Mycophenolate mofetil capsule and preparation method thereof

A technology of mycophenolate mofetil and capsules, applied in the field of biopharmaceuticals, to achieve the effect of saving time, low strength and low density

Inactive Publication Date: 2017-02-15
WUXI FORTUNE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no relevant report about mycophenolate mofetil capsules

Method used

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  • Mycophenolate mofetil capsule and preparation method thereof
  • Mycophenolate mofetil capsule and preparation method thereof
  • Mycophenolate mofetil capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] In this embodiment, pregelatinized starch is used as a filler, polyvinylpyrrolidone is used as a binder, croscarmellose sodium is used as a disintegrant, and magnesium stearate is used as a lubricant. In this example, every 2000 mycophenolate mofetil capsules include 1100g mycophenolate mofetil, 150g pregelatinized starch, 40g polyvinylpyrrolidone, 30g croscarmellose sodium, and magnesium stearate. 5g.

[0028] The raw and auxiliary materials are passed through an 80-mesh sieve. Take the above prescription amount of mycophenolate mofetil, pregelatinized starch, polyvinylpyrrolidone and croscarmellose sodium, and then add them to the wet granulator in turn, dry blend for 5-8 minutes, then transfer the mixed powder In the fluidized bed, set the inlet air temperature to 50~60℃ and the inlet air volume to 15~25m 3 / h, atomization pressure 0.1~0.2MPa, add purified water to granulate, measure the moisture after discharging, make the moisture of the granules drop below 2%, pass ...

Embodiment 2

[0031] In this embodiment, corn starch is selected as the filler, hypromellose is selected as the binder, crospovidone is selected as the disintegrant, and magnesium stearate is selected as the lubricant. In this embodiment, every 2000 mycophenolate mofetil capsules include 1400g mycophenolate mofetil, 170g pregelatinized starch, 60g polyvinylpyrrolidone, 40g croscarmellose sodium, and 10g talc.

[0032] The raw and auxiliary materials are passed through an 80-mesh sieve. Take the above prescription amount of mycophenolate mofetil, cornstarch, hypromellose and crospovidone into the wet granulator in turn, dry blend for 5-8 minutes, then transfer the mixed powder to the fluidized bed , Set the inlet air temperature to 50~60℃, and the inlet air volume to 15~25m 3 / h, atomization pressure 0.1~0.2MPa, add purified water to granulate, measure the moisture after discharging, make the moisture of the granules fall below 2%, pass through a 30-mesh sieve, and add talc powder after the yie...

Embodiment 3

[0035] In this embodiment, lactose is used as a filler, maltose is used as a binder, sodium carboxymethyl starch is used as a disintegrant, and magnesium stearate is used as a lubricant. In this embodiment, every 2000 mycophenolate mofetil capsules include 1300g mycophenolate mofetil, 160g lactose, 50g maltose, 35g sodium carboxymethyl starch, and 8g magnesium stearate.

[0036] The raw and auxiliary materials are passed through an 80-mesh sieve. Take the above-mentioned prescription amount of mycophenolate mofetil, lactose, maltose and sodium carboxymethyl starch into the wet granulator in sequence, dry-mix for 5-8 minutes, transfer the mixed powder to the fluidized bed, set the air inlet The temperature is 50~60℃, the inlet air volume is 15~25m 3 / h, atomization pressure 0.1~0.2MPa, add purified water to granulate, measure the moisture after discharging, make the moisture of the granules drop below 2%, pass through a 30-mesh sieve, and then add magnesium stearate and mix Evenl...

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Abstract

The invention provides a mycophenolate mofetil capsule and a preparation method thereof. The mycophenolate mofetil capsule comprises, by weight, 1100-1400 parts of mycophenolate mofetil, 150-170 parts of filler and 75-110 parts of pharmaceutical acceptable auxiliary materials; the filler is selectively prepared from a mixture of one or more optional proportions of pregelatinized starch, corn starch or lactose; the pharmaceutical acceptable auxiliary materials include adhesive, disintegrant and lubricant. A fluidized-bed granulation technology is adopted, the process is simplified, time is saved, labor intensity is low, obtained particles are porous soft particles, low density and low strength are achieved, the particles are evenly distributed in particle size, and good fluxility is achieved; the mycophenolate mofetil capsule has the advantages of high disintegration speed, good absorptivity, convenience in taking, small in intestinal irritation, stable in long-term storage quality and the like; the advantages of both simpleness in production equipment for ordinary capsules and convenience in package storage and transportation as well as carrying are achieved, and the mycophenolate mofetil capsule is convenient for patients to take.

Description

Technical field [0001] The invention relates to the technical field of biopharmaceuticals, in particular to a mycophenolate mofetil capsule and a preparation method thereof. Background technique [0002] Mycophenolate mofetil (MMF) was approved by the US FDA in October 1998 and has been imported into my country. It is a landmark and representative drug with a good market prospect and good social benefits. Currently, tablets, dispersible tablets and dry suspensions are mainly used in China. The chemical name of mycophenolate mofetil is: 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6methoxy-7-methyl-3-oxo- 5-Isobenzopyranyl)-4-methyl-4-vinyl salt, molecular formula: C23H31NO7, molecular weight: 433.48. Mycophenolate mofetil (MMF) is a 2-ethyl ester derivative of mycophenolic acid (MPA). It is a precursor substance. It is absorbed quickly and completely after oral administration, and is rapidly absorbed by liver esterase. It is transformed into mycophenolic acid (MPA), a metabo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/5377A61P37/06A61P13/12A61P37/02A61P19/02
CPCA61K9/4858A61K9/4866A61K31/5377
Inventor 米靖宇徐睿秦玉荣朱佳彬李晓明张莹
Owner WUXI FORTUNE PHARMA
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