Taste-stable aqueous pharmaceutical suspension of tall oil sitosterols and a method for the preparation thereof

Claim 1

A taste-stable aqueous pharmaceutical suspension for oral administration to reduce hypercholesteremia comprising: (a) a pharmaceutically active amount of finely ground tall oil sitosterols; (b) a pharmaceutically acceptable chelating agent in an amount sufficient to inhibit oxidative degradation of the tall oil sitosterols; (c) sodium carboxymethylcellulose; (d) sorbitol; (e) a surfactant selected from the class consisting of: polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monopalmitate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (20) sorbitan monostearate, and sodium lauryl sulfate; (f) simethicone; and, (g) water.

Claim 5

A method of preparing a taste-stable aqueous pharmaceutical suspension for oral administration to reduce hypercholesteremia comprising: a. commingling simethicone with water; b. mixing a pharmaceutically acceptable chelating agent in an amount sufficient to inhibit oxidative degradation of tall oil sitosterols, and a surfactant selected from the class consisting of polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (20) sorbitan monostearate, and sodium lauryl sulfate, to the preparation of (a); c. mixing a pharmaceutically active amount of tall oil sitosterols with the preparation of (b); d. adding sodium carboxymethylcellulose to the preparation of (c); e. hydrating the sodium carboxymethylcellulose in the preparation of (d) by mixing such preparation for 8 hours or more; f. blending sorbitol with the preparation of (e); g. homogenizing the preparation from (f); and h. deaerating the preparation of (g).

Claim 6

A method of preparing a taste-stable aqueous pharmaceutical suspension for oral administration to reduce hypercholesteremia comprising: a. commingling simethicone with water; b. mixing a pharmaceutically acceptable chelating agent in an amount sufficient to inhibit oxidative degradation of tall oil sitosterols, and a surfactant selected from the class consisting of polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (20) sorbitan monostearate, and sodium lauryl sulfate, to the preparation of (a); c. mixing a pharmaceutically active amount of tall oil sitosterols with the preparation of (b); d. adding sodium carboxymethylcellulose to the preparation of (c); e. hydrating the sodium carboxymethylcellulose in the preparation of (d) by mixing such preparation for 8 hours or more; f. blending sorbitol with the preparation of (e); g. homogenizing the preparation from (f); and h. deaerating the preparation of (g).

Claim 12

A method of preparing an aqueous pharmaceutical suspension for oral administration comprising: a. combining with agitation from about 0.05 to about 0.15 parts by weight of a 30% simethicone emulsion with about 60 parts by volume of water; b. adding with agitation from about 0.004 to about 0.01 parts by weight of edetate calcium disodium and from about 0.025 to about 0.075 parts by weight of sodium lauryl sulfate to the combination of (a); c. adding with agitation from about 10 to about 25 parts by weight of very finely ground tall oil sitosterols to te combination of (b); d. mixing the combination of (c) until uniform; e. adding from about 0.5 to about 2.0 parts by weight of sodium carboxymethylcellulose to the combination of (d); f. hydrating the sodium carboxymethylcellulose in the combination of (e) by mixing for 8 hours or more.

Claim 13

A method of preparing an aqueous pharmaceutical suspension for oral administration comprising: a. combining with agitation from about 0.05 to about 0.15 parts by weight of a 30% simethicone emulsion with about 60 parts by volume of water; b. adding with agitation from about 0.004 to about 0.01 parts by weight of edetate calcium disodium and from about 0.025 to about 0.075 parts by weight of sodium lauryl sulfate to the combination of (a); c. adding with agitation from about 10 to about 25 parts by weight of very finely ground tall oil sitosterols to te combination of (b); d. mixing the combination of (c) until uniform; e. adding from about 0.5 to about 2.0 parts by weight of sodium carboxymethylcellulose to the combination of (d); f. hydrating the sodium carboxymethylcellulose in the combination of (e) by mixing for 8 hours or more.

Claim 14

A method of preparing an aqueous pharmaceutical suspension for oral administration comprising: a. combining with agitation about 0.1 partly by weight of a 30% simethicone emulsion with about 60 parts by volume of water; b. combining with agitation about 0.01 parts by weight of edetate calcium disodium and about 0.05 parts by weight of sodium lauryl sulfate with the combination of (a); c. adding with agitation about 20 parts by weight of finely ground tall oil sitosterols to the combination of (b); d. mixing the combination of (c) until uniform; e. adding about 1 part by weight of sodium carboxymethylcellulose to the combination of (d); f. hydrating the sodium carboxymethylcellulose in the combination of (e) by mixing for 8 hours or more; g. adding with agitation about 10 parts by weight of solution sorbitol (70% sorbitol) to the combination of (f); h. homogenizing the combination of (g); i. deaerating the combination of (h); and j. adding water to q.s. to 100 parts by volume.

Claim 15

A method of preparing an aqueous pharmaceutical suspension for oral administration comprising: a. combining with agitation about 0.1 partly by weight of a 30% simethicone emulsion with about 60 parts by volume of water; b. combining with agitation about 0.01 parts by weight of edetate calcium disodium and about 0.05 parts by weight of sodium lauryl sulfate with the combination of (a); c. adding with agitation about 20 parts by weight of finely ground tall oil sitosterols to the combination of (b); d. mixing the combination of (c) until uniform; e. adding about 1 part by weight of sodium carboxymethylcellulose to the combination of (d); f. hydrating the sodium carboxymethylcellulose in the combination of (e) by mixing for 8 hours or more; g. adding with agitation about 10 parts by weight of solution sorbitol (70% sorbitol) to the combination of (f); h. homogenizing the combination of (g); i. deaerating the combination of (h); and j. adding water to q.s. to 100 parts by volume.