant is applied to an injectable form of cefazolin in a concentration range of between about 100 ppm to 1000 ppm.
Claim 17
Dependent Claim
37 words
A pharmaceutical dosage form which comprises (1) a pharmaceutical composition, comprising cefazolin in powder form coated with a surfactant; said pharmaceutical composition contained in a (2), plastic flexible container in which haze tends to form upon reconstitution.
Claim 18
Dependent Claim
37 words
A pharmaceutical dosage form which comprises (1) a pharmaceutical composition, comprising cefazolin in powder form coated with a surfactant; said pharmaceutical composition contained in a (2), plastic flexible container in which haze tends to form upon reconstitution.
Claim 19
Dependent Claim
98 words
A pharmaceutical dosage form of claim 15, wherein the surfactant is chosen from the group consisting of sucrose dioleate, polyoxyethylene glycol (200) monooleate, sorbitan monolaurate, polyoxyethylene (4) lauryl ether, polyoxyethylene (4) sorbitan monostearate, polyoxyethylene (6) cetyl ether, polyoxyethylene (20) sorbitan monooleate, poly(ethylene glycol)-30 castor oil, poly(ethylene glycol)-40 castor oil, poloxamer 188, polyoxyethylene (20) sorbitan tristearate, polyoxyethylene glycol (400) monooleate, polyoxyethylene glycol (400) monostearate, polyoxyethylene (9) nonyl phenol, polyoxyethylene glycol (400) monolaurate, polyoxyethylene (4) sorbitan monolaurate, polyoxyethylene (20) oleyl ether, polyoxyethylene (20) sorbitan monopalmitate, polyoxyethylene (20) cetyl ether, polyoxyethylene (40) stearate, sodium oleate, polyoxyethylene (100) stearate and potassium oleate.
Claim 20
Dependent Claim
22 words
A pharmaceutical dosage form of claim 16, wherein the surfactant is polyoxyethylene (20) sorbitan monooleate, poly(ethylene glycol)-40 castor oil, or poloxamer 188.
Claim 21
Dependent Claim
27 words
A pharmaceutical dosage form of claim 17, wherein the surfactant coating is present in the concentration from between about 10 ppm to about 5000 ppm of cefazolin.
Claim 22
Dependent Claim
15 words
A pharmaceutical dosage form of claim 18, wherein an injectable form of cefazolin is used.
Claim 23
Dependent Claim
15 words
A pharmaceutical dosage form of claim 19, wherein the surfactant is polyoxyethylene (20) sorbitan monooleate.
Claim 24
Dependent Claim
25 words
A pharmaceutical dosage form of claim 20, wherein the surfactant coating is present in the concentration from between about 100 ppm to about 1000 ppm.
Claim 25
Dependent Claim
15 words
A pharmaceutical dosage form of claim 21, wherein the plastic container is a flexible pouch.
Claim 26
Dependent Claim
22 words
A pharmaceutical dosage form of claim 22, wherein the plastic container is a flexible package with a port-forming member at one end.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1988-08-05 | 1989-02-04 | 1989-08-06 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-08-05 | 1993-02-04 | 1993-08-06 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-08-05 | 1997-02-04 | 1997-08-06 | $7700.00 | Window Closed / Lapsed |