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Olanzapine oral instant film

An oral instant film, olanzapine technology, applied in pharmaceutical formulations, nervous system diseases, sheet delivery, etc., can solve the problems of increased production cost, high price of auxiliary materials, and high equipment requirements, and achieves short production cycle and oral absorption. The effect of fast speed and simple process

Active Publication Date: 2020-09-01
QILU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the new dosage forms such as solid dispersions, clathrates, micelles or liposomes all have the characteristics of high excipient prices, difficult processes, and high equipment requirements, and the new dosage forms need to be prepared first, then freeze-dried, and then The process of preparing orally dissolving film is undoubtedly more complicated than that of olanzapine orally disintegrating tablets, which also increases the production cost

Method used

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  • Olanzapine oral instant film
  • Olanzapine oral instant film
  • Olanzapine oral instant film

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The prescription quantity is 1000 tablets (5mg specification)

[0041]

[0042] *Used in prescription but removed during processing.

[0043] First add the above-mentioned amount of sucralose, glycerin and polysorbate 80 into the aqueous solution, after stirring and dissolving, add hypromellose (15 centipoise), fully stir and dissolve to obtain the hypromellose blank glue, and then Add olanzapine and stir until evenly dispersed to obtain olanzapine drug-containing glue, stir and defoam under vacuum conditions, apply the drug-containing glue evenly on the polyester tape after defoaming, and heat at 70-80°C Drying, yellow after drying, extremely poor toughness and strength, unable to form a film.

Embodiment 2

[0045] The prescription quantity is 1000 tablets (5mg specification)

[0046]

[0047]

[0048] *Used in prescription but removed during processing.

[0049] First add the above-mentioned amount of sucralose, glycerin and polysorbate 80 into the aqueous solution, stir to dissolve, then add hydroxypropyl cellulose, stir and dissolve fully to obtain a hydroxypropyl cellulose blank glue, then add olanzapine and Stir until uniformly dispersed to obtain olanzapine drug-containing glue, stir and defoam under vacuum conditions, apply the drug-containing glue evenly on the polyester tape with a scraper after degassing, heat and dry at 70-80°C, and after drying, it becomes Yellow, very poor in toughness and strength, unable to form a film.

Embodiment 3

[0051] The prescription quantity is 1000 tablets (5mg specification)

[0052]

[0053] *Used in prescription but removed during processing.

[0054] First add the above-mentioned amount of sucralose, glycerin and polysorbate 80 into the aqueous solution, stir to dissolve, then add polyvinyl alcohol, fully stir and dissolve in a water bath at 80°C to obtain a polyvinyl alcohol blank glue, then add olanzapine and stir Until the olanzapine drug-containing glue is uniformly dispersed, stir and defoam under vacuum conditions, apply the drug-containing glue evenly on the polyester tape with a scraper, heat and dry at 70-80°C, and turn yellow after drying , The toughness and strength are extremely poor, and it is impossible to form a film.

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Abstract

The invention relates to an olanzapine oral instant film which can be dissolved immediately in the oral cavity, which is used for improving the use performance of the olanzapine and belongs to the field of pharmaceutical preparations. The mouth-dissolving film includes active pharmaceutical ingredients and pharmaceutically applicable auxiliary materials, the active pharmaceutical ingredient is olanzapine, and pharmaceutically applicable auxiliary materials include: film-forming materials, plasticizers, absorption accelerators, flavoring agents and other auxiliary materials, film-forming materials Include at least gelatin. This orally dissolving film has the advantages of high drug loading, thin thickness, good taste, instant dissolution in the oral cavity without drinking water, and fast oral absorption, which solves the poor drug compliance of schizophrenic patients and the phenomenon of Tibetan medicine and vomiting. Especially suitable for patients with swallowing difficulties.

Description

technical field [0001] The invention relates to an olanzapine oral instant film which can be dissolved immediately in the oral cavity, belonging to the field of pharmaceutical preparations. Background technique [0002] Olanzapine, a tribenzodiazepine compound, its chemical name is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-6 ][1,5]benzodiazine, the structural formula is as follows: [0003] [0004] Olanzapine is a second-generation antipsychotic drug with pharmacological effects on multiple receptor systems. Animal experiments have shown that olanzapine has affinity for multiple receptors such as 5-HT, dopamine D, α-adrenaline, and histamine H. Animal behavior studies have shown that olanzapine has 5-HT, dopamine and cholinergic antagonism, which is consistent with its receptor binding. Olanzapine has a greater affinity for the 5-HT2 receptor in vitro and in vivo than its affinity for the dopamine D2 receptor. Electrophysiological studies have shown that ola...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/551A61P25/18
Inventor 刘禄娟张勇王栋海杨清敏张明会程廷廷周志超李延志
Owner QILU PHARMA
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