title: Drug release phenomena within a hydrophobic starch acetate matrix: FTIR mapping of tablets after in vitro dissolution testing.
abstract: The aim of this study was to assess the utility of Fourier transform infrared mapping to study the drug release phenomena within a hydrophobic matrix tablet. Starch acetate with a degree of substitution (2.7) was used as a hydrophobic matrix former. Anhydrous caffeine and riboflavin sodium phosphate were used as water soluble model drugs. The USP (XXVIII) paddle-method was selected as an in vitro dissolution test. Mapping of the diluted tablets' cross-section was performed by attenuated total reflection mode. Fourier transform infrared mapping can distinguish drug particles from the bulk matrix and it can be considered as a valuable method for obtaining both quantitative and qualitative information on drug release processes. The physicochemical properties of the drug compound strongly contribute to its release behavior when the USP paddle in vitro dissolution test is used. Mapping of the riboflavin product revealed a more homogenous matrix distribution due to its smaller particle size. Consequently, its dissolution release profile was more uniform than caffeine which possessed a wider particle size distribution and lower solubility. Mapping showed that caffeine became localized in the lower part of the tablet unlike riboflavin. The hydrodynamic conditions during the in vitro release test might contribute to this differentiation.
authors: Department of Pharmaceutics, University of Kuopio, P.O. Box 1627, FI-70211 Kuopio, Finland. zongming.gao@fda.hhs.gov
authors: Jari
authors: J
authors: Pajander
authors: Anne-Marie
authors: AM
authors: Soikkeli
authors: Ossi
authors: O
authors: Korhonen
authors: Robert T
authors: RT
authors: Forbes
authors: Jarkko
authors: J
authors: Ketolainen
mesh_terms: D002110:Caffeine / Q000737:chemistry / Q000493:pharmacokinetics*; D004337:Drug Carriers; D005612:Freeze Drying; D010316:Particle Size; D012256:Riboflavin / Q000737:chemistry / Q000493:pharmacokinetics*; D012995:Solubility; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods*; D013213:Starch / Q000031:analogs & derivatives* / Q000737:chemistry; D013607:Tablets / Q000737:chemistry*
chemical_list: D004337:Drug Carriers; D013607:Tablets; D002110:Caffeine; D013213:Starch; C050766:starch acetate; D012256:Riboflavin