title: Influence of temperature and relative humidity conditions on the pan coating of hydroxypropyl cellulose molded capsules.
abstract: In a previous study, hydroxypropyl cellulose (HPC)-based capsular shells prepared by injection molding and intended for pulsatile release were successfully coated with 10mg/cm(2) Eudragit® L film. The suitability of HPC capsules for the development of a colon delivery platform based on a time dependent approach was demonstrated. In the present work, data logging devices (PyroButton®) were used to monitor the microenvironmental conditions, i.e. temperature (T) and relative humidity (RH), during coating processes performed under different spray rates (1.2, 2.5 and 5.5g/min). As HPC-based capsules present special features, a preliminary study was conducted on commercially available gelatin capsules for comparison purposes. By means of PyroButton data-loggers it was possible to acquire information about the impact of the effective T and RH conditions experienced by HPC substrates during the process on the technological properties and release performance of the coated systems. The use of increasing spray rates seemed to promote a tendency of the HPC shells to slightly swell at the beginning of the spraying process; moreover, capsules coated under spray rates of 1.2 and 2.5g/min showed the desired release performance, i.e. ability to withstand the acidic media followed by the pulsatile release expected for uncoated capsules. Preliminary stability studies seemed to show that coating conditions might also influence the release performance of the system upon storage.
authors.affiliation: Department of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico Health Sciences Center, Albuquerque, NM 87131, United States; Dipartimento di Scienze Farmaceutiche, Sezione di Tecnologia e Legislazione Farmaceutiche "Maria Edvige Sangalli", Università degli Studi di Milano, Via G. Colombo 71, 20133 Milan, Italy. Electronic address: EMacchi@salud.unm.edu.
authors.forename: Elena
authors.initials: E
authors.lastname: Macchi
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Sezione di Tecnologia e Legislazione Farmaceutiche "Maria Edvige Sangalli", Università degli Studi di Milano, Via G. Colombo 71, 20133 Milan, Italy. Electronic address: lucia.zema@unimi.it.
authors.forename: Lucia
authors.initials: L
authors.lastname: Zema
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb Co., One Squibb Drive, New Brunswick, NJ 08903, United States. Electronic address: Preetanshu.Pandey@bms.com.
authors.forename: Preetanshu
authors.initials: P
authors.lastname: Pandey
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Sezione di Tecnologia e Legislazione Farmaceutiche "Maria Edvige Sangalli", Università degli Studi di Milano, Via G. Colombo 71, 20133 Milan, Italy. Electronic address: andrea.gazzaniga@unimi.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Gazzaniga
authors.affiliation: Department of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico Health Sciences Center, Albuquerque, NM 87131, United States. Electronic address: lfelton@unm.edu.
authors.forename: Linda A
authors.initials: LA
authors.lastname: Felton
mesh_terms: D002214:Capsules / Q000138:chemical synthesis*; D002482:Cellulose / Q000031:analogs & derivatives* / Q000138:chemical synthesis; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D006813:Humidity / Q000592:standards*; D013696:Temperature
chemical_list: D002214:Capsules; D002482:Cellulose; C008079:hydroxypropylcellulose
keywords: Bed temperature; Enteric coating; Hydroxypropyl cellulose capsule; Injection molding; Oral pulsatile release; Relative humidity