title: Novel semisolid SNEDDS based on PEG-30-di-(polyhydroxystearate): Progesterone incorporation and in vitro digestion.
abstract: The aim of this work is to study the digestibility of PEG-30-di-(polyhydroxystearate) (Cithrol(®) DPHS) and its semisolid novel self-nanoemulsifying drug delivery systems (SNEDDS). Furthermore, the SNEDDS-mediated solubility enhancement of the poorly water-soluble drug Progesterone was evaluated in different media. Additionally, the impact of digestion on Progesterone solubilization was investigated in vitro by a pancreatin digestion assay. The Progesterone-loaded semisolid self-nanoemulsifying formulation (F2) was comprehensively characterized by photon correlation spectroscopy (PCS), differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD) and Fourier transform infrared spectroscopy (FTIR). SNEDDS were able to enhance the equilibrium solubility of Progesterone at various media. Only a minor part of Cithrol(®) DPHS was digested by pancreatin (less than 6%). Furthermore, protection of Progesterone against digestion-mediated precipitation was observed. Therefore, DPHS containing SNEDDS are attractive candidates for the development of bio robust drug delivery systems for the oral delivery of poorly soluble drugs.
authors: Department of Pharmaceutics and Biopharmaceutics, Institute of Pharmacy, Martin-Luther-Universität Halle-Wittenberg, Wolfgang-Langenbeck Str. 4, D-06120 Halle (Saale), Germany.
authors: Tamer H
authors: TH
authors: Hassan
authors: Department of Pharmaceutics and Biopharmaceutics, Institute of Pharmacy, Martin-Luther-Universität Halle-Wittenberg, Wolfgang-Langenbeck Str. 4, D-06120 Halle (Saale), Germany. Electronic address: karsten.maeder@pharmazie.uni-halle.de.
authors: Karsten
authors: K
authors: Mäder
mesh_terms: D002210:Caprylates / Q000737:chemistry*; D016503:Drug Delivery Systems; D005079:Excipients / Q000737:chemistry*; D005989:Glycerides / Q000737:chemistry*; D011091:Polyesters / Q000737:chemistry*; D011092:Polyethylene Glycols / Q000737:chemistry*; D011374:Progesterone / Q000737:chemistry*; D012995:Solubility; D013229:Stearic Acids / Q000737:chemistry*
chemical_list: D002210:Caprylates; D005079:Excipients; D005989:Glycerides; C000600434:PEG-30-dipolyhydroxystearate; D011091:Polyesters; D013229:Stearic Acids; D011092:Polyethylene Glycols; D011374:Progesterone; C067028:Solutol HS 15; C025343:monooctanoin
keywords: Cithrol(®) DPHS; HPTLC; Lipid digestion; Progesterone; Selfemuslifying; Semisolid SNEDDS; pH-stat