Fast dissolving films made of maltodextrins.
This work aimed to study maltodextrins (MDX) with a low dextrose equivalent as film forming material and their application in the design of oral fast-dissolving films. The suitable plasticizer and its concentration were selected on the basis of flexibility, tensile strength and stickiness of MDX films, and the MDX/plasticizer interactions were investigated by ATR-FTIR spectroscopy. Flexible films were obtained by using 16-20% w/w glycerin (GLY). This basic formulation was adapted to the main production technologies, casting and solvent evaporation (Series C) or hot-melt extrusion (Series E), by adding sorbitan monoleate (SO) or cellulose microcrystalline (MCC), respectively. MCC decreased the film ductility and significantly affected the film disintegration time both in vitro and in vivo (Series C<10s; Series E approximately 1min). To assess the film loading capacity, piroxicam (PRX), a water insoluble drug, was selected. The loading of a drug as a powder decreased the film ductility, but the formulation maintained satisfactory flexibility and resistance to elongation for production and packaging procedures. The films present a high loading capacity, up to 25mg for a surface of 6cm(2). The PRX dissolution rate significantly improved in Series C films independently of the PRX/MDX ratio.
Cilurzo
Francesco
F
Istituto di Chimica Farmaceutica e Tossicologica "P. Pratesi", Università degli Studi di Milano, Milano, Italy. francesco.cilurzo@unimi.it
Cupone
Irma E
IE
Minghetti
Paola
P
Selmin
Francesca
F
Montanari
Luisa
L
D000268:Adhesiveness; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry; D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms; D004337:Drug Carriers; D004339:Drug Compounding; D005990:Glycerol / Q000737:chemistry*; D006601:Hexoses / Q000737:chemistry; D007700:Kinetics; D010894:Piroxicam / Q000737:chemistry; D010968:Plasticizers / Q000737:chemistry*; D018583:Pliability; D011134:Polysaccharides / Q000737:chemistry*; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000379:methods; D013718:Tensile Strength
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004304:Dosage Forms; D004337:Drug Carriers; D006601:Hexoses; D010968:Plasticizers; D011134:Polysaccharides; C018665:sorbitan monooleate; D010894:Piroxicam; C008315:maltodextrin; D002482:Cellulose; C109691:microcrystalline cellulose; D005990:Glycerol