Dispersion comprising a partially neutralized esterified cellulose ether
View Patent ↗An aqueous composition comprising at least 10 weight percent of a dispersed esterified cellulose ether, based on the total weight of the aqueous composition, wherein the esterified cellulose ether comprises (i) groups of the formula —C(O)—R—COOH or (ii) a combination of aliphatic monovalent acyl groups and groups of the formula —C(O)—R—COOH, R being a divalent aliphatic or aromatic hydrocarbon group, and at least a part of the groups —C(O)—R—COOH are neutralized with an ammonium salt of carbonic acid, formic acid or acetic acid, and wherein d90 of the dispersed esterified cellulose ether particles is up to 10 micrometers, d90 being the diameter where 90 mass percent of the particles have a smaller equivalent diameter and the other 10 mass percent have a larger equivalent diameter, is useful for preparing coating dosage forms including tablets, capsules and others, or for the formation of capsules shells.
1. An aqueous composition comprising at least 10 weight percent of a dispersed hydroxypropyl methyl cellulose acetate succinate, based on the total weight of the aqueous composition, wherein in the aqueous composition at least a part of the succinate groups of the hydroxypropyl methyl cellulose acetate has been neutralizing with ammonium carbonate or ammonium hydrogen carbonate, and
wherein d90 of the dispersed hydroxypropyl methyl cellulose acetate succinate particles is up to 10 micrometers, d90 being the diameter where 90 mass percent of the particles have a smaller equivalent diameter and the other 10 mass percent have a larger equivalent diameter.
2. The aqueous composition of claim 1 wherein the median particle size d50 of the dispersed hydroxypropyl methyl cellulose acetate succinate particles is up to 5 micrometers, d50 being the diameter where 50 mass percent of the particles have a smaller equivalent diameter and 50 mass percent have a larger equivalent diameter.
3. The aqueous composition of claim 1 comprising at least 15 weight percent of the dispersed hydroxypropyl methyl cellulose acetate succinate, based on the total weight of the aqueous composition.
4. The aqueous composition of claim 1 wherein in the aqueous composition the hydroxypropyl methyl cellulose acetate succinate has been partially neutralized with ammonium carbonate or ammonium hydrogen carbonate.
5. The aqueous composition of claim 1 comprising the dispersed hydroxypropyl methyl cellulose acetate succinate and one or more polymers different from an esterified cellulose ether, provided that the dispersed hydroxypropyl methyl cellulose acetate succinate is at least 50 percent of the total weight of the polymers in the aqueous composition.
6. The aqueous composition of claim 1 additionally comprising at least one adjuvant selected from the group consisting of dispersants, plasticizers, gelling agents, film forming aids, coloring agents, pigments, opacifiers, flavor and taste improvers, and antioxidants.
7. The aqueous composition of claim 1 comprising at least 10 weight percent of dispersed hydroxypropyl methyl cellulose acetate succinate that is partially neutralized with ammonium carbonate or ammonium hydrogen carbonate, based on the total weight of the aqueous composition, d90 of the dispersed hydroxypropyl methyl cellulose acetate succinate particles being up to 5 micrometers and d50 of the dispersed hydroxypropyl methyl cellulose acetate succinate particles is up to 3 micrometers.
8. A process for producing the aqueous composition of claim 1 comprising the steps of grinding, in the presence of an aqueous diluent, a hydroxypropyl methyl cellulose acetate succinate and
blending ammonium carbonate or ammonium hydrogen carbonate and optionally one or more adjuvants with the hydroxypropyl methyl cellulose acetate succinate before, during or after the grinding of the hydroxypropyl methyl cellulose acetate succinate to neutralize at least a part of the succinate groups,
wherein aqueous diluent, hydroxypropyl methyl cellulose acetate succinate, ammonium carbonate or ammonium hydrogen carbonate, and the optional adjuvant(s) are added in such amounts that the weight of the hydroxypropyl methyl cellulose acetate succinate is at least 10 weight percent, based on the total weight of the aqueous composition.
9. A process for producing the aqueous composition of claim 1 comprising the steps of
melting a) a hydroxypropyl methyl cellulose acetate succinate,
emulsifying the molten hydroxypropyl methyl cellulose acetate succinate in b) an aqueous diluent,
adding c) ammonium carbonate or ammonium hydrogen carbonate, and optionally d) one or more adjuvants before, during or after the step of emulsifying the molten hydroxypropyl methyl cellulose acetate succinate in the aqueous diluent to neutralize at least a part of the succinate groups,
wherein the components a), b), c) and optionally d) are added in such amounts that the weight of the hydroxypropyl methyl cellulose acetate succinate is at least 10 weight percent, based on the total weight of the aqueous composition, and
cooling the emulsion to form an aqueous dispersion.
10. A dosage form being coated with a coating prepared from the aqueous composition of claim 1 .
11. A capsule shell made from the aqueous composition of claim 1 .
12. A capsule comprising a capsule shell of claim 11 and further comprising a drug or a nutritional or food supplement or a combination thereof.
13. A process for producing a capsule shell comprising the steps of
providing the aqueous composition of claim 1 ,
pre-heating molding pins to a temperature higher than the aqueous composition,
dipping the pre-heated molding pins into the aqueous composition,
forming a film on said molding pins by withdrawing said pins from said aqueous composition, and
drying the film on the molding pins.