Lornoxicam double-layer sustained release tablets

A technology of lornoxicam and sustained-release tablets, which is used in pharmaceutical formulations, pill delivery, non-central analgesics, etc. Problems such as low concentration and difficult treatment concentration

Active Publication Date: 2011-10-26
CHINA PHARM UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, if lornoxicam is made into ordinary sustained-release tablets for oral administration, since the release rate of the drug in the gastric juice is very low, it is difficult for the blood drug concentration to reach the therapeutic concentration rapidly after taking it, and the effect is slow and slow. Not good for quick relief of inflammation or pain
[0005] At present, there are no reports on the development and research of lornoxicam double-layer sustained-release tablets at home and abroad

Method used

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  • Lornoxicam double-layer sustained release tablets

Examples

Experimental program
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preparation example Construction

[0145] The preparation method comprises the following steps:

[0146] (i) providing an immediate release layer material and a sustained release layer material, wherein

[0147] The immediate-release layer material comprises: (a1) lornoxicam; (a2) a basic substance; (a3) ​​optional other pharmaceutically acceptable carriers or excipients;

[0148] The sustained-release layer material comprises: (b1) lornoxicam; (b2) sustained-release material; (b3) optional other pharmaceutically acceptable carriers or excipients; and

[0149] (ii) compressing the immediate-release layer material and the sustained-release layer material into a double-layer sustained-release tablet.

[0150] The content and ratio of each material component are as defined above.

[0151] For example, in a preferred embodiment of the present invention, a wet granulation and tableting method is adopted, and its specific technological process is:

[0152] A. Pretreatment of raw and auxiliary materials

[0153] P...

Embodiment 1

[0175] Example 1 Lornoxicam bilayer sustained-release tablet 1

[0176] formula

[0177] Immediate release layer part (amount per tablet)

[0178] lornoxicam 4 mg

[0179] L-Arginine 16 mg

[0180] Croscarmellose Sodium 10mg

[0181] Pregelatinized starch 84 mg

[0182] 5% Povidone 30mg

[0183] Magnesium Stearate 1 mg

[0184] Sustained release layer part (amount per tablet)

[0185] lornoxicam 8 mg

[0186] Hypromellose (viscosity: 4000 cps) 15 mg

[0187] Hypromellose (viscosity: 100 cps) 30 mg

[0188] Lactose 122 mg

[0189] 5% Povidone (Model: K30) solution 80 mg

[0190] Magnesium Stearate 1.8 mg

[0191] Preparation

[0192] (1) Preparation of immediate-release granules:

[0193] Pass lornoxicam, pregelatinized starch, L-arginine and croscarmellose sodium through a 60-mesh sieve and mix well. Add 5% povidone (g / 100ml, model: K30) solution during stirring to make soft material, pass through a 30-mesh sieve for granulation, dry at 50°C for 1 hour, pass...

Embodiment 2

[0198] Example 2 Lornoxicam bilayer sustained-release tablet 2

[0199] formula

[0200] Immediate release layer part (amount per tablet)

[0201] lornoxicam 6mg

[0202] L-Arginine 22 mg

[0203] Croscarmellose Sodium 15mg

[0204] Pregelatinized starch 105 mg

[0205] 5% Povidone 40mg

[0206] Magnesium Stearate 1.5 mg

[0207] Sustained release layer part (amount per tablet)

[0208] lornoxicam 12mg

[0209] Hypromellose (viscosity: 4000 cps) 20 mg

[0210] Hypromellose (viscosity: 100 cps) 50 mg

[0211] Lactose 105 mg

[0212] 5% Povidone (Model: K30) solution 80 mg

[0213] Magnesium Stearate 2.3 mg

[0214] Preparation

[0215] (1) Preparation of immediate-release granules:

[0216] Pass lornoxicam, pregelatinized starch, L-arginine and croscarmellose sodium through a 60-mesh sieve and mix well. Add 5% povidone ((g / 100ml, model: K30) solution during stirring to make soft material, pass through a 30-mesh sieve for granulation, dry at 50°C for 1 hour, p...

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Abstract

The invention relates to a double-layer sustained release lornoxicam tablet which comprises (a) a quick release layer and (b) a sustained release layer, wherein, the quick release layer comprises (a1) the lornoxicam, (a2) alkaline matter and (a3) an other optional carrier or pharmaceutically acceptable excipient and the sustained release layer comprises the (b1) lornoxicam, (b2) sustained releasesubstance and (b3) the other optional carrier or the pharmaceutically acceptable excipient. The weight proportion of (a1) and (b1) is 1:50 to 50:1. The invention also provides a preparation method ofthe double-layer sustained release lornoxicam tablet. The double-layer sustained release preparation of the invention has the advantages of the quick effect of the quick release preparation and the sustained effect of sustained release preparation. In addition, the double-layer sustained release preparation can maintain the effect of effective blood concentration continuously and stably after theeffective blood concentration is reached rapidly.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a double-layer sustained-release tablet of a non-steroidal anti-inflammatory drug lornoxicam and a preparation method thereof. Background technique [0002] Lornoxicam (Lornoxicam) is a non-steroidal anti-inflammatory drug of Oxycam, the chemical name is 6-chloro-4-hydroxy-2-methyl-3-N-(2-pyridyl)-2H-phenothia And[2,3-e]-1,2-thiazine-3-carboxamide-1,1-dioxide. Lornoxicam has good analgesic and anti-inflammatory effects, and the currently marketed dosage forms include film-coated tablets and freeze-dried powder injections. [0003] Due to the short half-life of lornoxicam in vivo, in order to maintain the effective blood concentration, clinical oral administration of lornoxicam film-coated tablets requires repeated administration, and multiple tablets need to be taken each time, which brings inconvenience to the clinical medication of patients, and due to bloo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/542A61K9/24A61P29/00
Inventor 张建军高缘樊伟明祁伟樑林谊
Owner CHINA PHARM UNIV
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