NOVEL FORMULATIONS OF PTHrP ANALOGUE

A technology of analogs and antimicrobial agents, applied in the field of treatment of osteoporosis to increase bone mass or increase bone mass, can solve the problems of dose range limitation, stimulation increase, etc., to achieve beneficial physiological effects increase, treatment duration decrease, eliminate The effect of adverse side effects

Inactive Publication Date: 2018-05-11
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Furthermore, existing osteoporosis drugs have limitations in suitable dosage ranges due to adverse side effects such as hypercalcemia and increased stimulation of bone resorption

Method used

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  • NOVEL FORMULATIONS OF PTHrP ANALOGUE
  • NOVEL FORMULATIONS OF PTHrP ANALOGUE

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0045] [Glu 22,25 , Leu 23,28,31 , Aib 29 ,Lvs 26,30 ]hPTHrP(1-34) NH 2 (SEQ ID NO.: 2) preparation

[0046] [Glu 22,25 ,Leu 23,28,31 , Aib 29 ,Lys 26,30 ]hPTHrP(1-34)NH 2 (SEQ ID NO.:2) 5.0 mg (free base) was dissolved in 4.50 mL of water for injection. The pH of the resulting solution was adjusted to 6.5 by using 1% hydrochloric acid solution and 1% sodium hydroxide solution, and the final volume of the solution was adjusted to 5.0 mL with water for injection.

example 2

[0048] [Glu in phosphate buffer at pH 7.5 22,25 , Leu 23,28,31 , Aib 29 ,Lvs 26,30 ]hPTHrP(1- 34) NH 2 (SEQ ID NO.: 2) preparation

[0049] [Glu 22,25 , Leu 23,28,31 , Aib 29 ,Lys 26,30 ]hPTHrP(1-34)NH 2 (SEQ ID NO.:2) 5.0 mg (free base) was dissolved in 5.0 mL of phosphate buffer (10 mM, Na 2 HPO 4 and NaH 2 PO 4 ). The resulting solution had a pH of 7.5.

example 3

[0051] [Glu 22,25 , Leu 23,28,31 , Aib 29 ,Lvs 26,30 ]hPTHrP(1-34)NH 2 (SEQ ID NO.: 2) preparation

[0052] [Glu 22,25 , Leu 23,28,31 , Aib 29 ,Lys 26,30 ]hPTHrP(1-34)NH 2 (SEQ ID NO.:2) 5.0 mg (free base) was dissolved in 4.60 mL water for injection containing 5.0 mg / mL phenol. The pH of the resulting solution was adjusted to 6.5 by using 1% hydrochloric acid solution and 1% sodium hydroxide solution, and the final volume of the solution was adjusted to 5.0 mL with water for injection containing phenol at a concentration of 5.0 mg / mL.

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Abstract

The present invention provides a non-buffered, neutral pH, easily prepared, storage-stable composition containing a parathyroid hormone-related protein (PTHrP) analogue and methods of using a PTHrP analogue and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition has a non-buffered neutral pH which avoids injection site reactions and is easy to prepare and storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to humanpatients.

Description

Background technique [0001] Parathyroid hormone-related protein ("PTHrP") is a protein of 139 to 173 amino acids. PTHrP and certain analogs are known to be useful in increasing bone mass and mass in the treatment of osteoporosis and related disorders. However, the commercial use of these proteins as pharmaceutical agents requires the development of proteins that are acceptable in terms of storage stability, ease of preparation, and suitable for subcutaneous injection without inducing injection site reactions (such as hypersensitivity to acidic solutions with buffered acidic pH). ) preparations. [0002] Furthermore, existing osteoporosis drugs have limitations in suitable dosage ranges due to adverse side effects such as hypercalcemia and increased stimulation of bone resorption. These adverse side effects and resulting dose limitations reduce the beneficial effects that can be achieved by these drugs. Therefore, there is a need for compounds that can be administered at dos...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/29
CPCA61K38/29A61P19/10A61K9/0019A61K47/10
Inventor 董正欣
Owner 董正欣
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