title: Preparation of fenofibrate dry emulsion and dry suspension using octenyl succinic anhydride starch as emulsifying agent and solid carrier.
abstract: Purpose of this study was to investigate the ability of octenyl succinic anhydride (OSA) starch as emulsifier and solid carrier in dry emulsion (DE) and dry suspension (DS) formulations. Fenofibrate (FF) was loaded at lower and higher than its saturation concentration in oil phase to prepare the DE and DS by spray drying method. The DE and DS were successfully prepared with 36-48% and 46% production yield, respectively. After reconstitution in water, the emulsion with mean droplet size of 1-2 μm was obtained. Solid state characterization revealed the amorphous state of FF and the crystalline state of OSA starch in both DE and DS formulations. Both DE and DS enhanced FF dissolution rate compared to pure material and DS showed the highest dissolution rate. The DE and DS could be compressed to the tablets with acceptable disintegration time and without changeable dissolution profile. Moreover, the dissolution profiles of both DE and DS remained unchanged after 2 months storage at 40 °C.
authors.affiliation: Department of Manufacturing Pharmacy, Faculty of Pharmacy, Mahidol University, Sri-Ayudhya Road, Bangkok 10400, Thailand; Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany.
authors.forename: Kasama
authors.initials: K
authors.lastname: Pongsamart
authors.affiliation: Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Kleinebudde
authors.affiliation: Department of Manufacturing Pharmacy, Faculty of Pharmacy, Mahidol University, Sri-Ayudhya Road, Bangkok 10400, Thailand; Center of Excellence in Innovative Drug Delivery and Nanomedicine, Faculty of Pharmacy, Mahidol University, Sri-Ayudhya Road, Bangkok 10400, Thailand. Electronic address: satit.put@mahidol.ac.th.
authors.forename: Satit
authors.initials: S
authors.lastname: Puttipipatkhachorn
mesh_terms: D002626:Chemistry, Pharmaceutical; D004337:Drug Carriers / Q000032:analysis / Q000138:chemical synthesis*; D045703:Emulsifying Agents / Q000032:analysis / Q000138:chemical synthesis*; D011345:Fenofibrate / Q000032:analysis / Q000138:chemical synthesis*; D012995:Solubility; D013213:Starch / Q000032:analysis / Q000138:chemical synthesis*; D013387:Succinic Anhydrides / Q000032:analysis / Q000138:chemical synthesis*; D013535:Suspensions; D014961:X-Ray Diffraction / Q000379:methods
chemical_list: D004337:Drug Carriers; D045703:Emulsifying Agents; D013387:Succinic Anhydrides; D013535:Suspensions; C031801:succinic anhydride; D013213:Starch; D011345:Fenofibrate
keywords: Dry emulsion; Emulsifying agent; Fenofibrate; Octenyl succinic anhydride starch; Solid carrier; Spray drying