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Rapid disintegration tabella and chill-pressing method thereof

A disintegrating tablet and disintegrating agent technology, which is applied in the field of pharmaceutical preparations and preparations, can solve problems such as inability to reflect disintegration, and achieve the effects of avoiding poor mold release performance, low solid content, and simple tableting process

Inactive Publication Date: 2013-07-10
HAINAN WEI KANG PHARMA QIANSHAN +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition to the above-mentioned shortcomings, the freeze-drying method is only used as a supplementary method to the conventional drying method in this patent, and the low water content of 0.3%-10% cannot reflect the high temperature left after the sublimation of the solid solvent by the freeze-drying method. Porosity facilitates disintegration for special applications

Method used

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  • Rapid disintegration tabella and chill-pressing method thereof
  • Rapid disintegration tabella and chill-pressing method thereof
  • Rapid disintegration tabella and chill-pressing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Compressed tablet core prescription:

[0039]

[0040] Preparation steps:

[0041] 1) Weigh gelatin, mannitol, and PVP K30 according to the prescription; then add the prescribed amount of deionized water; stir and sonicate to obtain a clear solution;

[0042] 2) Put the clarified solution into a freezer to freeze to a solid state;

[0043] 3) Use a pulverizer to crush the solid solution to obtain ice particles, and the ice particles pass through a 50-mesh sieve;

[0044] 4) Weigh the pre-frozen microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and carboxymethyl starch sodium (through a 100-mesh sieve) according to the prescription and mix them evenly, and then mix them evenly with ice particles;

[0045] 5) Press the ice pellets into 500 pieces with a tablet machine;

[0046] 6) The resulting tablet is dried in a freeze dryer to obtain an orally disintegrating tablet.

[0047] The specific freeze-drying parameters and process are as follows: s...

Embodiment 2

[0053] Compressed tablet core prescription:

[0054]

[0055] Preparation steps:

[0056] 1) Weigh gelatin, mannitol, and PVP K30 according to the prescription; then add the prescribed amount of deionized water; stir and sonicate to obtain a clear solution;

[0057] 2) Put the clarified solution into a freezer to freeze to a solid state;

[0058] 3) Use a pulverizer to crush the solid solution to obtain ice particles, and the ice particles pass through a 70-mesh sieve;

[0059] 4) Press the ice pellets into 500 pieces with a tablet machine;

[0060] 5) The resulting tablet is dried in a freeze dryer to obtain an orally disintegrating tablet.

[0061] The freeze-drying process, freeze-drying parameters, disintegration time limit and friability detection are as described in Example 1.

[0062] After testing, the disintegration time limit of the obtained rapidly disintegrating tablets was 35.6 s, and the friability was 0.9%.

Embodiment 3

[0064] Compressed tablet core prescription:

[0065]

[0066] Preparation steps:

[0067] 1) Weigh gelatin and mannitol according to the prescription; then add the prescribed amount of deionized water; stir and sonicate to obtain a clear solution;

[0068] 2) Put the clarified solution into a freezer to freeze to a solid state;

[0069] 3) Use a pulverizer to crush the solid solution to obtain ice particles, and the ice particles pass through a 60-mesh sieve;

[0070] 4) Weigh the pre-frozen povidone K30 (through a 100-mesh sieve) according to the prescription, and then mix it with ice particles evenly;

[0071] 5) Press the ice pellets into 500 pieces with a tablet machine;

[0072] 6) The resulting tablet is dried in a freeze dryer to obtain an orally disintegrating tablet.

[0073] The freeze-drying process, freeze-drying parameters, disintegration time limit and friability detection are as described in Example 1.

[0074] After testing, the disintegration time lim...

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Abstract

The invention provides a rapid disintegration tabella and a chill-pressing method thereof, and relates to the field of pharmaceutical preparations and preparation methods. The rapid disintegration tabella provided by the invention is characterized in that ice-shaped particles containing a drug and a necessary auxiliary material as well as an additionally precool drug and an auxiliary material are uniformly mixed and pressed to be in piece shape, and then the freeze drying is carried out so as to prepare the rapid disintegration tabella, and the problems that the tabella can not rapidly disintegrate and the tabella prepared through a method in which the freeze drying is carried out after model pouring is small in rigidity when the common particles are subjected to normal temperature piece pressing. The method provided by the invention has the advantage that the production efficiency is high, and the method is suitable for industry manufacture.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations and preparation methods. Specifically, the invention relates to an ice-like granule containing medicine and necessary auxiliary materials in a low-temperature environment, plus pre-frozen medicine and auxiliary materials. After mixing and pressing into tablets, Method of freeze-drying prepared rapidly disintegrating tablets. Background technique: [0002] There are various types of rapidly disintegrating tablets, and various types and uses of rapidly disintegrating tablets such as oral administration, gynecological external use, and solution preparation have been developed. Among them, oral and oral rapidly disintegrating preparations are the most commonly used. Orally Disintegrating Tablets, referred to as Orally Disintegrating Tablets, are tablets that can disintegrate or dissolve quickly in the oral cavity. Usually, the dissolution time is from a few seconds to tens of seconds, gene...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61J3/10
Inventor 张继稳郭桢刘从镖李海燕汪六一汪金灿李彪
Owner HAINAN WEI KANG PHARMA QIANSHAN
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