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Multi-use torasemide composition

A kind of technology of torasemide and composition, applied in the field of water-containing composition

Pending Publication Date: 2020-10-02
威隆股份公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] No known composition yet has a composition which, in addition to increased stability and antimicrobial effect, provides greater freedom to adjust the dosage at the time of application

Method used

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  • Multi-use torasemide composition
  • Multi-use torasemide composition
  • Multi-use torasemide composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Example 1: Preparation of a composition according to the invention

[0063] Preparation of mixture 1:

[0064] Water and tromethamine (buffer) were introduced at room temperature (18-25° C.) with stirring by a deflocculation turbine (speed: 200-600 RPM, duration: about 15 minutes).

[0065] Preparation of mixture 2:

[0066] Torsemide was added to Mixture 1 with stirring by a deflocculation turbine (speed: 200-600 RPM, duration: about 15 minutes).

[0067] Preparation of mixture 3:

[0068] Polymer was gradually added to Mixture 2 with agitation by deflocculation turbine and mechanical agitation (speed: 200-600 RPM, duration: about 15 minutes).

[0069] Preparation of mixture 4:

[0070] The remaining excipients (except the organic solvent) were added to mixture 3 and kept stirring until a clear solution was obtained.

[0071] Preparation of mixture 5:

[0072] Then, an organic solvent (propylene glycol) was added to the mixture 4 and kept stirring until...

Embodiment 2

[0080] Example 2: Optimized Stability of Compositions According to the Invention

[0081] Compositions 1 and 2 were evaluated for stability under accelerated harsh storage conditions: at a temperature of 40°C, at a relative humidity of 75% and for a period of T = 2 months.

[0082] For each composition tested, the level of impurities is measured by the method corresponding to the active ingredient, described in the European or US Pharmacopoeia monographs.

[0083] The results are listed in Table 2 below:

[0084]

[0085] Table 2: Stability tests of compositions 1 and 2.

[0086] "Unknown impurities" refer to impurities, degradation products and chemical impurities classified as "B" and "A" in the European Pharmacopoeia and "A" and "E" in the United States Pharmacopoeia (USP).

[0087] The results obtained show that the compositions according to the invention are more stable than the compositions of the prior art. Thus, the composition according to the invention meets th...

Embodiment 3

[0088] Example 3: Antimicrobial properties of compositions according to the invention

[0089] Antimicrobial efficacy was assessed according to European monographs.

[0090] The following compositions (A to I according to the invention and counter-examples according to CE1 to CE7) were prepared according to the procedure of Example 1.

[0091]

[0092] Table 3: Efficacy of different batches of antimicrobial storage using 0.2% carbomer and different amounts of propylene glycol. NC = not applicable, C = applicable.

[0093]

[0094]Table 4: Efficacy of different batches of antimicrobial storage using 1% HEC and different amounts of propylene glycol. NC = not applicable, C = applicable.

[0095]

[0096]

[0097] Table 5: Efficacy of different batches for antimicrobial storage using 0.3% xanthan gum and different amounts of propylene glycol. NC = not applicable, C = applicable.

[0098]

[0099] Table 6: Evaluation of the antimicrobial efficacy of propylene gl...

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Abstract

The present invention relates to an aqueous composition comprising torasemide and at least one organic solvent, to a flask or container comprising said composition, to a kit comprising said flask or container and to a device for dispensing said composition (for example a syringe). The invention also relates to a use of at least one organic solvent for increasing the stability and / or the antimicrobial properties of a composition comprising torasemide. Finally, the present invention also targets a method for preparing a composition according to the invention.

Description

technical field [0001] The present invention relates to an aqueous composition comprising torasemide and at least one organic solvent, to a bottle or container comprising said composition, and to a method comprising said bottle or container and for administering said Kits for systems (eg, syringes) of compositions. [0002] The present invention also relates to the use of at least one organic solvent for increasing the stability and / or antimicrobial properties of compositions comprising torasemide. [0003] Finally, the invention also relates to a process for the preparation of the composition according to the invention. Background technique [0004] Torsemide or torsemide (1-isopropyl-3-[(4-m-toluidinyl-3-pyridyl)sulfonyl]urea) is the known active ingredient, which has a potent diuretic effect . In human and veterinary medicine, it is used in the treatment of edema associated with heart failure, kidney disease, and in the treatment of high blood pressure. [0005] Torse...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/10A61K47/18A61K9/08A61K31/64
CPCA61K9/0019A61K9/0095A61K9/08A61K31/64A61K47/10A61K47/18A61P9/04A61P7/10A61P13/12A61P9/12A61K31/44
Inventor 马里内特·莫罗埃洛迪·莱戈
Owner 威隆股份公司
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