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Solid pharmaceutical composition containing Fingolimod hydrochloride and preparation method thereof

A technology of fingolimod hydrochloride and its composition, which is applied in the field of new solid pharmaceutical composition and its preparation, can solve the problems of pharmacological toxicity and side effects, achieve the effects of reducing side effects, expanding the application range of dosage forms, and good mixing uniformity

Inactive Publication Date: 2013-07-31
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

but pharmacological side effects

Method used

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  • Solid pharmaceutical composition containing Fingolimod hydrochloride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-8

[0022] Examples 1-8 ： 120mg tablet / capsule

[0023] Example 1 Example 2 Example 3 Example 4 components Quantity (mg) Quantity (mg) Quantity (mg) Quantity (mg) Fingolimod Hydrochloride 0.56 1.4 2.8 5.6 lactose 114.64 113.80 112. 40 109.60 povidone 2.4 2.4 2.4 2.4 Magnesium stearate 2.4 2.4 2.4 2.4 total 120 120 120 120 Example 5 Example 6 Example 7 Example 8 components Quantity (mg) Quantity (mg) Quantity (mg) Quantity (mg) Fingolimod Hydrochloride 0.56 1.4 2.8 5.6 lactose 115.84 115.00 113. 60 110.80 povidone 2.4 2.4 2.4 2.4 Magnesium stearate 1.2 1.2 1.2 1.2 total 120 120 120 120

[0024] crafting process:

[0025] (1) Weigh a specified amount of fingolimod hydrochloride and lactose fluidized bed jet milling in a ratio equal t...

Embodiment 9-16

[0028] Examples 9-16 ： 120mg tablet / capsule

[0029] Example 9 Example 10 Example 11 Example 12 components Quantity (mg) Quantity (mg) Quantity (mg) Quantity (mg) Fingolimod Hydrochloride 0.56 1.4 2.8 5.6 lactose 114.64 113.80 112. 40 109.60 Hydroxypropylmethylcellulose 2.4 2.4 2.4 2.4 Magnesium stearate 2.4 2.4 2.4 2.4 total 120 120 120 120 Example 13 Example 14 Example 15 Example 16 components Quantity (mg) Quantity (mg) Quantity (mg) Quantity (mg) Fingolimod Hydrochloride 0.56 1.4 2.8 5.6 lactose 115.84 115.00 113. 60 110.80 povidone 2.4 2.4 2.4 2.4 Magnesium stearate 1.2 1.2 1.2 1.2 total 120 120 120 120

[0030] crafting process:

[0031] (1) Weigh a specified amount of fingolimod hydrochloride and lactose fluidized bed j...

Embodiment 17-32

[0034] Examples 17-32 ： 120mg tablet / capsule

[0035] In another example, the methods of Examples 1 and 16 were repeated except that pregelatinized starch was used instead of lactose.

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Abstract

The invention belongs to the technical field of medicine, and concretely relates an oral pharmaceutical composition and a preparation method. The oral pharmaceutical composition comprises micronized fingolimod or pharmaceutically acceptable salts and pharmaceutically acceptable carriers thereof, and is existed in solid oral dosage forms such as tablets and capsules. The method is simple is preparation technology and suitable for industrial production; and the pharmaceutical composition can be used for treating multiple sclerosis, reduces frequency of clinical exacerbations and delays accumulation of physical disability.

Description

technical field [0001] The invention relates to a novel solid pharmaceutical composition and a preparation method thereof, in particular to a fingolimod pharmaceutical composition for treating multiple sclerosis and a preparation method thereof. Background technique [0002] Multiple sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system and immunity. In fact, nerve fibers (axon), neurons (neuron) and oligodedrocytes (oligodedrocyte) will also be damaged. It is an autoimmune disease related to the nervous system. It is the cause of disability in young and middle-aged people after trauma. At present, there is no effective treatment drug. Multifunctional disorder is scarier than cancer. Known as "Cancer That Can't Die". [0003] Fingolimod is the first new orally administered immunosuppressant for the treatment of relapsing-remitting multiple sclerosis. It has two main mechanisms of action. One is to promote the relocation of lymphocytes t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/48A61K31/137A61P25/00
Inventor 马莉黄雪任广智
Owner BEIJING VENTUREPHARM BIOTECH
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