title: Injectable PLGA/hydrocortisone formulation produced by continuous supercritical emulsion extraction.
abstract: The objective of the present study was to develop an anti-inflammatory prolonged action formulation for local injection in prefilled syringes. Hydrocortisone acetate (HA) was selected as a model corticosteroid drug to be incorporated in poly(lactic-co-glycolic) (PLGA) microspheres. The formulation was obtained by supercritical emulsion extraction in continuous operation layout (SEE-C) to test the process robustness for a continuous industrial production. PLGA/HA microspheres with mean sizes between 1 μm (SD±0.20) and 5 μm (SD±1.45) were obtained when operating at 80 bar and 38 °C with a L/G ratio of 0.1 in the counter-current tower. The produced microdevices showed excellent encapsulation efficiencies between 75% and 80%, depending on the emulsion formulations tested, and different sustained release in the range of 6-15 days. In dependence of the different emulsion (single or double) processed by SEE-C, different products can be obtained according to the therapeutic requests. SEE-C confirms to be an innovative and flexible technology for biopolymer microdevices production, coupling the efficiency of continuous operation to the easy process scalability.
authors.affiliation: Department of Industrial Engineering, University of Salerno, Via Ponte don Melillo 1, 84084 Fisciano (SA), Italy.
authors.forename: Nunzia
authors.initials: N
authors.lastname: Falco
authors.forename: Ernesto
authors.initials: E
authors.lastname: Reverchon
authors.forename: Giovanna
authors.initials: G
authors.lastname: Della Porta
mesh_terms: D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000737:chemistry; D025924:Chromatography, Supercritical Fluid / Q000379:methods; D003692:Delayed-Action Preparations; D004337:Drug Carriers / Q000737:chemistry*; D004655:Emulsions; D006854:Hydrocortisone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry; D019344:Lactic Acid / Q000737:chemistry*; D008863:Microspheres; D010316:Particle Size; D011100:Polyglycolic Acid / Q000737:chemistry*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D013594:Syringes; D013678:Technology, Pharmaceutical / Q000379:methods; D013997:Time Factors
chemical_list: D000893:Anti-Inflammatory Agents; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D004655:Emulsions; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; C021650:hydrocortisone acetate; D006854:Hydrocortisone