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A method to relieve stress in capsule shells to reduce propensity to break

A technology of capsule shell and hard capsule shell, which is applied in the directions of capsule transportation, pharmaceutical formulation, furnace, etc., can solve problems such as failure and brittle capsule shell.

Active Publication Date: 2019-08-23
R P SCHERER TECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the presence of too little plasticizer may cause the capsule shell to become brittle and / or fail in high stress areas

Method used

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  • A method to relieve stress in capsule shells to reduce propensity to break
  • A method to relieve stress in capsule shells to reduce propensity to break
  • A method to relieve stress in capsule shells to reduce propensity to break

Examples

Experimental program
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Effect test

example 1

[0064] Example 1 (impact and hardness of heat treated capsules):

[0065] The effect of heat treatment on the hardness and impact response of soft capsules was studied. For control experiments, the capsules containing the lipophilic fill material were placed in a weighing boat covered with a napkin under ambient conditions and allowed to dry. Similar results are expected to be obtained using hydrophilic materials.

[0066] The experimental capsules were subjected to accelerated drying, during which heat treatment occurred. For this process, the temperature was raised from about 30°C to about 48°C for about 14 hours, after which the temperature was lowered back to 25°C. The relative humidity was also maintained at a high level throughout the experiment and varied in the range of 79% RH to 2% RH as the temperature increased.

[0067] The hardness of the samples was measured using a Bareiss Digitest Gelomat according to ASTM D2240 at a rate of 0.01 mm / sec for a period of 20 ...

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PUM

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Abstract

A method of treating a soft or hard capsule shell to reduce or alleviate stress in the capsule shell. The method includes a step of heating at least a portion of the soft or hard capsule shell to a temperature above a glass transition temperature of the capsule shell but below a melt temperature of the capsule shell for a time sufficient to reduce internal stress in the capsule shell. The method can be used to reduce cracking of hard or soft capsule shells by application of the heat treatment to the filled capsule shells after fabrication and filling.

Description

technical field [0001] The present disclosure relates to a method of treating a capsule shell to relieve stress within the capsule shell and reduce the likelihood of the shell cracking or being damaged during storage or handling. Background technique [0002] Capsules are well known dosage forms which generally consist of a shell filled with a filler material containing one or more drugs or other substances. Such capsules can have a soft or hard capsule shell. [0003] Hard capsule shells are usually manufactured using a dip molding process. In this process, capsules are prepared by dipping mold pins into a polymer solution, optionally containing one or more gelling agents and co-gelling agents. The mold pins are designed to mold the cap and corresponding capsule body. The cap and capsule body are molded to provide a telescoping fit between the two components. The mold pins are then removed, turned over and dried to form a film on the surface. The dried capsule film is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/07
CPCA61J3/07F26B21/04F26B21/08F26B21/10F26B21/12F26B11/04F26B3/06A61K9/4825A61J3/077A61K9/48F26B21/004F26B3/02Y10S53/90
Inventor 莱斯特·大卫·富勒诺顿·哈特
Owner R P SCHERER TECH INC