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Formula and technology for improving strong wet-absorbing performance and dissolving-out behavior of levocarnitine tablets

A technology of L-carnitine tablet and hygroscopicity is applied in the field of improving the strong hygroscopicity and dissolution behavior of L-carnitine tablet, which can solve the problems of cracking of the tablet, easy moisture absorption of L-carnitine, sticking and punching of materials, etc. Consistent quality, solve the effect of easy moisture absorption

Active Publication Date: 2015-04-15
BEIJING CHENG JI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Because levocarnitine has strong hygroscopicity, according to the original research CARNITINE Prescription, under the humidity environment conditions (40%--60%RH) of the GMP workshop, there are production problems such as levocarnitine is easy to absorb moisture, material sticking, tablet cracking, etc.

Method used

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  • Formula and technology for improving strong wet-absorbing performance and dissolving-out behavior of levocarnitine tablets
  • Formula and technology for improving strong wet-absorbing performance and dissolving-out behavior of levocarnitine tablets
  • Formula and technology for improving strong wet-absorbing performance and dissolving-out behavior of levocarnitine tablets

Examples

Experimental program
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Effect test

example 1

[0017] According to the prescription in Table 1, 6.6kg of levocarnitine and 3.84kg of mannitol were mixed evenly in a high-efficiency wet mixing granulator (HLSG20B type, Beijing Aviation Manufacturing Engineering Research Institute of Bank of China Industry), and then added sodium starch glycolate in order 0.6kg, povidone K900.72kg, fumed silicon dioxide 0.18kg, and magnesium stearate 0.06kg were uniformly mixed, and the mixture was directly compressed into powder in a high-speed rotary tablet press (ZP35D type, Liaocheng Wanhe Industrial Manufacturing Co., Ltd.) (RH% control in the GMP workshop is 40%-60%), tablet diameter 13mm, shallow concave, thickness 5.30-5.60mm, plain tablet weight 600mg.

[0018] Table 1. Composition of generic L-carnitine tablet-330mg

[0019]

example 3

[0025] Under different relative humidity conditions at 25°C, the equilibrium moisture absorption curve of levocarnitine (pharmaceutical grade, Northeast Pharmaceutical Group Co., Ltd.) was measured with a moisture absorption analyzer (AQU ALB, Decagon Devices, Inc.), and the results are shown in figure 1 ..

example 4

[0027] Under different relative humidity conditions at 25°C, the equilibrium moisture absorption curve of mannitol (pharmaceutical grade, Hebei Huaxu Pharmaceutical Co., Ltd.) was measured with a moisture absorption analyzer (AQUA LAB, Decagon Devices, Inc.), and the results are shown in figure 2 ..

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Abstract

The invention discloses a formula and technology for improving the strong wet-absorbing performance and dissolving-out behavior of levocarnitine tablets. The API levocarnitine with a strong wet-absorbing performance and an auxiliary material namely mannitol, which can prevent the wet-absorbing property, are evenly mixed according to a ratio of 0.9:1-3.4:1; then an adhesive agent, a disintegrating agent, a flow aid, and a lubricant are added into the mixture and then evenly mixed, and the powder are directly pressed into tablets. Through the technical scheme mentioned above, solved are the problems that the levocarnitine absorbs water during the pressing process, the materials are adhesive, and the tablets crack during the production process. Furthermore, the dissolving-out curve of the prepared levocarnitine tablet is similar to the four dissolving-out curves of a reference preparation CARNITINE@ tablet, and thus the quality of the prepared levocarnitine tablet is identical with that of the reference preparation.

Description

technical background [0001] The invention relates to a method for improving the strong hygroscopicity and dissolution behavior of levocarnitine tablets in the medical and health industry. Background technique [0002] Human L-carnitine deficiency, clinical manifestations such as cardiomyopathy, skeletal muscle disease, arrhythmia, hyperlipidemia, and hypotension and muscle spasm during dialysis. Levocarnitine tablets are the safe and effective drug of choice for the treatment of this disease spectrum. Levocarnitine Tablets CARNITINE Developed by Sigma-tau and marketed in 1981, the prescription is levocarnitine, microcrystalline cellulose, povidone and magnesium stearate. [0003] Because levocarnitine has strong hygroscopicity, according to the original research CARNITINE Prescription, in the GMP workshop humidity environment conditions (40%--60%RH), there are production problems such as levocarnitine is easy to absorb moisture, material sticking, tablet cracking, etc....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/10A61K31/205A61K9/20A61P9/04A61P9/06A61P3/06A61P9/02A61P21/02
Inventor 童丰程梦威
Owner BEIJING CHENG JI PHARMA
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