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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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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
In Vivo Abuse Resistance Studies • Physical Disruption Study • Mastication (chewing) Study • Buccal Absorption Study
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
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)
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
Physical Disruption Study Mean Oxycodone Plasma Concentration-Time Profiles
Physical Disruption Study Mean Oxycodone Plasma Concentration-Time Profiles OxyContin Remoxy Statistical Comparison
Physical Disruption Study Mean Oxycodone Plasma Concentration-Time Profiles Statistical Comparison
Physical Disruption Study Cumulative Frequency Plots
Physical Disruption Study Conclusion • The extended-release characteristics appeared to be compromised when Remoxy was subjected crushing and extraction with a solvent
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
Mastication Study Mean Oxycodone Plasma Concentration-Time Profiles Statistical Comparison
Mastication Study Cumulative Frequency Plots
Mastication Study Conclusion • The extended-release characteristics appeared to be compromised when Remoxy was subjected to mastication
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
Buccal Absorption Study Mean Oxycodone Plasma Concentration-Time Profiles Statistical Comparison
Buccal Absorption Study Cumulative Frequency Plots
Buccal Absorption Study Conclusion • The extended-release characteristics appeared to be compromised when Remoxy was subjected to buccal absorption
Overall Summary • The extended-release characteristics appeared to be compromised when Remoxy was subjected to crushing and extraction with ethanol, mastication, and buccal absorption