Development and characterization of non-effervescent floating extended-release mini-matrices obtained by hot-melt extrusion

• Grant number: 15/15653-5
• Support Opportunities: Scholarships abroad - Research Internship - Doctorate
• Start date: May 06, 2016
• End date: December 05, 2016
• Field of knowledge: Health Sciences - Pharmacy - Pharmaceutical Technology
• Principal Investigator: Humberto Gomes Ferraz
• Grantee: Amanda Campos Fortes
• Supervisor: Roland Bodmeier
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Institution abroad: Freie Universität Berlin, Germany
• Associated to the scholarship: 13/14744-1 - Application of polyurethane resin derivative from castor oil on controlled release gastroretentive pellet drug delivery system, BP.DR

Abstract

Gastroretentive systems are oral drug delivery formulations that can withstand gastric emptying, while they release the drug in a suitable kinetic to optimize its bioavailability. These systems benefit, in particular, drugs absorbed preferentially in the upper gastrointestinal tract, highly soluble in acidic media or unstable in the inferior gastrointestinal tract. In this context, the aim of this project is to develop and characterize non-effervescent floating extended-release mini-matrices obtained by hot-melt extrusion. The mini-matrices composition will be defined by a 22 full factorial design to evaluate the influence of independent variables - proportion of the matrix polymers and the amount of low-density foam - on the response of the drug release and floating time. This experimental design will result in four extruded formulations that will contain a fixed amount of verapamil (model drug). The physical chemical properties of the raw materials, the extrudates and their physical mixtures will be evaluated by thermal analysis, X-ray diffraction and infrared. Finally, the water uptake and the in vitro buoyancy and drug release of the formulations will be performed.