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Controlled Release of Parathyroid Hormone as a Potential Treatment of Hypoparathyroidism

Amit Goyal1, Tiffany L Anthony1, Peter Fong2, W. Mark Saltzman2, Christopher Breuer1
1Yale University School of Medicine, New Haven, CT;2Department of Biomedical Engineering, Yale University, New Haven, CT

To develop controlled release delivery system for parathyroid hormone (PTH) that can maintain calcium homeostasis without adverse side effects of long term calcium and vitamin D replacements.
Experimental Animal Model
Most common cause of hypoparathyroidism is iatrogenic injury to parathyroid glands during thyroid resection. Estimates of transient hypoparathyroidism range between 6.9% and 46%. Estimates of permanent hypoparathyroidism range between 0.4% and 33%. Our drug delivery system will benefit these patients.
Other Participants:
Parathyroidectomized Sprague-Dawley rats.
Interventions: Biodegradable poly(Lactide-co-Glycolide) (PLGA) microspheres loaded with PTH (1-34) were made using double emulsion solvent evaporation technique. In vitro release profile for PTH microspheres was determined by incubating PTH microspheres in phosphate buffered saline using an enzyme-linked immunosorbent assay. To confirm bioactivity, in vivo studies with these microspheres were carried out using a surgically created hypoparathyroid rat model and serial serum calcium measurements.
Main Outcome Measures:
(1) PTH 1-34 levels in vitro (2) serum calcium levels in vivo.

(1) PTH was successfully incorporated into PLGA microspheres. (2) Controlled release of 8000 pcg of PTH was demonstrated in vitro over a 3 week period. (3) Bioactivity of PTH released from microspheres was demonstrated by elevation of serum calcium in the animal model. In hypoparathyroid rats (n=3) baseline calcium (5.85 mg/dl) increased by 2.34 ± 0.27 mg/dl or 40%. (4) Calcium homeostasis was maintained for up to five days after a single subcutaneous injection of these microspheres.

Controlled release of physiological concentrations of bioactive PTH can be achieved using PLGA microspheres.

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