STEROIDAL COMPOSITIONS

• Main Authors: GILIYAR CHANDRASHEKAR, SRINIVASAN VENKATESHWARAN, NACHIAPPAN CHIDAMBARAM, MAHESH V PATEL
• Format: Patent
• Language: English; Japanese
• Published: 02.07.2015
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

PROBLEM TO BE SOLVED: To provide a steroid-containing delayed-release oral formulation suitable for providing therapeutically effective amounts of at least one steroid to individuals.SOLUTION: The present invention provides an oral pharmaceutical composition comprising 1-50%w/w of one or more testosterone C2-C13 alkyl ester; 1-90%w/w of a hydrophilic carrier, and/or 1-90%w/w of a lipophilic carrier; and 1-50%w/w of a coagulant. When the composition is put in a USP Type-II (paddle) apparatus with conditions at 37±0.5°C and at 100 rpm, and a release test is performed in the aqueous medium which is deionized water comprising 8% w/v of Triton X-100, the oral pharmaceutical composition releases 90% or less of the testosterone C2-C13 alkyl ester into the aqueous medium within 30 minutes. 【課題】治療有効量の少なくとも１つのステロイドを個体に提供するために好適なステロイド含有遅延放出経口投与製剤の提供。【解決手段】１以上のテストステロンＣ２〜Ｃ１３アルキルエステルを１〜５０％ｗ／ｗ；親水性担体を１〜９０％ｗ／ｗ及び／又は親油性担体を１〜９０％ｗ／ｗ；並びに凝固剤を１〜５０％ｗ／ｗ；含む経口投与用の医薬組成物であって、１００ｒｐｍ及び３７?０．５℃でＵＳＰ２型（パドル）装置に前記組成物を付して、８％ｗ／ｖのＴｒｉｔｏｎＸ−１００を含む脱イオン水である水性媒体中で放出試験を行った場合に、前記テストステロンＣ２〜Ｃ１３アルキルエステルの９０％以下を３０分以内に前記水性媒体中に放出する、経口投与用の医薬組成物。【選択図】なし