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工業技術研究院

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技術名稱: 藥物固型/固性開發技術平台

技術簡介

新藥固形的溶解度、安定性以及可加工性於新藥開發期程中一直扮演橋接前期研發及臨床實驗的重要關鍵。目前新藥研發成功率極低,其原因在於leads和candidates多僅以藥效 (efficacy)、毒性 (toxicity) 與藥物動力學 (pharmacokinetics) 為篩選依據,於研發後期才探討drug-like properties以及first in human dose form,因此難以克服候選藥物化學結構的限制,無法滿足phase transition的需求,導致計畫延誤甚至失敗。Pre-formulation關鍵技術如:(1) 快速/小量鹽類及晶型篩選系統、(2) 多晶體(Polymorphism)鑑定、(3) 鹽類與晶型篩選與評估技術等,可以橋接新藥前期研發與臨床實驗,加速標的藥物固型研發,確保智財及準備產品生命週期延長的基礎。本技術除應用於新藥研發外,尚可應用於高價值學名藥的開發及商機拓展。

Abstract

The drug-like properties including: solubility, stability and manufacturability, are essential evaluation criteria to bridge the early development and clinical trial. Currently, the successful rate in new drug project is declining, because leads and candidates are selected based on pharmacodynamics, toxicology and pharmacokinetics criteria.

技術規格

新藥/原料藥多晶型篩選與開發 固體藥物最適化鹽型製作 藥物固型之物化性質與藥動特性評估系統

Technical Specification

Salt/polymorph screening API form selection and process optimization Solid state and formulation characterization

技術特色

結合藥化與藥動的研發能量,針對藥物之多型性進行快速且全面性的篩選,提供物化特性及活體藥動皆符合臨床實驗需求的穩定晶型

應用範圍

可應用於難溶性及低吸收率藥物,提供產、學、研界預配方評估工作技術服務,加速協助推至臨床前試驗階段之目標

接受技術者具備基礎建議(設備)

DSC、PLM / Hot Stage

接受技術者具備基礎建議(專業)

化學合成、化合物物化特性分析、藥動分析

技術分類 醫藥技術

聯絡資訊

聯絡人:許振霖 標靶藥物與傳輸技術組

電話:+886-3-5732580 或 Email:JamesJLSheu@itri.org.tw

客服專線:+886-800-45-8899

傳真:+886-3-5820369

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