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Safinamide mesylate tablet and preparation method thereof

A technology of safinamide mesylate tablets and safinamide mesylate, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of unsatisfactory quality and curative effect Performance evaluation, impact on drug safety and effectiveness, speed and degree of absorption, etc., to achieve good operability, excellent appearance, and high dissolution rate

Active Publication Date: 2019-06-21
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Those skilled in the art know that if the drug is released too fast, it will affect the speed and degree of absorption in the body, and it will easily cause the instantaneous blood drug concentration to be too high, which will affect the safety and effectiveness of the drug, and will not meet the quality and curative effect under the current situation. Technical Requirements for Consistency Evaluation

Method used

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  • Safinamide mesylate tablet and preparation method thereof
  • Safinamide mesylate tablet and preparation method thereof
  • Safinamide mesylate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047]

[0048] The preparation method is as follows: pulverize the raw material of safinamide mesylate with a pharmaceutical grinder, weigh the raw material of safinamide mesylate in the prescribed amount, and then mix it with crospovidone, microcrystalline cellulose, and magnesium stearate in sequence. , Colloidal silicon dioxide is fully mixed; after the content of the mixed material is tested, the weight of the tablet should be converted according to the content, and the tablet is pressed. The hardness of the tablet is adjusted to 3-6kg, and the difference in tablet weight is ± 5.0%, and the tablet is pressed.

Embodiment 2

[0050]

[0051]

[0052] The preparation method is as follows: pulverize the raw material of safinamide mesylate with a pharmaceutical grinder, weigh the raw material of safinamide mesylate in the prescribed amount, and then mix it with crospovidone, microcrystalline cellulose, and magnesium stearate in sequence. , Colloidal silicon dioxide is fully mixed; after the content of the mixed material is tested, the weight of the tablet should be converted according to the content, and the tablet is pressed. The hardness of the tablet is adjusted to 3-6kg, and the difference in tablet weight is ± 5.0%, and the tablet is pressed.

Embodiment 3

[0054]

[0055] The preparation method is as follows: pulverize the raw material of safinamide mesylate with a pharmaceutical grinder, weigh the raw material of safinamide mesylate in the prescribed amount, and then mix it with crospovidone, microcrystalline cellulose, and magnesium stearate in sequence. , Colloidal silicon dioxide is fully mixed; after the content of the mixed material is tested, the weight of the tablet should be converted according to the content, and the tablet is pressed. The hardness of the tablet is adjusted to 3-6kg, and the difference in tablet weight is ± 5.0%, and the tablet is pressed.

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Abstract

The invention discloses a methanesulfonic acid safinamide tablet which is prepared from, in weight percentage, 50%-55% of methanesulfonic acid safinamide, 25%-45% of microcrystalline cellulose, 3%-20% of polyvinylpolypyrrolidone, 0.5%-2% of magnesium stearate and 0.1%-1% of colloidal silicon dioxide. Besides, the invention further discloses a preparation method of the methanesulfonic acid safinamide tablet. By a direct power compressing method, the production process is simple, the production cycle of products is shortened, production cost is reduced, and the prepared methanesulfonic acid safinamide tablet is stable and reliable in quality, high in dissolution rate and consistent with original triturate.

Description

technical field [0001] The application belongs to the field of pharmaceutical preparations, in particular to a drug safinamide mesylate tablet for treating Parkinson's disease (idiopathic Parkinson's disease, PD) and a preparation method thereof. Background technique [0002] Safinamide mesylate is developed by Newron and its marketing partner Zambon, and is a new type of oral drug for the treatment of Parkinson's disease. It was approved by EMA for marketing in February 2015. The dosage form is film-coated tablets. The trade name is Xadago, and the specifications are 50mg and 100mg (calculated as safinamide). Safinamide mesylate is indicated for the treatment of adult patients with idiopathic Parkinson's disease with fluctuating symptoms in the middle and advanced stages, as an adjunct to stable dose levodopa monotherapy or in combination with other Parkinson's drugs. [0003] The chemical name of safinamide mesylate is (S)-2-[4-(3-fluorobenzyloxy)benzylamino]propionamide ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/165A61K47/38A61K47/32A61K47/04A61K47/12A61P25/16
CPCA61K9/2009A61K9/2027A61K9/2054A61K9/2095A61K31/165
Inventor 吕慧敏孙元朋杨英杰孟蓉蓉
Owner YANGTZE RIVER PHARM GRP CO LTD