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Pharmaceutical composition containing 1h-inden-1-amine, 2,3-dihydro-n-2-propynyl-, (1r)-, methanesulfonate

The technology of a composition and mesylate, applied in the fields of depression and hyperactivity syndrome in children, can solve the problems of unsuitability for consumption, lack of stable impurities in pharmaceutical compositions, etc.

Inactive Publication Date: 2012-02-01
SANDOZ AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Furthermore, the pharmaceutical compositions known in the prior art lack stability and over time generate impurities beyond pharmaceutical limits, making them unsuitable for consumption

Method used

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  • Pharmaceutical composition containing 1h-inden-1-amine, 2,3-dihydro-n-2-propynyl-, (1r)-, methanesulfonate
  • Pharmaceutical composition containing 1h-inden-1-amine, 2,3-dihydro-n-2-propynyl-, (1r)-, methanesulfonate
  • Pharmaceutical composition containing 1h-inden-1-amine, 2,3-dihydro-n-2-propynyl-, (1r)-, methanesulfonate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] making process:

[0032] 1. Sift mannitol, cornstarch and pregelatinized starch and mix in a suitable mixer;

[0033] 2. Dissolve rasagiline in purified water;

[0034] 3. Granulate mannitol, corn starch, pregelatinized starch with rasagiline solution and dry the granules in a suitable drier;

[0035] 4. Sieve the dried granules;

[0036] 5. Sieve colloidal silicon dioxide, talcum powder and stearic acid;

[0037] 6. Mix the sieved granules with colloidal silicon dioxide and lubricate with talc and stearic acid;

[0038] 7. Compress the lubricated mixture into tablets.

Embodiment 2

[0041] making process:

[0042] 1. Rasagiline, mannitol, cornstarch and pregelatinized starch and part of the colloidal silicon dioxide are sieved and mixed in a suitable mixer;

[0043] 2. Granulate the dry mixture with purified water and dry the granules in a suitable drier;

[0044] 3. Sieve the dried particles;

[0045] 4. Sieve the remaining colloidal silicon dioxide, talcum powder and stearic acid;

[0046] 5. Mix the sieved granules with colloidal silicon dioxide and lubricate with talc and stearic acid;

[0047] 6. Compress the lubricated mixture into tablets.

[0048] Table 1 below gives the stability data for the different batches of rasagiline that were sometimes examined.

[0049] Table 1: Stability data of formulations of the present invention

[0050]

[0051]

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Abstract

A pharmaceutical composition comprising as an active ingredient a therapeutically effective amount of R(+)-N-propargyl-1-aminoindan mesylate thereof, and less than 50% by weight of hexahydric sugar alcohols.

Description

technical field [0001] The present invention relates to pharmaceutical compositions containing R(+)-N-propargyl-1-aminoindan mesylate, especially for the treatment of Parkinson's disease, memory impairment and dementia of the Alzheimer's type (DAT) , depression, and ADHD in children. Background technique [0002] Rasagiline mesylate ((1R)-2,3-dihydro-N-2-propynyl-1H-indene-1-amine mesylate) has the following structure: [0003] [0004] It is known in the literature that rasagiline is used as an irreversible monoamine oxidase inhibitor for the monotherapy of early Parkinson's disease or as an adjuvant therapy for more advanced cases. It is selective for type B monoamine oxidase. [0005] US Patent No. 5,532,415 discloses R(+)-N-propargyl-1-aminoindan, its preparation and various pharmaceutically acceptable salts thereof. [0006] US Patent No. 6,126,968 (the '968 patent) discloses pharmaceutical compositions containing R(+)PAI. R(+)PAI and its salts have been shown to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/205A61K9/20A61P25/16
CPCA61K9/2018A61K31/205A61K9/2059A61P25/00A61P25/16A61P25/24A61P25/28A61K9/20
Inventor K·塔洛希拉H·纳克赫德A·达罗伊
Owner SANDOZ AG
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