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Milling induced amorphisation and recrystallization of alpha-lactose monohydrate
RISE Res Intitutes Sweden, Div Biosci & Mat, Box 5607, SE-11486 Stockholm, Sweden.;KTH Royal Inst Technol, Div Surface & Corros Sci, Drottning Kristinas Vag 51, SE-10044 Stockholm, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
RISE Res Intitutes Sweden, Div Biosci & Mat, Box 5607, SE-11486 Stockholm, Sweden..
Novartis Pharma AG, Novartis Inst Biomed Res, GDC, Novartis Campus, CH-4002 Basel, Switzerland..
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2018 (English)In: International Journal of Pharmaceutics, ISSN 0378-5173, E-ISSN 1873-3476, Vol. 537, no 1-2, p. 140-147Article in journal (Refereed) Published
Abstract [en]

Preprocessing of pharmaceutical powders is a common procedure to condition the materials for a better manufacturing performance. However, such operations may induce undesired material properties modifications when conditioning particle size through milling, for example. Modification of both surface and bulk material structure will change the material properties, thus affecting the processability of the powder. Hence it is essential to control the material transformations that occur during milling. Topographical and mechanical changes in surface properties can be a preliminary indication of further material transformations. Therefore a surface evaluation of the alpha-lactose monohydrate after short and prolonged milling times has been performed. Unprocessed alpha-lactose monohydrate and spray dried lactose were evaluated in parallel to the milled samples as reference examples of the crystalline and amorphous lactose structure. Morphological differences between un-processed a-lactose, 1 h and 20 h milled lactose and spray dried lactose were detected from SEM and AFM images. Additionally, AFM was used to simultaneously characterize particle surface amorphicity by measuring energy dissipation. Extensive surface amorphicity was detected after 1 h of milling while prolonged milling times showed only a moderate particle surface amorphisation. Bulk material characterization performed with DSC indicated a partial amorphicity for the 1 h milled lactose and a fully amorphous thermal profile for the 20 h milled lactose. The temperature profiles however, were shifted somewhat in the comparison to the amorphous reference, particularly after extended milling, suggesting a different amorphous state compared to the spraydried material. Water loss during milling was measured with TGA, showing lower water content for the lactose amorphized through milling compared to spray dried amorphous lactose. The combined results suggest a surface-bulk propagation of the amorphicity during milling in combination with a different amorphous structural conformation to that of the amorphous spray dried lactose. The hardened surface may be due to either surface crystallization of lactose or to formation of a low-water glass transition.

Place, publisher, year, edition, pages
ELSEVIER SCIENCE BV , 2018. Vol. 537, no 1-2, p. 140-147
Keywords [en]
Tableting, Milling, Lactose, Amorphisation, Recrystallization, Mechanical properties, Atomic force microscopy, Differential scanning calorimetry, TGA
National Category
Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:uu:diva-346658DOI: 10.1016/j.ijpharm.2017.12.021ISI: 000424263700016PubMedID: 29262302OAI: oai:DiVA.org:uu-346658DiVA, id: diva2:1192287
Available from: 2018-03-22 Created: 2018-03-22 Last updated: 2018-03-22Bibliographically approved

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Pazesh, SamanehAlderborn, Göran

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