title: Effect of plasticizers on the physico-mechanical properties of pullulan based pharmaceutical oral films.
abstract: The effect of different plasticizers (glycerol, vitamin E TPGS and triacetin) and their concentrations on the physico-mechanical properties of pullulan based oral films was studied. A full factorial (32) design of experiments was used. Elastic modulus, tensile strength, elongation at break and disintegration time were selected as response variables. Modulated differential scanning calorimeter (MDSC) was used for determining glass transition temperature (Tg) of pullulan films. The surface morphology of films was evaluated by SEM, while ATR-FTIR was used to obtain a molecular level understanding of polymer-plasticizer interactions. The DoE analysis allowed for the modelling of tensile strength and elongation at break. The highest elongations were observed in glycerol at 20% w/w. Majority of the films disintegrated within one minute without significant differences. ATR-FTIR spectra of pullulan alone and different plasticizer blend films show characteristic molecular interactions. The present study concluded that glycerol is suitable plasticizer compared to others for manufacturing pullulan based oral films.
authors.affiliation: Department of Health Sciences, Luleå University of Technology, Luleå 97187, Sweden. Electronic address: parameswara.rao.vuddanda@ltu.se.
authors.forename: Parameswara Rao
authors.initials: PR
authors.lastname: Vuddanda
authors.affiliation: Department of Pharmaceutical Sciences and Technology, University of Chile, Santiago 8380494, Chile. Electronic address: miguel.montenegro@ug.uchile.cl.
authors.forename: Miguel
authors.initials: M
authors.lastname: Montenegro-Nicolini
authors.affiliation: Department of Pharmaceutical Sciences and Technology, University of Chile, Santiago 8380494, Chile; Advanced Center for Chronic Diseases (ACCDiS), Santiago 8380494, Chile. Electronic address: jomorales@ciq.uchile.cl.
authors.forename: Javier O
authors.initials: JO
authors.lastname: Morales
authors.affiliation: Department of Health Sciences, Luleå University of Technology, Luleå 97187, Sweden. Electronic address: sitaram.velaga@ltu.se.
authors.forename: Sitaram
authors.initials: S
authors.lastname: Velaga
mesh_terms: D000284:Administration, Oral; D055598:Chemical Phenomena; D004337:Drug Carriers / Q000008:administration & dosage / Q000737:chemistry; D005936:Glucans / Q000008:administration & dosage / Q000737:chemistry*; D010968:Plasticizers / Q000008:administration & dosage / Q000737:chemistry*; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods; D013314:Stress, Mechanical; D013718:Tensile Strength
chemical_list: D004337:Drug Carriers; D005936:Glucans; D010968:Plasticizers; C009109:pullulan
keywords: Glycerol; Glycerol (PubChem CID: 753); MDSC; Oral films; Orodispersible films; Plasticizers; Pullulan; Pullulan (PubChem CID: CA002935); Triacetin; Triacetin (Pubchem CID: 5541); Vitamin E TPGS; Vitamin E TPGS (PubChem CID: 71406)