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Zero level drug administration oral administration controlled-release tablet and preparation thereof

A technology for controlled-release tablets and drug delivery, which is applied in pharmaceutical formulations, devices for making drugs into special physical or taking forms, and drug delivery. It can solve problems such as insufficient research and development, and achieve good drug release reproducibility. The effect of high degree of automation and simple preparation process

Inactive Publication Date: 2008-08-20
DONGHUA UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is obviously insufficient research and development on how to take advantage of the technical advantages of 3DP and obtain the required controlled release characteristics through the differences in structure and local active ingredients
This patent designs and prepares a zero-order drug delivery controlled-release tablet with a structure of two-terminal release-restraining layers and the middle area has the same drug loading on different diameter ring surfaces. There are no related reports at home and abroad.

Method used

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  • Zero level drug administration oral administration controlled-release tablet and preparation thereof
  • Zero level drug administration oral administration controlled-release tablet and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1: the deployment of layer powder and binder

[0035] Pass 5 cps ethyl cellulose through a 200-mesh sieve, and take powder with a particle size of less than 74 μm for the top and bottom layers; weigh 4 grams of 5 cps ethyl cellulose powder, dissolve it in 100 mL of 90% ethanol aqueous solution, and prepare into top and bottom powder forming binders.

[0036] The raw material composition and content (by weight percentage) of intermediate mixing powder are as follows:

[0037] Hydroxypropyl methylcellulose HPMC E50 35 parts

[0038] Lactose 54 parts

[0039] Polyvinylpyrrolidone K30 10 parts

[0040] 1 part colloidal silicon dioxide

[0041] Take by weighing 5 grams of polyvinylpyrrolidone K30 powder and be dissolved in 100mL of 75% aqueous ethanol to be prepared as a drug-free binder in the middle zone; take by weighing 12 grams of diclofenac sodium powder, be dissolved in 100mL of 75% aqueous ethanol,

Embodiment 2

[0042] Example 2: Determining 3D printing forming parameters

[0043] Top and bottom surface spray forming parameters:

[0044] Layer interval time 3min

[0045] Powder layer thickness 200μm

[0046] Spraying rate [spraying drop volume (droplet quantity × droplet size) × spraying frequency] 0.4nL × 12kz

[0047] Spray times 3 times

[0048] The spray forming parameters of the fully sprayed drug layer in the middle drug-loading area:

[0049] Layer interval time 2min

[0050] Powder layer thickness 200μm

[0051] Spray rate (spray drop volume × spray frequency) 0.4nL × 12kz

[0052] Spraying times 2 times

[0053] Spraying forming parameters of the intermediate drug-loading area partly sprayed with drug-containing binder and partly sprayed with drug-free binder:

[0054] Layer interval time 4min

[0055] Powder layer thickness 200μm

[0056] Spray rate (spray drop volume × spray frequency) 0.4nL × 12kz

[0057] Spraying times (medicated binder and some non-medicated bi...

Embodiment 3

[0058] Embodiment 3: Optimization of spray drop spacing

[0059] Printing and spraying tests with different drop spacings were carried out on the intermediate mixed powder with a thickness of 200 μm. The bonding effect and the migration and spread of printing liquid powders were observed and compared through three-dimensional video microscopic controlled release tablets, and the most suitable drop spacing was optimized. .

[0060] As shown in Figure 3, when the droplet distance is 50 μm, it can be seen that there is a better bonding effect, and the size of the droplet is 40 μm, allowing the adhesive to migrate and spread at 10 μm is more conducive to the uniformity of the drug and the bonding effect. The white filamentous substance is incompletely dissolved hydroxypropyl methylcellulose.

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Abstract

The invention relates to a zero order administration oral controlled release tablet and a preparation method of the tablet. The top surface and the bottom surface of the column tablet is formed by bonding the polymer accessories, namely the retarded release material, the medicine loading area in the middle part is formed by bonding and spraying the printing liquid loading the medicine. The two faces at the axial direction are sealed by ethyl cellulose, which makes the medicine discharged at two dimensions at the radial direction. The selective areas are sprayed with the printing liquid with medicine to obtain the character of the same amount of medicine distribution at the ring surfaces with different diameters and the other areas are sprayed with the printing liquid without medicine and then are formed by bonding. The zero order administration oral controlled release tablet has the advantages of simple technology, high degree of automation and favorable reproducibility of medicine discharge.

Description

technical field [0001] The invention belongs to the field of medical pharmaceutical preparations and preparations, in particular to a zero-order administration controlled-release oral tablet and a preparation method thereof. Background technique [0002] The three-dimensional printing (Three Dimensional Print, 3DP) forming technology first proposed by MIT Sachs et al. (US patent, NO.5204055, 1993) is based on the concept of "layer-by-layer printing, layer-by-layer superposition" to prepare a special shape. or objects with complex internal structures. This technology uses powder as the material, the processing process is very flexible, the forming speed is fast, the operating cost is low and the reliability is high. It is one of the most viable new technologies in the rapid prototyping industry. The key equipment of this technology - 3D printer is generally composed of computer terminal, powder processing controlled release tablet (including powder feeding, layering and reco...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/38A61K47/32A61K47/34A61K31/196A61K31/167A61K31/192A61K31/522A61J3/00
Inventor 朱利民余灯广申夏夏
Owner DONGHUA UNIV
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