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Parathyroid hormone compositions and uses thereof

A parathyroid hormone and composition technology, applied in the field of oral delivery of polypeptides, can solve the problem that parathyroid hormone cannot be taken orally

Active Publication Date: 2022-03-25
HEFEI TIANHUI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, parathyroid hormone cannot be administered orally

Method used

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  • Parathyroid hormone compositions and uses thereof
  • Parathyroid hormone compositions and uses thereof
  • Parathyroid hormone compositions and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Preparation of Teriparatide Enteric-Coated Capsules

[0053] Prepare coating solution:

[0054] 1.5 mg of Eudragit L-100, 3 mg of Talc and 1 mg of polyethylene glycol were dissolved in dichloromethane and isopropanol to obtain a coating solution.

[0055] To prepare enteric-coated capsules:

[0056] Mix teriparatide with Tween 80 (if there is Tween 20 in the composition, then mix teriparatide with Tween 20 and Tween 80), then add SBTI, mix, put into capsules, pack The coating liquid is sprayed onto the capsule surface to obtain teriparatide enteric-coated capsules. SBTI is soybean trypsin inhibitor.

Embodiment 2

[0058] Prepare the enteric-coated capsule of following composition according to embodiment 1

[0059] Composition A: 2mg teriparatide;

[0060] Composition B: 2 mg teriparatide + 60 mg SBTI + 3 mg Tween 20;

[0061] Composition C: 2mg teriparatide + 60mg SBTI + 20mg Tween 80;

[0062] Composition D: 2 mg teriparatide + 60 mg SBTI + 3 mg Tween 20 + 20 mg Tween 80;

[0063] Composition E: 2 mg teriparatide + 15 mg SBTI + 0.2 mg Tween 20;

[0064] Composition F: 2 mg teriparatide + 15 mg SBTI + 5 mg Tween 80;

[0065] Composition G: 2 mg Teriparatide + 15 mg SBTI + 0.2 mg Tween 20 + 5 mg Tween 80.

[0066] SBTI is soybean trypsin inhibitor. Those skilled in the art will understand that the SBTI can be Bowman-Birk trypsin inhibitor or Kunitz trypsin inhibitor or a combination of the two.

[0067] The above composition was administered to rhesus monkeys in the following manner. The monkeys were divided into groups, and each group of monkeys was administered the corresponding ...

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Abstract

Aiming at the problem that parathyroid hormone cannot be taken orally in the prior art, the present invention provides a polypeptide composition on the one hand, and the polypeptide composition includes a therapeutically effective amount of polypeptide, a soybean trypsin inhibitor and a first absorption promoter, so The first absorption-promoting agent is Tween 20. It can realize the oral administration of polypeptides. Another aspect provides the use of the polypeptide composition in preparing a medicament for oral administration of the polypeptide composition to a human subject.

Description

[0001] This application claims the priority of the Chinese patent application submitted to the China Patent Office on March 07, 2021, with the application number 202110248307.3, and the invention title is "parathyroid hormone composition and its use", the entire content of which is incorporated in this application by reference middle. technical field [0002] The present invention belongs to the field of oral delivery of polypeptides, in particular, relates to the oral delivery of parathyroid hormone (PTH). Background technique [0003] Parathyroid hormone (PTH) in mammals such as humans, cattle, and pigs is a polypeptide hormone composed of 84 amino acids, which is synthesized by parathyroid chief cells. PTH acts directly on the bones and kidneys, and indirectly on the gastrointestinal tract to maintain blood calcium levels. PTH maintains the balance of bone remodeling by directly acting on osteoblasts and osteocytes and indirectly acting on osteoclasts. [0004] Parathyr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/29A61K38/56A61K9/48A61K47/26A61P19/10A61P5/14A61P19/08
CPCA61K38/29A61K38/56A61K47/26A61P19/08A61P19/10A61P5/14A61K9/0053A61K9/4866A61K9/4891A61K2300/00
Inventor 盛海圆张磊柏冠军杨俊朋梁晓晖
Owner HEFEI TIANHUI BIOTECH CO LTD
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