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Oral pharmaceutical composition with plant alkaloid for treatment of dependencies

A composition and alkaloid technology, which is applied in the direction of drug combination, medical preparations containing active ingredients, active ingredients of heterocyclic compounds, etc., can solve the problem of providing uniformity and solubility of alkaloids, and the difficulty of providing uniform content of alkaloids Sexuality, concealing the risk of overdose and other issues, to achieve the effect of improving product efficacy, reducing the risk of side effects, and reducing anxiety and fear

Pending Publication Date: 2021-07-30
索非药剂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The composition of this tablet material makes it difficult to provide the desired uniformity of the alkaloid content and to mask the bitter taste of the tablet during sucking, as well as to provide the uniformity and solubility of the alkaloid in the oral cavity and to hide an overdose risks of
[0012] A particular problem with solid forms is the segregation of the substances involved, which subsequently leads to differences in the distribution of substances in the composition of the solid form

Method used

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  • Oral pharmaceutical composition with plant alkaloid for treatment of dependencies
  • Oral pharmaceutical composition with plant alkaloid for treatment of dependencies
  • Oral pharmaceutical composition with plant alkaloid for treatment of dependencies

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-9

[0030] Example No / composition 1 2 3 4 5 6 7 8 9 Cytisine 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 Galantamine HBr - - - - - - - - - Pseudine HCl - - - - - - - - - Lobetaine HCl - - - - - - - - - L-Carnitine - - - - 0.3 0.2 - - - Tryptophan - - - - - 25.0 30.0 - - Cellulose Powder 5.0 5.0 5.0 5.0 92.2 59.8 60.0 84.5 61.5 calcium sulfate dihydrate 92.5 90.0 90.0 87.5 5.0 5.0 5.0 8.0 35.0 Magnesium stearate 0.5 0.5 3.0 3.0 0.5 0.5 3.0 3.0 1.0 Anhydrous colloidal silica 0.5 3.0 0.5 3.0 0.5 3.0 0.5 3.0 1.0 total weight 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 film coating 2.0 3.0 - 4.0 5.0 - 2.0 - 3.0

Embodiment 10-18

[0032]

[0033]

Embodiment 19-27

[0035] Example No / composition 19 20 21 22 23 24 25 26 27 Cytisine - - - - - - - - - Galantamine HBr 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Pseudine HCl - - - - - - - - - Lobetaine HCl - - - - - - - - - L-Carnitine - - - - 0.3 0.2 - - - Tryptophan - - - - - 10.0 - - - Cellulose Powder 5.0 5.0 5.0 5.0 88.7 76.3 86.5 84.0 47.0 calcium sulfate dihydrate 89.0 86.5 86.5 84.0 5.0 5.0 5.0 5.0 45.0 Magnesium stearate 0.5 0.5 3.0 3.0 0.5 0.5 3.0 3.0 1.5 Anhydrous colloidal silica 0.5 3.0 0.5 3.0 0.5 3.0 0.5 3.0 1.5 total weight 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 film coating - 3.0 4.0 - 5.0 2.0 - 4.0 -

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PUM

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Abstract

This invention is related to an oral pharmaceutical composition that contains a cholinergic agent, a natural plant alkaloid in particular, selected from the group of lobeline, anabasine, cytisine, galantamine or their acceptable salts, in the form of tablets and capsules. The excipients of the developed oral composition include cellulose powder, calcium sulphate, silica colloidal and magnesium stearate, the total content of cellulose powder and calcium sulphate dihydrate being from 64,5 to 97,5 % of the mass of the dosage form and at least 90% of the alkaloid particles being < 100um. The oral composition contains also at least one biologically active amino acid selected from: L-carnitine, tryptophan or a combination of them. The oral composition according to this invention achieves uniform distribution of the active substance in the composition, as well as stability of the composition due to the included excipients selected so as to react to a minimum with the alkaloid to form the qualitative and quantitative related substances admissible for the pharmaceutical composition. The composition according to this invention is applicable in the treatment of dependency and addiction to nicotine, tobacco products and alcohol.

Description

technical field [0001] The present invention relates to an oral pharmaceutical composition, which contains a cholinergic agent, especially a natural plant alkaloid selected from the group consisting of cytisine, galanthamine, lobeline, Anabasine or an acceptable salt thereof, the oral pharmaceutical composition for the treatment of dependence and addiction to nicotine, tobacco products and alcohol. Background technique [0002] Alcohol and nicotine, like all drugs, have the potential to create and maintain dependence. Through their direct effects on cells, including nerve cells and their transmission systems (so-called neurotransmitters - acetylcholine, dopamine, serotonin), a condition known as "dependency syndrome" occurs due to the systemic uptake of the relevant substances Conditions - physical and mental. The central and peripheral nervous systems (CNS and PNS) are among those organ systems in which alcohol and nicotine produce various and intense effects, leading to ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/445A61K31/439A61K31/55A61K31/4545A61P25/34A61P25/32A61K9/48
CPCA61P25/32A61P25/34A61K31/445A61K31/439A61K31/55A61K31/4545A61K9/2009A61K9/485A61K9/2054A61K9/2013A61K47/12A61K47/183A61K47/22A61K9/4866A61K9/4858A61K31/14A61K31/405A61K31/444
Inventor A·A·阿列克谢夫V·E·达斯卡洛夫
Owner 索非药剂有限公司
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