Composition comprising an organic liquid diluent and a cellulose ether of very low viscosity
A liquid composition which comprises an organic liquid diluent and at least one non-ionic cellulose ether having a viscosity of up to 2.33 mPa·s, measured as a 2 wt.-% solution in water at 20° C., is stable over an extended time period. The liquid composition is useful for preparing a solid dispersion comprising at least one active ingredient in at least one cellulose ether by spray-drying. Alternatively a solid dispersion can be produced by blending and extruding at least one active ingredient, at least one cellulose ether having a viscosity of up to 2.33 mPa·s and optionally one or more adjuvants.
1. A process for producing a solid dispersion comprising at least one active ingredient in at least one water-soluble non-ionic cellulose ether having a viscosity of from 1.20 to 2.33 mPa·s, measured as a 2 wt.-% solution in water at 20° C.,
comprising the steps of blending a) at least one water-soluble non-ionic cellulose ether having a viscosity of from 1.20 to 2.33 mPa·s, measured as a 2 wt.-% solution in water at 20° C., b) at least one active ingredient and c) one or more optional additives, and subjecting the blend to extrusion at a temperature of from 90 to 190° C.,
wherein the water-soluble non-ionic cellulose ether is a hydroxypropyl methylcellulose having a DS(methyl) of from 1.0 to 2.5 and an MS(hydroxypropyl) of from 0.05 to 0.90 or a methylcellulose having a DS(methyl) of from 1.0 to 2.5.
2. The process of claim 1 wherein the water-soluble non-ionic cellulose ether has a viscosity of from 1.20 to 2.26 mPa·s, measured as a 2 wt.-% solution in water at 20° C.
3. The process of claim 1 wherein the hydroxypropyl methylcellulose has a DS(methyl) of from 1.1 to 2.2 and the methylcellulose has a DS(methyl) of from 1.1 to 2.2.
4. The process of claim 3 wherein the hydroxypropyl methylcellulose has a DS(methyl) of from 1.6 to 2.05 and the methylcellulose has a DS(methyl) of from 1.6 to 2.05.
5. The process of claim 1 wherein the hydroxypropyl methylcellulose has an MS(hydroxypropyl) of from 0.12 to 0.60.
6. The process of claim 5 wherein the hydroxypropyl methylcellulose has an MS(hydroxypropyl) of from 0.12 to 0.50.
7. The process of claim 1 wherein the water-soluble non-ionic cellulose ether is a hydroxypropyl methylcellulose having a DS(methyl) of from 1.6 to 2.05 and an MS(hydroxypropyl) of from 0.12 to 0.50.
8. The process of claim 2 wherein the water-soluble non-ionic cellulose ether is a hydroxypropyl methylcellulose having a DS(methyl) of from 1.6 to 2.05 and an MS(hydroxypropyl) of from 0.12 to 0.50.
9. The process of claim 1 wherein the water-soluble non-ionic cellulose ether is a methylcellulose having a DS(methyl) of from 1.0 to 2.5.
10. The process of claim 1 wherein the active ingredient is a drug having an aqueous solubility of 0.5 mg/mL or less.
11. The process of claim 1 wherein the components a), b) and optionally c) are blended in the form of particles.