title: Self-nanoemulsifying drug delivery systems (SNEDDS) for oral delivery of protein drugs: I. Formulation development.
abstract: The global aim of this research project was to develop a self-nanoemulsifying drug delivery system (SNEDDS) for non-invasive delivery of protein drugs. The specific aim of this study was to develop SNEDDS formulations. An experimental design was adopted to develop SNEDDS. Fluorescent labeled beta-lactamase (FITC-BLM), a model protein, was loaded into SNEDDS through solid dispersion technique. The experimental design provided 720 compositions of different oil, surfactant, and co-surfactant at various ratios, of which 33 SNEDDS prototypes were obtained. Solid dispersion of FITC-BLM in SoyPC prepared was able to dissolve in 16 SNEDDS prototypes (approximately 2200 mU BLM in 1g SNEDDS). SNEDDS NE-12-7 (composition: Lauroglycol FCC, Cremophor EL and Transcutol; ratio: 5:4:3) formed O/W nanoemulsion with mean droplet size in the range of 22-50 nm when diluted with various pH media and different dilution factor with PBS (pH 7.4). The phase diagram of NE-12-7 indicated a broad region of nanoemulsion. BLM-loaded SNEDDS (NE-12-7) stored at 4 degrees C for 12 weeks indicated 10% loss of BLM activity. A SNEDDS was developed to load FITC-BLM into the oil phase which can spontaneously form O/W nanoemulsion upon the addition of water.
authors.affiliation: Biotechnology and Drug Delivery Laboratory, Department of Pharmacy and Administrative Sciences, College of Pharmacy and Allied Health Professions, St. John's University, 8000 Utopia Parkway, Queens, NY 11439, USA.
authors.forename: Sripriya Venkata Ramana
authors.initials: SV
authors.lastname: Rao
authors.forename: Jun
authors.initials: J
authors.lastname: Shao
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D004337:Drug Carriers / Q000737:chemistry; D016503:Drug Delivery Systems / Q000379:methods*; D015195:Drug Design; D004355:Drug Stability; D004655:Emulsions; D053758:Nanoparticles / Q000737:chemistry*; D009821:Oils / Q000737:chemistry; D010316:Particle Size; D055550:Protein Stability; D013501:Surface-Active Agents / Q000737:chemistry; D001618:beta-Lactamases / Q000008:administration & dosage*
chemical_list: D004337:Drug Carriers; D004655:Emulsions; D009821:Oils; D013501:Surface-Active Agents; D001618:beta-Lactamases