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Method for preparing Niraparib microcapsule preparation

A preparation and capsule material technology, applied in the field of anticancer drug microcapsule preparations, niraparib microcapsule preparations and their preparation fields, can solve the problems of low drug loading, limited wide use, poor encapsulation rate and the like, and achieve dissolution The effect of stable, increasing drug loading and improving encapsulation efficiency

Inactive Publication Date: 2020-11-27
湖南博隽生物医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Microcapsules are a new dosage form developed in the past 30 years. At present, there are problems such as low drug loading and poor encapsulation efficiency, which limit the widespread use of this method.

Method used

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  • Method for preparing Niraparib microcapsule preparation
  • Method for preparing Niraparib microcapsule preparation
  • Method for preparing Niraparib microcapsule preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: the preparation of niraparib capsules of the present invention

[0038]

[0039] Preparation Process:

[0040] ① Mix and pulverize niraparib and boric acid to 80 meshes, place in a fluidized bed, pass hot air into it to suspend and fluidize it, and the temperature of the hot air is 65-75°C;

[0041] ②Add polyvinyl alcohol into purified water at 65-75°C while stirring, and prepare a polyvinyl alcohol solution with a mass percentage of 5-10%.

[0042] ③ Atomize the polyvinyl alcohol solution of the capsule material through the nozzle of the fluidized bed and continuously add it to the fluidized bed. The atomization pressure is 0.2-0.4Mpa; the conveying speed is 15-20r / min; Moisture content <1.5%, stop heating, cool and discharge, and obtain niraparib microcapsules;

[0043] 4. Mix the niraparib microcapsules with the prescribed amount of copovidone S-630 and dextrin evenly, and directly fill to obtain the niraparib microcapsule capsules of the present i...

Embodiment 2

[0044] Embodiment 2: the preparation of niraparib microcapsule capsule of the present invention

[0045]

[0046] Preparation Process:

[0047] ① Mix and pulverize niraparib and boric acid to 80 meshes, place in a fluidized bed, pass hot air into it to suspend and fluidize it, and the temperature of the hot air is 65-75°C;

[0048] ②Add polyvinyl alcohol into purified water at 65-75°C while stirring, and prepare a polyvinyl alcohol solution with a mass percentage of 5-10%.

[0049]③ Atomize the polyvinyl alcohol solution of the capsule material through the nozzle of the fluidized bed and continuously add it to the fluidized bed. The atomization pressure is 0.2-0.4Mpa; the conveying speed is 15-20r / min; Moisture content <1.5%, stop heating, cool and discharge, and obtain niraparib microcapsules;

[0050] 4. mix the niraparib microcapsules and the prescription amount of crospovidone and xylitol evenly, and directly fill to obtain the niraparib microcapsule capsules of the p...

Embodiment 3

[0051] Embodiment 3: the preparation of niraparib microcapsule capsule of the present invention

[0052]

[0053] Preparation Process:

[0054] ① Mix and pulverize niraparib and boric acid to 80 meshes, place in a fluidized bed, pass hot air into it to suspend and fluidize it, and the temperature of the hot air is 65-75°C;

[0055] ②Add polyvinyl alcohol into purified water at 65-75°C while stirring, and prepare a polyvinyl alcohol solution with a mass percentage of 5-10%.

[0056] ③ Atomize the polyvinyl alcohol solution of the capsule material through the nozzle of the fluidized bed and continuously add it to the fluidized bed. The atomization pressure is 0.2-0.4Mpa; the conveying speed is 15-20r / min; Moisture content <1.5%, stop heating, cool and discharge, and obtain niraparib microcapsules;

[0057] 4. Mix the niraparib microcapsules with the prescribed amount of microcrystalline cellulose and pregelatinized starch evenly, and directly fill to obtain the niraparib mi...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations and relates to a method for preparing a Niraparib microcapsule preparation. According to the method, the Niraparib microcapsule preparation is prepared through taking a principal drug Niraparib and an adjuvant boric acid as capsule cores, adding polyvinyl alcohol to prepare Niraparib microcapsules, and then, uniformly mixing the microcapsules with other auxiliaries. The Niraparib microcapsule preparation prepared by the method is high in drug loading capacity and good in entrapment rate, the stability of the Niraparibis improved remarkably, adverse reactions of the Niraparib are reduced, drugs are released stably in vivo, actions of the Niraparib are better exerted, and thus, the Niraparib microcapsule preparationis suitable for being industrially produced on a large scale.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an anticancer drug microcapsule preparation, in particular to a niraparib microcapsule preparation and a preparation method thereof. [0002] technical background [0003] Ovarian cancer is the leading cause of death from gynecological cancer in the United States and the fifth leading cause of cancer death in women, and less than 40% of women with ovarian cancer can be cured. The incidence of ovarian cancer increases with age, with the highest incidence in the 60-70 age group, the median age at diagnosis is 63 years, and 70% of them are diagnosed with advanced disease. The incidence of ovarian cancer may be related to the following aspects: external factors of cancer incidence (including chemical, physical, biological and other carcinogenic factors); internal factors of cancer incidence (including immune function, endocrine, genetic, mental factors, etc.), and di...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/454A61K47/32A61K47/04A61P35/00
CPCA61K9/4816A61K9/485A61K31/454A61K47/32A61P35/00
Inventor 朱露晶万迎春
Owner 湖南博隽生物医药有限公司
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