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Tandospirone Microporous Osmotic Pump Preparation

The technology of tandospirone citrate and osmotic pump is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulas, nervous system diseases, etc., and can solve the problem of increased preparation cost, high performance requirements of production equipment and cumbersome preparation process And other issues

Active Publication Date: 2018-10-02
SICHUAN CREDIT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patent CN1899287B discloses a tandospirone citrate skeleton-type sustained-release preparation, although it can solve the trouble of frequent administration of common preparations, but because it is a first-order release rather than a constant-speed release, the release rate of the drug is limited. The influence of factors such as gastrointestinal fluid in the patient's body is uncontrollable to a certain extent
U.S. Patent Nos. 5,185,158, 5,246,711, 5,246,710, 5,330,762, 5,858,407, and 5,688,518 disclose a porous tandospirone citrate osmotic pump-type controlled release preparation, which includes a double-layer tablet core, a coating film, and a drug release hole. The tablet core is composed of a drug-containing layer and a booster layer. Although the drug release of this preparation is relatively stable, there are many factors affecting its drug release behavior, and the preparation process is cumbersome, and the technical level of the process is high. Recognition of the upper and lower layers during pressing and punching, etc., have higher performance requirements for production equipment, and the cost of preparations has also increased accordingly

Method used

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  • Tandospirone Microporous Osmotic Pump Preparation
  • Tandospirone Microporous Osmotic Pump Preparation
  • Tandospirone Microporous Osmotic Pump Preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0098] Tablet prescription:

[0099]

[0100]

[0101] Coating Solution Prescription:

[0102]

[0103] Preparation Process:

[0104] Pass the tandospirone citrate, sodium chloride, sucrose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, lactose and microcrystalline cellulose of the amount to be prepared through an 80 mesh sieve and mix thoroughly, and add an appropriate amount of 5 The ethanol solution of % povidone k15 is used to make soft materials; the soft materials are granulated with a 30-mesh sieve; after drying, 20-mesh granules are granulated, and then magnesium stearate is added and mixed; the prepared granules are compressed with a tablet machine.

[0105] Dissolve the raw materials of cellulose acetate, polyethylene glycol-400, diethyl phthalate and dibutyl sebacate, which make up the controlled-release film coat, in a mixed solvent composed of acetone and isopropanol. The core was coated with a controlled-release film, and the weight of the c...

Embodiment 2

[0110] Tablet prescription:

[0111]

[0112]

[0113] Coating Solution Prescription:

[0114]

[0115] Preparation Process:

[0116] Pass the tandospirone citrate, sucrose, malic acid, hydroxypropyl cellulose, sodium carboxymethyl cellulose, lactose and microcrystalline cellulose in the amount to be prepared through a 80-mesh sieve and mix thoroughly, adding an appropriate amount of 5% The ethanol solution of povidone k15 is used to prepare soft material; the soft material is granulated with a 30-mesh sieve; after drying, it is granulated with a 20-mesh sieve, and then magnesium stearate is added and mixed evenly; the prepared granules are compressed with a tablet machine.

[0117] Dissolve the raw materials of cellulose acetate, polyethylene glycol-400, diethyl phthalate and dibutyl sebacate, which make up the controlled-release film coat, in a mixed solvent composed of acetone and isopropanol. The core was coated with a controlled-release film, and the weight of ...

Embodiment 3

[0122] Tablet prescription:

[0123]

[0124]

[0125] Coating Solution Prescription:

[0126]

[0127] Preparation Process:

[0128] Pass the tandospirone citrate, sucrose, malic acid, povidone k30, sodium carboxymethylcellulose, lactose and dextrin in the amount to be prepared through a 80-mesh sieve and mix thoroughly, and add an appropriate amount of 5% povidone K15 ethanol solution to make soft material; soft material is granulated with 30 mesh sieve; after drying, granulate with 20 mesh, then add magnesium stearate and mix well; compress the prepared granule with tablet machine.

[0129] The raw materials of cellulose acetate, polyethylene glycol-400, diethyl phthalate and tributyl citrate, which make up the controlled-release film coat, are dissolved in a mixed solvent composed of acetone and isopropanol. Perform controlled-release film coating, increase the weight of the coating to 12% of the tablet core mass, and cure at 45°C for 12 hours.

[0130] Accordi...

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Abstract

The invention provides a tandospirone micropore osmotic pump preparation. The osmotic pump preparation can reach zero-level release, reaches 24-hour drug release, can effectively prolong the time of drug action, makes patients reduce the number of times of taking medicine daily, and improves compliance.

Description

technical field [0001] The invention relates to a tandospirone microporous osmotic pump preparation and a preparation method and use thereof. Background technique [0002] Tandospirone was developed by Sumitomo Pharmaceutical Co., Ltd., and was approved for marketing in Japan in 1996. It is a 5-HT 1A Receptor agonists belong to the third generation of anti-anxiety drugs, mainly used for the treatment of generalized anxiety disorder and mixed anxiety and depression, with relatively good safety, low incidence of adverse reactions, and mild severity. Its mechanism of action is to interact with 5-HT in the brain 1A Selective binding of receptors, the main action sites are concentrated in the hippocampus, amygdala and other brain limbic systems in the emotional center, and the raphe nucleus projecting 5-HT energy nerves, through stimulating 5-HT 1A Autoreceptors, regulate the 5-HT projected from the raphe nucleus to the hippocampus, inhibit the 5-HT effect of the action inhibi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K31/506A61P25/22A61P25/24
Inventor 傅霖邓丽敏林科名陈刚
Owner SICHUAN CREDIT PHARMA
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