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Method for controlling medicament release rate of orally disintegrating tablet

A technology for oral disintegrating tablets and disintegrating agents, which is applied in the field of oral disintegrating tablets, can solve the problems of unqualified product content uniformity, exceeding the disintegration time, and increasing the amount of binder, so as to achieve easy product quality, reduce The effect of slow release rate and reduced contact area

Inactive Publication Date: 2012-10-10
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because orally disintegrating tablets are required to disintegrate in the oral cavity within 1 minute, increasing the amount of binders and reducing the amount of disintegrants will lead to disintegration time exceeding the limit, and the coating of active ingredients uses powder coating technology, which is technically difficult Large, and after coating the active ingredient, the particle size becomes larger, and there will be a sandy feeling, which will affect the taste
Increasing the particle size of the active ingredient is only suitable for large-scale drugs and will also affect the mouthfeel
For small doses of drugs, increasing the particle size of the active ingredient will lead to substandard content uniformity of the product

Method used

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  • Method for controlling medicament release rate of orally disintegrating tablet
  • Method for controlling medicament release rate of orally disintegrating tablet
  • Method for controlling medicament release rate of orally disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047]

[0048]

[0049] Preparation method: mix aripiprazole, microcrystalline cellulose, pregelatinized starch, mannitol, ethyl cellulose, and aspartame evenly, add appropriate amount of absolute ethanol to granulate, and dry in a fluidized bed to obtain dry granules The dry granules are uniformly mixed with croscarmellose sodium, silicon dioxide and magnesium stearate after granulation, and pressed into tablets.

[0050] The samples of comparative example 1 and embodiment 1 are all tested stripping curves with the same method (paddle method 50rpm, pH1.0 hydrochloric acid solution 900mL), and the results are as follows:

[0051] sample

Embodiment 2

[0053]

[0054] Preparation method: Mix aripiprazole, microcrystalline cellulose, pregelatinized starch, mannitol, ethyl cellulose, red iron oxide, and aspartame evenly, add appropriate amount of absolute ethanol to granulate, pass through a fluidized bed Dried to obtain dry granules, which are uniformly mixed with croscarmellose sodium, silicon dioxide and magnesium stearate after granulation, and pressed into tablets.

Embodiment 3

[0056]

[0057] Preparation method: dissolve ethyl cellulose in an appropriate amount of isopropanol, mix aripiprazole, anhydrous calcium hydrogen phosphate, pregelatinized starch, glucose, and sucralose evenly, add ethyl cellulose in isopropanol The solution is granulated, dried in a fluidized bed to obtain dry granules, and after granulation, the dry granules are evenly mixed with croscarmellose sodium, micropowder silica gel and magnesium stearate, and pressed into tablets.

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Abstract

The invention relates to a preparation method of an orally disintegrating tablet. The orally disintegrating tablet contains active ingredients, a water-insoluble film-forming material accounting for 0.1%-4% of the total weight of the tablet and other pharmaceutically acceptable additives, and is prepared through a wet granulation process. The orally disintegrating tablet prepared according to the method disclosed by the invention can control the release rate of the active ingredients and is favorable for ensuring the bioequiavailability, clinical safety and efficacy of a product. Furthermore, the method disclosed by the invention has the advantages of simple process flow and easiness in realization of industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to orally disintegrating tablets. Background technique [0002] Orally disintegrating tablets, referred to as orally disintegrating tablets, are tablets that can disintegrate quickly in the oral cavity without water. When taking, they do not need water to assist swallowing, and do not need to be chewed. The tablets are placed on the tongue. It disintegrates rapidly when it encounters saliva, and enters the gastrointestinal tract to absorb and take effect by swallowing power. Compared with ordinary tablets, orally disintegrating tablets are especially suitable for people who have difficulty swallowing (especially the elderly and children) or patients in special environments where water is not available. [0003] Orally disintegrating tablets usually have a fast dissolution rate due to their rapid disintegration characteristics. A large number of literatures have reported t...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/32
Inventor 胡李斌彭俊清李巧霞胡功允
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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