FORMULATIONS OF 4-(7-HYDROXY-2-ISOPROPYL-4-OXO-4H-QUINAZOLIN-3-YL)-BENZONITRILE

1 - 94 . (canceled)

95 . A formulation, comprising:

a suspension of 4-(7-Hydroxy-2-isopropyl-4-oxo-4H-quinazolin-3-yl)-benzonitrile (compound I) or a salt, co-crystal, or polymorph thereof, in an amount of 0.5% w/v to 2.5% w/V;

a non-ionic surfactant which is tyloxapol, poloxamer, or combinations thereof, in an amount of from 0.01% w/v to 0.2% w/V;

a suspending agent which is hydroxypropyl methyl cellulose, polyethylene glycol, carbomer homopolymer Type B, or combinations thereof;

a tonicity agent which is at least one polyol in an amount of from 0.05% w/v to 10% w/V;

a buffer which is edetate, phosphate, borate, tromethamine, or combinations thereof;

a salt; and

water in a quantity sufficient (qs) to 100%,

wherein the pH of the formulation is in the range of from 5.5 to 8.0.

96 . The formulation according to claim 95 , wherein:

4-(7-Hydroxy-2-isopropyl-4-oxo-4H-quinazolin-3-yl)-benzonitrile (compound I) or a salt, co-crystal, or polymorph thereof, is present in an amount of about 0.5% w/v, about 1.0% w/v, about 1.5% w/v, about 2.0% w/v, or about 2.5% w/v;

the non-ionic surfactant is tyloxapol in an amount of 0.04% w/v to 0.06% w/v, poloxamer in an amount of 0.01% w/v to 0.2% w/v, or combinations thereof;

the suspending agent is hydroxypropyl methyl cellulose in an amount of from 0.1% w/v to 0.8% w/v, polyethylene glycol in an amount of from 2% w/v to 8% w/v, carbomer homopolymer Type B in an amount from 0.05% w/v to 0.5% w/v, or combinations thereof;

the tonicity agent is mannitol or glycerin in an amount of from 0.1% w/v to 5% w/v;

the buffer is edetate, phosphate, borate, tromethamine, or combinations thereof; and

the salt is sodium chloride in an amount of from 0.01% w/v to 1% w/v.

97 . The formulation according to claim 95 , wherein:

4-(7-Hydroxy-2-isopropyl-4-oxo-4H-quinazolin-3-yl)-benzonitrile (compound I) or a salt, co-crystal, or polymorph thereof, is present in an amount of about 0.5% w/v, about 1.0% w/v, about 1.5% w/v, about 2.0% w/v, or about 2.5% w/v;

the non-ionic surfactant is tyloxapol in an amount of 0.04 w/v to 0.06% w/v;

the suspending agent is carbomer homopolymer Type B in an amount from 0.05% w/v to 0.4% w/V;

the tonicity agent is glycerin in an amount of from 0.5% w/v to 5% w/v;

the buffer is edetate, phosphate, borate, tromethamine, or combinations thereof; and

the salt is sodium chloride in an amount of from 0.01% w/v to 1% w/v.

98 . The formulation according to claim 95 , wherein compound I is in polymorphic form B.

99 . The formulation according to claim 98 , wherein:

4-(7-Hydroxy-2-isopropyl-4-oxo-4H-quinazolin-3-yl)-benzonitrile (compound I) or a salt, co-crystal, or polymorph thereof, is present in an amount of about 0.5% w/v, about 1.0% w/v, about 1.5% w/v, about 2.0% w/v, or about 2.5% w/v;

the non-ionic surfactant is about 0.05% w/v of tyloxapol;

the suspending agent is about 0.2% w/v of carbomer homopolymer Type B;

the tonicity agent is about 2.0% w/v of glycerin;

the buffer is a tromethamine buffer; and

the salt is sodium chloride in an amount of about 0.05% w/v;

wherein the formulation contains hydrochloric acid to adjust the pH to a range of from 6.4 to 8.4; and

wherein the formulation does not include a preservative.

100 . The formulation according to claim 95 , wherein:

the at least one polyol is present in an amount of from about 0.1% w/v to about 5% w/v.

101 . The formulation according to claim 100 , wherein:

the at least one polyol comprises mannitol, glycerin, xylitol, sorbitol, propylene glycol, or combinations thereof.

102 . The formulation according to claim 101 , wherein:

the at least one polyol comprises glycerin in an amount of from 0.5% w/v to 5% w/v.

103 . The formulation according to claim 102 , wherein:

the at least one polyol further comprises propylene glycol.

104 . The formulation according to claim 95 , wherein:

the suspending agent is hydroxypropyl methyl cellulose in an amount of from 0.1% w/v to 0.8% w/v.

105 . The formulation according to claim 104 , wherein:

the suspending agent is hydroxypropyl methyl cellulose in an amount of from 0.1% w/v to 0.6% w/v.

106 . The formulation according to claim 95 wherein:

hydrochloric acid, sodium hydroxide, or combinations thereof are used to adjust the pH of the formulation.

107 . The formulation according to claim 106 wherein:

sodium hydroxide is used to adjust the pH of the formulation to about 6.0.

108 . The formulation according to claim 95 wherein:

the poloxamer is poloxamer 407.

109 . The formulation according to claim 95 wherein:

the buffer comprises edetate.

110 . The formulation according to claim 95 wherein:

the salt is sodium chloride in an amount of about 0.05% w/v.

111 . The formulation according to claim 95 wherein:

the pH of the formulation is in the range of about 6.0 to about 7.4.