3D printed pharmaceutical composition containing levetiracetam

A 3D printing and composition technology, which is applied in the direction of drug combinations, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of large size and volume, low raw material utilization rate, high cost, etc., and achieve small volume and size, The effect of high raw material utilization rate and low production cost

Active Publication Date: 2021-07-20
ZHEJIANG JINGXIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem solved by the present invention is to overcome the low API drug loading, large size and volume in the existing levetiracetam 3D printing preparation, which is not conducive to taking, and the hardness and friability are not good, and the surface defects of the preparation Many, the current 3D printed levetiracetam dispersion preparation process has defects such as high cost and low raw material utilization rate, and a new type of 3D printed levetiracetam-containing pharmaceutical composition and its preparation method are provided

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] The prescription of pharmaceutical composition is as follows:

[0054] Table 1

[0055] raw material Dosage Product content (wt%) Levetiracetam 18.6 93％ Sodium carboxymethyl starch 1.0 5％ Sodium carboxymethyl cellulose 0.40 2％ Absolute ethanol 0.70ml - water 6.3ml -

[0056] Prepare the pharmaceutical composition containing levetiracetam of 3D printing according to the formula in Table 1, and the specific operations are:

[0057] (1) Take levetiracetam, carboxymethyl starch sodium and carboxymethyl cellulose sodium by recipe quantity, mix it for 30min to mix evenly, obtain material;

[0058] (2) adding the ethanol aqueous solution to the material dropwise under stirring to obtain a soft material;

[0059] (3) Put the soft material into the printing cavity, and print according to the printing parameters set as follows according to the set printing model:

[0060] Print head diameter: 0.5mm; Printing speed: 8.0mm / s; E...

Embodiment 2

[0066] Table 2

[0067] raw material Dosage (g) Product content (wt%) Levetiracetam 19.2 96％ Sodium carboxymethyl starch 0.4 2％ Sodium carboxymethyl cellulose 0.40 2％ Absolute ethanol 0.70ml - water 6.3ml -

[0068] A 3D printed levetiracetam-containing pharmaceutical composition was prepared according to the formula in Table 2. The specific operation was the same as in Example 1, except that the printing grid filling width, that is, the filling rate of the tablet, and each printing speed. Printing speed: 6.5mm / s; Extrusion speed: 0.0065mm / s; Grid width: 0.7mm; Contour width: 0mm; Contour times: 0.

[0069] The obtained pharmaceutical composition is a cylindrical tablet with a diameter of 12mm and a thickness of 7.0mm, and the dosage of the tablet is 500mg. The surface of the pharmaceutical composition is smooth and even, and the hardness is 10-15kPa.

Embodiment 3

[0071] table 3

[0072] raw material Dosage (g) Product content (wt%) Levetiracetam 18.0 90％ Sodium carboxymethyl starch 1.60 8％ Sodium carboxymethyl cellulose 0.40 2％ Absolute ethanol 0.70ml - water 6.3ml -

[0073] The 3D printed levetiracetam-containing pharmaceutical composition was prepared according to the formula in Table 3, and the specific operation was the same as in Example 1, except that the printing grid filling width, that is, the filling rate of the tablet, and each printing speed parameter. Printing speed: 6.5mm / s; Extrusion speed: 0.0065mm / s; Grid width: 1.0mm; Contour width: 0.55mm; Contour times: 2.

[0074] The obtained pharmaceutical composition is a cylindrical tablet with a diameter of 12mm and a thickness of 7.0mm, and the dosage of the tablet is 450mg. The surface of the pharmaceutical composition is smooth and even, and the hardness is 8-10kPa.

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Abstract

The invention discloses a 3D printed pharmaceutical composition containing levetiracetam and a preparation method thereof. The pharmaceutical composition comprises 80%-96% levetiracetam, 2-10% disintegrant and 1.5%-5% carboxymethylcellulose sodium. The pharmaceutical composition of the present invention has high content of API, less excipients, maximum drug dosage, small volume and size of the unit composition, few surface defects of the preparation, easy oral administration, high hardness and low friability, It is beneficial to storage and transportation; the preparation method of the present invention adopts the technology of 3D extrusion printing (pressure extrusion printing), not only the prepared product has high drug loading capacity and small size, but also the process of the preparation method is simple and the production cost is low. The raw material utilization rate is high, and it is suitable for individualized production and individualized drug delivery.

Description

technical field [0001] The invention relates to a 3D printed pharmaceutical composition containing levetiracetam and a preparation method thereof. Background technique [0002] The chemical name of levetiracetam is (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, which is a second-generation acetylcholine agonist developed by UCB Company in Belgium. Compared with most antiepileptic drugs, levetiracetam exhibits stronger antiepileptic properties and can effectively control epileptic seizures. The drug not only has a high therapeutic index, but also has unique pharmacokinetic characteristics, rapid and safe oral absorption, and a bioavailability of 100%. Its pharmacokinetic distribution is similar to the ideal kinetic distribution model of antiepileptic drugs. , a broad-spectrum antiepileptic drug with less toxic and side effects, and has great development value. [0003] Levetiracetam tablet (Keppra, KEPPRA) was approved by the U.S. FDA in November 1999, and it is listed in the U....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/36A61K47/38A61K31/4015A61P25/08B33Y10/00B33Y70/10B33Y80/00
CPCA61K9/2054A61K9/2059A61K31/4015A61P25/08B33Y10/00B33Y70/00B33Y80/00
Inventor 潘卫三崔梦锁潘昊陈奋李琦君徐文婷李平飞
Owner ZHEJIANG JINGXIN PHARMA
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