Vui lòng dùng định danh này để trích dẫn hoặc liên kết đến tài liệu này: 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

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