title: Development of reconstitutable suspensions containing diclofenac sodium-loaded microspheres for pediatric delivery.
abstract: Effective clinical utilisation of non-steroidal anti-inflammatory drugs, such as diclofenac sodium (DS) is significantly limited by their ulcerogenic potential and poor bioavailability after oral administration. The objective of this work was to develop reconstitutable pediatric suspensions of DS-loaded microspheres prepared with an acrylic polymer (Eudragit RS) for improved pediatric delivery of DS. The microspheres were prepared by the water-in-oil-in-water or solid-in-oil-in-water emulsion techniques. Enviromental scanning electron microscopy observations clearly showed that microspheres have spherical shape. The drug entrapment efficiency of these microspheres was found 47.96 ± 0.79% to 88.57 ± 0.59% and their average particle sizes were 23.94-60.78 µm, which are within the desired range for the development of suspension formulation. The in vitro dissolution indicated prolonged sustained release of DS over 8 h. The results of preliminary characterisation studies of suspensions show that a liquid pharmaceutical preparation for oral administration capable of providing a sustained release of DS was successfully obtained.
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, Ankara University , Tandoğan, Ankara , Turkey.
authors.forename: Umut Can
authors.initials: UC
authors.lastname: Oz
authors.forename: Burcu
authors.initials: B
authors.lastname: Devrim
authors.forename: Asuman
authors.initials: A
authors.lastname: Bozkır
authors.forename: Kandemir
authors.initials: K
authors.lastname: Canefe
mesh_terms: D000180:Acrylic Resins / Q000737:chemistry*; D000284:Administration, Oral; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000737:chemistry; D002648:Child; D003692:Delayed-Action Preparations / Q000737:chemistry*; D004008:Diclofenac / Q000008:administration & dosage* / Q000737:chemistry; D006801:Humans; D010316:Particle Size; D012995:Solubility; D013535:Suspensions / Q000737:chemistry
chemical_list: D000180:Acrylic Resins; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D013535:Suspensions; D004008:Diclofenac; C050528:Eudragit RS
keywords: Diclofenac sodium; Eudragit RS; microsphere; reconstitutable pediatric suspension; solid-in-oil-in-water emulsion method