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Medicinal composition containing mycophonolate mofetil and its preparation method

A technology of mycophenolate mofetil and composition, which is applied in the field of pharmaceutical composition containing mycophenolate mofetil and its preparation, which can solve the problems of poor drug compliance and difficulty in swallowing, and achieve fast absorption and overcome difficulty in swallowing , The effect of convenient clinical use

Inactive Publication Date: 2007-08-01
HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to overcome the defects of dysphagia and poor drug compliance in existing clinical patients, and provide a mycophenolate mofetil preparation with low cost, convenient storage and transportation, and improved drug compliance

Method used

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  • Medicinal composition containing mycophonolate mofetil and its preparation method
  • Medicinal composition containing mycophonolate mofetil and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Main and auxiliary materials

[0024] Mycophenolate Mofetil 250g

[0025] Microcrystalline Cellulose 40g

[0026] 40g pregelatinized starch

[0027] Low-substituted hydroxypropyl cellulose 7g

[0028] Sodium carboxymethyl starch 3.5g

[0029] 10% PVP alcohol / water (40 / 60) solution appropriate amount

[0030] Polyethylene glycol 6000 10.0g

[0031]

[0032] Made into 1000 pieces

[0033] Note: PVP is povidone K30.

[0034] 10% PVP alcohol / water (40 / 60) solution: 10g PVP is dispersed in 100ml 40% alcohol solution.

[0035] The mycophenolate mofetil is pulverized and passed through a 100-mesh sieve for later use. After drying all auxiliary materials at 60°C, except polyethylene glycol 6000, the remaining auxiliary materials were passed through 80-mesh sieves for later use. Take by weighing mycophenolate mofetil mofetil fine powder, pregelatinized starch, microcrystalline cellulose, low-...

Embodiment 2

[0037] Main and auxiliary materials

[0038] Mycophenolate Mofetil 250g

[0039] Croscarmellose Sodium 25g

[0040] 5% PVP alcohol / water (30 / 70) solution appropriate amount

[0041] Magnesium Stearate 4.0g

[0042]

[0043] Made into 1000 pieces

[0044] Note: PVP is Povidone K30.

[0045] 5% PVP alcohol / water (30 / 70) solution: 5g PVP is dispersed in 100ml 30% alcohol solution.

[0046] The preparation method is the same as in Example 1.

Embodiment 3

[0048] Main and auxiliary materials

[0049] Mycophenolate Mofetil 250g

[0050] Lactose 375g

[0051] Starch 300g

[0052] Crospovidone 45g

[0053] 10% PVP alcohol / water (50 / 50) solution appropriate amount

[0054] Magnesium Stearate 10.0g

[0055]

[0056] Made into 1000 pieces

[0057] Note: PVP is Povidone K30.

[0058]10% PVP alcohol / water (50 / 50) solution: 10g PVP is dispersed in 100ml 50% alcohol solution. The preparation method is the same as in Example 1.

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Abstract

The invention relates to a medicinal composition containing mycophenolate mofetil, which can be prepared into dispersible tablets, thereby overcoming the shortcomings of difficult swallowing and weak medicine compliance existed in the conventional dose forms, as a result, the patients can administrate the medicament more easily. The invention relates to the process for preparing compositions containing mycophenolate mofetil.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing mycophenolate mofetil which can be made into dispersible tablets and a preparation method thereof. Background technique [0002] Mycophenolate mofetil, also known as mycophenolate mofetil, English name Mycophenolate Mofetil, chemical name: (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7 -Methyl-3-oxo-5-isobenzofuryl)-4-methyl-4-hexene-2-ethylmorpholine ester, which is an antimetabolite mycophenolic acid produced by fungi of the genus Penicillium (also known as mycophenolic acid, mycophenolic acid, MPA) semi-synthetic, is an immunosuppressant with a novel mechanism of action, and is widely used in clinical organ transplantation. [0003] The current preparation of mycophenolate mofetil is ordinary tablets, because the daily dose is high, so each tablet contains 500mg of active ingredients, plus excipients, each tablet is heavier and larg...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/5377A61P37/06
Inventor 范军民
Owner HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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