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Compositions and methods for enhanced mucosal delivery of parathyroid hormone

a parathyroid hormone and mucosal technology, applied in the direction of animal/human protein, biocide, non-active ingredients of pharmaceuticals, etc., can solve the problems of accelerating bone loss, affecting the effect of oxidative stress, so as to reduce damage-causing attrition, high adhesive bond strength, and high permeability

Inactive Publication Date: 2007-07-05
NASTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The formulation achieves therapeutically effective levels of PTH in the blood, promoting bone mass increase and reducing fracture risk, offering a more acceptable and effective treatment option for osteoporosis and osteopenia.

Problems solved by technology

The prevalence of osteoporosis poses a serious health problem.
Furthermore, as women age the rate of bone turnover increases, resulting in accelerated bone loss because of the lack of estrogen after menopause.
However, many people are adverse to injections, and thus become non-compliant with the prescribed dosing of the PTH.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0184] An exemplary formulation for enhanced nasal mucosal delivery of PTH following the teachings of the instant specification can be prepared and evaluated as shown in Table 1.

example 2

Nasal Mucosal Delivery—Permeation Kinetics and Cytotoxicity

[0185] The following methods are generally useful for evaluating nasal mucosal delivery parameters, kinetics and side effects for PTH within the formulations and method of the invention, as well as for determining the efficacy and characteristics of the various intranasal delivery-enhancing agents disclosed herein for combinatorial formulation or coordinate administration with PTH.

[0186] Permeation kinetics and cytotoxicity are also useful for determining the efficacy and characteristics of the various mucosal delivery-enhancing agents disclosed herein for combinatorial formulation or coordinate administration with mucosal delivery-enhancing agents. In one exemplary protocol, permeation kinetics and lack of unacceptable cytotoxicity are demonstrated for an intranasal delivery-enhancing agent as disclosed above in combination with a biologically active therapeutic agent, exemplified by PTH.

[0187] The EPIAIRWAY system was d...

example 3

Preparation of a Parathyroid Hormone Formulation Free of a Stabilizer That is a Protein

[0234] A parathyroid hormone formulation suitable for intranasal administration of parathyroid hormone, which was substantially free of a stabilizer that is a protein was prepared having the formulation listed below. About ¾ of the water was added to a beaker and stirred with a stir bar on a stir plate and the sodium citrate was added until it was completely dissolved. The EDTA was then added and stirred until it was completely dissolved. The citric acid was then added and stirred until it was completely dissolved. The methyl-β-cyclodextrin was added and stirred until it was completely dissolved. The DDPC was then added and stirred until it was completely dissolved. The lactose was then added and stirred until it was completely dissolved. The sorbitol was then added and stirred until it was completely dissolved. The chlorobutanol was then added and stirred until it was completely dissolved. The p...

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Abstract

Pharmaceutical compositions and methods are described comprising at least a parathyroid hormone peptide (PTH) preferably PTH1-34 and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of PTH, for treating or preventing osteoporosis or osteopenia in a mammalian subject, preferably a human.

Description

[0001] This application is a divisional claiming the benefit under 35 U.S.C. § 121 of U.S. patent application Ser. No. 11 / 126,996, filed May 10, 2005, which claimed the benefit of U.S. Provisional Application No. 60 / 570,113, filed May 10, 2004, each of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTION [0002] The teachings of all the references cited in the present specification are incorporated in their entirety by reference. [0003] Osteoporosis can be defined as a systemic skeletal disease characterized by low bone mass, microarchitectural deterioration of bone tissue, and increased bone fragility and susceptibility to fracture. It most commonly affects older populations, primarily postmenopausal women. [0004] The prevalence of osteoporosis poses a serious health problem. The National Osteoporosis Foundation has estimated that 44 million people are experiencing the effects of osteoporosis or osteopenia. By the year 2010, osteoporosis will affect ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/29A61K31/724A61K9/12A61K9/00A61K9/127A61K47/00A61K47/18A61K47/30A61K47/48A61P5/18A61P19/10
CPCA61K9/0043A61K47/183A61K38/29A61K31/724A61P19/08A61P19/10A61P43/00A61P5/18
Inventor QUAY, STEVEN C.COSTANTINO, HENRY R.KLEPPE, MARY S.LI, CHING-YUAN
Owner NASTECH PHARMA
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