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Diclofenac sodium multi-unit sustained-release micro-pill

A technology of diclofenac sodium and sustained-release micropills, which is applied in pill delivery, sugar-coated pills, coatings, etc., can solve the problems of micropill rupture, adverse safety hazards, and high production costs, so as to facilitate large-scale production and avoid sudden Release effect, effect of flexible dosing regimen

Pending Publication Date: 2017-11-03
仁合熙德隆药业有限公司 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN1460470 discloses a sustained-release preparation of diclofenac sodium with a bioskeleton membrane as a carrier. Although this sustained-release preparation has excellent biocompatibility, it cannot provide a clinically superior dosage plan because of its inseparability , there are still some bad security risks
Chinese patent CN105534940A discloses a diclofenac sodium sustained-release tablet composition and a preparation method. It uses a waxy material as an adhesive, an ion-exchange resin as a skeleton material, and adopts a hot-melt wrapping process to produce a non-erodible skeleton sustained-release tablet. This invention process is comparatively complicated, and production cost price is higher
The choice of pressure is a great challenge to the formation of sustained-release pellets. Using ordinary sustained-release materials, the sustained-release layer of the sustained-release pellets formed is relatively brittle and has poor plastic deformation. The rupture and adhesion of the pellets are caused, and the compressibility of ordinary cushioning auxiliary powders under direct pressure is not ideal. The compressibility should also be improved accordingly, so that tablets with suitable hardness can be prepared under the most appropriate pressure

Method used

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  • Diclofenac sodium multi-unit sustained-release micro-pill
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  • Diclofenac sodium multi-unit sustained-release micro-pill

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Weigh 60g of diclofenac sodium, 20g of microcrystalline cellulose, and 200g of lactose, mix them through an 80-mesh sieve, transfer them to a wet granulator, adjust the parameters, add a 1% aqueous solution of hypromellose E15 as a binder to make soft Diclofenac sodium drug-containing pellets were prepared by extrusion and spheronization, wherein the extrusion screen aperture was 0.5mm, the extrusion speed was 20r / min, the spheronization speed was 1000r / min, the fluidized bed was dried at 40°C, and 30-40 mesh drug-containing pellets were sieved. The pellets are for use.

[0033] Place the screened diclofenac sodium pellets in a fluidized bed, prepare a coating solution, and adjust the air intake to 130m 3 / h, fan frequency 26.5HZ, material temperature 28 ℃, coating solution flow rate 2rpm, control coating weight gain 27%, obtained diclofenac sodium sustained-release pellets.

[0034] Coating solution ratio:

[0035]

[0036] Weigh 30g of diclofenac sodium pellets, ...

Embodiment 2

[0038] Weigh 60g of diclofenac sodium, 150g of microcrystalline cellulose, and 90g of lactose, mix them through an 80-mesh sieve, transfer them to a wet granulator, adjust the parameters, and add a 1% aqueous solution of hypromellose E15 as a binder to make soft Diclofenac sodium drug-containing pellets were prepared by extrusion and spheronization, wherein the extrusion screen aperture was 0.5mm, the extrusion speed was 20r / min, the spheronization speed was 1000r / min, the fluidized bed was dried at 40°C, and 30-40 mesh drug-containing pellets were sieved. The pellets are for use.

[0039] Place the screened diclofenac sodium pellets in a fluidized bed, prepare a coating solution, and adjust the air intake to 130m 3 / h, fan frequency 26.5HZ, material temperature 28°C, coating solution flow rate 2rpm, coating weight gain of 29% was controlled to prepare diclofenac sodium sustained-release pellets.

[0040] Coating solution ratio:

[0041] Sustained release material ...

Embodiment 3

[0044] Weigh 60g of diclofenac sodium, 90g of microcrystalline cellulose, and 150g of lactose, mix them through an 80-mesh sieve, transfer them to a wet granulator, adjust the parameters, add a 1% aqueous solution of hypromellose E15 as a binder to make soft Diclofenac sodium drug-containing pellets were prepared by extrusion and spheronization, wherein the extrusion screen aperture was 0.5mm, the extrusion speed was 20r / min, the spheronization speed was 1000r / min, the fluidized bed was dried at 40°C, and 30-40 mesh drug-containing pellets were sieved. The pellets are for use.

[0045] Place the screened diclofenac sodium pellets in a fluidized bed, prepare a coating solution, and adjust the air intake to 130m 3 / h, fan frequency 26.5HZ, material temperature 28 ℃, coating solution flow rate 2rpm, control coating weight gain 25%, obtained diclofenac sodium sustained-release pellets.

[0046] Coating solution ratio:

[0047] Sustained release material

[0048] Weigh ...

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Abstract

The invention relates to the field of medicinal preparations, in particular to a diclofenac sodium multi-unit sustained-release micro-pill. The diclofenac sodium multi-unit sustained-release micro-pill is formed by tabletting a diclofenac sodium sustained-release micro-pill and a filling auxiliary material, the diclofenac sodium sustained-release micro-pill is prepared by coating a drug-containing pill core with a water insoluble polymer film for drug permeation, and a water soluble polymer is also contained in the film, so that the weight of the coated polymer is increased by 10-30 percent; the filling auxiliary material is one or more of microcrystalline cellulose, corn starch, lactose, cross-linked povidone, cross-linked sodium carboxymethyl cellulose, sodium carboxymethyl starch, hydroxypropyl methylcellulose, povidone, stearic acid, magnesium stearate, colloidal silicon dioxide and talcum powder, and occupies 40-60 percent of the total pill weight. The diclofenac sodium sustained-release micro-pill can be quickly disintegrated into separate small micro-pill units in digestive fluid, and the micro-pill units can reach a 12-hour sustained release effect in a gastrointestinal tract.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a diclofenac sodium multi-unit sustained-release pellet tablet and a preparation method thereof. Background technique [0002] Diclofenac sodium is a non-steroidal anti-inflammatory drug, which is clinically used to treat various pains caused by various rheumatism, rheumatoid arthritis, neuritis, ankylosing spondylitis and cancer surgery, as well as pain caused by various reasons. fever etc. Although it has the characteristics of good curative effect and low side effects, but because of its rapid oral absorption and short biological half-life, t 1 / 2 It takes about 1.5 hours. Ordinary tablets often need to be taken 3-4 times a day to maintain the drug effect, which leads to the peak and valley phenomenon of blood drug concentration in the body. Acceptable sustained-release tablets and sustained-release capsules are now available on the market. Chinese patent CN1460470...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/32A61K31/196A61K9/26A61P29/00A61P19/02A61P25/00A61P19/08
CPCA61K31/196A61K9/0002A61K9/2095A61K9/2846A61K9/2866
Inventor 陈水库张培培贾冰冰任立志丁红强肖春峰黄占海方水霞李市伟崔浩
Owner 仁合熙德隆药业有限公司
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