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Parathyroid hormone medicine coposition

A parathyroid hormone, hormone technology, applied in the direction of drug combination, drug delivery, pharmaceutical formulation, etc., can solve problems such as large variability

Inactive Publication Date: 2003-08-06
ASTRAZENECA AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because it is a protein, it has greater variability than traditional small molecule drugs. Therefore, the formulation process of parathyroid hormone encounters different challenges from the general pharmaceutical industry.

Method used

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  • Parathyroid hormone medicine coposition
  • Parathyroid hormone medicine coposition
  • Parathyroid hormone medicine coposition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0031] Liquid PTH formulations were first prepared prior to lyophilization by mixing human PTH (1-84) as hormone, mannitol as excipient and citrate as buffer.

[0032] The first step of production preparation is to be made into two kinds of mixtures with injectable 20% (w / v) sterile mannitol solution (British Pharmacopeia): add in 20% mannitol solution: (1) lemon acid solution to obtain a mixed solution containing 10mM citric acid and 5% mannitol; (2) sodium citrate monohydrate solution to obtain a second part of a mixed solution containing 10mM citrate and 5% mannitol, the two mixed solutions Miscible in appropriate volume ratios to obtain 5% mannitol solutions with pHs of 4 (±0.2) and 6 (±0.2), respectively.

[0033] Then a certain amount of lyophilized human PTH (1-84) was added to 5% mannitol solution (pH 4 and 6, respectively). PTH is produced by microbial fermentation and needs to be purified and sterilized before freeze-drying. Quantitative PTH was added to the 5% man...

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Abstract

Described herein are preparations containing parathyroid hormone that has been stabilized with an excipient and buffering agent. Preferred preparations incorporate human PTH(1-84), mannitol as excipient and citrate as buffering agent, and are incorporated in vials as a freeze-dried powder for reconstitution to treat osteoporosis.

Description

field of invention [0001] The present invention relates to pharmaceutical compositions containing parathyroid hormone, and more particularly to pharmaceutical compositions of parathyroid hormone with improved storage stability. Background of the invention [0002] Parathyroid hormone (PTH) is an 84 amino acid secretory product of the mammalian parathyroid gland. It controls blood calcium levels through its actions on various tissues, including bone tissue. Studies on certain forms of parathyroid hormone in humans have demonstrated that it can promote bone synthesis, suggesting that it can be used in the treatment of osteoporosis and related bone diseases. [0003] Taking the N-terminal 34 amino acids of bovine and human PTH (which have all the biological activities of the entire hormone) as an example, it has been proved that when administered subcutaneously and intravenously alternately, parathyroid hormone can significantly promote bone loss in humans. tissue growth. Si...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K9/00A61K9/19A61K38/22A61K38/29A61K47/10A61K47/12A61K47/26A61P3/02A61P3/14A61P19/10A61P43/00
CPCY10S514/97A61K9/0019A61K9/19A61K47/12A61K47/26A61K38/29A61P19/10A61P3/02A61P3/14A61P43/00
Inventor 约瑟夫斯·约翰内斯·玛丽·霍尔特休斯艾尔伯特·迈金阿尔温纳斯·安东尼厄斯·弗特曼
Owner ASTRAZENECA AB