会期：2025年5月22日(木）～2025年5月24日(土）*キャタレントは5/23のみ参加
会頭：深水 啓朗（明治薬科大学 教授）
学会会場：TFTホール（TFTビル）（東京都江東区有明３丁目4-10 TFTビル西館2階）
展示会場：TFTホール（TFTビル）西館 2階
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キャタレント展示
- 5月23日（金）8:30〜18:00
- TFTホール（TFTビル）西館 2階
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キャタレントランチョンセミナー
- セミナー名： ランチョンセミナー６
- 日時： 2025年5月23日（金） 11:55～12:55
- 会場： 第6会場 / TFTビル東館 9階 / 研修室908
Lipinski’s Rule of Fiveに該当しない経口低分子の臨床評価のための製剤技術の選択（アモルファス分散体をスクリーニングする際に、Lipid-based formulationを含めるべき理由）
(スティーブン・ティンドール キャタレントファーマソリューションズ)
【セミナー概要】
This seminar introduces Catalent’s approach to supporting small biotechnology customers who are interested in selecting and progressing oral small molecules into Phase 1 clinical studies. The seminar presents a typical approach used in the industry, and then proposes new approaches for molecules that have difficult physico chemical properties such as poor solubility and poor permeability.
This seminar first introduces Catalent, a global leader in contract development and manufacturing who are looking to become a trusted partner with small biotech companies in early development.
There follows a description of the type of challenges that small biotech companies have faced in the past few years when bringing small molecules to the clinic.
Next, the seminar provides an overview of the current typical industry approach to technology selection for oral small molecules intended for preclinical and clinical evaluation that focuses on poor solubility.
A brief description of the main technologies (jet milling, nanomilling, spray dried amorphous dispersion, hot melt extrusion and lipid based formulation) will be provided.
Amorphous dispersions and lipid formulations are most frequently considered for early development due to their ability to dissolve API and avoid API form issues to save time and money, while progressing to Phase 1 studies.
Whilst it is not the major focus of this lecture to discuss scale up considerations, it is important to consider long term strategies, where keeping two options running in parallel might be the best long term plan. This is particularly the case where the final formulation for phase 2 may not need to be the same as the one that is used for dose escalation in GLP Tox and Human Phase 1 studies.
It may be possible to take some short cuts in drug product design depending on the phase, and this may be done without sacrificing quality or the long term goals of the project. It is also often the case for small biotechs that the clinical formulation for orphan indications is eventually launched as the commercial formulation. Some example applications will be provided.