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A kind of dexketoprofen coated sustained-release microparticle capsule

A technology of dexketoprofen and coating sustained-release, which is applied in the directions of non-active ingredients medical preparations, organic active ingredients, non-central pain relievers, etc., and can solve the problems of poor drug release reproducibility and large individual differences. , to achieve the effect of improving bioavailability, eliminating irritation and improving therapeutic effect

Active Publication Date: 2011-11-30
NEW FOUNDER HLDG DEV LLC +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] There are few studies on dexketoprofen sustained-release preparations in the literature at present. Chinese patent 98122858.5 discloses the prescription of dexketoprofen sustained-release preparations. The sustained-release technology used in the sustained-release preparations involved in this patent is traditional pro- Hydrogel matrix sustained release or large particle coating sustained release, this technology has the disadvantages of poor drug release reproducibility and large individual differences

Method used

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  • A kind of dexketoprofen coated sustained-release microparticle capsule
  • A kind of dexketoprofen coated sustained-release microparticle capsule
  • A kind of dexketoprofen coated sustained-release microparticle capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] Core Particle Formula:

[0118] weight

weight percentage

Dexketoprofen

682g

68.2％

MCC

91g

9.1％

lactose

136g

13.6％

6% HPMC solution (6cps)

91g

9.1％

common

1000g

100％

[0119] Core particle preparation process:

[0120] 1. Weigh HPMC (6cps), add it to an appropriate amount of water under stirring, and stir until clarified to make a 6% aqueous solution for later use;

[0121] 2. Weigh the dexketoprofen, lactose, and MCC of the formula, pass through an 80-mesh sieve respectively, and mix thoroughly;

[0122]3. Put the uniformly mixed auxiliary materials into the fluidized bed of the multifunctional granulation coating machine (powder coating machine), and check the tightness of the fluidized bed;

[0123] 4. Adjust the air volume to keep the material in a fluidized state. The air volume (0-15min) at the initial stage of granulation is 20-25m 3 / h, continuous ...

Embodiment 2

[0140] Core Particle Formula:

[0141] weight

weight percentage

Dexketoprofen

730g

73％

MCC

60g

6％

lactose

100g

10％

6% HPMC solution (6cps)

110g

11％

common

1000g

100％

[0142] Core particle preparation process:

[0143] 1. Weigh HPMC (6cps), add it to an appropriate amount of water under stirring, and stir until clarified to make a 6% aqueous solution for later use;

[0144] 2. Weigh the dexketoprofen, lactose, and MCC of the formula, pass through an 80-mesh sieve respectively, and mix thoroughly;

[0145] 3. Put the uniformly mixed auxiliary materials into the fluidized bed of the multifunctional granulation coating machine (powder coating machine), and check the tightness of the fluidized bed;

[0146] 4. Adjust the air volume to keep the material in a fluidized state. The air volume (0-15min) at the initial stage of granulation is 20-25m 3 / h, continuous air v...

Embodiment 3

[0163] Core Particle Formula:

[0164] weight

weight percentage

Dexketoprofen

630g

63％

MCC

120g

12％

lactose

160g

16％

6% HPMC solution (6cps)

90g

9％

common

1000g

100％

[0165] Core particle preparation process:

[0166] 1. Weigh HPMC (6cps), add it to an appropriate amount of water under stirring, and stir until clarified to make a 6% aqueous solution for later use;

[0167] 2. Weigh the dexketoprofen, lactose, and MCC of the formula, pass through an 80-mesh sieve respectively, and mix thoroughly;

[0168] 3. Put the uniformly mixed auxiliary materials into the fluidized bed of the multifunctional granulation coating machine (powder coating machine), and check the tightness of the fluidized bed;

[0169] 4. Adjust the air volume to keep the material in a fluidized state. The air volume (0-15min) at the initial stage of granulation is 20-25m 3 / h, continuou...

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Abstract

The invention provides a dexketoprofen coated sustained-release microparticle capsule and a preparation method thereof. It belongs to the technical field of chemical pharmaceutical preparations. The coated sustained-release microparticle capsule of the present invention is composed of coated sustained-release microparticles and a capsule shell, and the coated sustained-release microparticles are made of core particles containing dexketoprofen main drug through a coating process. The coated sustained-release microparticle capsule of the present invention can reduce the stimulating effect of dexketoprofen on the gastrointestinal tract, reduce the number of times of taking, thereby improving the patient's medication compliance, and can also reduce the fluctuation of dexketoprofen blood drug concentration and improve Bioavailability, thereby improving the therapeutic effect and reducing adverse reactions.

Description

technical field [0001] The invention relates to a dexketoprofen coated sustained-release microparticle capsule and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] The chemical name of ketoprofen is α-methyl-3-benzophthalene phenylacetic acid, which belongs to the 2-aryl propionic acid class of non-steroidal anti-inflammatory analgesics. Dexketoprofen (dexketoprofen, also known as dexketoprofen) is the optical isomer of ketoprofen obtained by the resolution method, its effect is almost twice that of the same dose of ketoprofen, strong analgesic effect, Rapid effect, less adverse reactions. [0003] Dexketoprofen was developed by Italian company Menarini and first launched in Spain in 1996. Dexketoprofen is suitable for the treatment of mild to moderate pain of different causes such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, joint pain of gouty arthritis, as well as dysmenorrhe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/56A61K31/192A61K47/38A61P29/00
Inventor 李泳陈维秋易崇勤罗雪磊
Owner NEW FOUNDER HLDG DEV LLC
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