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Sustained-release pharmaceutical composition and preparation method thereof

A technology for sustained-release medicines and compositions, applied in the field of sustained-release pharmaceutical compositions and their preparation, can solve the problems of loss of gastric floating effect and immediate floating of tablets, and achieve easy industrial scale-up production, good therapeutic effect and stable quality Effect

Pending Publication Date: 2022-02-18
CHANGZHOU HANSOH PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Most of the gastric floating tablets reported in the existing literature need a floating time, that is, the tablet itself cannot float immediately when it first contacts water (or gastric juice). Usually, the floating time is more than ten minutes, which causes potential risks. , that is, before the tablet floats, it is excluded from the pylorus and enters the intestinal tract, thus losing the gastric floating effect

Method used

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  • Sustained-release pharmaceutical composition and preparation method thereof
  • Sustained-release pharmaceutical composition and preparation method thereof
  • Sustained-release pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0141] prescription

[0142]

[0143] The preparation steps are:

[0144] Floating layer: fully mix polyvinyl acetate povidone mixture and polycarbomer;

[0145] Drug-containing layer: Lurasidone hydrochloride and hypromellose are granulated in a fluidized bed, and purified water is used as a wetting agent to prepare drug-containing layer granules;

[0146] The two-part material is compressed into a bilayer tablet.

Embodiment 2

[0148] prescription

[0149]

[0150] The preparation steps are:

[0151] floating layer:

[0152] 1) Fully mix polyvinyl acetate povidone mixture and polycarbomer;

[0153] 2) Add magnesium stearate to the above materials and mix evenly as a floating layer.

[0154] Drug-containing layer:

[0155] 1) Lurasidone hydrochloride and hypromellose are granulated in a fluidized bed, and purified water is used as a wetting agent to prepare drug-containing layer granules;

[0156] 2) Add magnesium stearate to the above granules and mix evenly to form a drug-containing layer.

[0157] The two-part material is compressed into a bilayer tablet.

Embodiment 3

[0159] prescription:

[0160]

[0161]

[0162] The preparation steps are:

[0163] floating layer:

[0164] 1) Fully mix polyvinyl acetate povidone mixture, carbomer, and cross-linked povidone;

[0165] 2) Add magnesium stearate to the above materials and mix evenly as a floating layer.

[0166] Drug-containing layer:

[0167] 3) Lurasidone hydrochloride and lactose hypromellose are granulated in a fluidized bed, and purified water is used as a wetting agent to prepare drug-containing layer granules;

[0168] 4) Add magnesium stearate to the above granules and mix evenly to form a drug-containing layer.

[0169] The two-part material is compressed into a bilayer tablet.

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Abstract

The invention relates to a sustained-release pharmaceutical composition and a preparation method thereof, the sustained-release pharmaceutical composition is a double-layer tablet and comprises a floating layer and a drug-containing layer, and the floating layer comprises a floating material and continuously floats and releases drugs in the stomach. The preparation method of the sustained-release pharmaceutical composition is simple and suitable for industrial large-scale production, and the sustained-release pharmaceutical composition can prolong the retention time of the drug in the stomach so as to prolong the action time of the drug and improve the medication safety and patient compliance.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and relates to a slow-release pharmaceutical composition and a preparation method thereof. Background technique [0002] With the rapid development of the pharmaceutical industry in recent years, new drug delivery systems have always been one of the main directions for the development of pharmaceuticals, and sustained and controlled release formulations have been extensively studied. Sustained and controlled release preparations can maintain the drug concentration within the effective concentration range for a long time. Ideal for drugs that require frequent dosing or have a narrow therapeutic window. Compared with common preparations, sustained-release preparations reduce the frequency of administration, and can significantly increase patient compliance or reduce drug side effects. [0003] Despite such advances in sustained-release formulation technology, sustained-release formulati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/24A61K47/32A61K47/38A61K47/26A61K47/10A61K47/12A61K47/02A61K9/28A61K45/00A61K31/496A61P25/18
CPCA61K9/0065A61K9/2027A61K9/2054A61K9/2018A61K9/2031A61K9/2013A61K9/2009A61K9/2095A61K9/209A61K9/28A61K45/00A61K31/496A61P25/18
Inventor 赵娜刘慧黄健张震
Owner CHANGZHOU HANSOH PHARM CO LTD
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