title: Formulation of monolayered films with drug and polymers of opposing solubilities.
abstract: The aim of this study was to prepare and characterise monolayered multipolymeric films (MMFs) comprising of a hydrophilic drug (Propranolol HCl) (PHCl) and polymers of opposing solubilities. Films were prepared by emulsification and casted by a new approach using a silicone-molded tray with individual wells. MMFs comprising of PHCl with Eudragit 100 (EUD100) and Chitosan (CHT), i.e. films with drug and polymers of opposing solubilities were successfully prepared (PHCl:EUD100:CHT; 1:10:0.5) and demonstrated uniform and reproducible drug content (100.71+/-2.66%), thickness (0.442+/-0.030 mm), mucoadhesivity (401.40+/-30.73 mN) and a controlled drug release profile. Drug release followed Higuchi's square-root model. Maximum swelling of the films occurred after 1h and 28.26% of the films eroded during the 8-h test period. Mechanical testing revealed that the MMFs displayed a greater abrasion resistance, were more elastic and also required more energy to break, rendering them tougher and more suitable for buccal delivery than the monopolymeric PHCl:EUD100 film. The inclusion of CHT to the film led to a more porous surface morphology. The surface pH of the films remained constant at neutral pH. This study confirmed the potential of the above MMFs as a promising candidate for buccal delivery of PHCl.
authors.affiliation: School of Pharmacy and Pharmacology, University of KwaZulu-Natal, Durban 4000, South Africa.
authors.forename: V A
authors.initials: VA
authors.lastname: Perumal
authors.forename: D
authors.initials: D
authors.lastname: Lutchman
authors.forename: I
authors.initials: I
authors.lastname: Mackraj
authors.forename: T
authors.initials: T
authors.lastname: Govender
mesh_terms: D000180:Acrylic Resins / Q000737:chemistry; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D048271:Chitosan / Q000737:chemistry; D004339:Drug Compounding; D005079:Excipients / Q000737:chemistry*; D006207:Half-Life; D006244:Hardness; D006863:Hydrogen-Ion Concentration; D007700:Kinetics; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry*; D011433:Propranolol / Q000008:administration & dosage / Q000737:chemistry; D015203:Reproducibility of Results; D012995:Solubility; D013499:Surface Properties; D014014:Tissue Adhesives
chemical_list: D000180:Acrylic Resins; D000319:Adrenergic beta-Antagonists; D005079:Excipients; D004364:Pharmaceutical Preparations; D014014:Tissue Adhesives; C050528:Eudragit RS; D048271:Chitosan; D011433:Propranolol