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Risperidone-containing oral membranous medicinal composition

A technology of composition and oral film, which is applied in the field of oral film-like pharmaceutical composition, and can solve the problems of heavy bitterness and the like

Active Publication Date: 2018-10-23
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Aiming at the problem of severe bitter taste of risperidone oral preparations existing in the prior art, the inventors finally provided a kind of risperidone with good physical properties, good stability and good taste through a large number of experiments and research on preparation technology, which can be used in the oral cavity. Risperidone oral film pharmaceutical composition with rapid dissolution and high bioavailability

Method used

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  • Risperidone-containing oral membranous medicinal composition
  • Risperidone-containing oral membranous medicinal composition
  • Risperidone-containing oral membranous medicinal composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Embodiment 1 Preparation and evaluation of risperidone film-like pharmaceutical composition without PVP

[0076] In this example, citric acid was used as a sour agent, HPMC was used as a film-forming material, sucralose was used as a sweetener, and glycerin was used as a plasticizer to prepare a film-shaped pharmaceutical composition of risperidone. The specific preparation process is as follows:

[0077] Weigh 0.3 g of risperidone and add it into 20 ml of water to disperse evenly, then weigh 2 g of anhydrous citric acid, 0.5 g of sucralose, 0.2 g of strawberry essence, and 1 g of titanium dioxide, add in and stir to dissolve. After that, 2.5 g of hypromellose (HPMC) with a model number of E5 and 2 g of hypromellose with a model name of E15 were weighed and added and stirred until completely swollen. Finally, 1.5 g of glycerin was weighed, added and stirred evenly to obtain a feed liquid. After vacuum defoaming the material liquid, use a coating machine to coat and dr...

Embodiment 2

[0079] Example 2 Preparation and evaluation of risperidone film-like pharmaceutical composition containing PVP

[0080] In this example, citric acid was used as a sour agent, PVP was used as a taste-masking agent, HPMC was used as a film-forming material, sucralose was used as a sweetener, and glycerin was used as a plasticizer to prepare a risperidone film-like pharmaceutical composition. The specific preparation process is as follows:

[0081] After weighing 1 g of risperidone and adding it to 20 ml of water to disperse evenly, sequentially weigh 1.0 g of anhydrous citric acid, 0.3 g of sucralose, 0.2 g of strawberry essence, and 0.5 g of titanium dioxide, add them and stir to dissolve. After that, weigh 2g of PVP (K30) and add it and stir it well to dissolve. Then add 2 g of hypromellose (HPMC) of type E5 and 2 g of hypromellose of type E15 and stir until completely swollen. Finally, 1 g of glycerin was weighed, added and stirred evenly to obtain a feed liquid. After vac...

Embodiment 3

[0083] Example 3 Preparation and Stability Research of Risperidone Film-like Pharmaceutical Composition Containing Drug Stabilizer

[0084] In this example, tartaric acid is used as a sour agent, PVP is used as a taste-masking agent, HPMC is used as a film-forming material, sucrose is used as a sweetener, glycerin is used as a plasticizer, and disodium edetate is used as a drug stabilizer to prepare Ripe Ketone film-like pharmaceutical composition. The specific preparation process is as follows:

[0085]Weigh 0.8 g of risperidone and add it into 20 ml of water to disperse evenly, then weigh 3.0 g of L-tartaric acid, 0.2 g of sucrose, 0.2 g of sweet orange essence, 0.3 g of titanium dioxide, and 0.02 g of disodium edetate, add them and stir to dissolve. After that, weigh 1.5g of PVP (K30) and add it and fully stir to dissolve. Then add 2.0 g of hypromellose (HPMC) of model E3 and 1 g of hypromellose of model E15 and stir until completely swollen. Finally, 0.098 g of glycerin...

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Abstract

The invention belongs to the field of medicinal preparations, and concretely provides a risperidone-containing oral membranous medicinal composition having the advantages of excellent taste, rapidnessin dissolving in the oral cavity, and high bioavailability. The medicinal composition includes: (a) a medicine active component selected from risperidone or its pharmaceutically acceptable salts; (b)an acidulant selected from one or an arbitrary combination citric acid, tartaric acid, hydrochloric acid and malic acid; (c) an odor masking additive selected from polyvinylpyrrolidone; (d) a sweetener; and (e) a film forming material. The bitterness of the risperidone medicine is effectively covered through a specific preparation technology by using the polyvinylpyrrolidone as the main odor masking additive and using the acidulant and the sweetener as auxiliary materials. The above prepared risperidone membranous preparation has the advantages of excellent taste, good physical performances,good stability, fastness in dissolving in the oral cavity, and high bioavailability. The medicinal composition is used for treating schizophrenia.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an oral film-like pharmaceutical composition with good taste, which uses risperidone or a pharmaceutically acceptable salt thereof as an active ingredient. Background technique [0002] Schizophrenia is a common severe mental disorder characterized by loss of contact with reality, hallucinations, delusions, abnormal thinking, flat affect, decreased will, and work and social dysfunction. [0003] Worldwide, the incidence rate of schizophrenia is about 1%, and the incidence rate varies from region to region. In the United States, patients with schizophrenia account for a quarter of all hospital admissions and 20 percent of Social Security disability claims. Schizophrenia is more common than Alzheimer's disease, diabetes or multiple sclerosis. [0004] The peak age of onset of schizophrenia is about 18-25 years old in men, and 26-45 years old in women, but pa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/519A61K47/32A61K47/12A61K47/04A61P25/18
CPCA61K47/02A61K47/12A61K47/32A61K9/0056A61K9/7007A61K31/519
Inventor 王栋海杨清敏张明会
Owner QILU PHARMA CO LTD
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