Pharmacokinetic profile of a 24-hour controlled-release OROS® formulation of hydromorphone in the presence and absence of food
Tóm tắt
Từ khóa
Tài liệu tham khảo
Quigley C, Wiffen P: A systematic review of hydromorphone in acute and chronic pain. J Pain Symptom Manage. 2003, 25: 169-178. 10.1016/S0885-3924(02)00643-7.
Hill HF, Coda BA, Tanaka A, Schaffer R: Multiple-dose evaluation of intravenous hydromorphone pharmacokinetics in normal human subjects. Anesth Analg. 1991, 72: 330-336. 10.1213/00000539-199103000-00009.
Vallner JJ, Stewart JT, Kotzan JA, Kirsten EB, Honigberg IL: Pharmacokinetics and bioavailability of hydromorphone following intravenous and oral administration to human subjects. J Clin Pharmacol. 1981, 21: 152-156.
Palangio M, Northfelt DW, Portenoy RK, Brookoff D, Doyle RT, Dornseif BE, Damask MC: Dose conversion and titration with a novel, once-daily, OROS osmotic technology, extended-release hydromorphone formulation in the treatment of chronic malignant or nonmalignant pain. J Pain Symptom Manage. 2002, 23: 355-368. 10.1016/S0885-3924(02)00390-1.
Drover DR, Angst MS, Valle M, Ramaswamy B, Naidu S, Stanski DR, Verotta D: Input characteristics and bioavailability after administration of immediate and a new extended-release formulation of hydromorphone in healthy volunteers. Anesthesiology. 2002, 97: 827-836. 10.1097/00000542-200210000-00013.
Summary of Product Characteristics for JURNISTA. ALZA Corporation, MountainView, CA.,
Gupta S, Xu E, Sathyan G: Pharmacokinetic investigation of dose proportionality across the OROS hydromorphone dose range. IASP Press. 2005, 631-
Eckenhoff B, Theeuwes F, Urquhart J: Osmotically activated dosage forms forrate-controlled drug delivery. Pharm Technol. 1981, 5: 35-
Sathyan G, Weiting H, Gupta SK: Lack of effect of food on the pharmacokinetics of an extended-release oxybutynin formulation. J Clin Pharmacol. 2001, 41: 187-192. 10.1177/00912700122010014.
Gutstein HB, Akil H: Opioid Analgesics. Goodman & Gilman's The Pharmacological Basis of Therapeutics. Edited by: Hardman JG, Limbird LE and Gilman AG. 2001, New York, McGraw-Hill, 23: 569-619. 10th
Bashaw ED, Kaiko RF, Grandy RP, Reder RF, Goldenheim PD: Relative bioavailability of controlled-release oral morphine sulfate during naltrexone blockade. Int J Clin Pharmacol Ther. 1995, 33: 524-529.
FDA CDER Guidelines for Industry: Food-Effect Bioavailability and FedBioequivalence Studies. 2002, [ http://www.fda.gov/cder/guidance/index.htm ]
Durnin C, Hind ID, Channon E, Yates DB, Cross M: Effect of food on the pharmacokinetics of oral immediate-release hydromorphone (Dilaudid IR). Proc West Pharmacol Soc. 2001, 44: 75-76.
Wilson CG, Washington N, Greaves JL, Kamali F, Rees JA, Sempik AK, Lampard JF: Bimodal release of ibuprofen in a sustained-release formulation: A scintigraphic and pharmacokinetic open study in healthy volunteers under different conditions of food intake. Int J Pharm. 1989, 50: 155-161. 10.1016/0378-5173(89)90140-3.
PalladoneTM label. 2004, [ http://www.fda.gov/cder/foi/label/2004/021044lbl.pdf ]