Controlled release pellet preparation and its preparation method

A technology of sustained-release pellets and sustained-release layers, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. problem, to achieve the effects of good release uniformity, good drug release, and simple preparation process

Inactive Publication Date: 2013-06-12
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Application No. 200910233724.X discloses a kind of tamsulosin hydrochloride containing drug-containing pellet double-coated micropill, which is controlled by double-layer slow-release coating to obtain a preparation whose release degree in acid-base medium meets the quality standard. The disadvantage is that although the drug-containing pills are used to assist in the controlled release, and the double-layer coating is jointly controlled, the requirements for the coating parameters are high, especially for small-scale drugs such as tamsulosin, the release rate is difficult to control

Method used

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  • Controlled release pellet preparation and its preparation method
  • Controlled release pellet preparation and its preparation method
  • Controlled release pellet preparation and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] Tamsulosin Hydrochloride Sustained Release Capsules (5000 capsules)

[0135] 1) Sucrose core 605g

[0136] 2) Drug-loaded slow-release layer

[0137] Tamsulosin Hydrochloride 1g

[0138] Cellulose acetate 33.75g

[0139] Tween 80 7.5g

[0140] 3) Coating layer

[0141] Udrake L100-55 11.25g

[0142] Sodium Lauryl Sulfate 7.5g

[0143] Weigh the prescribed amount of 2) each component in the drug-loaded sustained-release layer, and dissolve it in about 600 g of 95% ethanol solution to prepare the drug solution.

[0144] Weigh 3) each component of the coating layer and about 500 g of purified water, and prepare the coating liquid with the above auxiliary materials.

[0145] Put the blank pellet core in the fluidized bed, control the temperature of the material at 30-35°C, adjust the fluidized state, apply the medicine for about 2 hours, dry for 10 minutes after the medicine is applied, take out the upper pill and sieve, the mesh size of the sieve is 18-30 mesh, tak...

Embodiment 2

[0148] Tamsulosin Hydrochloride Sustained Release Capsules (5000 capsules)

[0149] 1) Sucrose core 505g

[0150] 2) Drug-loaded slow-release layer

[0151]

[0152] 3) Coating layer

[0153]

[0154]

[0155] Preparation

[0156] Step 1: Weigh each component according to the formula, dissolve each component of the drug-loaded sustained-release layer in about 500g of 95% ethanol to prepare a drug solution, apply the drug in a fluidized bed, and control the temperature of the material at 30-55°C to prepare on the pill.

[0157] Step 2: Sieve the upper pills with a mesh number of 15-30 mesh.

[0158] Step 3: Take about 550g of ethanol to dissolve the components of the coating layer; place the sieved upper pills in a fluidized bed, control the temperature of the material at 45-55°C, and continue drying for 15 minutes after the coating is completed.

[0159] Step 4: Add about 1 / 2 the amount of talcum powder to 3 times the amount of water, spray it in after homogenizi...

Embodiment 3

[0162] Tamsulosin Hydrochloride Sustained Release Capsules (5000 capsules)

[0163] 1) Sucrose core 660g

[0164] 2) Drug-loaded slow-release layer

[0165] Tamsulosin Hydrochloride 10g

[0166] Sodium Alginate 300g

[0167] 3) Coating layer

[0168] Udrake L100-55 10g

[0169] TEC 5g

[0170] 4) Micropowder silica gel 4g

[0171] Talc powder 10g

[0172] Preparation

[0173] Step 1: Weigh each component according to the formula, dissolve each component of the drug-loaded slow-release layer in about 300g ethanol to prepare a drug solution, apply the drug in a fluidized bed, and control the temperature of the material at 40-45°C to prepare the drug solution. pill.

[0174] Step 2: Add micropowder silica gel to twice the amount of water, spray it in after homogenizing with a high-speed homogenizer for 5 minutes, dry it for 5 minutes, and take it out.

[0175] Step 3: Sieve the upper pills with a mesh number of 15-30 mesh.

[0176] Step 4: Take about 100g of ethanol to...

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PUM

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Abstract

The invention relates to a novel controlled release pellet preparation and its preparation method, and especially relates to a tamsulosin hydrochloride controlled release pellet preparation and its preparation method. The controlled release pellet adopts a drug-loaded controlled release layer to coat a blank pellet and an enteric coating to coat the drug-loaded controlled release layer in order to control the drug release, the drug release can be realized in an acidic or weakly alkaline environment, and good absorption is realized when the pellet enters a body. The pellet has the advantages of good release degree homogeneity, simple preparation technology and good repeatability. The invention further provides a novel drug controlled release pellet suitable for small-dimension drugs. The novel drug controlled release pellet still well controls the drug release when the drug load amount reduces to 10% or less of a total weight.

Description

technical field [0001] The invention relates to a novel sustained-release pellet preparation and a preparation method thereof, in particular to a tamsulosin hydrochloride sustained-release pellet preparation and a preparation method thereof. Background technique [0002] Tamsulosin hydrochloride is the third-generation super-selective long-acting α-1 inhibitor for prostate smooth muscle. It is a drug that has a therapeutic effect on urinary tract obstructive lesions caused by benign prostatic hyperplasia. Its daily dose is 0.2~ 0.8 mg. Tamsulosin hydrochloride has higher selectivity to the smooth muscle of the prostate, and its dosage is therefore smaller. In order to prevent side effects such as orthostatic hypotension caused by rapid absorption of tamsulosin hydrochloride, it is necessary to prepare it as a sustained-release preparation. better choice. It was successfully developed by Japan's Yamanouchi Pharmaceutical Co., Ltd., and was approved by the FDA in July 1992 u...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K45/00A61K31/18A61K47/38A61K47/36A61K47/34A61K47/32A61P13/08
Inventor 蔡状朱德志
Owner COSCI MED TECH CO LTD
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