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Elagolix freeze-dried tablets and preparation method thereof

A technology of freeze-dried tablets and solvents, which is applied in the field of medicine, can solve the problems of high protection requirements for operators, high production environment requirements, and inevitable environmental pollution, and achieve rapid clinical effect, low water content, and low environmental pollution. Effect

Active Publication Date: 2022-01-04
南京唯创远医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005]However, due to the fact that sodium carbonate monohydrate itself may absorb carbon dioxide during the production process, some crystal transformations will inevitably occur, and the requirements for the production environment are relatively high
Moreover, the above-mentioned hot-melt extrusion and dry granulation processes inevitably cause environmental pollution, and the protection requirements for operators are relatively high.

Method used

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preparation example Construction

[0033] The preparation technology of elagoli freeze-dried tablet of the present invention:

[0034] 1) The raw materials are crushed mechanically, such as universal grinder, hammer mill, ball star grinder, etc., until the particle size reaches D90<10μm, D50≈5μm;

[0035] 2) Weigh the material according to the prescription amount;

[0036] 3) raw material solution: add the raw material and anhydrous sodium carbonate to 50% purified water (50% of the total prescription of purified water), stir and dissolve at room temperature;

[0037] 4) Excipient solution: dissolve povidone in 40% purified water (40% of the total prescription volume of purified water), then add xylitol, sucralose and essence, and stir and mix evenly at 30-35°C;

[0038] 5) Homogenization: Mix the raw material solution and the povidone auxiliary material solution, and use a homogenizer to homogenize at 2000 rpm for 20 to 30 minutes;

[0039] 6) Constant volume: add purified water to constant volume, and conti...

Embodiment 1

[0046] Materials are shown in the table below.

[0047] materials Dosage (mg) Ella Goli 200 Xylitol 30 povidone 20 Anhydrous Sodium Carbonate 10 lemon zest 3 Sucralose 20 purified water Add to 1ml

[0048] 1) The raw materials are crushed mechanically, such as universal grinder, hammer mill, ball star grinder, etc., until the particle size reaches D90<10μm, D50≈5μm;

[0049] 2) Weigh the material according to the prescription amount;

[0050] 3) raw material solution: add the raw material and anhydrous sodium carbonate to 50% purified water, stir and dissolve at room temperature;

[0051] 4) Excipient material solution: dissolve povidone in 40% purified water, then add xylitol, sucralose and essence, stir and mix evenly at 30-35°C;

[0052] 5) Homogenization: mix the raw material solution and povidone solution, and use a homogenizer to homogenize at 2000 rpm for 20 to 30 minutes;

[0053] 6) Constant volume: add puri...

Embodiment 2

[0060] Materials are shown in the table below.

[0061] materials Dosage (mg) Ella Goli 200 Xylitol 50 povidone 30 Anhydrous Sodium Carbonate 5 lemon zest 1 Sucralose 10 purified water Add to 1ml

[0062] 1) The raw materials are crushed mechanically, such as universal grinder, hammer mill, ball star grinder, etc., until the particle size reaches D90<10μm, D50≈5μm;

[0063] 2) Weigh the material according to the prescription amount;

[0064] 3) raw material solution: add the raw material and anhydrous sodium carbonate to 50% purified water, stir and dissolve at room temperature;

[0065] 4) Excipient material solution: dissolve povidone in 40% purified water, then add xylitol, sucralose and essence, stir and mix evenly at 30-35°C;

[0066] 5) Homogenization: mix the raw material solution and povidone solution, and use a homogenizer to homogenize at 2000 rpm for 20 to 30 minutes;

[0067] 6) Constant volume: add purif...

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Abstract

The invention discloses elagolix freeze-dried tablets. The elagolix freeze-dried tablets comprise an active ingredient elagolix, an excipient, an adhesive, a pH regulator, a taste masking agent, a flavoring agent and a solvent, and comprises the following components in parts by weight: 200 parts of active component elagolix, 30-50 parts of excipient, 20-50 parts of adhesive, 5-20 parts of pH regulator, 1-5 parts of taste masking agent, 10-40 parts of flavoring agent and 800-900 parts of solvent. The invention further discloses a preparation method of the elagolix freeze-dried tablets. The elagolix freeze-dried tablets and the preparation method thereof have the following advantages: no dust is generated in the production process, and the environmental pollution is less; the prepared products are smaller in tablet weight and adopt fewer auxiliary materials; the freeze-dried tablets are low in water content and stable in quality, and impurities are hardly increased in the storage process; in the clinical using process, the elagolix freeze-dried tablets can be quickly dissolved in the mouth, the dissolution and release of the drug cannot be influenced by the digestion process of gastrointestinal tracts, and the clinical response is quicker.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to elagoli, in particular to a elagoli freeze-dried tablet and a preparation method thereof. Background technique [0002] Elagolis is an oral GnRH antagonist jointly developed by Abbvie and its partner Neurocrine Bioscience. It is currently the first and only oral gonadotropin-releasing hormone (GnRH) antagonist. Elagolis inhibits the gonadotropin-releasing hormone receptors of the pituitary gland, ultimately reducing the level of circulating gonadal hormones. [0003] As an oral, non-peptide GnRH receptor antagonist, elagolix has a short half-life and can quickly restore the function of the hypothalamus-pituitary-gonadal axis after drug withdrawal. Clinical studies have shown that elagolix alone can significantly improve MBL compared with placebo, and combined with reverse addition of low-dose E2 / progestin can reduce the incidence of hot flashes. Compared with agonists, elagolix t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/513A61K47/32A61K47/26A61K47/02A61P5/02
CPCA61K31/513A61K9/2018A61K9/2009A61K9/2027A61K9/2095A61K9/0056A61P5/02
Inventor 陈林朱磊贾元超李谢王张权刘志朋
Owner 南京唯创远医药科技有限公司
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