PROBLEM TO BE SOLVED: To provide an improved quetiapine dosage form being a containing high-dose quetiapine which contains substantially the same dose of quetiapine and becomes smaller than a conventional dosage form, and which is a controlled release dosage form and/or a sustained release dosage form.SOLUTION: An extended-release dosage form includes: first granulation containing quetiapine or its pharmaceutically acceptable salt and one or more controlled release materials second granulation containing one or more controlled release materials which are the same or different from one or more controlled release materials of the first granulation and, optionally, quetiapine or its pharmaceutically acceptable salt. In a preparation method of a sustained release dosage form, after pulverization subsequent to the first granulation and the second granulation and mixing the pulverized granules after the second granulation with lubricant are performed, the mixture is compressed to form the sustained release dosage form. The sustained release dosage form includes: a rapid-acting core containing quetiapine or its pharmaceutically acceptable salt and one or more pharmaceutically acceptable additives, and sustained release coating containing one or more non-gelatinization controlled release materials.COPYRIGHT: (C)2015,JPO&INPIT【課題】実質的に同じ用量のクエチアピンを含み従来の剤形より小さなサイズになる高用量のクエチアピンを含む剤形であり、制御放出剤形および/または徐放性剤形である改良型クエチアピン剤形の提供【解決手段】クエチアピン又はその薬学的に許容される塩及び1つ以上の放出制御材料を含む第1の造粒と、前記第1の造粒の1つ以上の放出制御材料と同じか又は異なる1つ以上の放出制御材料及び任意にはクエチアピン又はその薬学的に許容される塩とを含む第2の造粒と、を含む持続放出剤形。第1の造粒及び第2の造粒に続いて粉砕することと、第2の造粒後の前記粉砕された顆粒と潤滑剤とを混合した後、圧縮して徐放性剤形を形成する徐放性剤形の調製方法。クエチアピン又はその薬学的に許容される塩及び1つ以上の薬学的に許容される添加剤を含む即効型コアと、1つ以上の非ゲル化放出制御材料を含む徐放性コーティングとを含む徐放性剤形。【選択図】なし
