Capsule stable against mastication

A technology of capsules and capsule shells, which can be used in the fields of capsule delivery, inactive components of polymer compounds, and nervous system diseases, etc., and can solve problems such as no specific disclosure.

Inactive Publication Date: 2007-07-18
ONO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] But until now, there is no specific disclosure for soft capsules containing (

Method used

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  • Capsule stable against mastication

Examples

Experimental program
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Effect test

Embodiment 1

[0149] Embodiment 1: the preparation of the soft capsule containing (2R)-2-propyl octanoic acid (300mg)

Embodiment 1-1

[0151] Composition of capsule shell Bovine gelatin: glycerol = 100:30

[0152] Bovine gelatin (20 kg) and concentrated glycerin (6 kg) were mixed at 70°C in the presence of purified water (20 kg) to obtain a homogeneous solution. This solution and (2R)-2-propyl octanoic acid (0.9kg) are dropped into soft capsule filling machine (rotary soft capsule forming machine H-1 type; Kamata), obtain filling (2R)-2-propyl octanoic acid Softgels in raw balls. By drum-drying the obtained green pellets (24°C, 3 hours) and rack drying (29°C, 15-45 hours) in sequence to obtain 300 mg of (2R)-2-propyloctanoic acid in each capsule Softgels (2100 Capsules). Carry out the same operation 6 times further, obtain altogether 7 batches of soft capsules. The rack drying time for each batch was: 27 hours for batches #1 to #5, 15 hours for batch #6, and 45 hours for batch #7.

Embodiment 1-2

[0154] Composition of capsule shell Porcine gelatin: glycerol = 100:30

[0155] Porcine gelatin (20 kg) and concentrated glycerol (6 kg) were mixed at 75°C in the presence of purified water (16 kg) to obtain a homogeneous solution. The solution and (2R)-2-propyl octanoic acid (1.8kg) were put into a soft capsule filling machine (Rotary (ロ-タリ-) type soft capsule molding machine H-1 type; Kamata) to obtain filling (2R) -2-Propyl octanoic acid in raw pellets of soft capsules. The obtained green pellets were subjected to drum drying (23.5°C, 3 hours) and rack drying (29°C, 27 hours) in sequence to obtain soft-shelled (2R)-2-propyloctanoic acid containing 300 mg per capsule. capsules (5700 capsules).

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Abstract

Soft capsules being easily disintegratable in the stomach and avoiding any ready leakage of contents at mastication, which soft capsules encapsulate (2R)-2-propyloctanoic acid or its salt and are characterized in that there is realized at least one property, preferably all thereof, selected from among (A) strength of 150 to 400 N as measured by a cracking load test; (B) disintegration time of 3 to 10 min as measured by a disintegration testing method stipulated in Japanese Pharmacopoeia; (C) thickness of 0.05 to 0.50 mm with respect to the central part of capsule shell; (D) thickness of 0.10 to 0.55 mm with respect to the first joint part of capsule shell; (E) thickness of 0.05 to 0.50 mm with respect to the second joint part of capsule shell; and (F) capsule shell water content of 5.0 to 9.0%.

Description

technical field [0001] The present invention relates to capsules containing compounds that are oral irritants, but the contents do not easily leak out when chewed. Background technique [0002] Pharmaceutical preparations for oral administration such as tablets or capsules are generally taken with water or the like without chewing, except special preparations such as chewable tablets or sublingual tablets. However, it has been reported that there are many cases where these pharmaceutical preparations are intentionally or unintentionally chewed or crushed when elderly people etc. take them. Since the administration method of pharmaceutical preparations is inherent to each preparation designed based on the absorption site of the active ingredient or the duration in the blood, etc., wrong administration method will not only fail to obtain the desired effect, but may also cause serious side effects. Therefore, although medical institutions such as hospitals and pharmacies instr...

Claims

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Application Information

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IPC IPC(8): A61K31/20A61K9/48A61K47/10A61K47/42A61P25/00A61K47/36
Inventor 冈本一郎宫本佑司西村英克
Owner ONO PHARMA CO LTD
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