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Lornoxicam double-layer sustained release tablets

A technology of lornoxicam and sustained-release tablets, which is applied in pharmaceutical formulations, pill delivery, non-central analgesics, etc., can solve the problem of slow effect and no reports on the development and research of lornoxicam double-layer sustained-release tablets , slow functioning and other issues

Active Publication Date: 2009-01-14
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
Comparison scheme
Effect test

preparation example Construction

[0145] The preparation method includes the following steps:

[0146] (i) Provide quick-release layer materials and slow-release layer materials, of which

[0147] The immediate-release layer material comprises: (a1) lornoxicam; (a2) alkaline 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) Pressing the quick-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 used, and the specific process flow is:

[0152] A. Pretreatment of raw and auxiliary materials

[0153] Pass lornoxicam and magnesium stearate th...

Embodiment 1

[0175] Example 1 Lornoxicam double-layer sustained-release tablet 1

[0176] formula

[0177] Immediate release layer (amount per tablet)

[0178] Lornoxicam 4 mg

[0179] L-Arginine 16 mg

[0180] Croscarmellose Sodium 10mg

[0181] Pregelatinized starch 84 mg

[0182] 5% povidone 30 mg

[0183] Magnesium stearate 1 mg

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

[0185] Lornoxicam 8 mg

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

[0187] Hypromellose (viscosity: 100 centipoise) 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 to make soft material during stirring, pass through a 30-mesh sieve to granulate, dry at 50°C for 1 hour, pass the d...

Embodiment 2

[0198] Example 2 Lornoxicam double-layer sustained-release tablet 2

[0199] formula

[0200] Immediate release layer (amount per tablet)

[0201] Lornoxicam 6 mg

[0202] L-Arginine 22 mg

[0203] Croscarmellose Sodium 15mg

[0204] Pregelatinized starch 105 mg

[0205] 5% povidone 40 mg

[0206] Magnesium stearate 1.5 mg

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

[0208] Lornoxicam 12 mg

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

[0210] Hypromellose (viscosity: 100 centipoise) 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 to the soft material during stirring, pass through a 30-mesh sieve to granulate, dry at 50°C for 1 hour, pass t...

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Abstract

The invention relates to a double-layer sustained release lornoxicam tablet comprising (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 excipient acceptable to pharmacy and the sustained release layer comprises the (b1) lornoxicam, (b2) sustained release substance and (b3) the other optional carrier or the excipient acceptable to the pharmacy. The weight proportion of (a1) and (b1) is 1:50 to 50:1. The invention also provides a preparation method of the 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 the effective blood concentration is reached rapidly.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and specifically relates to a double-layer sustained-release tablet of the non-steroidal anti-inflammatory drug lornoxicam and a preparation method thereof. Background technique [0002] Lornoxicam (Lornoxicam) is a non-steroidal anti-inflammatory drug of oxicam, with a chemical name of 6-chloro-4-hydroxy-2-methyl-3-N-(2-pyridyl)-2H-phenothi And [2,3-e]-1,2-thiazine-3-carboxamide-1,1-dioxide. Lornoxicam has good analgesic and anti-inflammatory effects, and 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 effective blood drug concentration, clinical oral lornoxicam film-coated tablets need to be administered repeatedly, and multiple tablets need to be taken each time, which brings inconvenience to the clinical medication of patients. Large fluctuations in dr...

Claims

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Application Information

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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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