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Lomerizine hydrochloride osmotic pump tablet and preparation method thereof

A technology of lomerizine hydrochloride and osmotic pump tablets, which is used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc.

Active Publication Date: 2012-01-18
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Capsules and tablets are currently on the market. In order to maintain the long-term high-efficiency blood drug concentration in the body and improve the efficacy of the drug, it needs to be administered multiple times a day, which increases the patient's non-compliance. market share, it is imminent to develop a new formulation of lomerizine hydrochloride with 0-level release

Method used

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  • Lomerizine hydrochloride osmotic pump tablet and preparation method thereof
  • Lomerizine hydrochloride osmotic pump tablet and preparation method thereof
  • Lomerizine hydrochloride osmotic pump tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] prescription:

[0033]

[0034] Preparation method:

[0035] Grind lomerizine hydrochloride, meglumine, starch, mannitol, and povidone K30 respectively through a 100-mesh sieve, mix well, add water, and make a soft material, pass through a 24-mesh granulation, dry at 60°C for 2 hours, pass through 18-mesh granulation, adding magnesium stearate, mixing evenly, and pressing into tablet cores with a hardness of 2-8kg. Dissolve ethyl cellulose and triethyl citrate in acetone, mix well to obtain a coating solution, place the tablet core in a coating pan for coating, and cure at 50°C for 15 hours after coating. Prepare a small hole with a diameter of 0.2-0.8mm on one side of the chip core using a mechanical punching machine or a laser punching machine.

Embodiment 2

[0037] prescription:

[0038]

[0039] Preparation method:

[0040] Grind lomerizine hydrochloride, poloxamer, pregelatinized starch, lactose, and povidone K30 through a 100-mesh sieve, mix evenly, add water, and make a soft material, pass through a 24-mesh granulation, and dry at 60°C for 2 hour, cross 18 mesh granules, add magnesium stearate, mix uniformly, and compress into a tablet core with a hardness of 2-8kg. Dissolve methylcellulose and citric acid ester in acetone, mix evenly to obtain a coating solution, place the tablet core in a coating pan for coating, and cure at 50°C for 15 hours after coating. Prepare a small hole with a diameter of 0.2-0.8mm on one side of the chip core using a mechanical punching machine or a laser punching machine.

[0041] Study on the Release of Lomerizine Hydrochloride Osmotic Pump Tablets in 0.25% Sodium Lauryl Sulfate Aqueous Solution

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Abstract

The invention discloses a lomerizine hydrochloride osmotic pump tablet and a preparation method thereof, belongs to the novel technical field of medicaments, and relates to a novel preparation formulation of lomerizine hydrochloride. The osmotic pump tablet is a preparation taking the lomerizine hydrochloride as a main component, and is coated by a semipermeable film which contains a tablet core and is provided with drug-release pores. The osmotic pump tablet has the advantages of taking zero-order release kinetics as a characteristic, continuously releasing a certain amount of drugs at a constant rate, maintaining long-term high-efficiency blood concentration in a body, improving the curative effect of drugs, reducing the administration times of patients, improving the preparation stability, and regulating the drug release rate by changing the semitransparent property, sizes of the pore diameters and other factors, having nothing to do with external factors and drug properties, and being insensitive to gastrointestinal tract and other variable factors, good in vitro-in vivo correlation and the like.

Description

technical field [0001] The invention belongs to the field of pharmaceutical manufacturing, and relates to a new dosage form of lomerizine hydrochloride, in particular to a lomerizine hydrochloride osmotic pump tablet and a preparation method thereof. Background technique [0002] Lomerizine Hydrochloride is a calcium-antagonistic migraine treatment drug and belongs to the third-generation piperazine cerebrovasodilator. Jointly developed by Kanebo and Phamacia & Upjohn, it was first approved to go on the market in Japan in March 1999, and achieved sales of nearly 1 billion yen that year. Through application practice, its curative effect and safety have been unanimously recognized by both doctors and patients, and then it has been marketed in Europe, America and other countries. Migraine is a recurrent vascular headache that is mainly unilateral, and some patients may be accompanied by lifelong onset. With the acceleration of the pace of life, the pressure of modern people's...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/22A61K31/495A61K47/36A61P25/06
Inventor 徐卓业汪磊文意芬
Owner NANJING ZENKOM PHARMA
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