Preparation process of quetiapine fumarate slow release tablet

A technology of quetiapine fumarate and quinoline fumarate, which can be used in drug delivery, oil/fat/wax inactive ingredients, nervous system diseases, etc., and can solve the problems that the sustained-release tablet technology has not been reported in the literature.

Inactive Publication Date: 2011-09-28
SICHUAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] After patent search, it was found that quetiapine fumarate used erodible sustained-release excipients as retarders, and prepared sustained-release granules by melting method solid dispersion technology, which was pressed into tablets. Made into sustained-release matrix tablets, outsourced with immediate-release film coating process Preparation of sustained-release tablet technology has not been reported in the literature

Method used

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  • Preparation process of quetiapine fumarate slow release tablet
  • Preparation process of quetiapine fumarate slow release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Preparation of Quetiapine Fumarate 50 mg, 200mg, 300mg, 400mg Sustained Release Tablets

[0035] prescription

quantity

content%

Quetiapine Fumarate

230.4 mg mg

46.08%

Kollicoat MAE 100P

69.6mg

13.92%

Sichuan wax powder

25mg

5.00%

hydrogenated castor oil

50mg

10.00%

lactose

110mg

22.00%

Micropowder silica gel

10mg

2.00%

Magnesium stearate

5mg

1.00%

Total

500mg

100%

[0036] 1) Pass quetiapine fumarate through a 100-mesh sieve, pass hydrogenated castor oil through a 100-mesh sieve, add Sichuan wax powder and Kollicoat MAE 100P into a three-dimensional mixer and mix for 15 minutes, and spread the mixture evenly on a stainless steel plate superior.

[0037] 2) Put the stainless steel plate from operation 1) into an oven and heat it to 100°C, continue heating for 2 hours, take out the stainless steel plate from the oven and cool it down to r...

Embodiment 2

[0046] Preparation of Quetiapine Fumarate 50 mg, 200mg, 300mg, 400mg Sustained Release Tablets

[0047] prescription

quantity

content%

Quetiapine Fumarate

230.4mg

41.89%

Kollicoat MAE 100P

69.6mg

12.65%

Sichuan wax powder

30mg

5.46%

hydrogenated castor oil

55mg

10.00%

lactose

145mg

26.36%

Micropowder silica gel

15mg

2.73%

Magnesium stearate

5mg

0.91%

Total

550mg

100%

[0048] 1) Pass quetiapine fumarate through a 100-mesh sieve, pass hydrogenated castor oil through a 100-mesh sieve, add Sichuan wax powder and Kollicoat MAE 100P into a three-dimensional mixer and mix for 15 minutes, and spread the mixture evenly on a stainless steel plate superior.

[0049] 2) Put the stainless steel plate from operation 1) into an oven and heat it to 100°C, continue heating for 2 hours, take out the stainless steel plate from the oven and cool it down to room ...

Embodiment 3

[0058] Preparation of Quetiapine Fumarate 50 mg, 200mg, 300mg, 400mg Sustained Release Tablets

[0059] prescription

quantity

content%

Quetiapine Fumarate

230.4 mg mg

38.40%

Kollicoat MAE 100P

69.6mg

11.60%

Sichuan wax powder

35mg

5.83%

hydrogenated castor oil

60mg

10.00%

lactose

180mg

30.00%

Micropowder silica gel

20mg

3.33%

Magnesium stearate

5mg

0.84%

Total

600mg

100%

[0060] 1) Pass quetiapine fumarate through a 100-mesh sieve, pass hydrogenated castor oil through a 100-mesh sieve, add Sichuan wax powder and Kollicoat MAE 100P into a three-dimensional mixer and mix for 15 minutes, and spread the mixture evenly on a stainless steel plate superior.

[0061] 2) Put the stainless steel plate from operation 1) into an oven and heat it to 100°C, continue heating for 2 hours, take out the stainless steel plate from the oven and cool it down to r...

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PUM

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Abstract

The invention discloses a preparation process of a quetiapine fumarate slow release tablet, belonging to the technical field of preparing medicinal slow / controlled-release preparations. In the process, a soluble slow-release accessory is used as a retarding agent, and slow-release particles are prepared by using a fusion-method solid dispersion technology and are tabletted. The quetiapine fumarate slow release tablet is the slow-release matrix tablet prepared by using a process of externally covering the tablet with a quick-release thin-film coating. The quetiapine fumarate in the invention has the in-vitro release characteristics as follows: after 750ml of 0.1NHCl is added for 2 hours, the release amount of quetiapine fumarate within 0-2 hours is 0-35%, and after 250ml of K3PO4 is added, the release amounts of the quetiapine fumarate within 2-8 hours, 8-12 hours and 12-20 hours are respectively 35-60%, 60-80% and 80-100%. The process has the advantages of simple and safe flow, controllable quality, low cost, short production period and great suitability for large-scale industrial production.

Description

technical field [0001] The invention relates to a preparation process of quetiapine fumarate sustained-release tablets, belonging to the technical field of preparation of drug sustained-release preparations. Background technique [0002] Quetiapine fumarate is used in the treatment of schizophrenia. [0003] Administer twice a day, both before and after meals. The total daily dose for the first 4-day treatment period in adults is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From the fourth day onwards, the dose is gradually increased to the effective dose range, generally 300-450 mg / day. The dose can be adjusted between 150-750 mg / day according to the patient's clinical response and tolerance. For the treatment of schizophrenia. [0004] Precautions [0005] Cardiovascular disease may cause orthostatic hypotension, especially during the initial dosing period; this phenomenon is more common in elderly patients than in younger patients. In clinical...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/554A61K47/44A61P25/18
Inventor 李晖贾桂琼刘海峰
Owner SICHUAN UNIV
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