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Slow-release capsule with pomalidomide and preparation method of slow-release capsule

A technology for pomalidomide and sustained-release capsules, applied in the field of pomalidomide sustained-release capsules and its preparation

Inactive Publication Date: 2018-05-08
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

[0022] Preparation of pill cores

[0023] 1. The preparation of the coating solution of the main drug: add 15 g of ethyl cellulose and 0.1 g of pomalidomide accurately weighed into the 60% ethanol solution, stir evenly, and filter the resulting suspension with an 80-mesh sieve to form a solid For the coating solution with a content of 55%, keep stirring when spraying the solution.

[0024] 2. Pour 20g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating. The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0025] Preparation of i...

Embodiment 2

[0036] Preparation of pill cores

[0037] 1. Preparation of the main drug coating solution: Add 20 g of hypromellose and 0.2 g of pomalidomide accurately weighed in purified water, stir evenly, and filter the resulting suspension with a 80-mesh sieve to form a solid content of 50 % coating solution, keep stirring when spraying.

[0038] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0039] Preparation of isolation coating layer

[0040] 1. Add 3g of polyethy...

Embodiment 3

[0050] Preparation of pill cores

[0051] 1. Preparation of the main drug coating solution: Add 10 g of polyethylene glycol 4000 and 0.5 g of pomalidomide accurately weighed in purified water, stir evenly, and filter the resulting suspension with an 80-mesh sieve to form a solid content of 45 % coating solution, keep stirring when spraying.

[0052] 2. Pour 23g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0053] Preparation of isolation coating layer

[0054] 1. Add 2...

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PUM

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Abstract

The invention discloses a slow-release capsule with pomalidomide, and a preparation method and application thereof. The slow-release capsule is prepared by filling an empty capsule with slow-release pellets with the pomalidomide. The slow-release pellet with the pomalidomide is prepared from a pellet core with medicines, an isolated coating layer, a slow-release coating layer and a protective coating layer from inside to outside; the pellet core with the medicines is prepared from the specific components in percent by weight: 0.1%-5% of the pomalidomide, 10%-30% of adhesive and 10%-80% of sucrose empty pellet core. The slow-release preparation with the pomalidomide has the beneficial effects that the maintenance time of the treatment concentration of the pomalidomide in a body can be prolonged to 12 hours, the side effect caused by overlarge fluctuation of the blood concentration is reduced, the medicine-taking times are reduced, and for a patient, the effect is obvious for a patient,and the use is convenient.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pomalidomide sustained-release capsule 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 to respond) ...

Claims

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Application Information

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IPC IPC(8): A61K9/62A61K9/50A61K47/32A61K47/38A61K31/454A61P35/00
CPCA61K9/5026A61K9/5047A61K31/454
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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