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Remoxy In Vivo Abuse Resistance Studies

Remoxy In Vivo Abuse Resistance Studies. Ping Ji, PhD Senior Clinical Pharmacologist Office of Clinical Pharmacology Center of Drug Evaluation and Research Food and Drug Administration. In Vivo Abuse Resistance Studies. Physical Disruption Study Mastication (chewing) Study

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Remoxy In Vivo Abuse Resistance Studies

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  1. RemoxyIn Vivo Abuse Resistance Studies Ping Ji, PhD Senior Clinical Pharmacologist Office of Clinical Pharmacology Center of Drug Evaluation and Research Food and Drug Administration

  2. In Vivo Abuse Resistance Studies • Physical Disruption Study • Mastication (chewing) Study • Buccal Absorption Study

  3. Dose Dumping • For opioids, Cmax is a critical pharmacokinetic parameter • For the assessment of dose dumping, it is important to examine data from both individual and group mean basis

  4. Cumulative Frequency Analysis • In a data set, the ‘more than’ cumulative frequency of a value x is the total number of observations that are more than or equal to x • Frequency counts can be measured in terms of absolute numbers or relative numbers (e.g., proportions or percentages)

  5. Physical Disruption Study • Treatment A: Remoxy 40 mg capsule (whole) • Treatment B: Remoxy 40 mg capsule (crushed, extracted with solvent) • Treatment C: OxyContin 40 mg tablet (whole) • Treatment D: OxyContin 40 mg tablet (crushed, extracted with solvent) • Treatment E: Oxycodone oral solution 40 mg

  6. Physical Disruption Study Mean Oxycodone Plasma Concentration-Time Profiles

  7. Physical Disruption Study Mean Oxycodone Plasma Concentration-Time Profiles OxyContin Remoxy Statistical Comparison

  8. Physical Disruption Study Mean Oxycodone Plasma Concentration-Time Profiles Statistical Comparison

  9. Physical Disruption Study Cumulative Frequency Plots

  10. Physical Disruption Study Conclusion • The extended-release characteristics appeared to be compromised when Remoxy was subjected crushing and extraction with a solvent

  11. Mastication Study • Treatment A: Remoxy 40 mg capsule (whole) • Treatment B: Remoxy 40 mg capsule masticated rigorously and then swallowed • Treatment C: Oxycondone oral solution 40 mg

  12. Mastication Study Mean Oxycodone Plasma Concentration-Time Profiles Statistical Comparison

  13. Mastication Study Cumulative Frequency Plots

  14. Mastication Study Conclusion • The extended-release characteristics appeared to be compromised when Remoxy was subjected to mastication

  15. Buccal Absorption Study • Treatment A: Remoxy 40 mg capsule (whole) • Treatment B: Remoxy 40 mg capsule held in the buccal cavity and then swallowed • Treatment C: Oxycodone oral solution 40 mg

  16. Buccal Absorption Study Mean Oxycodone Plasma Concentration-Time Profiles Statistical Comparison

  17. Buccal Absorption Study Cumulative Frequency Plots

  18. Buccal Absorption Study Conclusion • The extended-release characteristics appeared to be compromised when Remoxy was subjected to buccal absorption

  19. Overall Summary • The extended-release characteristics appeared to be compromised when Remoxy was subjected to crushing and extraction with ethanol, mastication, and buccal absorption

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