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Oral testosterone tridecanoate therapy

a testosterone tridecanoate and oral technology, applied in the field of oral testosterone tridecanoate therapy, can solve the problem that the efficacy of testosterone levels may not provide safe and efficacious levels for another patien

Inactive Publication Date: 2018-06-07
LIPOCINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a way to take testosterone orally as a pill or liquid. This method involves giving a set amount of testosterone each day, which is usually between 750 mg and 1150 mg. This amount can be taken once or twice a day, depending on the type of testosterone pill. The therapy is safe and effective without the need for dose adjustments. The amount of testosterone taken can be determined using biomarkers, such as consistent testosterone levels, hematocrit levels, and PSA levels. Overall, this method of taking testosterone as a pill or liquid can provide a steady and effective treatment for men with testosterone deficiencies.

Problems solved by technology

A dose of a testosterone product for one patient that provides safe and efficacious testosterone levels may not provide safe and efficacious levels for another patient.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example a

[0130]

Dosage Form A1Dosage Form A2Ingredient Name% w / wmg / unit% w / wmg / unitTestosterone Tridecanoate10-20140-30010-15140-195PharmaceuticalLipophilice.g. Castor oil——48-55600-850acceptableadditives*e.g. Oleic acid80-90 900-1400——carrierse.g. Propylene——30-40400-600glycolmonolaurateOther additives** (e.g. 0-10 0-100 0-12 0-120antioxidant, solidifer, etc)Total1001000-16501001000-1650*Lipophilic additives used in these compositions (e.g. castor oil, oleic acid, and propylene glycol monolaurate) can be replaced with other lipophilic additives or combinations described in the above contexts. This can be applied to all other examples.**Other additives exemplified as antioxidant or solidifer in these compositions can be replaced with different other additives or combinations described in the above contexts. This can be applied to all other examples.

example b

[0131]

Dosage Form B1Dosage Form B2Dosage Form B3Ingredient Name% w / wmg / unit% w / wmg / unit% w / wmg / unitTestosterone Tridecanoate13-18140-20025-32200-30018-25140-300PharmaceuticalLipophilicMono / diglyceride60-65575-830————acceptableadditives*1 (e.g. Glycerylcarriersmonolinoleate)Mono / diglyceride——4-850-80——2 (e.g. Glyceryldistearate)Fatty acid1 (e.g.——50-60350-55045-55350-800Oleic acid)Fatty acid2 (e.g.——2-625-40——Stearic acid)Triglyceridel (e.g.———— 8-12 70-155Borage oil)Triglyceride2 (e.g.————2-415-40Peppermint oil)Hydrophilic additives** (e.g.13-17140-2102-625-4014-18110-250Polyoxyl 40 hydrogenated castor oil)OtherSolidifiers (e.g.4-850-80————additives***PEG)Antioxidant  0-0.30-4  0-0.30-4  0-0.30-4Total100 850-1350100 650-1200100 900-1550*Lipophilic additives used in these compositions can be replaced with other lipophilic additives or combinations described in the above contexts. This can be applied to all other examples.*Hydrophilic additives used in these compositions (e.g. polyoxy...

example c

[0132]

Dosage Form C1Dosage Form C2Dosage Form C3Ingredient Name% w / wmg / unit% w / wmg / unit% w / wmg / unitTestosterone Tridecanoate10-15140-20010-15140-20010-15140-200PharmaceuticalLipophilicTriglyceride22-28300-450————acceptableadditives*(e.g. Castorcarriersoil)Fatty acid——24-30300-47024-30300-470(Oleic acid)Mono / diglyceride 15-18200-300————derivative(e.g. Propyleneglycolmonolaurate)Mono / diglyceride ————12-15150-240(e.g. Glyceryldistearate)Monoglyceride ——14-18180-280 5-10100-170(e.g. Glycerylmonooleate)Glyceride10-15150-23010-15130-2254-6 50-100derivative (e.g.Oleoylpolyoxyl-6glycerides)Lipophilic0.5-1.5 5-150.5-1.5 5-150.5-1.5 5-15surfactant (e.g.Lecithin)Lipophilic1-325-401-325-401-325-40surfactant (e.g.Phytosterol)Hydrophilice.g. Polyoxyl 4025-35350-525 6-12110-185 6-12110-185additives**hydrogenatedcastor oile.g.——18-22230-35018-22230-350Polysorbate 80e.g. D-α-——1-320-401-320-40tocopherolOtherControl release0.5-1.5 5-150.5-1.5 5-150.5-1.5 5-15additives***agentAntioxidant  0-0.3  0-1.0...

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PUM

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Abstract

The present disclosure provides methods and compositions for testosterone replacement therapy. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester while avoiding unacceptably high testosterone levels.

Description

PRIORITY DATA[0001]This application claims the benefit of U.S. Provisional Application Ser. No. 62 / 428,167, filed on Nov. 30, 2016, and U.S. Provisional Application Ser. No. 62 / 428,317, filed on Nov. 30, 2016, each of which is incorporated herein by reference.BACKGROUND[0002]Most testosterone based pharmaceutical products on the market employ dose titration schemes to ensure that patients are safely (e.g., avoiding unacceptably high testosterone levels) and efficaciously treated (e.g., achieving typical eugonadal testosterone levels in hypogonadal patients). Dose titrations are typically required because different patients can absorb and metabolize testosterone based products in substantially different manners. A dose of a testosterone product for one patient that provides safe and efficacious testosterone levels may not provide safe and efficacious levels for another patient.SUMMARY OF INVENTION[0003]Disclosed herein is an oral testosterone therapy (“TT”) dosing regimen. In a speci...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/568A61K9/00A61K9/48A61P5/24
CPCA61K31/568A61K9/0053A61K9/48A61P5/24A61K9/4858
Inventor CHIDAMBARAM, NACHIAPPANNACHAEGARI, SATISH KUMARPATEL, MAHESH V.KIM, KILYOUNG
Owner LIPOCINE
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