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Vaginal sustained and controlled release drug delivery system containing aromatase inhibitor and preparation method thereof

A technology of aromatase and drug delivery system, which is applied in the field of pharmacy, can solve the problems of serious burst release phenomenon, unstable drug release, poor curative effect, etc., and achieve the solution of burst release effect, reduction of adverse reactions, and stable drug release Effect

Active Publication Date: 2021-08-13
国家卫生健康委科学技术研究所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] An object of the present invention is to provide a vaginal sustained and controlled release drug delivery system containing an aromatase inhibitor, to solve the problem of poor curative effect, unstable drug release, especially burst release in ATZ preparations used for the treatment of EMs in the prior art Serious symptoms or poor compliance

Method used

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  • Vaginal sustained and controlled release drug delivery system containing aromatase inhibitor and preparation method thereof
  • Vaginal sustained and controlled release drug delivery system containing aromatase inhibitor and preparation method thereof
  • Vaginal sustained and controlled release drug delivery system containing aromatase inhibitor and preparation method thereof

Examples

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Effect test

Embodiment 1

[0043] In this example, the raw materials for preparing the vaginal sustained and controlled release drug delivery system are shown in Table 1 below.

[0044] Table 1

[0045] name level batch number Manufacturer anastrozole API HSF1903001 Shanghai Hushi Pharmaceutical Technology Co., Ltd. EVA600^28% medical grade 56492201 Korea Lotte Chemical EVA810^33% medical grade E19222127 Korea Lotte Chemical

[0046] Take ATZ 12.5g, EVA28 (containing 28% VA) blank powder 100g, fully stir for 1min, then transfer the mixture to a twin-screw extruder (parameters: the temperature of the first zone, the second zone and the third zone are all 83 °C, the speed of the main engine is 76rpm, and the feeding rotating speed 50rpm) to extrude into thin tubular lines, and then use a granulator to granulate (with a particle diameter of about 3mm to 5mm) to obtain an EVA particle matrix with a drug loading of 12.5%. Add the drug-containing EVA particl...

Embodiment 2

[0048] In this example, the raw materials for preparing the vaginal sustained and controlled release drug delivery system are shown in Table 2 below. Table 2

[0049] name level batch number Manufacturer anastrozole API HSF1903001 Shanghai Hushi Pharmaceutical Technology Co., Ltd. EVA810^33% medical grade E19222127 Korea Lotte Chemical EVA40-45^40% medical grade 77625022 Arkema, France

[0050] Take ATZ 15g, EVA33 (containing 33% VA) blank powder 100g, fully stir for 1min, then transfer the mixture to a twin-screw extruder (parameters: the temperature in the first zone, the second zone and the third zone is 73°C, the speed of the main engine is 76rpm, and the speed of feeding 50rpm) to extrude into a thin tubular line, and then use a granulator to granulate (the particle diameter is about 3mm to 5mm) to obtain an EVA particle matrix with a drug loading of 15%. The drug-containing EVA particle matrix is ​​added to the single-s...

Embodiment 3

[0052] In this example, the raw materials for preparing the vaginal sustained and controlled release drug delivery system are shown in Table 3 below. table 3

[0053] name level batch number Manufacturer anastrozole API HSF1903001 Shanghai Hushi Pharmaceutical Technology Co., Ltd. EVA25-28^28% medical grade 56492201 Arkema, France EVA810^33% medical grade E19222127 Korea Lotte Chemical

[0054]Take 15g of ATZ, 100g of EVA28 (containing 28% VA) blank powder, fully stir for 1min, and then transfer the mixture to a twin-screw extruder (parameters: the temperature of the first zone is 76°C, the temperature of the second zone is 73°C, and the temperature of the third zone is 73°C, The main engine speed is 50rpm, the feeding speed is 50rpm) and extruded into thin tubular lines, and then granulated by a granulator (particle size is about 3mm-5mm) to obtain an EVA particle matrix with a drug loading of 15%. The drug-containing EVA pa...

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Abstract

The invention provides a vaginal sustained and controlled release drug delivery system containing an aromatase inhibitor and a preparation method thereof. The drug delivery system is an aromatase inhibitor reservoir-type vaginal ring prepared by loading aromatase inhibitor drugs with EVA as a carrier material. The vaginal ring includes a core layer and a film layer wrapped outside the core layer. The core layer It is formed after the aromatase inhibitor drug is evenly mixed with the EVA material; the film layer is formed of the EVA material. The release period of the vaginal sustained and controlled release drug delivery system of the present invention is 28 days to 42 days, the use process is more flexible, the preparation cost is also lower, and there is no obvious burst release effect, and the desired release can be achieved in a short time Therefore, the drug release is more stable and the application is safer.

Description

technical field [0001] The present invention relates to a vaginal sustained and controlled release drug delivery system and a preparation method thereof, in particular to an aromatase inhibitor (AIs) reservoir type slow control system using medical ethylene-vinyl acetate copolymer (EVA) as a carrier The invention relates to a vaginal release ring, a preparation method and related applications thereof, and belongs to the field of pharmacy. Background technique [0002] Endometriosis (EMs) is one of the common diseases in clinical gynecology. The disease will seriously affect women's physical health and fertility, seriously affect women's quality of life, it needs to be paid attention to. In recent years, the incidence of EMs has increased significantly. The incidence of EMs in women of childbearing age is 10%, and the infertility rate related to EMs is 17% to 47%. Therefore, effective treatment of EMs and reducing its recurrence will improve the quality of life of patients. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K47/32A61K31/4196A61P15/00A61P29/00A61P35/00
CPCA61K9/0036A61K31/4196A61K47/32A61P15/00A61P29/00A61P35/00
Inventor 宁美英杨紫霞夏良育马旭贺斌
Owner 国家卫生健康委科学技术研究所
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