title: The solution and solid state stability and excipient compatibility of parthenolide in feverfew.
abstract: The objectives of this research were to evaluate the stability of parthenolide in feverfew solution state and powdered feverfew (solid state), and explore the compatibility between commonly used excipients and parthenolide in feverfew. Feverfew extract solution was diluted with different pH buffers to study the solution stability of parthenolide in feverfew. Powdered feverfew extract was stored under 40 degrees C/0% approximately 75% relative humidities (RH) or 31% RH/5~50 degrees C to study the influence of temperature and relative humidity on the stability of parthenolide in feverfew solid state. Binary mixtures of feverfew powered extract and different excipients were stored at 50 degrees C/ 75% RH for excipient compatibility evaluation. The degradation of parthenolide in feverfew solution appears to fit a typical first-order reaction. Parthenolide is comparatively stable when the environmental pH is in the range of 5 to 7, becoming unstable when pH is less than 3 or more than 7. Parthenolide degradation in feverfew in the solid state does not fit any obvious reaction model. Moisture content and temperature both play important roles affecting the degradation rate. After 6 months of storage, parthenolide in feverfew remains constant at 5 degrees C/31% RH. However, approximately 40% parthenolide in feverfew can be degraded if stored at 50 degrees C/31% RH. When the moisture changed from 0% to 75% RH, the degradation of parthenolide in feverfew increased from 18% to 32% after 6-month storage under 40 degrees C. Parthenolide in feverfew exhibits good compatibility with commonly used excipients under stressed conditions in a 3-week screening study.
authors.affiliation: University of Maryland, Baltimore, School of Pharmacy, 20 N. Pine Street, Baltimore, MD 21201, USA.
authors.forename: Ping
authors.initials: P
authors.lastname: Jin
authors.forename: Shadi
authors.initials: S
authors.lastname: Madieh
authors.forename: Larry L
authors.initials: LL
authors.lastname: Augsburger
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients / Q000737:chemistry*; D006813:Humidity; D006863:Hydrogen-Ion Concentration; D006868:Hydrolysis; D007700:Kinetics; D028321:Plant Preparations / Q000737:chemistry*; D011208:Powders; D012717:Sesquiterpenes / Q000737:chemistry*; D012996:Solutions; D020903:Tanacetum parthenium; D013678:Technology, Pharmaceutical / Q000379:methods; D013696:Temperature; D014867:Water / Q000737:chemistry
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005079:Excipients; D028321:Plant Preparations; D011208:Powders; D012717:Sesquiterpenes; D012996:Solutions; D014867:Water; C002669:parthenolide