US4439181A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Polyol-hormone mixture for use in chronic parenteral hormone administration
Assignee: University of Minnesota System
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Filing: 1981-01-26
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Granted: 1984-03-27
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Expires: 2001-01-26
Abstract
Abstract A method of preventing the precipitation of proteins, such as hormone preparations, within drug delivery systems that depend on the fluidity of the infusate for proper function. A polyol, such as glycerol, is mixed with the protein solution prior to the introduction of the solution into the drug delivery system. The polyol is added in amount sufficient to prevent precipitation of the protein during long-term storage in the drug delivery device. According to one form of usage, the protein-polyol solution is injected to the pressurized drug storage reservoir of an implanted infusion pump by injection through the patient's skin. As the solution is discharged from the delivery device by the constant pressure exerted upon the storage chamber, its low rate of flow is controlled by a restricted fluid passage. The solution is conveyed to an infusion site and diluted by the blood stream.
Inventors
- 👤 Perry J. Blackshear
- 👤 John L. Palmer
- 👤 Thomas D. Rohde
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 13:45
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/06; A61K47/26; A61K9/00; A61K9/0012; A61K9/0019
Claims Analysis
Total Claims: 16
Claim 1
Independent Claim
110 words
A method of maintaining the fluidity of protein solutions for parenteral administration at a low flow rate to a chronically ill patient suffering from a protein-deficiency disease from a drug delivery device that depends on the fluidity of the infusate for proper functioning, without loss of biological activity, which method comprises: (A) dissolving an effective amount between about 10 and 90 percent by weight/volume, sufficient to prevent precipitation of the protein, of a biocompatible C-4 to C-18 polyol in the protein solution prior to injection into the drug storage chamber of the delivery device, and (B) charging the drug storage chamber of the drug delivery device with said protein-polyol solution.
Claim 2
Independent Claim
110 words
A method of maintaining the fluidity of protein solutions for parenteral administration at a low flow rate to a chronically ill patient suffering from a protein-deficiency disease from a drug delivery device that depends on the fluidity of the infusate for proper functioning, without loss of biological activity, which method comprises: (A) dissolving an effective amount between about 10 and 90 percent by weight/volume, sufficient to prevent precipitation of the protein, of a biocompatible C-4 to C-18 polyol in the protein solution prior to injection into the drug storage chamber of the delivery device, and (B) charging the drug storage chamber of the drug delivery device with said protein-polyol solution.
Claim 3
Dependent Claim
12 words
A method according to claim 1 wherein said protein is a hormone.
Claim 4
Dependent Claim
11 words
A method according to claim 2 wherein said hormone is insulin.
Claim 5
Dependent Claim
34 words
A method according to claim 1 wherein said drug delivery device is an implanted pressure actuated device whose storage chamber is charged by injection of the protein-polyol solution through the skin of the patient.
Claim 6
Dependent Claim
22 words
A method according to claim 1 wherein said polyol is glycerol present in amount between about 10 and 90 percent by volume.
Claim 7
Dependent Claim
21 words
A method according to claim 5 wherein said glycerol is present in amount between about 50 and 80 percent by volume.
Claim 8
Dependent Claim
35 words
A method according to claim 1 wherein said polyol is a solid selected from the class consisting of ribose, xylose, mannose, fructose and sorbose present in amount between about 10 and 90 percent by weight.
Claim 9
Independent Claim
143 words
A method of administering a protein solution at a low flow rate to a chronically ill patient suffering from a protein-deficiency disease, which method comprises: (A) dissolving an effective amount between about 10 and 90 percent by weight/volume, sufficient to prevent precipitation of the protein, of a biocompatible C-4 to C-18 polyol in the protein solution to maintain the fluidity of the solution without loss of biological activity, (B) charging the drug storage chamber of a drug delivery device that depends on the fluidity of the infusate for proper functioning with the protein-polyol solution, (C) continuously discharging the solution from the storage chamber through a restricted flow passage into the blood stream of the patient at a rate between about 1 cc and 15 cc solution per day, and (D) diluting the solution with the blood stream as it enters the blood stream.
Claim 10
Independent Claim
143 words
A method of administering a protein solution at a low flow rate to a chronically ill patient suffering from a protein-deficiency disease, which method comprises: (A) dissolving an effective amount between about 10 and 90 percent by weight/volume, sufficient to prevent precipitation of the protein, of a biocompatible C-4 to C-18 polyol in the protein solution to maintain the fluidity of the solution without loss of biological activity, (B) charging the drug storage chamber of a drug delivery device that depends on the fluidity of the infusate for proper functioning with the protein-polyol solution, (C) continuously discharging the solution from the storage chamber through a restricted flow passage into the blood stream of the patient at a rate between about 1 cc and 15 cc solution per day, and (D) diluting the solution with the blood stream as it enters the blood stream.
Claim 11
Dependent Claim
12 words
A method according to claim 2 wherein said protein is a hormone.
Claim 12
Dependent Claim
11 words
A method according to claim 9 wherein said hormone is insulin.
Claim 13
Dependent Claim
34 words
A method according to claim 2 wherein said drug delivery device is an implanted pressure actuated device whose storage chamber is charged by injection of the protein-polyol solution through the skin of the patient.
Claim 14
Dependent Claim
22 words
A method according to claim 8 wherein said polyol is glycerol present in amount between about 10 and 90 percent by volume.
Claim 15
Dependent Claim
21 words
A method according to claim 16 wherein said glycerol is present in amount between about 50 and 80 percent by volume.
Claim 16
Dependent Claim
35 words
A method according to claim 8 wherein said polyol is a solid selected from the class consisting of ribose, xylose, mannose, fructose and sorbose present in amount between about 10 and 90 percent by weight.
References Cited (Backward Citations)
US3731681A
Cited
US4306553A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1987-03-27 | 1987-09-26 | 1988-03-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-03-27 | 1991-09-26 | 1992-03-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-03-27 | 1995-09-26 | 1996-03-27 | $7700.00 | Window Closed / Lapsed |