title: A new biodegradable polythiourethane as controlled release matrix polymer.
abstract: The main aim of this paper is the synthesis and characterization of a new linear functional biodegradable polythiourethane-d,l-1,4-dithiothreitol-hexamethylene diisocyanate [PTU(DTT-HMDI)]. The SeDeM diagram has been obtained to investigate its suitability to be processed through a direct compression process. Furthermore, the ability of this polymer to act as controlled release matrix forming excipient has been studied. Four batches of matrices containing 10-40% of polymer and theophylline anhydrous as model drug have been manufactured. Release studies have been carried out using the paddle method and the polymer percolation threshold has been estimated. The principal parameters of the SeDeM Expert system, such as the parametric profile (mean radius) and the good compression index (IGC=4.59) for the polymer are very close to the values considered as adequate for direct compression even with no addition of flow agents. Furthermore, the results of the drug release studies show a high ability of the polymer to control the drug release. The excipient percolation threshold has been estimated between 20% and 30% w/w of polymer.
authors.affiliation: Department of Pharmacy and Pharmaceutical Technology, University of Seville, C/Profesor García González 2, 41012 Seville, Spain. Electronic address: mcampinez@us.es.
authors.forename: M D
authors.initials: MD
authors.lastname: Campiñez
authors.affiliation: Department of Organic and Pharmaceutical Chemistry, University of Seville, C/Profesor García González 2, 41012 Seville, Spain. Electronic address: cferris@us.es.
authors.forename: C
authors.initials: C
authors.lastname: Ferris
authors.affiliation: Department of Organic and Pharmaceutical Chemistry, University of Seville, C/Profesor García González 2, 41012 Seville, Spain. Electronic address: vdepaz@us.es.
authors.forename: M V
authors.initials: MV
authors.lastname: de Paz
authors.affiliation: Department of Pharmacy and Pharmaceutical Technology, University of Seville, C/Profesor García González 2, 41012 Seville, Spain. Electronic address: aguilardeleyva@us.es.
authors.forename: A
authors.initials: A
authors.lastname: Aguilar-de-Leyva
authors.affiliation: Department of Organic and Pharmaceutical Chemistry, University of Seville, C/Profesor García González 2, 41012 Seville, Spain. Electronic address: jgalbis@us.es.
authors.forename: J
authors.initials: J
authors.lastname: Galbis
authors.affiliation: Department of Pharmacy and Pharmaceutical Technology, University of Seville, C/Profesor García González 2, 41012 Seville, Spain. Electronic address: caraballo@us.es.
authors.forename: I
authors.initials: I
authors.lastname: Caraballo
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D003692:Delayed-Action Preparations; D004339:Drug Compounding / Q000379:methods; D065546:Drug Liberation; D005079:Excipients / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry*; D011140:Polyurethanes / Q000737:chemistry*; D013806:Theophylline / Q000008:administration & dosage* / Q000737:chemistry
chemical_list: D003692:Delayed-Action Preparations; D005079:Excipients; D011108:Polymers; D011140:Polyurethanes; C000602564:polythiourethane-1,4-dithiothreitol-hexamethylene diisocyanate; D013806:Theophylline
keywords: 1,6-Diisocyanatohexane (PubChem CID: 13192); Biodegradable polythiourethane; Diethyl ether (PubChem CID: 3283); Dithiothreitol (PubChem CID: 19001); Inert matrices; N-methylpyrrolidone (PubChem CID: 13387); Percolation theory; Percolation threshold; SeDeM expert system; Theophylline (PubChem CID: 2153)