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Pomalyst gastric-soluble pellet and preparing method thereof

A technology of malidomide pellets and pomalidomide, applied in the field of pharmacy, to achieve the effects of improving drug stability, easy storage, and accurate dosage

Inactive Publication Date: 2018-05-11
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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  • Pomalyst gastric-soluble pellet and preparing method thereof
  • Pomalyst gastric-soluble pellet and preparing method thereof
  • Pomalyst gastric-soluble pellet and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1 preparation of pomalidomide stomach-dissolving type pellets

[0053] 1.1 Prescription

[0054] A. Pomalidomide gastric-soluble pellets

[0055] pomalidomide

2g

Starch core

150g

hypromellose

10g

talcum powder

3g

Gastric-soluble coating powder

10g

purified water

300g

ethanol

100g

[0056] B. Pomalidomide stomach-soluble pellets

[0057]

[0058] 1.2 The method for preparing the above-mentioned prescription pomalidomide gastric-dissolved pellets is carried out according to the following steps:

[0059] 1) adding hypromellose to water, heating to make it completely dissolve, cooling, adding pomalidomide, after it is completely dissolved, dispersing talcum powder evenly in the solution;

[0060] 2) Place the starch pellet core in a fluidized bed, and then evenly spray the solution in "1)" on the surface of the starch pellet core with a fluidized bed device to make pomalidomide pelle...

Embodiment 2

[0067] Embodiment 2 preparation of pomalidomide stomach-dissolving type pellets

[0068] 2.1 Prescription

[0069] A. Pomalidomide gastric-soluble pellets

[0070] pomalidomide

1g

Starch core

100g

hypromellose

8g

talcum powder

3g

Gastric-soluble coating powder

10g

purified water

250g

ethanol

100g

[0071] B. Pomalidomide stomach-soluble pellets

[0072]

[0073] 2.2 The method for preparing the above-mentioned prescription pomalidomide gastric-dissolved pellets is carried out according to the following steps:

[0074] 1) adding hypromellose to water, heating to make it completely dissolve, cooling, adding pomalidomide, after it is completely dissolved, dispersing talcum powder evenly in the solution;

[0075] 2) Place the starch pellet core in a fluidized bed, and then evenly spray the solution in "1)" on the surface of the starch pellet core with a fluidized bed device to make pomalidomide pell...

Embodiment 3

[0082] Embodiment 3 preparation of pomalidomide stomach-dissolving type pellets

[0083] 3.1 Prescription

[0084] A. Pomalidomide gastric-soluble pellets

[0085] pomalidomide

3g

Starch core

100g

hypromellose

6g

talcum powder

3g

Gastric-soluble coating powder

10g

purified water

260g

ethanol

150g

[0086] B. Pomalidomide stomach-soluble pellets

[0087]

[0088] 3.2 The method for preparing the above-mentioned prescription pomalidomide gastric-dissolved pellets is carried out according to the following steps:

[0089] 1) adding hypromellose to water, heating to make it completely dissolve, cooling, adding pomalidomide, after it is completely dissolved, dispersing talcum powder evenly in the solution;

[0090] 2) Place the starch pellet core in a fluidized bed, and then evenly spray the solution in "1)" on the surface of the starch pellet core with a fluidized bed device to make pomalidomide pell...

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Abstract

The invention discloses a pomalyst gastric-soluble pellet and a preparing method thereof. The main medicine (pomalyst) is prepared into a gastric-soluble encapsulated pellet through a fluidized bed encapsulating process, and the encapsulated pellet is mixed with a filling agent, a disintegrating agent, a binding agent, a plasticizing agent, a lubricating agent and the like to prepare the gastric-soluble pellet through a dry method tabletting technology. The tablet can be directly swallowed and can also be rapidly disintegrated into the pellet in water to be conveniently taken by patients especially children having difficulty in swallowing. The pellet can ensure the accurate dosage and safe and convenient to take.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a micropill tablet, in particular to a pomalidomide stomach-soluble micropill tablet and a preparation method thereof. Background technique [0002] On January 8, 2013, the US FDA approved Pomalyst (pomalidomide, pomalidomide) to treat patients with multiple myeloma whose disease has progressed after treatment with other anticancer drugs. [0003] Multiple myeloma is a blood cancer that primarily affects the elderly and originates in the plasma cells of the bone marrow. The National Cancer Institute estimates that about 21,700 Americans are diagnosed with multiple myeloma each year and 10,710 die from the disease. [0004] Pomalyst is a pill that regulates the body's immune system to destroy cancer cells and inhibit their growth. It is indicated for patients who have received at least two prior treatments, including lenalidomide and bortezomib, who have not responded to treatment (failure ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/50A61K31/454A61P35/00
CPCA61K9/2081A61K9/2054A61K9/5078A61K31/454
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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