title: Effect of polymer, plasticizer and filler on orally disintegrating film.
abstract: BACKGROUND
  Difficulty in swallowing tablets or capsules has been identified as one of the contributing factors to non-compliance of geriatric patients. Although orally disintegrating tablet was designed for fast disintegration in mouth, the fear of taking solid tablets and the risk of choking for certain patient populations still exist.
  
  
  OBJECTIVE
  The objective of this study was to develop and characterize orally disintegrating film (ODF), which was prepared using different combinations of polymers, plasticizers and fillers.
  
  
  METHODS
  Effects of hydroxypropyl methylcellulose (HPMC), polyethylene glycol 400 (PEG 400), glycerin, polyvinyl pyrrolidone (PVP), mannitol and microcrystalline cellulose (MCC) on physical property of ODF formed were studied. The ODF was prepared using the solvent casting method.
  
  
  RESULTS
  Increase in HPMC concentration formed ODF with greater tensile strength. Incorporation of plasticizer (PEG 400 and glycerin) reduced tensile strength but increased elasticity of the ODF formed. PVP increased both tensile strength and elasticity of the ODF. Increase in MCC:mannitol ratio reduced the tensile strength and elasticity of the ODF. Disintegration time of film decreased corresponding to decrease in tensile strength of the film. Formulation R with the optimum tensile strength (13.10 N/mm(2)), bending flexibility (40 times) and disintegration time (41.50 s) was chosen as final formulation. A total of 80% of the drug was released within five minutes and the ODF was stable at least for one year actual condition.
  
  
  CONCLUSIONS
  An ODF containing donepezil HCl was developed and characterized. The donepezil HCl ODF has the potential to improve the compliance of Alzheimer disease patients.
authors: Department of Pharmaceutical Technology, School of Pharmaceutical Sciences, Universiti Sains Malaysia , Minden, Penang , Malaysia.
authors: Kai Bin
authors: KB
authors: Liew
authors: Yvonne Tze Fung
authors: YT
authors: Tan
authors: Kok-Khiang
authors: KK
authors: Peh
mesh_terms: D000284:Administration, Oral; D000544:Alzheimer Disease / Q000188:drug therapy; D002626:Chemistry, Pharmaceutical; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000737:chemistry; D000077265:Donepezil; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients / Q000737:chemistry*; D005260:Female; D006801:Humans; D007189:Indans / Q000008:administration & dosage* / Q000737:chemistry; D008297:Male; D055118:Medication Adherence; D010880:Piperidines / Q000008:administration & dosage* / Q000737:chemistry; D010968:Plasticizers / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry*; D012995:Solubility; D013607:Tablets; D013718:Tensile Strength; D013997:Time Factors; D055815:Young Adult
chemical_list: D002800:Cholinesterase Inhibitors; D005079:Excipients; D007189:Indans; D010880:Piperidines; D010968:Plasticizers; D011108:Polymers; D013607:Tablets; D000077265:Donepezil