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Duloxetine hydrochloride enteric pellet and preparation method thereof

A loxetine enteric and hydrochloric acid technology, which is applied in the direction of medical formula, non-active ingredient medical preparations, medical preparations containing active ingredients, etc., can solve the problem of small particle size, irregular shape and roundness of pellet cores. Poor and other problems, to achieve the effect of good content uniformity and obvious effect of the finished product

Active Publication Date: 2014-02-12
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by the present invention is to overcome the problem that the small-diameter sucrose ball core is broken and powdered during coating due to the small particle diameter, poor roundness and irregular shape of the core at the initial coating stage.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] 10mg duloxetine / capsule

[0032] blank core 180μm~250μm blank sucrose core 60.28mg The protective layer Hydroxypropylmethylcellulose 0.09mg talcum powder 0.68mg sucrose 1.03mg drug layer Duloxetine Hydrochloride 11.23 mg Hydroxypropylmethylcellulose 3.74mg Isolation layer Hydroxypropylmethylcellulose 2.51 mg sucrose 5.00mg talcum powder 10.03mg Enteric layer HPMCAS-LF 25.05mg talcum powder 7.52mg triethyl citrate 5.00mg retouching layer Hydroxypropylmethylcellulose 8.44mg Titanium dioxide 2.81mg talcum powder Trace total 143.4mg

[0033] Weigh an appropriate amount of hydroxypropyl methylcellulose and sucrose according to the prescription ratio and dissolve them in purified water, then add the prescribed amount of talcum powder, stir evenly, and configure a protective layer with a solid content of 10%~25% ...

Embodiment 2

[0036] 10mg duloxetine / capsule

[0037] blank core 710μm~850μm blank sucrose core 60.28mg drug layer Duloxetine Hydrochloride 11.23 mg Hydroxypropylmethylcellulose 3.74mg Isolation layer Hydroxypropylmethylcellulose 2.51 mg sucrose 5.00mg talcum powder 10.03mg Enteric layer HPMCAS-LF 25.05mg talcum powder 7.52mg triethyl citrate 5.00mg retouching layer Hydroxypropylmethylcellulose 8.44mg Titanium dioxide 2.81mg talcum powder Trace total 143.4mg

[0038] This example is to prepare a batch of products according to the prescription and process scheme provided in Example 10 of US Patent US5508276. The particle size of the prepared enteric-coated capsules is about 900 μm ~ 1200 μm, and the filling is carried out according to the specifications, and the average value of the final product is measured. The content is 99.5%, and its content uniformit...

Embodiment 3

[0041] 10mg duloxetine / capsule

[0042] blank core 180μm~250μm blank sucrose core 60.28mg drug layer Duloxetine Hydrochloride 11.23 mg Hydroxypropylmethylcellulose 3.74mg Isolation layer Hydroxypropylmethylcellulose 2.51 mg sucrose 5.00mg talcum powder 10.03mg Enteric layer HPMCAS-LF 25.05mg talcum powder 7.52mg triethyl citrate 5.00mg retouching layer Hydroxypropylmethylcellulose 8.44mg Titanium dioxide 2.81mg talcum powder Trace total 143.4mg

[0043] This prescription is the same as the prescription of Example 10 recorded in US Patent No. 5,508,276, except that the blank sucrose ball core of 710 μm ~ 850 μm in the original prescription is replaced by a sucrose ball core of 180 μm ~ 250 μm, there is no change in the rest, and a For batches of products, when the drug layer was coated, it was found that the pressure difference of the filter ...

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PUM

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Abstract

The invention relates to a duloxetine hydrochloride enteric pellet and a preparation method thereof. The pellet comprises a blank cane sugar pellet core, a protection layer, a drug layer, an isolating layer, an enteric layer and an optional modification layer. The method comprises the following steps: coating the blank pellet core with the protection layer; and then carrying out coating by successively using the drug layer, the isolating layer, the enteric layer and the optional modification layer so as to prepare the duloxetine hydrochloride enteric pellet. According to the invention, the blank cane sugar pellet core with a small particle size is employed, coating with the protection layer is carried out at first, so the problems of fragmentation and powder falling of the pellet core in the process of coating are effectively overcome; the prepared enteric pellet has a small particle size, a capsule filled with the enteric pellet has good content uniformity, and industrial mass production of the enteric pellet is facilitated.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a duloxetine hydrochloride enteric-coated pellet and a preparation method thereof. Background technique [0002] Duloxetine hydrochloride capsules have been marketed by Eli Lilly and Company under the trade name Cymbalta, and are mainly used for the treatment of depression. U.S. Patent No. 5,508,276 discloses duloxetine enteric-coated pills. The pellet coating technology is used to pack raw materials on blank ball cores to prepare drug-containing sugar ball cores, and use this as the base to sequentially coat the isolation layer, enteric-coated layer, and modified pellets. layer to make enteric-coated pellets. The initial blank core of the coating in this patent is preferably a sucrose core, and the particle size is most suitable between 300 μm and 800 μm. The advantage of selecting sucrose cores in this particle size range as the initial pellets is that: there are many...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/381A61K47/38A61P13/10A61P25/24A61P29/00
Inventor 朱锋曹呈勇
Owner YAOPHARMA CO LTD
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