Pomalyst orally disintegrating tablets and preparation method thereof

A technology for pomalidomide and orally disintegrating tablets, applied in the field of orally disintegrating tablets containing pomalidomide and its preparation, to achieve the effects of short disintegration time, easy dissolution, and refreshing taste

Inactive Publication Date: 2018-04-06
佛山市弘泰药物研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

2. Phase III clinical trials have proved that the POM+LoDEX regimen in the treatment of RRMM, especially RRMM resistant to lenalidomide and / or bortezomib, has encouraging curative effect and controllable side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Ingredient name weight ratio (%) pomalidomide 0.1% mannitol 60% lactose 30% sodium carboxymethyl starch 10% povidone 3% aspartame 1% micronized silica gel 1% magnesium stearate 1%

[0031] Preparation:

[0032] (1) Pomalidomide is micronized, and the rest of the auxiliary materials are separately ground through a 100-mesh sieve;

[0033] (2) After sieving pomalidomide, mannitol, lactose, 5% sodium carboxymethyl starch, aspartame, and mixing uniformly, add a 20% aqueous solution of povidone ethanol to prepare Soft material

[0034] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture of the granules is between 1.5~3.5%, and then pass through a 24-mesh sieve for granulation;

[0035] (4) Add micronized silica gel, magnesium stearate, and the remaining amount of sodium carboxymethyl starch to the dry granules obtained in (3), and mix them evenly;

[0036] (5) Determine the content of the intermediates, determine the weight of the tablet, and then press th...

Embodiment 2

[0038] Ingredient name weight ratio (%) pomalidomide 0.2% mannitol 55% lactose 25% croscarmellose sodium 10% hydroxypropyl cellulose 2% aspartame 2% magnesium stearate 1%

[0039] Preparation:

[0040] (1) Pomalidomide is micronized, and the rest of the auxiliary materials are separately ground through a 100-mesh sieve;

[0041] (2) After sieving pomalidomide, mannitol, lactose, croscarmellose sodium and aspartame with a prescription amount of 5%, add hydroxypropyl fiber with a prescription amount of 25%. Alcohol aqueous solution to prepare soft materials;

[0042] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture of the granules is between 1.5~3.5%, and then pass through a 24-mesh sieve for granulation;

[0043] (4) Add magnesium stearate and the remaining amount of croscarmellose sodium to the dry granules obtained in (3), and mix them evenly;

[0044] (5) Determine the content of the intermediates, determine the weight of the tablet, and then press the ...

Embodiment 3

[0046] Ingredient name Weight ratio (%) pomalidomide 0.6% mannitol 50% xylitol 31% crospovidone 6% hydroxypropyl cellulose 4% aspartame 2% lemon flavor 1% micronized silica gel 1% Magnesium stearate 1%

[0047] Preparation:

[0048] (1) Pomalidomide is micronized, and the rest of the auxiliary materials are separately ground through a 100-mesh sieve;

[0049] (2) After sieving pomalidomide, mannitol, xylitol, crospovidone, aspartame, and lemon flavor with a prescription amount of 3%, add hydroxypropyl with a prescription amount of 20%. Base cellulose ethanol aqueous solution to prepare soft materials;

[0050] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture of the granules is between 1.5~3.5%, and then pass through a 24-mesh sieve for granulation;

[0051] (4) Add micro-powdered silica gel, magnesium stearate, and the remaining amount of crospovidone to the dry particles obtained in (3), and mix well;

[0052] (5) Determine the content of the intermedia...

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PUM

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Abstract

The invention discloses Pomalyst orally disintegrating tablets and a preparation method thereof. The orally disintegrating tablets are pharmaceutical composition containing Pomalyst, filler, a disintegrant, a wetting agent, a binder, a flavoring agent and a lubricant, and the preparation method adopts a wet granulation tabletting process. The Pomalyst orally disintegrating tablets adopt a simple preparation process, are low in cost, convenient to take and high in bioavailability and take effect quickly. The dosage form can improve medication compliance of a patient.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an orally disintegrating tablet containing pomalidomide and a preparation method thereof. Background technique [0002] On January 8, 2013, the US FDA approved Pomalyst (pomalidomide) for the treatment of multiple myeloma patients whose condition is still progressing after treatment with other anticancer drugs. [0003] Multiple myeloma is a blood cancer that mainly affects the elderly and is induced by plasma cells in the bone marrow. According to estimates by the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma each year, and 10,700 die from the disease. [0004] Pomalyst is a pill that regulates the body's immune system, destroys cancer cells and inhibits their growth. It is suitable for patients who have previously received at least two treatments, including lenalidomide and bortezomib, which did not respond to treatment (failed t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/26A61K31/454A61P35/00
CPCA61K9/2054A61K9/0056A61K9/2018A61K31/454
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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