TESTOSTERONE UNDECANOATE COMPOSITIONS
The present disclosure is drawn to pharmaceutical compositions and oral dosage forms containing testosterone undecanoate, as well as related methods of treatment. In one embodiment, the oral dosage form can include a therapeutically effective amount of testosterone undecanoate and a pharmaceutically acceptable carrier. The dosage form can be formulated such that, when measured using a USP Type II apparatus in 1000 mL of 8 wt % Triton X-100 in water at 37° C. and 100 rpm, the oral dosage form releases at least 20% more testosterone undecanoate after the first 120 minutes than an equivalent dose testosterone undecanoate containing oral dosage form without the pharmaceutically acceptable carrier.
1 - 40 . (canceled)
41 . A tablet for oral administration comprising 100 mg to 400 mg testosterone undecanoate and a pharmaceutically acceptable carrier including at least one of polyvinyl alcohol, polyvinyl pyrrolidones, polyethylene glycols having molecular weight from about 100 to about 20,000; propylene glycol; starches; sodium starch glycolate; croscarmellose; sucrose; lactose; cyclodextrins; carboxymethyl cellulose; microcrystalline cellulose, hydroxyl propyl methyl cellulose; ethyl cellulose; carbomers; gelatin; poloxamers; sodium dodecyl sulfate; sodium docusate; polyoxyethylene sorbitan esters; glycerin; paraffin oil; silicone oils; magnesium aluminosilicates; silicon dioxide; ethyl alcohol; benzyl alcohol; benzyl benzoate; ascorbic acid; oleic acid; linoleic acid; stearic acid; capric acid; caprylic acid; hydrogenated castor oil; caprylocaproyl macrogolglycerides; cholesterol; tocopherol; tocopherol succinate; polyoxyl castor oils; polyethoxylated cholesterol or mixtures thereof.
42 . The tablet of claim 41 free of lipophilic surfactants.
43 . The tablet of claim 41 which releases at least 35% of the testosterone undecanoate at 120 minutes when tested, using a USP Type II apparatus, in 1000 mL of 8 wt % Triton X-100 at 37° C. and 100 rpm.
44 . The tablet of claim 41 which does not form an oil-in-water emulsion when contacted with water with adequate mixing.
45 . The tablet of claim 41 wherein testosterone undecanoate is present in solid particulate form.
46 . The tablet of claim 41 wherein 30% (w/w) or more of the testosterone undecanoate is present in solid particulate form.
47 . The tablet of claim 41 including 15% or less of lipid substance.
48 . A tablet for oral administration comprising testosterone undecanoate and a pharmaceutically acceptable carrier including at least one of polyvinyl alcohol, polyvinyl pyrrolidones, polyethylene glycols having molecular weight from about 100 to about 20,000; propylene glycol; starches; sodium starch glycolate; croscarmellose; sucrose; lactose; cyclodextrins; carboxymethyl cellulose; microcrystalline cellulose, hydroxyl propyl methyl cellulose; ethyl cellulose; carbomers; gelatin; poloxamers; sodium dodecyl sulfate; sodium docusate; polyoxyethylene sorbitan esters; glycerin; paraffin oil; silicone oils; magnesium aluminosilicates; silicon dioxide; ethyl alcohol; benzyl alcohol; benzyl benzoate; ascorbic acid; oleic acid; linoleic acid; stearic acid; capric acid; caprylic acid; hydrogenated castor oil; caprylocaproyl macrogolglycerides; cholesterol; tocopherol; tocopherol succinate; polyoxyl castor oils; polyethoxylated cholesterol or mixtures thereof, wherein testosterone undecanoate is at least 30% (w/w) solid particulate testosterone undecanoate
49 . The tablet of claim 48 free of lipophilic surfactants.
50 . The tablet of claim 48 which releases 35% or more of the testosterone undecanoate at 120 minutes when tested, using a USP Type II apparatus, in 1000 mL of 8 wt % Triton X-100 at 37° C. and 100 rpm.
51 . The tablet of claim 48 which does not form an oil-in-water emulsion when contacted with water with adequate mixing.
52 . The tablet of claim 48 wherein testosterone undecanoate is present in solid particulate form.
53 . The tablet of claim 48 wherein 30% (w/w) or more of the testosterone undecanoate is present in solid particulate form.
54 . The tablet of claim 48 including 15% or less of lipid substance.
55 . The tablet of claim 48 having from about 100 mg to about 400 mg testosterone undecanoate.
56 . A tablet for oral administration comprising testosterone undecanoate and a pharmaceutically acceptable carrier including at least one of polyvinyl alcohol, polyvinyl pyrrolidones, polyethylene glycols having molecular weight from about 100 to about 20,000; propylene glycol; starches; sodium starch glycolate; croscarmellose; sucrose; lactose; cyclodextrins; carboxymethyl cellulose; microcrystalline cellulose, hydroxyl propyl methyl cellulose; ethyl cellulose; carbomers; gelatin; poloxamers; sodium dodecyl sulfate; sodium docusate; polyoxyethylene sorbitan esters; glycerin; paraffin oil; silicone oils; magnesium aluminosilicates; silicon dioxide; ethyl alcohol; benzyl alcohol; benzyl benzoate; ascorbic acid; oleic acid; linoleic acid; stearic acid; capric acid; caprylic acid; hydrogenated castor oil; caprylocaproyl macrogolglycerides; cholesterol; tocopherol; tocopherol succinate; polyoxyl castor oils; polyethoxylated cholesterol or mixtures thereof wherein said tablet comprises 100 mg to 400 mg of testosterone undecanoate and releases 35% or more of the testosterone undecanoate at 120 minutes when tested, using a USP Type II apparatus, in 1000 mL of 8 wt % Triton X-100 at 37° C. and 100 rpm.
57 . The tablet of claim 56 including 15% or less of lipid substance.
58 . The tablet of claim 56 wherein 30% (w/w) or more of the testosterone undecanoate is present in solid particulate form.
59 . The tablet of claim 56 which does not form an oil-in-water emulsion when contacted with water with adequate mixing.
60 . The tablet of claim 56 having an amount of testosterone undecanoate to pharmaceutically acceptable carrier ratio of from about 8:1 (w/w) to about 1:8 (w/w).