Dispersion comprising an esterified cellulose ether
An aqueous composition useful for producing capsules shells comprises a) at least one dispersed esterified cellulose ether comprising (i) groups of the formula —C(O)—R—COOA or (ii) a combination of aliphatic monovalent acyl groups and groups of the formula —C(O)—R—COOA, wherein R is a divalent aliphatic or aromatic hydrocarbon group and A is hydrogen or a cation, and b) from 0.05 to 20 percent of at least one salt of a fatty acid, based on the weight of the dispersed esterified cellulose ether, wherein the median particle size, d50, of the dispersed esterified cellulose ether particles is up to 7 micrometers, such median particle size (d50) being the size at which 50 mass percent of the particles have a smaller equivalent diameter and 50 mass percent have a larger equivalent diameter.
1. An aqueous composition consisting of:
a) at least 15 weight percent, based on the total weight of the aqueous composition, of dispersed hydroxypropyl methyl cellulose acetate succinate,
b) from 0.05 to 5.0 percent of at least one salt of a fatty acid, based on the weight of the dispersed hydroxypropyl methyl cellulose acetate succinate,
c) optionally one or more ingredient selected from the group consisting of fertilizers, herbicides, pesticides, vitamins, herbals and mineral supplements, drugs, plasticizers, film forming aids, coloring agents, pigments, opacifiers, flavors, taste improvers and antioxidants, and
d) an aqueous diluent,
wherein the median particle size, d50, of the dispersed hydroxypropyl methyl cellulose acetate succinate particles is up to 3 micrometers, such median particle size (d50) being the size at which 50 mass percent of the particles have a smaller equivalent diameter and 50 mass percent have a larger equivalent diameter, and wherein said composition has a viscosity between 20 mPa·s and 1000 mPa·s at 20° C.
2. The aqueous composition of claim 1 comprising from 0.5 to 5 percent of an ammonium, alkali metal or alkaline earth metal salt of a saturated or unsaturated fatty acid, based on the weight of the dispersed hydroxypropyl methyl cellulose acetate succinate.
3. The aqueous composition of claim 1 wherein the salt of a fatty acid is an ammonium, alkali metal or alkaline earth metal salt of stearic acid or oleic acid.
4. The aqueous composition of claim 1 comprising two or three plasticizers selected from i) citric esters, ii) esters of dicarboxylic acids, and iii) acetoglycerides or block copolymers comprising blocks of poly(ethylene oxide) and poly(propylene oxide), provided that two or three plasticizers are selected from different groups i)-iii).
5. The aqueous composition of claim 1 wherein the median particle size, d50, is up to 2 micrometers, such median particle size (d50) being the size at which 50 mass percent of the particles have a smaller equivalent diameter and 50 mass percent have a larger equivalent diameter.
6. The aqueous composition of claim 1 wherein d90 of the dispersed hydroxypropyl methyl cellulose acetate succinate particles is up to 9 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.
7. The aqueous composition of claim 1 comprising
a) at least 20 weight percent, based on the total weight of the aqueous composition, of dispersed hydroxypropyl methyl cellulose acetate succinate particles having a median particle size, d50, of up to 3 micrometers and a d90 of up to 9 micrometers and
b) from 1.0 to 5.0 percent of an alkali metal salt of stearic acid or oleic acid, based on the weight of the dispersed hydroxypropyl methyl cellulose acetate succinate.
8. The aqueous composition of claim 1 comprising at least 20 weight percent of said hydroxypropyl methyl cellulose acetate succinate, based on the total weight of the aqueous composition.
9. The aqueous composition of claim 1 comprising at least 27.6 weight percent of said hydroxypropyl methyl cellulose acetate succinate, based on the total weight of the aqueous composition.
10. A process for producing the aqueous composition of claim 1 comprising the steps of
grinding, in the presence of an aqueous diluent, at least one hydroxypropyl methyl cellulose acetate succinate, and
blending from 0.05 to 5.0 percent of at least one salt of a fatty acid 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, the percentage of the fatty acid salt being based on the weight of the hydroxypropyl methyl cellulose acetate succinate.
11. A process for producing the aqueous composition of claim 1 comprising the steps of:
melting a hydroxypropyl methyl cellulose acetate succinate;
emulsifying the molten hydroxypropyl methyl cellulose acetate succinate in an aqueous diluent,
adding from 0.05 to 5.0 percent of a salt of a fatty acid, based on the weight of the dispersed hydroxypropyl methyl cellulose acetate succinate, and optionally one or more adjuvants before, during or after the step of emulsifying the molten hydroxypropyl methyl cellulose acetate succinate in the aqueous diluent, and
cooling the emulsion to form an aqueous dispersion.
12. A dosage form being coated with a coating prepared from the aqueous composition of claim 1 .
13. A capsule shell made from the aqueous composition of claim 1 .
14. A process for producing capsule shells 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.