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Title: Investigations on Co-Milling of Active Pharmaceutical Ingredients
Keywords: Co-milling, Excipients, Crystallinity, Stability, Triboelectrification, X-ray Powder Diffraction,
Issue Date: 27-Oct-2010
Citation: BALANI PRASHANT NIRMAL (2010-10-27). Investigations on Co-Milling of Active Pharmaceutical Ingredients. ScholarBank@NUS Repository.
Abstract: Milling, a commonly used process in pharmaceutical secondary manufacturing for reducing particle size of crystalline active pharmaceutical ingredients (APIs), leads to generation of thermodynamically unstable amorphous regions on particle surfaces which can undergo re-crystallization on storage. This reversion affects physicochemical properties of APIs such as solubility, physical stability, flow properties and aerosolization behavior which eventually affects the performance of the drug product. Co-milling is a process of milling two or more materials concurrently. It is alternatively referred to as co-grinding. Literature reports the use of co-milling as a simple and effective method of improving the physicochemical properties such as solubility, stability of various APIs. This research explored new applications of co-milling in formulating pharmaceutical products by: 1) mitigating amorphization of milled API with the aid of crystalline excipients; 2) demonstrating that a stable and homogenous amorphous dispersion of API can be obtained with the addition of amorphous excipient; 3) producing stable amorphous form of API on co-milling with an ionic polymer; 4) demonstrating that stable amorphous co-milled mixtures were effective in minimizing the surface electrostatic of charged APIs. These findings may contribute to the fields of formulation science and manufacturing of pharmaceutical, food, chemical and other products where size reduction of the ingredients and components is required.
Appears in Collections:Ph.D Theses (Open)

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