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Quetiapine fumarate slow release pharmaceutical composition and preparation method thereof

A technology of quetiapine fumarate and sustained-release drugs, which is applied in the directions of drug combination, pharmaceutical formulation, drug delivery, etc., to achieve the effects of enhancing patient compliance, rapid onset of action, and simple preparation process

Inactive Publication Date: 2017-06-13
SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the prior art, there are many studies on the sustained and controlled release preparations of quetiapine, but most of them belong to the replacement of raw materials and the limitation of particle size.

Method used

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  • Quetiapine fumarate slow release pharmaceutical composition and preparation method thereof
  • Quetiapine fumarate slow release pharmaceutical composition and preparation method thereof
  • Quetiapine fumarate slow release pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] follow the prescription

[0039] Table 1 Specifications: 200mg

[0040]

[0041] The preparation method comprises: making drug delivery systems I and II into dry granules with an appropriate amount of ethanol-water solvent with a volume ratio of 30 / 70, adding an acrylic resin copolymer with 10% by mass of drug delivery system I as an isolation layer, and then using A multi-layer tablet press is pressed into a multi-layer tablet. The tablet is coated with Opadry, and the weight gain is 3% after coating. The tablet structure refers to figure 1 . The dissolution refers to the first method for the determination of the release rate in Appendix XD of the second part of the Chinese Pharmacopoeia in 2015, and the device for the second method of the 0931 dissolution and release test method under the item of the fourth part of the Chinese Pharmacopoeia in 2015 is used. 900mL of water is the release medium, and the rotation speed is 50r / min, the temperature is 37°C, operate ...

Embodiment 2

[0044] follow the prescription

[0045] Table 2 Specifications: 200mg

[0046]

[0047]

[0048] The preparation method comprises: making drug delivery systems I and II into dry granules with an appropriate amount of ethanol-water solvent with a volume ratio of 30 / 70, adding cellulose acetate with 12% by mass of drug delivery system I as an isolation layer, and then using multiple The laminated tablet machine is pressed into a multi-layer tablet, which is coated with Opadry, and the weight gain is 3% after coating. The tablet structure refers to figure 1 shown. The release curve is basically consistent with Example 1.

Embodiment 3

[0050] follow the prescription

[0051] Table 3 Specifications: 200mg

[0052]

[0053] The preparation method comprises: making drug delivery systems I and II into dry granules with an appropriate amount of ethanol-water solvent with a volume ratio of 30 / 70, adding cellulose acetate with 10% by mass of drug delivery system I as an isolation layer, and then using multiple The laminated tablet machine is pressed into a multi-layer tablet, which is coated with Opadry, and the weight gain is 3% after coating. The tablet structure refers to figure 1 shown. The release curve is basically consistent with Example 1.

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Abstract

The invention discloses a quetiapine fumarate slow release pharmaceutical composition and a preparation method thereof. The slow release pharmaceutical composition comprises a drug release system I and a drug release system II, wherein the drug release system I comprises quetiapine fumarate, a filling agent, a disintegrant, a binder, a lubricant and an antisticking agent; the drug release system II comprises quetiapine fumarate, a slow release material, a pore-foaming agent, a binder, a lubricant and an antisticking agent; the pharmaceutical composition also comprises an isolating layer which is formed primarily by an isolating material, and the isolating material is selected from one of an acrylic resin copolymer and cellulose acetate. The pharmaceutical composition not only can quickly take effect, but also can ensure effectiveness within 24 hours continuously, and meanwhile, can reduce the maximum blood concentration on a basis of ensuring the blood concentration, so that the patient blood concentration is improved on the premise of lowering the curative effect and the medicinal safety is improved.

Description

technical field [0001] The invention belongs to the field of quetiapine fumarate pharmaceutical preparations, in particular to a sustained-release quetiapine fumarate pharmaceutical composition and a preparation method thereof. Background technique [0002] Sustained-release preparations refer to a new class of preparations that purposely control the release of drugs to achieve a reasonable therapeutic effect. It enables the human body to obtain a stable therapeutic blood drug concentration and optimizes the therapeutic dose. Compared with ordinary oral preparations, it reduces the number of times of taking medicine, can achieve the curative effect of conventional dosage with a smaller dosage than conventional dosage, reduces the total dosage of medication, and improves the compliance of patients; it also has the ability to stabilize blood concentration, avoid peaks and valleys, and is effective. It is beneficial to reduce the adverse reactions of drugs and other characteris...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/28A61K47/38A61K47/34A61K31/554A61P25/18
CPCA61K9/0002A61K9/2846A61K9/2866A61K31/554
Inventor 贾文强黄伟堂王秋成
Owner SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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