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Paliperidone slow release formulation and preparation method thereof

The technology of paliperidone and sustained-release agent is applied in the field of paliperidone sustained-release agent and its preparation, which can solve the problems of high quality of excipients, complicated preparation process, difficult industrialization of laser drilling equipment, etc. Side effects, the process is simple and practical, and the effect of reducing the fluctuation of blood drug concentration

Inactive Publication Date: 2011-05-18
泰州万全医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Due to the current osmotic pump preparations, the preparation process is complicated and high-quality excipients are required. In production, it is difficult to industrialize due to laser drilling equipment and double-layer tablet technology.

Method used

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  • Paliperidone slow release formulation and preparation method thereof
  • Paliperidone slow release formulation and preparation method thereof
  • Paliperidone slow release formulation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] formula:

[0028]

[0029] Coating solution formula and ratio:

[0030]

[0031] Preparation of sustained-release tablet: get the paliperidone, lactose, acrylic resin and microcrystalline cellulose of formula quantity and mix, these ingredients are mixed in mixer for 30 minutes, add magnesium stearate, mix, add binding agent, press piece.

[0032] Coating: use ethanol as a solvent, prepare a coating solution according to the coating solution formula and ratio, and coat the above-mentioned compressed tablets.

Embodiment 2

[0034] formula:

[0035]

[0036] Coating solution formula and ratio:

[0037]

[0038] The preparation of sustained-release tablet: get the paliperidone, ethyl cellulose, mannitol, acrylic resin and povidone K30 of formula quantity to mix, these compositions are mixed in mixer for 30 minutes, add stearic acid, mix, prepare Granules, compressed tablets.

[0039] Coating: use ethanol as a solvent, prepare a coating solution according to the coating solution formula and ratio, and coat the above-mentioned compressed tablets.

Embodiment 3

[0041] formula:

[0042]

[0043] Coating solution formula and ratio:

[0044]

[0045] Preparation of sustained-release tablets: get paliperidone, dextrin, povidone K30 and macrogol 4000, and acrylic resin in the formula and mix them. These ingredients are mixed in a mixer for 30 minutes, add calcium stearate, mix , Granulating, Tabletting.

[0046] Coating: use ethanol as a solvent, prepare a coating solution according to the coating solution formula and ratio, and coat the above-mentioned compressed tablets.

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Abstract

The invention relate to a paliperidone slow release formulation and a preparation method thereof. The slow release formulation comprises a slow release skeleton, a film controlling coating layer, a thinner, a binding agent and a lubricant. Because the slow release formulation can be released at a continuous constant rate within a long period of time, a stable blood medicament level is provided and maintained in a stable and efficient range, the administration frequency is reduced, and the medicament plays the role of long action.

Description

technical field [0001] The invention relates to a sustained-release agent, in particular to a paliperidone sustained-release agent and a preparation method thereof. technical background [0002] Some drugs are inherently long-acting, and only need to be administered once a day to maintain the effective blood concentration and achieve the desired therapeutic effect. Such drugs are usually prepared as traditional immediate-release preparations. However, for those who do not have long-term Drugs with high efficacy require multiple doses to achieve the desired therapeutic effect. Administration of multiple doses often causes significant patient inconvenience, resulting in missed doses, self-regimen changes, and low patient compliance. When the patient cannot take the medicine according to the prescribed time, the blood drug concentration fluctuates with time, and the medicine cannot achieve the best therapeutic effect. If the dosing frequency is too high, it is easy to reach th...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/30A61K9/36A61K9/32A61K31/519A61K47/38A61K47/32A61K47/34A61K47/14A61K47/10
Inventor 马文武陈拥军
Owner 泰州万全医药科技有限公司
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