Pulmonary delivery of active fragments parathyroid hormone
Inactive Publication Date: 2008-03-27
NOVARTIS FARMA
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[0012] In addition to the preferred pulsatile pharmacokinetic serum profile of the PTH fragments, the methods and compositions of the present invention provide a high level of patient acceptability. PTH administration does not require injection and can be self-admini
Problems solved by technology
The need to inject PTH (or any other drug) on a daily basis, however, is undesirable.
Most patients have an aversion to self-injection of drugs, and the need to visit a clinic or doctor's office for administration is inconvenient and burdensome.
While other forms of administration have been suggested, such as oral delivery to the stomach, transdermal delivery, and nasopharyngeal absorption, none of these delivery routes has been proven to be effective and each suffers from certain drawbacks.
Oral delivery results in very low bioavailability of polypeptide drugs, usually below 1%, due to degradation in the gastrointestinal tract.
Even with such penetration enhancers, bioavailabi
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[0015] Parathyroid hormone (PTH) is delivered to a mammalian host by inhalation into the alveolar region of the host's lungs. The cellular lining of the deep mammalian lung is extremely thin (0.1 mu.m) and has been found to be naturally permeable to both full length PTH and certain biologically active and N-terminal fragments of PTH, as described below. Surprisingly, however, such pulmonary or respiratory delivery of the PTH fragments only (and not the full length PTH) has been found to provide a desired pulsatile serum concentration profile of the PTH, as is believed to enhance the biological activity of the PTH, particularly when treating osteoporosis.
[0016] Thus, the present invention provides for the pulmonary or respiratory delivery of biologically active N-terminal fragments of PTH by inhalation by a patient through the mouth, where such fragments have a size which is less than that of full size native human PTH (human PTH is 84 amino acids) and which results in a pulsatile s...
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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.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of application Ser. No. 10 / 245,707, filed Sep. 18, 2002, which application is a continuation of application Ser. No. 09 / 577,264, filed May 22, 2000, which application is a continuation of application Ser. No. 09 / 128,401, filed Aug. 3, 1998, now issued as U.S. Pat. No. 6,080,721, which application is a divisional of application Ser. No. 08 / 625,586; filed on Mar. 28, 1996, now issued as U.S. Pat. No. 5,814,607, which application is a continuation of application Ser. No. 08 / 232,849; filed Apr. 25, 1994, now issued as U.S. Pat. No. 5,607,915, which application is a continuation of application Ser. No. 07 / 953,397; filed Sep. 29, 1992, now abandoned, the full disclosures of which are incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] The present invention relates generally to methods and compositions for systemic administration of parathyroid hormone to mammalian hosts. More particularly, th...
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