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Buspirone hydrochloride slow/controlled release micro pill

A technology of buspirone hydrochloride and pellets, which is applied in the direction of block delivery, organic active ingredients, nervous system diseases, etc., can solve the problems of difficulty in the development of slow/controlled release preparations, and achieve the effect of good slow release effect

Active Publication Date: 2007-06-13
北京华素制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] There is an obvious first-pass effect of buspirone, and there are significant differences in pharmacokinetics among individuals, which makes the development of slow / controlled release formulations of buspirone quite difficult. This may be because there are few slow / controlled release formulations of buspirone Due to research reports, there is currently no sustained / controlled release formulation of buspirone used in clinical treatment

Method used

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  • Buspirone hydrochloride slow/controlled release micro pill
  • Buspirone hydrochloride slow/controlled release micro pill
  • Buspirone hydrochloride slow/controlled release micro pill

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Buspirone Hydrochloride 60g

[0037] Blank ball core 500g

[0038] Hypromellose (6mPa.s) 20g

[0039] Polyethylene glycol 4000 (PEG4000) 4g

[0040] Talc powder 3g

[0041] Ethyl cellulose aqueous dispersion 200g

[0042] Appropriate amount of water

[0043] The specific coating process is as follows:

[0044] 1) Weigh 700 / 900 500g of blank pellet core, put it in the fluidized bed, set the equipment parameters, control the inlet air temperature at 61°C, the material temperature at 50°C, and the air volume at 120m 3 / h, the spray pressure is 2×10 5 Pa, using coating solution 1 * Coat the blank core.

[0045] 2) After coating the upper drug layer, take 10% HPMC+0.5% PEG4000 100ml to coat the isolation layer.

[0046] 3) After coating, take the coating solution 2 * Coating of sustained-release coating is carried out.

[0047] 4) Fill the empty capsules according to the specifications (eg, 15 mg or 30 mg per capsule).

[0048] * Coating Solution 1: Weigh 10g of...

Embodiment 2

[0051] Buspirone Hydrochloride 60g

[0052] Blank ball core 500g

[0053] Hypromellose (6mPa.s) 20g

[0054] Polyethylene glycol 4000 (PEG4000) 4g

[0055] Talc powder 3g

[0056] Ethyl cellulose aqueous dispersion 200g

[0057] Appropriate amount of water

[0058] 1) Weigh 700 / 900 500g of blank pellet core, put it in the fluidized bed, set the equipment parameters, control the inlet air temperature at 61°C, the material temperature at 50°C, and the air volume at 120m 3 / h, the spray pressure is 2×10 5 Pa, using coating solution 1 * Coat the blank core.

[0059] 2) After coating the upper drug layer, take 10% HPMC+0.5% PEG4000 100ml to coat the isolation layer.

[0060] 3) After coating, take the coating solution 2 * Coating of sustained-release coating is carried out.

[0061] 4) After wrapping the slow-release coat, cure at a suitable temperature for 24 hours.

[0062] 5) Fill the empty capsules according to the specifications (eg, 15 mg or 30 mg per capsule).

...

Embodiment 3

[0066] Buspirone Hydrochloride 60g

[0067] Blank ball core 500g

[0068] Hypromellose (6mPa.s) 20g

[0069] Polyethylene glycol 4000 (PEG4000) 4g

[0070] Talc powder 3g

[0071] Ethylcellulose aqueous dispersion 374g

[0072] Appropriate amount of water

[0073] The specific coating process is as follows:

[0074] 1) Weigh 700 / 900 500g of blank pellet core, put it in the fluidized bed, set the equipment parameters, control the inlet air temperature at 61°C, the material temperature at 50°C, and the air volume at 120m 3 / h, the spray pressure is 2×10 5 Pa, using coating solution 1 * Coat the blank core.

[0075] 2) After coating the upper drug layer, take 10% HPMC+0.5% PEG4000 100ml to coat the isolation layer.

[0076] 3) After coating, use coating solution 2 * Surelease is used for the coating of sustained release coating.

[0077] 4) Fill the prepared sustained-release pellets into capsules containing 15 mg of buspirone hydrochloride, and measure the release cur...

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Abstract

The present invention discloses a kind of buspirone hydrochloride slow / control released micropills and capsule and their preparation method. The invented buspirone hydrochloride slow / control released micropill includes buspirone hydrochloride medicine pill core and isolating layer (slow-released coating layer) which can be used for covering exterior of said medicine pill core. Said buspirone hydrochloride slow / control released micropills and capsule can be used for curing anxiety neurosis.

Description

technical field [0001] The invention relates to the field of drug slow / controlled release preparations, in particular to buspirone hydrochloride slow / controlled release pellets and capsules that can treat anxiety. Background technique [0002] At present, anti-anxiety and antidepressant drugs are rising rapidly. In 2000, the global sales of antidepressant drugs were about 11 billion US dollars. In China, selective serotonin reuptake inhibitors have gradually occupied an absolute share of the anxiolytic and antidepressant drug market. In 2000, the market share of selective serotonin reuptake inhibitors reached 85%. [0003] According to the analysis of Dongyi Xinda Pharmaceutical Market Research Center, the overall scale of China's antidepressant drug market is still quite small, with sales of about 1.5 billion yuan in 2000, accounting for a very low proportion of the total pharmaceutical market. Considering that mental illnesses are on the rise and China is about to enter ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/506A61K9/16A61P25/24
Inventor 龙永鹏陈燕王晋
Owner 北京华素制药股份有限公司
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