Tamsulosin sustained release pellet and preparation method thereof

A technology of sustained-release pellets and tamsulosin, which is applied in the field of sustained-release pellets that change the release behavior of tamsulosin and the field of preparation thereof

Active Publication Date: 2012-07-18
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Although the sustained-release pellets have the above advantages, in the actual preparation process, the preparation of different tamsulosin into sustained-release pellets will face different technical difficulties

Method used

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  • Tamsulosin sustained release pellet and preparation method thereof
  • Tamsulosin sustained release pellet and preparation method thereof
  • Tamsulosin sustained release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Example 1 Tamsulosin sustained-release pellets and tablets (1000 preparation units)

[0016] The prescription of preparation and preparation method thereof are:

[0017] prescription

[0018] Pill heart:

[0019]

[0020] Coating:

[0021] Carbomer 8g

[0022] Ethylcellulose 9g

[0023] Triethyl citrate 3g

[0024] Preparation:

[0025] Take povidone and add 80% ethanol to dissolve, and use it as a binder for later use; put the components in other pellet formulations in an extrusion spheronizer, add a binder to prepare a pellet core, and dry it in a fluidized bed at 60°C;

[0026] Take the core of the ball, put it in the coating pan, spray the coating ingredients dissolved in acetone for coating, and dry for 1 hour after coating. Then dry at 40° C. for 12 hours to obtain sustained-release pellets.

[0027] Put the desustained-release pellets into capsules.

[0028] Or add microcrystalline cellulose and magnesium stearate to the above-mentioned pellets, mix, ...

Embodiment 2

[0030] Example 2 Tamsulosin sustained-release pellets and tablets (1000 preparation units)

[0031] The prescription of preparation and preparation method thereof are:

[0032] prescription

[0033] Pill heart:

[0034]

[0035] Coating:

[0036] Sodium Alginate 15g

[0037] Ethylcellulose 29g

[0038] Magnesium Stearate 6g

[0039] Preparation:

[0040] Take povidone and add 80% ethanol to dissolve, and use it as a binder for later use; put the components in the other pellet formulations in an extrusion spheronizer, add binders to prepare pellet cores, and dry them in a fluidized bed at 60°C;

[0041] Take the core of the ball, put it in the coating pan, spray the coating ingredients dissolved in acetone for coating, and dry for 1 hour after coating. Then dry at 40° C. for 12 hours to obtain sustained-release pellets.

[0042] Put the desustained-release pellets into capsules.

[0043] Or add microcrystalline cellulose and magnesium stearate to the above-mentioned...

Embodiment 3

[0045] Example 3 Tamsulosin sustained-release pellets and tablets (1000 preparation units)

[0046] The prescription of preparation and preparation method thereof are:

[0047] prescription

[0048] Pill heart:

[0049]

[0050] Coating:

[0051]

[0052] Preparation:

[0053] Take povidone and add 80% ethanol to dissolve, and use it as a binder for later use; put the components in the other pellet formulations in an extrusion spheronizer, add binders to prepare pellet cores, and dry them in a fluidized bed at 60°C;

[0054] Take the core of the ball, put it in the coating pan, spray the coating ingredients dissolved in acetone for coating, and dry for 1 hour after coating. Then dry at 40° C. for 12 hours to obtain sustained-release pellets.

[0055] Put the desustained-release pellets into capsules.

[0056] Or add microcrystalline cellulose and magnesium stearate to the above-mentioned pellets, mix, and press into tablets of suitable size.

[0057] The release r...

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PUM

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Abstract

The invention provides a tamsulosin sustained release pellet. The tamsulosin sustained release pellet comprises a medicine-containing pellet core and a sustained release coating layer, wherein the sustained release coating layer comprises a hydrophobic matrix and a hydrophilic polymer which is sensitive to pH values. The pH values of a high molecular polymer in the dissolving process are 1 to 14, so that medicines are released at different pH values; and simultaneously, the high molecular polymer can be used as a carrier for controlling tamsulosin to be released, so that a prescription is simplified, preparation difficulties are reduced, and the tamsulosin sustained release pellet is easy to industrially produce in batches. Surprisingly, the preparation can be used for preparing various tamsulosin sustained release formulations without dependence on the physicochemical property of the tamsulosin.

Description

technical field [0001] The invention relates to the field of tamsulosin preparations, in particular to slow-release pellets for changing the release behavior of tamsulosin and a preparation method thereof. Background technique [0002] Pellets (small pills, Pellets is the English name) refer to small spherical oral dosage forms with a diameter of about 1 mm, generally not more than 2.5 mm. According to the release speed, the pellets mainly include immediate-release pellets and sustained-release or controlled-release pellets. Immediate-release pellets are pellets made of drugs and general excipients with a relatively fast release rate. Generally, the dissolution rate in 30 minutes should not be less than 70%. A certain amount of disintegrant or surfactant is often added to the pellet prescription , to ensure rapid disintegration and drug dissolution of the pellets. Sustained-release or controlled-release pellets can be divided into (1) skeleton sustained-release pellets: dr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/22A61K31/18A61K47/32A61K47/34A61K47/36A61P13/08
Inventor 蒋海松王锦刚
Owner COSCI MED TECH CO LTD
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