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http://thuvienso.vanlanguni.edu.vn/handle/Vanlang_TV/15140
Nhan đề: | Uncovering Hidden Risks in Solid-State API Properties |
Tác giả: | Loughrey, Jonathan |
Từ khoá: | Phase transitions Crystallization Humidity Manufacturing Hydration Design of experiments Solvents Morphology Polymorphism Bioavailability |
Năm xuất bản: | 2019 |
Nhà xuất bản: | MultiMedia Healthcare Inc. |
Tóm tắt: | Locating and understanding hydrated forms of an API As discussed, facile hydrate formation can drastically alter the processability, stability, and aqueous solubility of a given API; this example shows how an API was fully characterized to allow the development of a reliable method for synthesis, avoiding an undesirable hemi-hydrated form that was uncovered during a polymorph screening project. [...]thermal gravimetric analysis (TGA) confirmed the anhydrous, non-solvated nature of the form, while analysis by dynamic vapor sorption (DVS) at 25 °C, showed minor hysteresis with a maximum mass uptake of 0.95 wt.% at 90% relative humidity (RH), confirming its status as a developable form (Figure 1). Using the non-random two-liquid (NRTL) equation and measured water activity, a detailed hydration map was investigated across multiple organic solvents; it was found that the morphology of Form 1 was greatly improved using small volume aliquots of water in ICH class 3 solvents (e.g., 0.5 Aw = 95 % isopropanol : 5 % water, % v/v) to minimize the risk of hemi-hydrate formation. |
Mô tả: | Pharmaceutical Technology APIs, Excipients, and manufacturing 2019 |
Định danh: | http://thuvienso.vanlanguni.edu.vn/handle/Vanlang_TV/15140 |
ISSN: | 1543-2521 2150-7376 (e) |
Bộ sưu tập: | Bài báo_lưu trữ |
Các tập tin trong tài liệu này:
Tập tin | Mô tả | Kích thước | Định dạng | |
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BBKH693_TCCN_Uncovering Hidden Risks in.pdf Giới hạn truy cập | Uncovering Hidden Risks in Solid-State API Properties | 3.04 MB | Adobe PDF | Xem/Tải về Yêu cầu tài liệu |
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