Preparation method of piperacypress and cefoxil capsule

A technology for piperacillide and capsules, which is applied in the field of preparation of piperacillin capsules, can solve problems such as poor dissolution uniformity, and achieve the effects of improved content uniformity, good appearance and guaranteed product quality.

Pending Publication Date: 2021-01-29
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a method of dry granulation, by selecting a suitable range of fine powder proportions, the content uniformity of the mixed granules obtained in the preparation process of palbociclib capsules is improved, and the problem of each sampling of palbociclib capsules is solved. Problems with poor dissolution uniformity across time points

Method used

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  • Preparation method of piperacypress and cefoxil capsule
  • Preparation method of piperacypress and cefoxil capsule
  • Preparation method of piperacypress and cefoxil capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: Effect of Large Sheet Density

[0038] Since the dry granulation process first compresses large tablets and then granulates, different large tablet densities will affect the particle size distribution of the granules, and then affect the dissolution results. Therefore, the influence of different large tablet densities on the particle size distribution should be investigated.

[0039] Table 1 Prescribing Information

[0040]

[0041]

[0042] Concrete preparation process is as follows:

[0043] (1) Premix:

[0044] Premix 1: Weigh the prescription amount of palbociclib, microcrystalline cellulose, lactose, sodium starch glycolate (internal addition), colloidal silicon dioxide, magnesium stearate (internal addition), and mix for 2 minutes (speed: 10rpm ).

[0045] Pre-mixing 2: Pass the above-mentioned mixed powder through a sieve with a pore size of 1.0mm for granulation and deagglomeration, and then mix for 5 minutes (speed: 10rpm).

[0046] (2) Dry...

Embodiment 2

[0057] Example 2: Effects of different large flake densities on particle size and proportion of fine powder <60 mesh obtained by multiple granulation

[0058] Adopt the prescription of embodiment 1, control large sheet density 0.9-1.0g / cm 3 , and according to the following preparation method:

[0059] (1) Premix:

[0060] Premix 1: Weigh the prescription amount of palbociclib, microcrystalline cellulose, lactose, sodium starch glycolate (internal addition), colloidal silicon dioxide, magnesium stearate (internal addition), and mix for 2 minutes (speed: 10rpm ).

[0061]Pre-mixing 2: Pass the above-mentioned mixed powder through a sieve with a pore size of 1.0mm for granulation and deagglomeration, and then mix for 5 minutes (speed: 10rpm).

[0062] (2) Dry granulation (multiple granulation): Control the density of large flakes by adjusting the screw speed, drum speed and drum pressure. Pass the large pieces through a 20-mesh sieve for granulation and then sieve the granule...

Embodiment 3

[0072] Embodiment 3: the influence of different fine powder proportions on mixing uniformity

[0073] It is 1.0g / cm to choose that the bulk density is 1.0g / cm among the embodiment 2 3 or 0.9g / cm 3 The total mixed granule that step (3) makes at the same time. Samples were taken at different locations (11 sampling points in total) to determine the content uniformity of the blended particles.

[0074] Table 6 The density of large pieces is 1.0g / cm 3 , the impact of the particle size distribution of the obtained particles in step (2) on the content uniformity of the blended particles in step (3)

[0075]

[0076] Table 7 The density of large pieces is 0.9g / cm 3 , the impact of the particle size distribution of the obtained particles in step (2) on the content uniformity of the blended particles in step (3)

[0077]

[0078] According to the results of Table 6 and Table 7, it can be seen that when the bulk density is 1.0g / cm 3 or 0.9g / cm 3 Under normal circumstances, w...

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Abstract

According to the dry granulation method provided by the invention, the content uniformity of the total mixed particles obtained in the preparation process of the pimpinella capsule is improved by selecting an appropriate fine powder proportion range, and a problem that the dissolution uniformity of the pimpinella capsule at each sampling time point is poor is solved.

Description

technical field [0001] The invention belongs to the field of preparation methods, and in particular relates to a preparation method of palbociclib capsules. Background technique [0002] Palbociclib capsules (IBRANCE) are developed by Pfizer, with specifications of 75mg, 100mg and 125mg. IBRANCE was first approved for marketing in the United States on February 3, 2015. It is used in combination with letrozole as a first-line therapy for estrogen receptor-positive (ER+) and human epidermal growth factor receptor-negative patients who have not previously received systemic treatment. Postmenopausal women with (HER2-) advanced breast cancer. Palbociclib capsules were approved for marketing in China on July 31, 2018, with specifications of 125, 100, and 75mg, and the product name is "Aiboxin". [0003] Patent CN201510732916.0 discloses a pharmaceutical composition containing palbociclib (ie palbociclib) obtained by a dry granulation process. It is prepared by the following met...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/519A61P35/00A61J3/07
CPCA61K31/519A61K9/1652A61P35/00A61J3/07
Inventor 吕硕刘娜黄皓月杜晓俐文师龙
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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