New multi-functional auxiliary material for orally disintegrating tablets and preparation method thereof

An oral disintegrating tablet and multifunctional technology, which is applied in the field of new multifunctional excipients and their preparation, can solve the problems of large disintegration time difference of finished products, poor user feeling, low particle density, etc., and achieves improved drug content and industrialization The effect of high production feasibility and simple preparation method

Inactive Publication Date: 2010-09-15
SHANGHAI HUAMAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Commonly used powerful disintegrants have a heavy granular feeling after disintegration, bad taste, and poor feeling for users. Moreover, these disintegrants have small particle density and poor fluidity, and it is difficult to mix them evenly with the main drug and other excipients. Large differences in tablet weight and disintegration time of finished products are prone to quality problems during tablet compression

Method used

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  • New multi-functional auxiliary material for orally disintegrating tablets and preparation method thereof
  • New multi-functional auxiliary material for orally disintegrating tablets and preparation method thereof
  • New multi-functional auxiliary material for orally disintegrating tablets and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0039] Embodiment 1, the preparation of pharmaceutical excipient of the present invention

[0040] Get 56kg of mannitol, 14kg of isosorbide and 5kg of crospovidone into the reaction tank, add 14L of deionized water into the reaction tank, and stir evenly under heating to 55°C to form a solution; Cool at a speed of h to 26°C to partially crystallize mannitol and isosorbide to form a "crystal cake"; use a centrifugal spray dryer to spray dry at a temperature of 60°C to obtain 58kg of finished product with a yield of 82.86%.

Embodiment 2

[0041] Embodiment 2, the preparation of pharmaceutical excipient of the present invention

[0042] Take 100kg of mannitol, 25kg of isosorbide and 5kg of crospovidone into the reaction tank, add 100L of deionized water in the reaction tank, stir evenly under the condition of heating to 60°C, and form a solution; the solution is heated at 4°C / h Cool at a high speed to 30°C to partially crystallize mannitol and isosorbide to form a "crystal cake"; use a centrifugal spray dryer to spray dry at a temperature of 90°C to obtain 110kg of finished product with a yield of 88.00%.

Embodiment 3

[0043] Embodiment 3, the preparation of pharmaceutical excipient of the present invention

[0044] Get mannitol 72kg, isosorbide 18kg and crospovidone 5kg, drop into reaction tank, in the deionized water of 45L in the reaction tank, stir under heating to 58 ℃ of conditions, form a solution; Cool at a speed of h to 28°C to partially crystallize mannitol and isosorbide to form a "crystal cake"; use a centrifugal spray dryer to spray dry at a temperature of 80°C to obtain 85kg of finished product with a yield of 94.44%.

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Abstract

The invention relates to a new multi-functional auxiliary material for orally disintegrating tablets and a preparation method thereof, and belongs to the field of pharmacy. The preparation method comprises the following steps of: weighting and mixing mannitol, isosorbide and crospovidone; under the condition of using water as a solvent, carrying out high-shear dispersion on the obtained mixture so as to obtain solution; and then carrying out spray drying on the solution to obtain the new multi-functional auxiliary material.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a novel multifunctional auxiliary material for orally disintegrating tablets and a preparation method thereof. Background technique [0002] The definition of orally disintegrating tablets by the Center for Drug Evaluation of the State Food and Drug Administration (SFDA) refers to tablets that can disintegrate or dissolve in the oral cavity without water or a small amount of water after ingestion. Rapidly disintegrating or rapidly dissolving solid preparations, orally rapidly disintegrating tablets have the advantages of rapid release and convenient administration, especially for the elderly, children and patients with dysphagia who use traditional tablets, capsules, pills and solutions. Difficulties, orally disintegrating tablets have become a research hotspot for new dosage forms in the field of pharmacy because of their above-mentioned advantages. In 2003, the National Center for Drug E...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/32A61K47/26A61K9/20
Inventor 步振权
Owner SHANGHAI HUAMAO PHARMA
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