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Risperidone oral rapidly disintegrating film preparation and preparation method thereof

An oral instant film, risperidone technology, applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. The effect of avoiding Tibetan medicine or vomiting and improving compliance

Inactive Publication Date: 2015-03-25
段珍波
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But generally speaking, the oral instant film is made of hydrophilic matrix material, but risperidone is almost insoluble in water, so it is difficult to disperse in the hydrophilic solution
In patent CN 101632651 B, 70% ethanol is used to dissolve risperidone, but during the drying process, the main drug of risperidone will be agglomerated, affecting the main content uniformity, and there is a gritty feeling when taken orally; patent CN 101632651 B Among them, 70% ethanol is used to dissolve risperidone, and the amount of use is large. As a flammable and explosive organic solvent, ethanol brings some unsafe factors to large-scale production

Method used

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  • Risperidone oral rapidly disintegrating film preparation and preparation method thereof
  • Risperidone oral rapidly disintegrating film preparation and preparation method thereof
  • Risperidone oral rapidly disintegrating film preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The prescription amount is 1000 tablets (specification 2mg) or 2000 tablets (specification 1mg)

[0036]

[0037] *Removed during the drying process of the knife coating.

[0038] Process:

[0039] Weigh 2g of d-α-tocopherol polyethylene glycol succinate, place it in a suitable container, add 120g of water, heat to 40℃ to dissolve, add 2g of risperidone, stir to dissolve, add 15g of mannitol, stir Uniform, regarded as A.

[0040] Weigh 30 g of hypromellose, place it in a suitable container, add 80 g of distilled water at 80-95°C, stir uniformly, and cool to 40°C to obtain glue B.

[0041] Add glue B to A, shear at 15000 rpm for 1 minute, and then sonicate for 30 minutes to remove air bubbles to obtain glue for scraping. Scrape the glue onto a stainless steel film plate, dry at 60°C, peel the film agent from the stainless steel film plate, cut and pack, and then obtain the film agent.

Embodiment 2

[0043] The prescription amount is 1000 tablets (specification 2mg) or 2000 tablets (specification 1mg)

[0044]

[0045] *Removed during the drying process of the knife coating.

[0046] Process:

[0047] Weigh 1g of d-α-tocopherol polyethylene glycol succinate, place it in a suitable container, add 200g of water, heat to 40℃ to dissolve, add 2g of risperidone, stir to dissolve, add 10g of mannitol, add 20 g of polyoxyethylene, high-speed shearing at 15000 rpm for 1 minute, and standing under vacuum conditions for 4 hours to remove air bubbles, to obtain a glue for scraping. Scrape the glue onto a stainless steel film plate, dry at 60°C, peel the film agent from the stainless steel film plate, cut and pack, and then obtain the film agent.

Embodiment 3

[0049] The prescription amount is 1000 tablets (specification 2mg) or 2000 tablets (specification 1mg)

[0050]

[0051] *Removed during the drying process of the knife coating.

[0052] Process:

[0053] Weigh 0.5g of d-α-tocopherol polyethylene glycol succinate, place it in a suitable container, add 200g of water, heat to 40°C to dissolve, add 2g of risperidone, stir to dissolve, add 20g of mannitol, Stir uniformly, add 30 g of polyvinyl alcohol, shear at a high speed at 15000 rpm for 1 minute, and let it stand for 4 hours under vacuum to remove air bubbles to obtain a glue for knife coating. Scrape the glue onto a stainless steel film plate, dry at 60°C, peel the film agent from the stainless steel film plate, cut and pack, and then obtain the film agent.

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Abstract

The invention belongs to the field of medicine preparations, and particularly relates to a risperidone oral rapidly disintegrating film preparation and a preparation method thereof. The risperidone oral rapidly disintegrating film preparation is prepared from the following components in percentage by weight: 0.1-10 percent of risperidone, 0.05-30 percent of a solubilizer, 20-90 percent of a high-molecular film-forming material, 0-40 percent of a plasticizer, 0-40 percent of a flavoring preparation and 0-8 percent of other auxiliaries. The preparation can be taken without water, can be quickly dissolved in the oral cavity to avoid the phenomenon that a schizophrenic patient hides medicines in the oral cavity or spits medicines, and is advantageous to improve the medication compliance of patients. By using the preparation method, the main drug of the preparation can achieve a good dissolution promoting effect under the action of the solubilizer, so that the contents of the main drugs are uniform, the main drugs are quickly dissolved and good in stability, the product dosage is accurate, and the preparation has good taste without sand feeling; no dust is generated in the production process, so that the problems of labor protection and environmental pollution can be solved; and no organic solvent is used, so that the preparation has high production safety.

Description

Technical field [0001] The invention belongs to the field of chemical pharmacy, and specifically relates to a risperidone oral instant film and a preparation method thereof. technical background [0002] Risperidone is a new type of atypical antipsychotic drug developed by Janssen Pharmaceuticals in Belgium. It is suitable for the treatment of acute and chronic schizophrenia and other obvious positive symptoms and obvious negative symptoms of various mental states, and can also be used to reduce emotional conditions related to schizophrenia, such as depression, guilt, and anxiety. [0003] The commonly used clinical dosage forms of risperidone are ordinary tablets, capsules, and orally disintegrating tablets. Ordinary tablets and capsules are difficult to swallow, so children and elderly patients are not very suitable for taking these types of medicines, and they are not convenient for patients to take them without water. Although the orally disintegrating tablet solves the above...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/519A61K47/34A61P25/18A61P25/22A61P25/24
Inventor 王国振
Owner 段珍波