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Pharmaceutical composition containing taxane-cyclodextrin complex, method of manufacture and method of use

A composition and taxane technology, applied in the direction of drug combinations, medical preparations containing active ingredients, medical preparations with non-active ingredients, etc., can solve problems such as increased risk of cytotoxic compounds

Active Publication Date: 2020-07-10
HUNAN JINZHUN MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Healthcare workers are at increased risk of exposure to these cytotoxic compounds as the powder must be reconstituted prior to use

Method used

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  • Pharmaceutical composition containing taxane-cyclodextrin complex, method of manufacture and method of use
  • Pharmaceutical composition containing taxane-cyclodextrin complex, method of manufacture and method of use
  • Pharmaceutical composition containing taxane-cyclodextrin complex, method of manufacture and method of use

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Experimental program
Comparison scheme
Effect test

Embodiment

[0071] Accelerated Aging Stability Study

[0072] The above liquid pharmaceutical composition comprising -10 mg / mL docetaxel was diluted and subjected to accelerated aging at 40°C for 11 days. Impurity levels specified by USP35 (United States Pharmacopeia 35) for taxane compositions were analyzed by HPLC at timed intervals. Stability was tested on day 0 at 6 hours. The impurity levels in the liquid pharmaceutical compositions were compared to the tolerable levels according to the USP35 standard. The results are shown in figure 1 middle. It can be seen that all impurities (Substances A-F) are well below the USP35 limit for the full 1 day period of accelerated aging. Furthermore, during the 11 days tested, there was no increase in the impurities present and no new impurities or degradation products were formed, indicating that the composition is chemically stable. The composition is also physically stable as no precipitate or haze is formed.

[0073] Furthermore, the con...

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Abstract

The present invention provides a pharmaceutical formulation for parenteral administration comprising a taxane compound complexed with cyclodextrin and polyethylene glycol, a method for producing the pharmaceutical formulation, and a method for treating cancer patients using the pharmaceutical formulation.

Description

[0001] field of invention [0002] The present disclosure relates to pharmaceutical formulations of taxane compounds for parenteral administration, methods of manufacturing the pharmaceutical formulations, and methods of using the pharmaceutical formulations to treat cancer patients. Background technique [0003] Taxanes are diterpenes widely used in chemotherapy. They were originally found in the yew plant (yew) and were first obtained from these natural sources. Several chemical synthesizers exist. Among the taxanes, the best known are paclitaxel (TAXOL) and the semi-synthetic analogue of paclitaxel, docetaxel (TAXOTERE). Taxanes exert their anticancer activity by inhibiting the depolymerization of tubulin in cells, thereby inhibiting mitosis. [0004] Parenteral administration by injection is the typical route of administration for taxanes. However, taxanes are substantially insoluble in water and other commonly used medical parenteral organic solvents, which presents c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/337A61K9/08A61K31/724A61K47/08A61K47/10A61P35/00
CPCA61K31/337A61K9/08A61K47/10A61K47/6951A61P35/00A61K9/0019A61K47/32C08B37/0015A61K2300/00
Inventor W·W·赵J·K·托塔斯伊尔D·史密斯孙晓东董祥玉
Owner HUNAN JINZHUN MEDICAL TECH CO LTD