Patent US1569061A successfully refreshed from Google Patents.
US3878664A
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US
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Process for producing a therapeutic composition
Assignee: Cybersol Inc
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Filing: 1972-11-27
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Granted: 1975-04-22
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Expires: 1992-11-27
Abstract
Abstract A stabilized, therapeutic composition is provided which comprises an aqueous medium containing known amounts of Na , K , HCO3 , and Cl wherein the pH of the solution is maintained between about 6 and 8.5 and the osmolality is maintained between about 170 and 460 by maintaining a gaseous mixture as a blanket over the solution during manufacture and storage, the gaseous mixture containing a sufficient amount of carbon dioxide to substantially equal the partial pressure of the carbon dioxide produced from equilibrium within the solution.
Inventors
- 👤 Charles D Zinke
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 23:26
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K33/00; A61K33/14
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
187 words
A METHOD OF MAKING AN INJECTABLE AQUEOUS SOLUTION COMPRISING: A. DISSOLVING IN A STERILE WATER VOLUME FROM ABOUT 75 TO ABOUT 150 MILLIMOLES PER LITER OF SODIUM CATION, ABOUT 5 TO ABOUT 50 MILLIMOLES PER LITER OF POTASSIUM CATION, ABOUT 5 TO ABOUT 50 MILLIMOLES PER LITER OF BICARBONATE ION, AND ABOUT 75 TO ABOUT 150 MILLIMOLES PER LITER OF CHLORIDE ION TO FORM A SOLUTION HAVING AN OSMOLALITY IN THE RANGE FROM ABOUT 170 TO ABOUT 460 AND A PH IN THE RANGE OF FROM ABOUT 6-8.5; B. BLANKETING THE RESULTING SOLUTION WITH A MIXTURE OF CARBON DIOXIDE AND ANOTHER INERT GAS, THE CARBON DIOXIDE BEING PRESENT IN SAID GASEOUS MIXTURE IN AN AMOUNT TO PROVIDE A PARTIAL PRESSURE ON SAID LIQUID WHICH IS SUBSTANTIALLY EQUAL TO THE PARTIAL PRESSURE OF CARBON DIOXIDE WHICH IS PRODUCED FROM EQUILIBRIUM WITH THE BICARBONATE IONS IN SAID SOLUTION TO THEREBY STABLIZE SAID SOLUTION; AND C. DISPENSING SAID SOLUTION INTO AT LEAST ONE STERILE CONTAINER, AND WHILE SAID DISPENSED SOLUTION IS STILL BLANKETED BY SAID GAS MIXTURE, HHORMETICALLY SEALING SAID CONTAINER CONTAINING SAID SOLUTION AND SAID GAS MIXTURE BLANKETED THEREOVER.
Claim 2
Independent Claim
187 words
A METHOD OF MAKING AN INJECTABLE AQUEOUS SOLUTION COMPRISING: A. DISSOLVING IN A STERILE WATER VOLUME FROM ABOUT 75 TO ABOUT 150 MILLIMOLES PER LITER OF SODIUM CATION, ABOUT 5 TO ABOUT 50 MILLIMOLES PER LITER OF POTASSIUM CATION, ABOUT 5 TO ABOUT 50 MILLIMOLES PER LITER OF BICARBONATE ION, AND ABOUT 75 TO ABOUT 150 MILLIMOLES PER LITER OF CHLORIDE ION TO FORM A SOLUTION HAVING AN OSMOLALITY IN THE RANGE FROM ABOUT 170 TO ABOUT 460 AND A PH IN THE RANGE OF FROM ABOUT 6-8.5; B. BLANKETING THE RESULTING SOLUTION WITH A MIXTURE OF CARBON DIOXIDE AND ANOTHER INERT GAS, THE CARBON DIOXIDE BEING PRESENT IN SAID GASEOUS MIXTURE IN AN AMOUNT TO PROVIDE A PARTIAL PRESSURE ON SAID LIQUID WHICH IS SUBSTANTIALLY EQUAL TO THE PARTIAL PRESSURE OF CARBON DIOXIDE WHICH IS PRODUCED FROM EQUILIBRIUM WITH THE BICARBONATE IONS IN SAID SOLUTION TO THEREBY STABLIZE SAID SOLUTION; AND C. DISPENSING SAID SOLUTION INTO AT LEAST ONE STERILE CONTAINER, AND WHILE SAID DISPENSED SOLUTION IS STILL BLANKETED BY SAID GAS MIXTURE, HHORMETICALLY SEALING SAID CONTAINER CONTAINING SAID SOLUTION AND SAID GAS MIXTURE BLANKETED THEREOVER.
Claim 3
Independent Claim
187 words
A method of making an injectable aqueous solution comprising: a. dissolving in a sterile water volume from about 75 to about 150 millimoles per liter of sodium cation, about 5 to about 50 millimoles per liter of potassium cation, about 5 to about 50 millimoles per liter of bicarbonate ion, and about 75 to about 150 millimoles per liter of chloride ion to form a solution having an osmolality in the range from about 170 to about 460 and a pH in the range of from about 6-8.5; b. blanketing the resulting solution with a mixture of carbon dioxide and another inert gas, the carbon dioxide being present in said gaseous mixture in an amount to provide a partial pressure on said liquid which is substantially equal to the partial pressure of carbon dioxide which is produced from equilibrium with the bicarbonate ions in said solution to thereby stabilize said solution; and c. dispensing said solution into at least one sterile container, and while said dispensed solution is still blanketed by said gas mixture, hermetically sealing said container containing said solution and said gas mixture blanketed thereover.
Claim 4
Independent Claim
187 words
A method of making an injectable aqueous solution comprising: a. dissolving in a sterile water volume from about 75 to about 150 millimoles per liter of sodium cation, about 5 to about 50 millimoles per liter of potassium cation, about 5 to about 50 millimoles per liter of bicarbonate ion, and about 75 to about 150 millimoles per liter of chloride ion to form a solution having an osmolality in the range from about 170 to about 460 and a pH in the range of from about 6-8.5; b. blanketing the resulting solution with a mixture of carbon dioxide and another inert gas, the carbon dioxide being present in said gaseous mixture in an amount to provide a partial pressure on said liquid which is substantially equal to the partial pressure of carbon dioxide which is produced from equilibrium with the bicarbonate ions in said solution to thereby stabilize said solution; and c. dispensing said solution into at least one sterile container, and while said dispensed solution is still blanketed by said gas mixture, hermetically sealing said container containing said solution and said gas mixture blanketed thereover.
Claim 5
Dependent Claim
26 words
The method of claim 1 wherein said solution is maintained at a temperature in the range of from about 25* to about 50*C during said blanketing.
Claim 6
Dependent Claim
37 words
The method of claim 2 wherein said blanket is maintained at about 1 atmosphere pressure and the partial pressure of said carbon dioxide within said blanket is maintained in a range of from 0.0007 to 0.92 atmospheres.
Claim 7
Dependent Claim
11 words
The method of claim 3 wherein said inert gas is nitrogen.
Claim 8
Dependent Claim
12 words
The method of claim 1 further comprising sterilizing the resultant stabilized solution.
Claim 9
Dependent Claim
22 words
The method of claim 5 wherein said sterilizing comprises filtering said resultant stabilized solution while under said blanket to remove contaminants therefrom.
Claim 10
Dependent Claim
24 words
The method of claim 6 wherein said filtering comprises passing said solution through a membrane filter having pore sizes of less than 1 micron.
Claim 11
Dependent Claim
14 words
The method of claim 7 wherein said filter has pore sizes of 0.22 microns.
Claim 12
Dependent Claim
17 words
The method of claim 7 wherein said solution is passed through two of said filters in series.
Claim 13
Dependent Claim
28 words
The method of claim 1 wherein said sterile container is preflushed with gas having the same composition of the said gaseous mixture prior to dispensing said solution therein.
Claim 14
Independent Claim
221 words
A method of making an injectable aqueous solution comprising: a. adding to a sterile water volume, water soluble salts containing from about 75 to about 150 millimoles per liter of sodium cation, about 5 to about 50 millimoles per liter of potassium cation, about 5 to about 50 millimoles per liter of bicarbonate ion, and about 75 to about 150 millimoles per liter of chloride ion sufficient to form an aqueous solution having an osmolality in the range from about 170 to about 460 and a pH in the range of from about 6.0 to 8.5; b. blanketing the resulting mixture with a mixture of carbon dioxide and another inert gas, the carbon dioxide being present in said gaseous mixture in an amount to provide a partial pressure on said liquid which is substantially equal to the partial pressure of carbon dioxide which is produced with water from equilibrium with said bicarbonate ion in said solution to thereby stabilize said solution; c. agitating the resulting mixture while under said blanket to cause said salts to thoroughly dissolve in said sterile water and form said solution; and d. dispensing saiD solution into at least one sterile container, and while said dispensed solution is still blanketed by said gas mixture, hermetically sealing said container containing said solution and said gas mixture blanketed thereover.
Claim 15
Independent Claim
221 words
A method of making an injectable aqueous solution comprising: a. adding to a sterile water volume, water soluble salts containing from about 75 to about 150 millimoles per liter of sodium cation, about 5 to about 50 millimoles per liter of potassium cation, about 5 to about 50 millimoles per liter of bicarbonate ion, and about 75 to about 150 millimoles per liter of chloride ion sufficient to form an aqueous solution having an osmolality in the range from about 170 to about 460 and a pH in the range of from about 6.0 to 8.5; b. blanketing the resulting mixture with a mixture of carbon dioxide and another inert gas, the carbon dioxide being present in said gaseous mixture in an amount to provide a partial pressure on said liquid which is substantially equal to the partial pressure of carbon dioxide which is produced with water from equilibrium with said bicarbonate ion in said solution to thereby stabilize said solution; c. agitating the resulting mixture while under said blanket to cause said salts to thoroughly dissolve in said sterile water and form said solution; and d. dispensing saiD solution into at least one sterile container, and while said dispensed solution is still blanketed by said gas mixture, hermetically sealing said container containing said solution and said gas mixture blanketed thereover.
Claim 16
Dependent Claim
25 words
The method of claim 11 wherein said mixture is maintained at a temperature in the range from about 25* to about 50*C during said blanketing.
Claim 17
Dependent Claim
37 words
The method of claim 12 wherein said blanket is maintained at about 1 atmosphere pressure and the partial pressure of said carbon dioxide within said blanket is maintained in a range of from 0.0007 to 0.92 atmospheres.
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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) | 1978-04-21 | 1978-10-21 | 1979-04-22 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1982-04-21 | 1982-10-21 | 1983-04-22 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1986-04-21 | 1986-10-21 | 1987-04-22 | $7700.00 | Window Closed / Lapsed |