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A dalfampridine slow-release tablet and a preparing method thereof

A technology of dafampridine and sustained-release tablets, applied in the directions of pharmaceutical formulation, coating, pill delivery, etc., can solve problems such as reducing production cost and strengthening labor protection, and achieves the effect of reducing production cost, improving labor protection, and simple prescription

Inactive Publication Date: 2017-04-05
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The Dafangpyridine Sustained-release Tablets of the present invention can solve the problem of the content uniformity of Dafangpyridine in the Dafangpyridine Sustained-release Tablets, and the preparation method of the Dafangpyridine Sustained-release Tablets of the present invention can reduce the impact of Dafangpyridine powder on operators. Stimulation to strengthen labor protection while reducing production costs

Method used

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  • A dalfampridine slow-release tablet and a preparing method thereof
  • A dalfampridine slow-release tablet and a preparing method thereof
  • A dalfampridine slow-release tablet and a preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1: Darfangyridine Sustained-release Tablets of the present invention

[0045] prescription:

[0046]

[0047]Preparation:

[0048] a), in the isolator, dissolve the prescribed amount of darfanpyridine and hydroxypropyl methylcellulose E5Lv in 50% ethanol aqueous solution, and use it as a drug-containing adhesive for subsequent use;

[0049] b), hydroxypropyl methylcellulose K100Lv and pregelatinized starch are placed in a fluidized bed, mixed uniformly, the drug-containing binder is sprayed into the fluidized bed at a constant speed for granulation, and dried;

[0050] c), after drying, granulate, add colloidal silicon dioxide and magnesium stearate, mix, compress into tablets, and wrap into film coating.

Embodiment 2

[0051] Embodiment 2: Darfangyridine Sustained-release Tablets of the present invention

[0052] prescription:

[0053]

[0054] Preparation:

[0055] a), in the fume hood, the prescription amount of darfanpyridine and povidone are dissolved in 40% ethanol aqueous solution, and they are used as the drug-containing adhesive for subsequent use;

[0056] b) Hypromellose, microcrystalline cellulose, and lactose are placed in a wet granulator, mixed evenly, and the drug-containing binder is sprayed into the high-shear wet granulator at a constant speed for granulation, Fluidized bed drying;

[0057] c), after drying, granulate, add colloidal silicon dioxide and magnesium stearate, mix, compress into tablets, and wrap into film coating.

Embodiment 3

[0058] Embodiment 3: Darfangyridine Sustained-release Tablets of the present invention

[0059] prescription:

[0060]

[0061]

[0062] Preparation:

[0063] a), in the fume hood, dissolve the prescribed amount of darfanpyridine and hydroxypropyl cellulose in 70% ethanol aqueous solution, and use it as a drug-containing adhesive for subsequent use;

[0064] b) Put hypromellose and microcrystalline cellulose in a wet granulator, mix well, spray the drug-containing binder into the high-shear wet granulator at a constant speed for granulation, and fluidize bed dry,

[0065] c), after drying, granulate, add colloidal silicon dioxide and magnesium stearate, mix, compress into tablets, and wrap into film coating.

[0066] The preparation of three batches was repeated, and three batches of dalfampridine sustained-release tablets were prepared respectively.

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Abstract

The invention belongs to the field of medicinal preparations and particularly relates to a dalfampridine slow-release tablet and a preparing method thereof. The sustained release tablet comprises a dalfampridine-containing tablet core. The dalfampridine-containing tablet core comprises dalfampridine, a slow release material, an adhesive, a filler, a glidant and a lubricant. The prescription of the slow release tablet is simple, content uniformity is far lower than limit requirements, releasing rate differences among batches are low, reappearance is good and the slow release tablet and the method are suitable for industrial production. The preparing method is simple in operation. Through subjecting the adhesive containing dalfampridine, the slow release material, and the filler to fully mixing and wet granulation, irritation of dalfampridine powder to operators can be reduced, labor protection is improved and the production cost is reduced.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to Dafangpyridine sustained-release tablets and a preparation method thereof. Background technique [0002] Multiple sclerosis (MS) is a chronic autoimmune disease that attacks the nervous system, causing muscle weakness, pain and cognitive difficulties. In multiple sclerosis, a very specific, not uncommon, disease of the nervous system, a patient's immune system damages neurons in the brain and spinal cord, attacking the myelin sheath that insulates those nerves. About 85 percent of patients initially suffer from relapsing-remitting MS, which is characterized by flare-ups or illness that cause lesions to form in parts of the brain and affect a person's ability to walk, see and control their bladder, among other neurological damage. These illnesses are short-lived and patients usually recover. However, most people miss the chance of treatment due to lack of a...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/28A61K9/36A61K31/4409A61P25/00A61P37/02
CPCA61K9/2095A61K9/2054A61K9/284A61K9/2866A61K31/4409
Inventor 刘慧王世刚龙文颜携国陶安进袁建成
Owner HYBIO PHARMA
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