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Hydroxypropyl methyl cellulose hard capsules and process of manufacture

A technology of hydroxypropyl methylcellulose and hard capsules, applied in the field of hydroxypropyl methylcellulose hard capsules and preparation, can solve problems such as poor appearance quality and solubility properties

Active Publication Date: 2012-11-14
CAPSUGEL BELGIUM NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Similarly, capsules prepared by combining HPMC with gelling agents have very poor appearance quality and dissolution properties due to their cation and pH sensitivity

Method used

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  • Hydroxypropyl methyl cellulose hard capsules and process of manufacture
  • Hydroxypropyl methyl cellulose hard capsules and process of manufacture
  • Hydroxypropyl methyl cellulose hard capsules and process of manufacture

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] Example 1: Aqueous composition for the manufacture of hydroxypropylmethylcellulose hard capsules

[0100] 5 kg of a composition of 18.8% HPMC type 2906 (28.7% methoxyl content, 5.4% hydroxypropoxyl content) with a viscosity of 4.4 cPs at 2% strength (w / w) was prepared as follows:

[0101] Under stirring, the HPMC powder was dispersed into hot water at 75 °C. Foam formation was observed. After powder dispersion was complete, the temperature was maintained at 75°C with very gentle stirring to defoam the dispersion. The dispersion was then cooled to 10° C. with gentle stirring to achieve dissolution of the HPMC. Holding the composition at 10° C. for more than 30 minutes, a ready dipping composition for capsule manufacture was obtained.

[0102] The gel temperature of the HPMC composition was determined by gradually heating the composition for viscosity measurement. The gelling temperature was found to be 34°C.

Embodiment 2

[0103] Embodiment 2: the manufacture of hard capsule

[0104] The composition prepared in Example 1 was poured into the dip pan of a pilot plant for hard capsule manufacture. Dip pins of size 0 were preheated at 75°C while maintaining the dipping composition at 32°C. At this temperature, the viscosity of the dipping composition is 2000 cPs. Size 0 capsules were made via the conventional dipping method but using preheated pins. After impregnation, the capsules were dried in an oven with hot air at 60°C and 40% RH for 3 minutes, followed by hot air at 40°C and 40% RH.

[0105] The obtained capsules are of high quality: good and standard size (top wall thickness > 140 μm), high transparency (similar to gelatin hard capsules), excellent dissolution and mechanical properties.

Embodiment 3

[0106] Example 3: Optimum preheating temperature for pins

[0107] Example 2 was repeated, but preheating the dipped pins at 60°C instead of 75°C. It should be noted that pin size 0 is considered a medium-large size.

[0108] After dipping, gelation on the pins is suboptimal to obtain commercially usable capsules. During drying, the solution partly flowed down the pin, resulting in a top wall thickness of less than 50 μm.

[0109] Conclusion: For the manufacture of size 0 capsules, 60°C is less preferable than 75°C as the pin preheating temperature.

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Abstract

A composition for manufacture of hard hydroxypropyl methyl cellulose capsules comprising a film forming material of hydroxypropyl methyl cellulose having a methoxy content of 27.0-30.0% (w / w), and a hydroxypropoxy content of 4.0 - 7.5% and as a 2% weight solution, a viscosity of 3.5 - 6.0 cPs at 20 DEG C, dipping compositions, process for manufacture of hard hydroxypropyl methyl cellulose capsules according to a dip coating process and hard capsule shells.

Description

technical field [0001] The present invention relates to an aqueous composition for the preparation of hydroxypropylmethylcellulose (hereinafter also referred to as "HPMC") hard capsules, a process for the preparation of HPMC hard capsules and hard capsules obtained thereby. Background technique [0002] Capsules are well-known dosage forms, usually consisting of a shell filled with one or more specific substances. The shell may be a soft or hard (as in the present invention) stable shell comprising film-forming polymers such as gelatin, modified starch, modified cellulose, and the like. [0003] Hard capsules are usually manufactured by using the dip molding method. In this method, the pin mold is dipped into the film-forming composition. The film is formed by gelling the film-forming polymer on the pin, which is then dried on the pin to obtain the capsule shell. The housing is then stripped from the pins and cut to the desired length. Thus, a capsule cap and a capsule b...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B11/193A61J3/07A61K9/48
CPCC08L1/284A61J3/077A61K9/4816C08L1/14A61K9/0075A61K9/4833C08B11/193C08L1/26
Inventor 多米尼克·N·凯德何雄伟
Owner CAPSUGEL BELGIUM NV