Acid resistant capsules

A technology of capsules and capsule shells, which can be used in capsule delivery, household components, applications, etc., and can solve problems affecting capsule dissolution curves, etc.

Inactive Publication Date: 2019-04-19
CAPSUGEL BELGIUM NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] However, it has been found that although the addition of a neutralizing agent allows effective dissolution of the enteric polymer, thereby benefiting the capsule manufacturing process, t

Method used

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[0123] Acid-resistant capsules were prepared as follows. The dissolving solution was prepared by adding 153 L of water to a 250 L vessel equipped with a stirrer propeller and anchor at room temperature. While stirring, HPMCAS (32 kg) was dispersed in water. Achieve effective dispersion and avoid foaming by manually adjusting the impeller speed as needed. Ammonia solution from 35% by weight feedstock was added in small aliquots over 30 minutes to achieve an initial pH of 5.8 to 5.9. The solution was then stirred for 2 hours until visually all HPMCAS appeared to be dissolved. Additional ammonia solution was added in small aliquots at 30 minute intervals to achieve a target pH of 6.00 + / - 0.05. The total amount of ammonia solution added in these steps was 2.34 kg. After the pH stabilized, 59 L of a 21 wt% HPMC solution was added to the vessel at room temperature. The resulting solution was then stirred for 1 hour to homogenize. The solution was then kept at room temperature...

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Abstract

An acid resistant capsule comprises at least one hard capsule shell, said shell comprising: an enteric polymer having acid groups; a film-forming aid; and an alkaline material, wherein said alkaline material is present in an amount such that said carboxylic acid groups of said enteric polymer have a degree of ionization of less than 15%.

Description

technical field [0001] The present disclosure relates to novel acid-resistant hard capsules suitable for pharmaceutical use, methods for their manufacture and particularly, but not exclusively, the use of such capsules for the oral administration of medicaments, veterinary products, foods and meals to subjects selected from humans or animals supplements. Background technique [0002] Hard drug capsules are usually manufactured by using the dip molding method. In this method, a pin mold is dipped into a water-based film-forming composition. The film is formed by subsequent gelation of the composition adhered to the pin. The film is then dried, peeled from the pins and cut to the desired length. Thereby a capsule cap and a body are obtained, which can then be filled with a substance and are telescopically connected together such that a filled hard drug capsule is obtained. As for patent documents disclosing this method, see eg US5264223, US5756123 and US5756123. [0003] ...

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Application Information

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IPC IPC(8): A61K9/48
CPCA61K9/4816A61K31/167A61J3/07A61K9/4808A61K9/4833B29C41/003B29C41/14B29C41/46B29K2105/0073B29L2031/7174
Inventor X.D.何S.J.范奎肯博恩J.L.凯普D.T.弗里森
Owner CAPSUGEL BELGIUM NV
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