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2 protocols using lactose monohydrate

1

Fenofibrate Formulation Development and Characterization

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Fenofibrate was purchased from Jiangsu Nhwa Pharmaceutical Co. (Xuzhou, China). Fenofibric acid and 4-chlorophenyl-4′-hydroxyphenyl methanone (internal standard) were acquired from Zhejiang Yidu Biotech Co. (Jiangshan, China). Commercial capsules of Lipilfen® and Lipanthyl® were purchased from Shanghai Ethypharm Pharmaceuticals Co. (Shanghai, China) and Laboratories Fournier (Dijon, France), respectively. Sucrose/starch nonpareil seeds (0.4–0.6 mm) were purchased from Hangzhou Gaocheng Biological Nutrient Technology Co. (Hangzhou, China). Aerosil® 200, Eudragit® RS PO, Eudragit® E100 (Evonik, Essen, Germany), hydroxypropyl methylcellulose (HPMC) E5, ethyl cellulose (EC) 10 cPs (Dow Chemical Co., Midland, MI, USA), HPMC 6 cPs (Shin-Etsu Chemical Co., Tokyo, Japan), triethyl citrate (TEC [A Johnson Matthey, London, UK]), talc (passed through 200 mesh; Sichuan Serpentine Mineral Factory, Sichuan, China), polyethylene glycol (PEG) 4000, and lactose monohydrate (SLS, chemical grade) (Sinopharm Chemical Reagent Co., Shanghai, China) were used. Ethyl acetate, n-hexane, acetonitrile, and methanol were of chromatographic grade. All other reagents were of analytical grade or better.
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2

Synthesis of Isotope-Labeled Lactose Nanoparticles

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Lactose monohydrate (99.0%), melamine (99.0%), ammonium hydroxide (28–30%), tetraethyl orthosilicate (TEOS, 96%), ethanol absolute (99.7%), silver nitrate (99.5%), sodium hydroxide (96%), sodium borohydride (99%), potassium hexacyanoferrate (99.5%), zinc sulfate (99.5%), and Whatman No. 1 filter papers were purchased from Sinopharm Chemical Reagent Beijing Co., Ltd (Beijing, China). [UL-13C6glc]-Lactose monohydrate (the isotope contained six 13C) was purchased from Cambridge Isotope Laboratories (CIL, USA). Polyvinylpyrrolidone (PVP, MW 40 kDa) and bovine serum albumin (BSA) were purchased from Sigma, USA. All aqueous solutions were prepared using deionized water (18.2 MΩ cm, Milli-Q, Millipore, GmbH) throughout all experiments.
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