藥品的製作過程是否真的就像大家說的一樣，只要有效成分加上賦形劑攪一攪，再像搖湯圓一樣，搖一搖就可以完成一粒粒的藥丸? 檢視藥品製造到上市的管理，從最源頭的原料藥與賦形劑管理、製造工廠管理、臨床試驗成效、運輸儲存管理即上市後的風險管理，衛生主管機關對於每一個環節皆層層把關，目的是為了讓使用者服用的每一顆藥的品質都具一致性，都是安全的，且皆能達到有效的治療效果。
傳統的藥品製程為研磨、過篩、配方比例開發、造粒、混合、塗膜、打錠等步驟才能完成，製作上常會遇到的困難就是製備出來每一顆錠劑之間的含量均一度有可能會落差，導致服用後不一定能達到預期治療的效果，而本文針對使用3D 列印技術製程之藥錠做為比較，觀察使用新穎的技術，是否真的能對傳統製程上所遇到的問題能達到實質的幫助與改善。
美國食品和藥物管理局(Food and Drug Administration，FDA)於2015 年核准了第一款利用3D 列印技術製造的藥錠Spritam® ，過去FDA 核准過以3D 列印製造的醫材，但就核准的3D 列印藥品則是頭一遭，以現今3D 列印技術的發展，列印藥錠不會是太過困難的技術，但此技術於對藥品的製程、功效、臨床使用的改善是否有實質效益?甚至是後續藥品的管理辦法、專利申請等是如何操作?
本研究將對3D 列印藥品之技術介紹、改善傳統藥品製程上的問題、臨床研究比對、FDA 對此類藥品之上市管理以及探討此技術之專利申請，藉由分析
Spritam® 案例了逐步了解新技術開發到後續實際應用於醫療而帶來的生活品質改善、促進醫藥產業發展等，另外，可能產生的風險及問題都能防範並有更好的解決辦法，期望本研究對FDA 許可的3D 列印藥品許可藥證作探討，可讓台灣未來對於同樣的技術發展及相關法規的管理可更有效的幫助與應用。

Is it possible that only have to stir and shook the active ingredient with the excipient together to make a pill? review the management from drug production to marketing, the health authorities monitor from APIs and excipients, manufacturing plants, clinical trials, transportation and storage to post-marketing surveillance management, every step of these processes for keeping the quality of each drug taken by the patients consistent, safe and effective treatment.
Traditional pharmaceutical processes are grinding, sieving, formula ratio development, granulation, mixing, coating, and tableting, the difficulty often encountered in the processes is the inconsistency in the concentration between each lozenge, which may not achieve the desired therapeutic effect after taking it, this study compares the tablets process of 3D printing technology with traditional manufacturing and observe whether the use of new technologies can really help and improve problems encountered in traditional manufacturing.
The Food and Drug Administration has approved the first prescription drug made through 3D printing-Spritam®in 2015, the FDA has previously approved the use of 3D printed medical devices, but for the 3D printing drug is the first time.With the development of 3D printing technology, printing a tablet is not very difficult, but will this technology have significant benefits in terms of improving the process, efficacy, and clinical use of the drug? even subsequent New Drug Application (NDA) management and patent applications, how do these work?
This research will introduce the technology of 3D printing drugs how to improve traditional drug processes, comparative clinical research, FDA's NDA management and patent applications, through the case of Spritam®, we will know about the new technology will improve the quality of life and future development of practical applications in the pharmaceutical industry.

中文
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參、專利案
1. US 6,471,992 - Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same.
2. US 7,749,533 - Highly plastic granules for making fast melting tablets.
3. US 9,314,429 - Rapidly dispersible dosage form of oxcarbazepine.
4. US 9,339,489 - Rapid disperse dosage form containing levetiracetam.
5. US 9,463,160 - Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same.
6. US 9,669,009 - Rapid disperse dosage form containing levetiracetam.
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