Compositions

An aqueous solution and solution technology, applied in the direction of drug combination, drug delivery, inorganic non-active ingredients, etc., can solve the problem of no chromatography

Active Publication Date: 2017-05-31
埃克斯利亚制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In fact, when Wallace et al. and Healan et al. carried out their studies, there were no chromatographic methods available for the analysis of CMS

Method used

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] Aqueous solutions containing colistin sodium methanesulfonate (CMS) at three different concentrations (37.5 mg A / mL, 75 mg A / mL and 112.5 mg A / mL) were stored in airtight containers for a period of one week.

[0095] HPLC chromatograms (data not shown) showed degradation in aqueous solutions containing 37.5 mg A / mL of CMS, but not significant degradation in aqueous solutions containing 75 mg A / mL of CMS or 112.5 mg A / mL of CMS.

[0096] At temperatures (5°C (data not shown), 25°C, 30°C, and 40°C), several parameters of the above composition were observed for the stated time, including but not limited to: appearance, foreign matter (USP, the presence of visible particles ("VP") is a non-compliance), the clarity of the solution (USP, lack of clarity leads to non-compliance), the number of microscopically visible particles (≤10 μm and ≤25 μm two Those, USP), pH (USP), osmolality (USP), and turbidity (Ph.Eur.2.2.1). The results of these observations are presented in Table 2...

Embodiment 2

[0110] Aqueous solutions containing 94 mg A / mL colistin sodium methanesulfonate (CMS) were stored in airtight containers at different temperatures (5°C, 25°C, 30°C and 40°C) for 1 month. HPLC chromatograms (data not shown) showed no significant changes.

[0111] Several parameters of the composition described above were observed over a period of 1 month and the results are summarized in Table 4.

[0112] Table 4.

[0113] parameter initial 5℃ 25℃ 30℃ 40℃ Exterior a

SYS h

SYS h

SYS h

SYS h

SYS h

foreign matter b

C j

C j

C j

C j

C j

Clarity c

C j

C j

C j

C j

C j

PN d ≤10μm e

102 11 34 33 59 PN d ≤25μm f

2 0 2 3 1 pH 6.21 5.98 6.09 6.11 6.13 Osmolality (Osm / kg) 0.928 0.916 0.925 0.908 0.929 Turbidity g

0.4 0.3 0.3 0.4 0.4

[0114] Instructions and Notes

[0115] a Colorless to slightly yellow so...

Embodiment 3

[0119] The viscosity values ​​of the compositions comprising CMS at different compositions were measured at 25°C and the results are summarized in Table 5.

[0120] table 5.

[0121] sample Concentration (mg A / ml) Viscosity (cSt) water 0.0 0.94 1 37.5 1.25 2 75.0 1.89 3 94.0 2.24 4 112.5 3.05

[0122] The viscosity (η) values ​​plotted against the concentration (c) values ​​show a quadratic relationship (η=Ac2+Bc+C) with good agreement (R2=0.9901), where A=0.0002, B=0.0003 and C= 0.9642.

[0123] In view of the functional relationship shown above, another aspect of the first and second embodiments is a composition comprising a sulfomethylated colistin having a viscosity value as determined by the quadratic expression above.

[0124] While a full and complete description is believed to be contained herein, certain patent and non-patent documents, including the aforementioned USP and Ph. Eur. monographs, may cover certain major ...

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Abstract

A peptide comprising an amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2, according to the present invention, shows proliferation and differentiation promotion of osteoblast and proliferation and activation promotion of periodontal ligament fibroblast. A peptide, according to the present invention, increases BMP signaling such as SMAD1/5/8 phosphorylation and increases the growth of osteoblast and the expression of a differentiation marker such as COL1A1, BSP and ALP, thereby ultimately showing osteoblast activation. A peptide, according to the present invention, promotes the growth of periodontal ligament fibroblast by means of PI3K and Akt phosphorylation and increases the expression of an activation marker such as COL1A1 and DSPP, thereby ultimately showing periodontal tissue regeneration activation. Provided are a composition for preventing or treating bone diseases and a composition for preventing or treating periodontal diseases, the compositions comprising the aforementioned peptide.

Description

technical field [0001] Disclosed herein are aqueous solutions containing 80 mg A / mL to 400 mg A / mL sulfomethylated polymyxin and cartridges containing the same, and aqueous solutions for use in therapy. Background technique [0002] Bacterial lung infections are a major problem and can become life-threatening in patients with chronic lung conditions such as asthma, cystic fibrosis (CF), non-CF bronchiectasis, and chronic obstructive pulmonary disease disease. [0003] Colistin (colistin, polymyxin E, colistin) is a multicomponent polymyxin antibiotic that is prescribed for the treatment of severe bacterial pulmonary disease caused by Gram-negative bacteria. Colistinus strains of Bacillus polymyxa var. colistinus infected with Gram-negative bacteria such as, for example, Pseudomonas Aeruginosa or Klebsiella pneumoniae. Polymyxin E1 and polymyxin E2 are the main components of colistin. [0004] When colistin is sulfomethylated, colistin sodium methanesulfonate (colistimetha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/12A61K9/08A61K47/02A61P11/00A61P31/04
CPCA61K9/0019A61K9/0078A61K9/08A61K38/12A61K47/02A61P11/00A61P31/04Y02A50/30
Inventor 内纳德·本奇
Owner 埃克斯利亚制药有限公司
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