A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
167/103.41
A61K 38/28 (2006.01) A61K 47/10 (2006.01)
Patent
CA 1252717
ABSTRACT OF THE DISCLOSURE 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 while extending and maintaining the biological activity of the protein during its period of storage in the drug delivery system. 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 between about 10 and 90% by volume sufficient to prevent precipitation of the protein dur- ing long-term storage in the drug delivery device. A physiologi- cally compatible buffer system in concentration between about 1 mMolar and 1000 mMolar sufficient to maintain the pH of the solu- tion within about one unit of the optimum pH of the protein is added to maintain the bioactivity of the protein during its extended period of storage. According to one form of usage, the protein-polyol-buffer 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 infu- sion site and diluted by the blood stream.
468166
Marks & Clerk
The Regents Of The University Of Minnesota
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