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Treatment of osteoporosis

a technology for osteoporosis and treatment, applied in the field of treatment, can solve problems such as problems in the oral administration of peptide pharmaceuticals

Pending Publication Date: 2018-02-01
ENTERA BIO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The composition achieves rapid and transient elevation of PTH levels, facilitating bone growth enhancement while minimizing bone resorption, thereby effectively treating osteoporosis via oral administration.

Problems solved by technology

Oral administration of peptide pharmaceuticals is problematic due to degradation of peptides in the digestive system and poor absorption of large molecules.

Method used

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  • Treatment of osteoporosis
  • Treatment of osteoporosis

Examples

Experimental program
Comparison scheme
Effect test

example 1

Pharmacokinetic Profile of Orally Administered Parathyroid Hormone (PTH)

[0545]Pharmacokinetic Study Design:

[0546]An open label comparative pharmacokinetic study was performed in healthy volunteers over the course of 3 months. Each volunteer received—in each of two visits—the same oral tablet containing 0.75 mg of teriparatide, a recombinant form of parathyroid hormone (1-34).

[0547]The formulation was composed of teriparatide (0.75 mg), SNAC (sodium 8-N-(2-hydroxybenzoyl)aminocaprylate), soybean trypsin inhibitor (SBTI) and a small amount of magnesium stearate.

[0548]Tablets were administered in the morning after an 8-hour overnight fast and immediately followed by 150 ml of water. At each visit a standard meal was provided 3 hours after drug administration. Patients did not eat or drink alcoholic or caffeinated beverages. There was a two weeks period between the visits.

[0549]To determine parathyroid hormone(1-34) (PTH(1-34)) concentrations, blood samples (4 ml each) were drawn via an...

example 2

Phase I Clinical Trial of Orally Administered Parathyroid Hormone (PTH)

[0554]A Phase I clinical study of exemplary oral formulations comprising teriparatide (parathyroid hormone (1-34)) was conducted at the Hadassah Clinical Research Center. 42 healthy volunteers were included throughout the study.

[0555]The formulation was composed of teriparatide (200, 400, 680, 1400 or 1800 μg), SNAC (sodium 8-N-(2-hydroxybenzoyl) aminocaprylate), soybean trypsin inhibitor and magnesium stearate.

[0556]Tablets were administered in the morning after an 8-hour overnight fast and immediately followed by 150 ml of water. At each visit a standard meal was provided 3 hours after drug administration. Patients did not eat or drink alcoholic or caffeinated beverages.

[0557]To determine parathyroid hormone concentrations, blood samples (4 ml each) were drawn via an indwelling catheter from the forearm vein at predetermined time points. The cannula was flushed with 1.5 ml normal saline after each sampling. In ...

example 3

Casing Containing Parathyroid Hormone and Swellable Substance

[0565]A drug delivery system comprising a casing encapsulating active ingredients, parathyroid hormone and SNAC (sodium 8-N-(2-hydroxybenzoyl)aminocaprylate) (per se, or formulated as a pharmaceutical composition according to any of the respective embodiments described herein) according to some embodiments of the invention is optionally assembled as depicted in FIG. 12.

[0566]A first casing component (A) is filled with substance which swells upon contact with water (B), followed by a barrier (C), and active ingredients (parathyroid hormone and SNAC) (D), optionally in granular form. A second casing component (E) is then placed in contact with first casing component (A), thereby encapsulating (B), (C) and (D). A layer of enteric polymer (not shown) as described herein in any of the respective embodiments, is then formed over at least a portion of an external surface of casing components (A) and (E). Adhesion of the layer to ...

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Abstract

A pharmaceutical composition for use in the treatment of osteoporosis by oral administration of the composition is provided herein. The composition comprises parathyroid hormone or a fragment thereof; and SNAC (sodium 8-N-(2-hydroxybenzoyl)aminocaprylate). Further disclosed are uses of the composition in the preparation of a medicament and methods of treating osteoporosis utilizing the composition.

Description

FIELD AND BACKGROUND OF THE INVENTION[0001]The present invention, in some embodiments thereof, relates to therapy, and more particularly, but not exclusively, to compositions and methods for the treatment of osteoporosis by oral administration.[0002]Parathyroid hormone (PTH) is secreted by the parathyroid gland as a polypeptide containing 84 amino acids. PTH regulates serum calcium levels by enhancing release of calcium from bones (bone resorption), and by enhancing absorption of calcium in the intestines.[0003]Teriparatide is a recombinant form of the first 34 amino acids of human PTH (PTH (1-34)), and is used for treatment of osteoporosis. Administration is by subcutaneous injection once per day at a dose of 20 μg [Riek & Towler, Mo Med 2011, 108:118-123].[0004]PTH (including PTH (1-34)) has been reported to enhance bone growth provided that it is administered intermittently, with circulating levels returning to control levels within 3 hours [Martin, J Bone Metab 2014, 21:8-20]. I...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/29A61K9/20A61K45/06A61K31/20A61K9/00
CPCA61K38/29A61K31/20A61K9/0053A61K45/06A61K9/20A61P19/10A61K31/195A61K2300/00A61K9/28A61K9/2009A61K9/2013A61K9/2086A61K9/2886A61K38/55A61K47/12A61P5/18A61K9/2054A61K38/22A61K31/19A61K31/166A61K31/05
Inventor BURSHTEIN, GREGORYROTHNER, ARIELSCHWARTZ, PHILLIP M.GALITZER, HILLEL
Owner ENTERA BIO LTD
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