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Mirogabalin sustained-release tablet and preparation method thereof

A technology of sustained-release tablets and benzenesulfonic acid, which can be applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as disease reporting and insufficient treatment, and achieve good analgesic effects. , the effect of improving appearance and improving stability

Active Publication Date: 2020-03-27
南京康川济医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Peripheral neuropathy occurs in approximately 50% of diabetic patients, and diabetic peripheral neuropathic pain is predicted to occur in 11%-26% of diabetic patients, yet often such conditions are severely underreported and treated

Method used

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  • Mirogabalin sustained-release tablet and preparation method thereof
  • Mirogabalin sustained-release tablet and preparation method thereof
  • Mirogabalin sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] (1) Core layer (per piece):

[0041]

[0042] (2) Composition of film coating solution

[0043] Opadry 02N-650001-CN 15mg

[0044] Embodiment 1——Example 10 Milopalin Besylate Sustained-release Tablet Preparation Technology:

[0045] (1) Grinding the bulk drug to a particle size D 50 Less than 60μm. Pass the auxiliary material through a 40 mesh sieve. The raw and auxiliary materials are weighed according to the prescription amount, and mixed uniformly according to the equal amount incremental method to obtain the premixed powder. Add an appropriate amount of binder to make soft materials, granulate through a 18-mesh sieve, dry on a fluidized bed, and granulate through a 20-mesh sieve. Add the prescribed amount of lubricant and mix well.

[0046] (2) Tablet compression: use a special-shaped die with a size of 12.2mm×6.5mm, and control the hardness to 10-15kg.

[0047] (3) Colored film coating: use Opadry 02N-650001-CN to coat the above-mentioned tablet core, and...

Embodiment 2

[0051] (1) Core layer (per piece):

[0052]

[0053] (2) Composition of film coating solution

[0054] Opadry 02N-650001-CN 15mg

Embodiment 3

[0056] (1) Core layer (per piece):

[0057]

[0058] (2) Composition of film coating solution

[0059] Opadry 02N-650001-CN 15mg

[0060] The release rate of the milobarin besylate sustained-release tablet of embodiment 1 is shown in figure 1 . The release rate of the milobarin besylate sustained-release tablet of embodiment 2 is shown in figure 2 . The release rate of the milobarin besylate sustained-release tablet of embodiment 3 is shown in image 3 . It can be seen that the weight ratio between self-made samples 1, 2, and 3, that is, high-viscosity hypromellose and low-viscosity hypromellose, is 1:0.5, and more than 75% can be released in 12 hours, and The release was complete at 24 hours, indicating that the release curves of the three different specifications of milobarin besylate sustained-release tablets were consistent, and all of them could achieve good sustained-release effects in vitro.

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PUM

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Abstract

The invention provides a mirogabalin sustained-release tablet and a preparation method thereof. The sustained-release tablet contains mirogabalin, high-viscosity hydroxypropyl methylcellulose, low-viscosity hydroxypropyl methylcellulose, a filling agent and other medicinal adjuvants. For the mirogabalin sustained-release tablet, the mirogabalin accounts for 1-15 percent of the weight of a tablet core, the high-viscosity hydroxypropyl methylcellulose accounts for 20-40 percent of the weight of the tablet core, the low-viscosity hydroxypropyl methylcellulose accounts for 10-20 percent of the weight of the tablet core, the filling agent accounts for 30-50 percent of the weight of the tablet core, the other medicinal adjuvants account for 1-8 percent of the weight of the tablet core, and a colored film coating material accounts for 2-8 percent of the total weight of the tablet. The invention further discloses a preparation method for the mirogabalin sustained-release tablet. The mirogabalin sustained-release tablet prepared by using the method has the sustained-release characteristic, can slowly release a drug within 24h, is beneficial to maintaining a long-term efficient blood concentration in a body and improves the treatment effect of the drug.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to milobarin besylate sustained-release tablets and a preparation method thereof. Background technique [0002] Mirogabalin besylate (Mirogabalin) is a new drug for the treatment of chronic pain. It exerts an analgesic therapeutic effect by selectively binding to the α2δ-1 subunit of the voltage-dependent calcium channel (1 and 2). [0003] Miloparin besylate is white to slightly yellowish white powder, easily soluble in 1,3-dimethyl-2-imidazolidinone, methanol and ethanol (99.5), slightly soluble in water, insoluble in acetone, very insoluble in Acetonitrile, insoluble in anisole and methyl tert-butyl ether. Its chemical name is [(1R, 5S, 6S)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl]acetic acid monobenzenesulfonate, and its structural formula is as follows shown in the formula. [0004] [0005] Peripheral neuropathic pain (PNP) is caused by p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/38A61K47/26A61K31/195A61P25/02
CPCA61K9/2866A61K9/2018A61K9/2054A61K31/195A61P25/02
Inventor 尹来生陈金脱朱春莉袁哲哲
Owner 南京康川济医药科技有限公司
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