Pulmonary delivery of active fragments of parathyroid hormone
AssigneeNektar Therapeutics
InventorJohn S. Patton
Life of this patent
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Abstract
Systemic delivery of parathyroid hormone to a mammalian host is accomplished by inhalation through the mouth of a dispersion of an N-terminal fragment of PTH. It has been found that such respiratory delivery of the PTH fragment provides a pulsatile concentration profile of the PTH in the host's serum. PTH fragment compositions include dry powder formulations having the PTH present in a dry bulking powder, liquid solutions or suspensions suitable for nebulization, and aerosol propellants suitable for use in a metered dose inhaler.
Claims23
A method for pulsatile systemic delivery of an active fragment of parathyroid hormone (PTH) to a mammalian host, said method comprising:
- inhalation through the mouth by the host of a dispersion of an N-terminal fragment of PTH having a length which results in a pulsatile serum profile characterized by a rapid rise followed by a rapid fall after a peak has been released.
A method for pulsatile systemic delivery of an active fragment of parathyroid hormone (PTH) to a patient, said method comprising:
- (a) dispersing a preselected amount of the PTH fragment in a volume of gas to produce an aerosolized bolus;
- (b) inhaling of the aerosolized bolus by the patient through the mouth and into the alveolar region of the lungs;
- and
- repeating steps (a) and (b) a sufficient number of times until a desired total dosage of PTH fragment is delivered.
A pharmaceutical composition comprising a biologically active N-terminal fragment of parathyroid hormone (PTH) present as a dry powder having a mean particulate size in the range from 0.5 μm to 5 μm;
- and a pharmaceutically acceptable dry bulking powder, wherein the PTH is present at from 1% to 25% by weight.
A pharmaceutical composition comprising a biologically active N-terminal fragment of parathyroid hormone (PTH) present as a powder having a mean particle size in the range from 0.5 μm to 5 μm present in an aerosol propellant.
A pharmaceutical composition suitable for nebulization, said composition comprising a biologically active fragment of parathyroid hormone present in an aqueous buffer at pH 4-6 and a concentration in the range from 1 mg/ml to 20 mg/ml.
Dependencies are inferred from the claim text.