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Implantable pharmaceutical composition consisting of calcium sulfate alpha-hemihydrate, vancomycin and tobramycin
A pharmaceutical composition prepared from components consisting of: a) 18.4g pharmaceutical grade, phase pure calcium sulfate α-hemihydrate; b) 1000mg vancomycin hydrochloride; and c) 240mg tobramycin sulfate; wherein the calcium sulfate α-hemihydrate is prepared by first converting a source of pharmaceutical grade calcium sulfate dihydrate to soluble calcium sulfate anhydrite by hydrothermal treatment in suspension, and then converting the resulting soluble anhydrous calcium sulfate to calcium sulfate α-hemihydrate by the following steps: i) adding the calcium sulfate dihydrate to a quantity of water in a water:calcium sulfate dihydrate ratio of 0.3:1-0.5:1 to form a suspension and autoclaving the suspension at 235-265oC for 1-2 hours to dehydrate to form soluble anhydrite; ii) allowing the soluble anhydrite to cool in the autoclave in suspension to rehydrate back to calcium sulfate dihydrate; iii) draining off excess water and autoclaving again at 110-150oC for 1-2 hours to convert the rehydrated calcium sulfate dihydrate to calcium sulfate α-hemihydrate. A method of manufacturing the composition and therapeutic uses thereof comprising inserting the composition into a surgical void for the treatment of infection in bone and soft tissue in a patient are also provided.
Implantable pharmaceutical composition consisting of calcium sulfate alpha-hemihydrate, vancomycin and tobramycin
A pharmaceutical composition prepared from components consisting of: a) 18.4g pharmaceutical grade, phase pure calcium sulfate α-hemihydrate; b) 1000mg vancomycin hydrochloride; and c) 240mg tobramycin sulfate; wherein the calcium sulfate α-hemihydrate is prepared by first converting a source of pharmaceutical grade calcium sulfate dihydrate to soluble calcium sulfate anhydrite by hydrothermal treatment in suspension, and then converting the resulting soluble anhydrous calcium sulfate to calcium sulfate α-hemihydrate by the following steps: i) adding the calcium sulfate dihydrate to a quantity of water in a water:calcium sulfate dihydrate ratio of 0.3:1-0.5:1 to form a suspension and autoclaving the suspension at 235-265oC for 1-2 hours to dehydrate to form soluble anhydrite; ii) allowing the soluble anhydrite to cool in the autoclave in suspension to rehydrate back to calcium sulfate dihydrate; iii) draining off excess water and autoclaving again at 110-150oC for 1-2 hours to convert the rehydrated calcium sulfate dihydrate to calcium sulfate α-hemihydrate. A method of manufacturing the composition and therapeutic uses thereof comprising inserting the composition into a surgical void for the treatment of infection in bone and soft tissue in a patient are also provided.
Implantable pharmaceutical composition consisting of calcium sulfate alpha-hemihydrate, vancomycin and tobramycin
SEAN SYDNEY AIKEN (author) / PHILLIP ANTHONY LAYCOCK (author) / JOHN JOSEPH COOPER (author) / JOHN STEPHEN BRATT (author) / MICHAEL CHRISTOPHER JAMES HARRIS (author)
2023-02-15
Patent
Electronic Resource
English
IPC:
A61K
Zubereitungen für medizinische, zahnärztliche oder kosmetische Zwecke
,
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
/
A61L
Verfahren oder Vorrichtungen zum Sterilisieren von Stoffen oder Gegenständen allgemein
,
METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL
/
A61P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
,
Spezifische therapeutische Aktivität von chemischen Verbindungen oder medizinischen Zubereitungen
/
C01F
COMPOUNDS OF THE METALS BERYLLIUM, MAGNESIUM, ALUMINIUM, CALCIUM, STRONTIUM, BARIUM, RADIUM, THORIUM, OR OF THE RARE-EARTH METALS
,
Verbindungen der Metalle Beryllium, Magnesium, Aluminium, Calcium, Strontium, Barium, Radium, Thorium oder der Seltenen Erden
/
C04B
Kalk
,
LIME
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