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Technological method and composition for improving flowability of piperacipril isethionate

A technology of piperidine isethionate and piperidine isethionate, applied in the field of medicine, can solve problems such as poor fluidity, difficulty in large-scale manufacturing, etc., and achieve the effect of good fluidity

Pending Publication Date: 2022-03-29
NANJING GRITPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the problem of poor fluidity of palbociclib isethionate raw materials and difficulty in large-scale production in the prior art, the present invention provides a process and composition for improving the fluidity of palbociclib isethionate, combined with quality source Based on the design concept, through the premixing step in the process of preparing the composition and controlling the tap density and angle of repose of the particles in the dry granulation, a palbociclib isethionate composition with good fluidity can be obtained, and at the same time, the composition can be guaranteed The in vitro dissolution behavior is similar to that of free base, and the improved process method is conducive to the large-scale commercial development of palbociclib isethionate

Method used

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  • Technological method and composition for improving flowability of piperacipril isethionate
  • Technological method and composition for improving flowability of piperacipril isethionate
  • Technological method and composition for improving flowability of piperacipril isethionate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The composition of the prescription is as follows:

[0051]

[0052]

[0053] Preparation Process:

[0054] 1. Preparation of raw and auxiliary materials

[0055] Palbociclib isethionate, microcrystalline cellulose, and crospovidone are passed through a 40-mesh sieve, and lactose, colloidal silicon dioxide, and magnesium stearate are passed through a 80-mesh sieve for later use.

[0056] 2. Premix

[0057] Weigh respectively palbociclib isethionate and microcrystalline cellulose premixed according to the prescription quantity, pass through a 40-mesh sieve,

[0058] 3. mix

[0059] Add the premix, lactose, crospovidone, and colloidal silicon dioxide into a three-dimensional motion mixer and mix for 15 minutes;

[0060] 4. Dry granulation

[0061] After setting the parameters of the dry granulator (roller pressure is set to 35-45kg / cm 3 ), the mixture obtained in step 3 is subjected to dry granulation;

[0062] 5. Total mix

[0063] Add the magnesium stearat...

Embodiment 2

[0084] The composition of the prescription is as follows:

[0085]

[0086] 1. Preparation of raw and auxiliary materials

[0087] Palbociclib isethionate, pregelatinized starch, and crospovidone are passed through a 40-mesh sieve, and lactose, colloidal silicon dioxide, and magnesium stearate are passed through a 80-mesh sieve for later use.

[0088] 2. Premix

[0089] Weigh and premix palbociclib isethionate and pregelatinized starch respectively according to the prescription quantity, pass through a 40-mesh sieve,

[0090] 3. mix

[0091] Add the premix, lactose, crospovidone, and colloidal silicon dioxide into a three-dimensional motion mixer and mix for 15 minutes;

[0092] 4. Dry granulation

[0093] After setting the parameters of the dry granulator (roller pressure is set to 35-45kg / cm 3 ), the mixture obtained in step 3 is subjected to dry granulation;

[0094] 5. Total mix

[0095] Add the magnesium stearate and the granules obtained after dry granulation i...

Embodiment 3

[0099] The composition of the prescription is as follows:

[0100]

[0101] Preparation Process:

[0102] 1. Preparation of raw and auxiliary materials

[0103]Pass through a 40-mesh sieve, palbociclib isethionate, anhydrous calcium hydrogen phosphate, and crospovidone, and pass through a 80-mesh sieve for talcum powder and sodium stearyl fumarate for later use.

[0104] 2. Premix

[0105] Weigh respectively palbociclib isethionate and anhydrous calcium hydrogen phosphate premixed according to the prescription quantity, pass through a 40-mesh sieve,

[0106] 3. mix

[0107] Add the premix, talcum powder and crospovidone into the three-dimensional motion mixer and mix for 15 minutes;

[0108] 4. Dry granulation

[0109] After setting the parameters of the dry granulator (roller pressure is set to 35-45kg / cm 3 ), the mixture obtained in step 3 is subjected to dry granulation;

[0110] 5. Total mix

[0111] Add sodium stearyl fumarate and the granules obtained by dry g...

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Abstract

The invention discloses a process method and a composition for improving flowability of piperacedryl isethionate, and belongs to the field of pharmaceutical preparations. The method comprises the step of granulating pepericide isethionate and pharmaceutically acceptable auxiliary materials, the tap density of the obtained granules is 0.55-0.72 g / mL, and the angle of repose is smaller than or equal to 44 degrees. According to the process method disclosed by the invention, when the piperacipril isethionate composition is subjected to capsule filling, the particle fluidity is relatively good, and the prepared piperacipril isethionate capsule is uniform in content, good in stability and controllable in quality. The preparation method is convenient to operate, easy to master and adjust and good in production amplification controllability.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a process method and a composition for improving the fluidity of palbociclib isethionate, belonging to the technical field of medicine. Background technique [0002] Breast cancer is one of the major malignant tumors that endanger the health of women around the world. According to the report of the International Cancer Research Center of the World Health Organization, there were about 1.677 million new cases of female breast cancer in the world in 2012, accounting for 25.2% of female malignant tumors. The age-standardized incidence rate of breast cancer is 43.3 / 100,000, ranking first in the incidence of female malignant tumors; the age-standardized mortality rate of female breast cancer in the world is 12.9 / 100,000, ranking first in the order of female malignant tumor deaths. Breast cancer has become a major public health problem in today's society....

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K9/16A61K9/48A61K47/38A61P35/00
CPCA61K31/519A61K9/1682A61K9/1652A61P35/00A61K9/1694A61K9/1623A61K9/1611A61K9/1635A61K9/4825A61K9/485
Inventor 何红燕张倩倩杨建楠何亚洲左益彰赵璐魏伟业赵卿霍立茹李战
Owner NANJING GRITPHARMA CO LTD
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