Levetiracetam 3D printing preparation and preparation method thereof

A 3D printing and preparation technology, which is applied in the direction of pill delivery, pharmaceutical formula, medical preparations of non-active ingredients, etc., can solve the difference in drug dosage, surface powder falling, and rapid disintegration of tablets that cannot be well coordinated and appearance problems

Active Publication Date: 2020-10-30
ACADEMY OF MILITARY MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the appearance of the rapidly dispersible tablet prepared by the invention is rough, and the requirements for rapid disintegration and smooth appearance of the tablet cannot be well coordinated, and the printing of a dispersible tablet with a better appearance, especially a delicate cartoon tablet, cannot be realized.
[0012] The biggest defect of binder jet 3D printing is the appearance of the product. Due to the stacking of different polymers and powders, surface defects of the product may appear, such as insufficient mechanical properties such as tablet surface roughness, hardness, and friability. It may even affect the patient's medication experience, and there may even be differences in dosage due to powder falling off the surface of the tablet during storage and transportation.

Method used

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  • Levetiracetam 3D printing preparation and preparation method thereof
  • Levetiracetam 3D printing preparation and preparation method thereof
  • Levetiracetam 3D printing preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0142] Preparation Example 1: Preparation of Sample 1-1, Sample 1-2, Sample 1-3 and Sample 1-4

[0143] 1. Preparation of drug powder

[0144] Levetiracetam is pulverized through a 120 mesh sieve, colloidal silicon dioxide is passed through a 40 mesh sieve, and all the other auxiliary materials are passed through a 120 mesh sieve. Add the raw and auxiliary materials into the hopper mixer, set the speed at 20 rpm, and mix for 20 minutes to ensure that the drug powder is evenly mixed. The drug powder material composition is as follows:

[0145]

[0146] 2. Preparation of printing solution

[0147] A 50% ethanol solution (v / v) was used as base solvent.

[0148] The composition of each printing solution is as follows:

[0149] (1) Transparent printing fluid:

[0150] 50% ethanol solution 95.95% (w / w)

[0151] Povidone K30 0.05% (w / w)

[0152] Glycerin 4% (w / w)

[0153] (2) Cyan printing solution (C):

[0154]

[0155]

[0156] (3) Magenta printing solution (M):...

preparation example 2

[0174] Preparation Example 2: Preparation of Sample 2-1, Sample 2-2, Sample 2-3 and Sample 2-4

[0175] 1. Preparation of drug powder

[0176] Levetiracetam is pulverized through a 120 mesh sieve, colloidal silicon dioxide is passed through a 40 mesh sieve, and all the other auxiliary materials are passed through a 120 mesh sieve. Add the raw and auxiliary materials into the hopper mixer, set the speed at 20 rpm, and mix for 20 minutes to ensure that the drug powder is evenly mixed. The drug powder material composition is as follows:

[0177]

[0178] 2. Preparation of printing solution

[0179] A 40% isopropanol solution (v / v) was used as base solvent.

[0180] The composition of each printing solution is as follows:

[0181] (1) Transparent printing fluid:

[0182] 40% isopropanol solution 95.9% (w / w)

[0183] Povidone K30 0.1% (w / w)

[0184] Glycerin 4% (w / w)

[0185] (2) Cyan printing solution (C):

[0186]

[0187]

[0188] (3) Magenta printing solutio...

preparation example 3

[0207] Preparation Example 3: Preparation of Sample 3-1, Sample 3-2, Sample 3-3 and Sample 3-4

[0208] 1. Preparation of drug powder

[0209] With preparation example 2.

[0210] 2. Preparation of printing solution

[0211] With preparation example 2.

[0212] 3. Model design

[0213] With preparation example 1.

[0214] 4. Tablet printing

[0215] Transfer the model data to the 3D printer control software, set the printing quantity and typesetting, and the printing parameters are set as follows:

[0216]

[0217]

[0218]First, spread a certain thickness of drug powder on the printing platform, as a support for the bottom of the printing model and ensure that a single powder layer can be spread evenly during the printing process. The thickness of the powder layer is 2-5mm. During the printing process, the thickness of each powder layer is 150 μm. The print nozzle finely sprays a certain number of droplets on a specific part according to the instructions input b...

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Abstract

The invention belongs to the field of medicines and preparations, and relates to a levetiracetam 3D printing preparation and a preparation method thereof. The levetiracetam 3D printing preparation comprises levetiracetam accounting for 40-70% of the weight of the preparation, a filler, a disintegrating agent, a flavoring agent, a flow aid, an antioxidant and an adhesive, wherein the root mean square height (Sq) of the roughness characteristic value of the levetiracetam 3D printing preparation is not higher than 45 microns, the arithmetic mean height (Sa) is not higher than 40 microns, and themaximum height (Sz) is not higher than 350 microns. The preparation provided by the invention has excellent surface smoothness, can realize rapid drug release within a few seconds, can realize flexible adjustment of drug dosage, and greatly improves child medication compliance.

Description

technical field [0001] The invention belongs to the field of medicines and preparations, and relates to a levetiracetam 3D printing preparation and a preparation method thereof. Specifically, the present invention relates to a levetiracetam tablet such as levetiracetam dispersible tablet, and a method for preparing the levetiracetam tablet such as levetiracetam dispersible tablet using 3D printing technology . In particular, it relates to 3D printed tablets of levetiracetam suitable for administration to children. Background technique [0002] Levetiracetam is a pyrrolidone derivative and one of the most widely used broad-spectrum antiepileptic drugs in clinical practice. Levetiracetam is very soluble and highly permeable, and is rapidly absorbed after oral administration, with an absolute bioavailability close to 100%, linear metabolism, little intra-individual and inter-individual differences, and no gender, racial, and circadian rhythm differences. Due to the complete ...

Claims

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Application Information

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IPC IPC(8): A61K9/44A61K47/38A61K47/32A61K31/4015A61P25/08B33Y70/10B33Y80/00
CPCA61K9/2072A61K9/2095A61K9/2054A61K9/2027A61K31/4015A61P25/08B33Y70/10B33Y80/00
Inventor 郑爱萍王增明陈如心韩晓璐张慧高静刘楠高翔
Owner ACADEMY OF MILITARY MEDICAL SCI
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