Physically stable aqueous suspensions of active pharmaceuticals
First Claim
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1. A physically stable pharmaceutical suspension comprising:
- a) an active pharmaceutical component which is sparingly soluble to insoluble in water;
b) a water soluble, low viscosity grade cellulose polymer with a viscosity range of from about 3 to about 50 mPa·
s, measured at 2.0% concentration in water at 20°
C. as a surfactant;
c) a suspending agent; and
d) water.
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Abstract
The present invention concerns methods of making physically stable aqueous suspensions of sparingly soluble to insoluble in water, active pharmaceuticals. More particularly, the invention provides an aqueous pharmaceutical suspension composition comprising an active pharmaceutical component which is sparingly soluble to insoluble in water; a water soluble, low viscosity grade cellulose polymer with a viscosity range of 3 mPa·s to 50 mPa·s as a surfactant; a suspending agent; and water.
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Citations
28 Claims
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1. A physically stable pharmaceutical suspension comprising:
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a) an active pharmaceutical component which is sparingly soluble to insoluble in water; b) a water soluble, low viscosity grade cellulose polymer with a viscosity range of from about 3 to about 50 mPa·
s, measured at 2.0% concentration in water at 20°
C. as a surfactant;c) a suspending agent; and d) water. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A method of forming a physically stable pharmaceutical suspension comprising:
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I) combining a) an active pharmaceutical component which is sparingly soluble to insoluble in water, wherein the active pharmaceutical component comprises particle have an average particle size in the range of from about 10 μ
m to about 200 μ
m;b) a water soluble, low viscosity grade cellulose polymer with a viscosity range of from about 3 to about 50 mPa·
s, measured at 2.0% concentration in water at 20°
C.;c) a suspending agent; and d) water; II) dispersing the cellulose polymer and suspending agent in a non-solvent medium followed by hydration with the water, and then incorporating the active pharmaceutical component with high shear mixing.
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Specification