Hydroxypropyl methyl cellulose hard capsules and process of manufacture

Patent metadata

Field	Value
Publication number	US-9655860-B2
Application number	US-201615378856-A
Country	US
Kind code	B2
Filing date	Dec 14, 2016
Priority date	Oct 27, 2006
Publication date	May 23, 2017
Grant date	May 23, 2017

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° C., dipping compositions, process for manufacture of hard hydroxypropyl methyl cellulose capsules according to a dip coating process and hard capsule shells.

First claim

The invention claimed is:

1. A process comprising:
forming hydroxypropyl methyl cellulose hard capsules using thermogelation by:
(a) providing an aqueous composition of a 2906 hydroxypropyl methyl cellulose having a methoxy content of 27.0-30.0% (w/w), a hydroxypropoxy content of 4.0-7.5% (w/w) and a viscosity of 3.5-6.0 cPs as a 2% weight solution in water at 20° C., wherein the aqueous composition is substantially free of gelling agent;
(b) dipping heated dipping pins into the aqueous composition, wherein the aqueous composition is maintained at a temperature below a gelling temperature of the aqueous composition,
(c) withdrawing the dipping pins from the aqueous composition obtaining a film on the dipping pins; and
(d) drying the film on the dipping pins so as to obtain molded capsules on the pins.

2. The process of claim 1 wherein the hydroxypropyl methyl cellulose is present in a range from 15 to 25% by weight, based on the total weight of the aqueous composition.

3. The process of claim 1 wherein the dipping pins are heated such that the dipping pins are 55-95° C. when dipped into the aqueous composition.

4. The process of claim 1 wherein the dipping pins are heated such that the dipping pins are 60-90° C. when dipped into the aqueous composition.

5. The process of claim 1 wherein the aqueous composition in step (b) is maintained at a temperature of 10° C. to 1.0° C. below a gelling temperature of the aqueous composition.

6. The process of claim 1 wherein step (d) comprises (d1) exposing the pins to an environment having temperature of 50-90° C. and a relative humidity of 20-90%.

7. The process of claim 6 wherein the temperature is 60-85° C. and the relative humidity is 20-60%.

8. The process of claim 6 wherein after (d1) the pins are exposed to a temperature of 30-60° C. and a relative humidity of 20-90% as step (d2).

9. The process of claim 8 wherein the duration of step (d2) is between 30 and 60 minutes.

10. A hard capsule formed by the process of claim 1 .

11. A hydroxypropyl methyl cellulose hard capsule shell comprising:
a thermogelled hard capsule shell comprising hydroxypropyl methyl cellulose 2906 having a methoxy content of 27.0-30.0% (w/w), a hydroxypropoxy content of 4.0-7.5% (w/w) and a viscosity of 3.5-6.0 cPs as a 2% weight solution in water at 20° C., wherein the 2908 hydroxypropyl methyl cellulose is present in an amount ranging from 70% to 99% by weight of the shell weight.

12. The capsule shell of claim 11 wherein the hydroxypropoxy methyl cellulose is present in an amount between 70% and 90% by weight on the shell weight.

Assignees

• Capsugel Belgium Nv

Inventors

• Cade Dominique Nicolas
• Xiongwei David He

Classifications

• C08L1/284

  with hydroxylated hydrocarbon radicals · CPC title

• A61J3/077 Primary

  Manufacturing capsule shells · CPC title

• A61K9/0075

  for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles · CPC title

• C08L1/14 Primary

  Mixed esters, e.g. cellulose acetate-butyrate · CPC title

• A61K9/4833 Primary

  Encapsulating processes; Filling of capsules (mechanical aspects A61J3/07) · CPC title