title: Stability of dronabinol capsules when stored frozen, refrigerated, or at room temperature.
abstract: OBJECTIVE
  Results of a study to determine the 90-day stability of dronabinol capsules stored under various temperature conditions are reported.
  
  
  METHODS
  High-performance liquid chromatography (HPLC) with ultraviolet (UV) detection was used to assess the stability of dronabinol capsules (synthetic delta-9-tetrahydrocannabinol [Δ9-THC] mixed with high-grade sesame oil and other inactive ingredients and encapsulated as soft gelatin capsules) that were frozen, refrigerated, or kept at room temperature for three months. The dronabinol capsules remained in the original foil-sealed blister packs until preparation for HPLC-UV assessment. The primary endpoint was the percentage of the initial Δ9-THC concentration remaining at multiple designated time points. The secondary aim was to perform forced-degradation studies under acidic conditions to demonstrate that the HPLC-UV method used was stability indicating.
  
  
  RESULTS
  The appearance of the dronabinol capsules remained unaltered during frozen, cold, or room-temperature storage. Regardless of storage condition, the percentage of the initial Δ9-THC content remaining was greater than 97% for all evaluated samples at all time points over the three-month study. These experimental data indicate that the product packaging and the sesame oil used to formulate dronabinol capsules efficiently protect Δ9-THC from oxidative degradation to cannabinol; this suggests that pharmacies can store dronabinol capsules in nonrefrigerated automated dispensing systems, with a capsule expiration date of 90 days after removal from the refrigerator.
  
  
  CONCLUSIONS
  Dronabinol capsules may be stored at room temperature in their original packaging for up to three months without compromising capsule appearance and with minimal reduction in Δ9-THC concentration.
authors.affiliation: Department of Pharmaceutical Sciences, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Wempe
authors.affiliation: Acute Care Pharmacy, University of Colorado Hospital, Aurora, CO.
authors.forename: Alan
authors.initials: A
authors.lastname: Oldland
authors.affiliation: Department of Pharmacy, University of Colorado Hospital, Aurora, CO.
authors.forename: Nancy
authors.initials: N
authors.lastname: Stolpman
authors.affiliation: Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO. ty.kiser@ucdenver.edu.
authors.forename: Tyree H
authors.initials: TH
authors.lastname: Kiser
mesh_terms: D002214:Capsules; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003080:Cold Temperature; D013759:Dronabinol / Q000032:analysis* / Q000592:standards; D004349:Drug Packaging / Q000592:standards*; D004355:Drug Stability; D005615:Freezing; D006801:Humans; D011619:Psychotropic Drugs / Q000032:analysis / Q000592:standards; D013696:Temperature; D013997:Time Factors
chemical_list: D002214:Capsules; D011619:Psychotropic Drugs; D013759:Dronabinol