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PHARMACOKINETICS

Clinical Pharmacology and Pharmacokinetics of Once-Daily Hydromorphone Hydrochloride Extended-Release Capsules

Vijay Vashi, PhD, Stephen Harris, MD, Ahmed El-Tahtawy, PhD, Danlin Wu, PhD and Alessandra Cipriano, BS

From Purdue Pharma L.P., Stamford, Connecticut (Dr Vashi, Dr Harris, Dr El-Tahtawy, Ms Cipriano) and Purdue Research Center, Ardsley, New York (Dr Wu).

Hydromorphone hydrochloride extended release (HHER) is a multiparticulate melt-extrusion pellet capsule formulation administered q24h. Study 1 investigated the bioavailability of 24-mg HHER fed, as well as 24-mg and 12-mg HHER and 8-mg hydromorphone hydrochloride immediate-release (HHIR) tablets fasting. No clinically significant food effect was observed on hydromorphone Cmax or AUC for the 24-mg HHER, and dose proportionality (AUC) was demonstrated between 12- and 24-mg HHER. Study 2 demonstrated dose strength proportionality for 3 x 12-mg HHER versus 1 x 32-mg HHER. Study 3 evaluated 12-mg HHER q24h versus 3-mg HHIR q6h at steady state. HHER produced relatively constant steady-state concentrations over 24 hours. HHER and HHIR were equivalent for AUCss. Cssmax was 26% lower for HHER than HHIR, Cssmin was 43% higher for HHER, and peak-to-trough fluctuation was 126% for HHER versus 328% for HHIR, which are ideal attributes of a once-daily oral extended-release dosage form. HHER administration resulted in fewer adverse events than HHIR in study 3.

Key Words: Extended-release hydromorphone HCl • pharmacokinetics

Address for reprints: Vijay Vashi, PhD, Purdue Pharma, LP, One Stamford Forum, Stamford, CT 06901-3431.






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