title: Influence of fulvic acid and hydroxy propyl-beta-cyclodextrin on aspirin degradation.
abstract: OBJECTIVE
  The degradation of aspirin (ASA) was investigated to reveal information about the influence of complexation with fulvic acid (FA), as a new complexing agent and compared with hydroxy propyl-beta-cyclodextrin complex.
  
  
  METHODS
  ASA was complexed with FA in the molar ratio 1:0.5, 1:1, and 1:2 by different methods through lyophilization, solvent evaporation, and spray drying. Spray-dried (1:1) ASA-hydroxy propyl-beta-cyclodextrin complex was prepared and compared with optimized complex of FA. All the complexes and ASA alone were packaged in well-labeled sealed polythene-lined aluminum pouches and stored in stability chamber at 40 +/- 2 degrees C and 75 +/- 5% relative humidity for 120 days. Samples were analyzed for salicylic acid content at 0, 30, 60, 90, and 120 days.
  
  
  RESULTS
  Overall 4.31% salicylic acid was formed in 1:1 ASA-FA spray-dried complex, which was optimized stable complex among other complexes of FA prepared by different methods in different molar ratios. However, 2.35% salicylic acid was measured with 1:1 spray-dried ASA-hydroxy propyl-beta-cyclodextrin complex. Stability of ASA increased more when complexed with hydroxy propyl-beta-cyclodextrin as compared to FA.
  
  
  CONCLUSIONS
  A novel complexing agent in the form of FA was investigated to increase the stability of ASA. A marked improvement in stability of ASA was observed when complexed with hydroxy propyl-beta-cyclodextrin (1:1) by spray drying as compared to 1:1 spray-dried ASA-FA complex.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, New Delhi, India. mkanwer2002@yahoo.co.in
authors.forename: Mohammad Khalid
authors.initials: MK
authors.lastname: Anwer
authors.forename: Suraj Prakash
authors.initials: SP
authors.lastname: Agarwal
authors.forename: Asgar
authors.initials: A
authors.lastname: Ali
authors.forename: Yasmin
authors.initials: Y
authors.lastname: Sultana
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry; D001241:Aspirin / Q000737:chemistry*; D001578:Benzopyrans / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D004355:Drug Stability; D005079:Excipients; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000379:methods*; D047392:beta-Cyclodextrins / Q000737:chemistry*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001578:Benzopyrans; D005079:Excipients; D047392:beta-Cyclodextrins; D001241:Aspirin; C005023:fulvic acid