The exploitation of hot-melt extrusion and injection molding for the manufacturing of immediate-release (IR) tablets was preliminarily investigated in view of their special suitability for continuous manufacturing, which represents a current goal of pharmaceutical production because of its possible advantages in terms of improved sustainability. Tablet-forming agents were initially screened based on processability by single-screw extruder and micromolding machine as well as disintegration/dissolution behavior of extruded/molded prototypes. Various polymers, such as low-viscosity hydroxypropylcellulose, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, various sodium starch glycolate grades (e.g., Explotab® CLV) that could be processed with no need for technological aids, except for a plasticizer, were identified. Furthermore, the feasibility of both extruded and molded IR tablets from low-viscosity hydroxypropylcellulose or Explotab® CLV was assessed. Explotab® CLV, in particular, showed thermoplastic properties and a very good aptitude as a tablet-forming agent, starting from which disintegrating tablets were successfully obtained by either techniques. Prototypes containing a poorly soluble model drug (furosemide), based on both a simple formulation (Explotab® CLV and water/glycerol as plasticizers) and formulations including dissolution/disintegration adjuvants (soluble and effervescent excipients) were shown to fulfill the USP 37 dissolution requirements for furosemide tablets.
Evaluation of Hot-Melt Extrusion and Injection Molding for Continuous Manufacturing of Immediate-Release Tablets / A. Melocchi, G. Loreti, M.D. Del Curto, A. Maroni, A. Gazzaniga, L. Zema. - In: JOURNAL OF PHARMACEUTICAL SCIENCES. - ISSN 0022-3549. - 104:6(2015), pp. 1971-1980.
|Titolo:||Evaluation of Hot-Melt Extrusion and Injection Molding for Continuous Manufacturing of Immediate-Release Tablets|
LORETI, GIULIA (Secondo)
GAZZANIGA, ANDREA (Penultimo)
ZEMA, LUCIA (Ultimo)
|Parole Chiave:||Continuous manufacturing; Explotab®CLV; Extrusion; Formulation; Injection molding; Nisso HPCSSL; Oral drug delivery; Polymers; Solid dosage form; Tablet; Cellulose; Chemistry, Pharmaceutical; Diuretics; Drug Compounding; Excipients; Furosemide; Glycerol; Plasticizers; Polymers; Solubility; Tablets; Viscosity; 3003|
|Settore Scientifico Disciplinare:||Settore CHIM/09 - Farmaceutico Tecnologico Applicativo|
|Data di pubblicazione:||2015|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1002/jps.24419|
|Appare nelle tipologie:||01 - Articolo su periodico|