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US 5,496,801 AGranted
Parathyroid hormone formulation
AssigneeAllelix Biopharmaceuticals Inc.
InventorsJosephus J. M. Holthuis, Albert Mekking, Alwinus A. Voetman
Life of this patent
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Abstract
Described herein are preparations containing parathyroid hormone that has been stablized with an excipient and buffering agent. Preferred preparations incorporate human PTH(1-84), mannitol as excipient and citrate as buffering agent, and are incorporated in vials as a freeze-dried powder for reconstitution to treat osteoporosis.
Claims24
A parathyroid hormone preparation, comprising:
- a medically useful amount of parathyroid hormone (1-84);
- a polyol excipient that co-lyophilizes with said hormone to yield an amorphous cake;
- a non-volatile buffering agent in an amount sufficient to adjust the pH of the preparation to within a physiologically acceptable pH range;
- and
- water.
2 more elements
A parathyroid hormone preparation comprising
- parathyroid hormone (1-84) in a concentration within the range from 25 to 250 .mu.g/mL;
- mannitol in a concentration in the range from 3 to 7% (w/v);
- citrate buffer in an amount sufficient to adjust the pH of the preparation to within the range from pH 3.5 to pH 6.5;
- and
- water.
2 more elements
Dependencies are inferred from the claim text.