Experimental and Modeling Study of Drug Release from HPMC-Based Erodible Oral Thin Films
Alessandra Adrover,
Gabriele Varani,
Patrizia Paolicelli,
Stefania Petralito,
Laura Di Muzio,
Maria Antonietta Casadei,
Ingunn Tho
Affiliations
Alessandra Adrover
Dipartimento di Ingegneria Chimica, Materiali e Ambiente, Sapienza Universitá di Roma, Via Eudossiana 18, 00184 Rome, Italy
Gabriele Varani
Dipartimento di Ingegneria Chimica, Materiali e Ambiente, Sapienza Universitá di Roma, Via Eudossiana 18, 00184 Rome, Italy
Patrizia Paolicelli
Dipartimento di Chimica e Tecnologie del Farmaco, Sapienza Universitá di Roma, Piazzale Aldo Moro 5, 00185 Rome, Italy
Stefania Petralito
Dipartimento di Chimica e Tecnologie del Farmaco, Sapienza Universitá di Roma, Piazzale Aldo Moro 5, 00185 Rome, Italy
Laura Di Muzio
Dipartimento di Chimica e Tecnologie del Farmaco, Sapienza Universitá di Roma, Piazzale Aldo Moro 5, 00185 Rome, Italy
Maria Antonietta Casadei
Dipartimento di Chimica e Tecnologie del Farmaco, Sapienza Universitá di Roma, Piazzale Aldo Moro 5, 00185 Rome, Italy
Ingunn Tho
Section of Pharmaceutics and Social Pharmacy, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, 0316 Oslo, Norway
In this work hydroxypropyl methylcellulose (HPMC) fast-dissolving thin films for oral administration are investigated. Furosemide (Class IV of the Biopharmaceutical Classification System) has been used as a model drug for in vitro release tests using three different set-ups: the Franz cell, the millifluidic flow-through device, and the paddle type dissolution apparatus (USP II). In order to enable drug incorporation within HPMC films, a multifunctional excipient, hydroxypropyl- β -cyclodextrin (HP- β -CD) has been included in the formulation, and the influence of HP- β -CD on film swelling, erosion, and release properties has been investigated. Mathematical models capable of describing the swelling and release processes from HPMC erodible thin films in different apparatuses have been developed. In particular, we propose a new model for the description of drug transport and release in a Franz cell that accounts for the effect of the unavoidable imperfect mixing of the receptor chamber.
