Jeannine M Conway1, Angela K Birnbaum2, Ilo E Leppik3, Page B Pennell4, James R White5, John O Rarick1, Rory P Remmel6. 1. Experimental and Clinical Pharmacology, 308 Harvard Street SE, Minneapolis, MN 55455, United States. 2. Experimental and Clinical Pharmacology, 308 Harvard Street SE, Minneapolis, MN 55455, United States. Electronic address: birnb002@umn.edu. 3. Experimental and Clinical Pharmacology, 308 Harvard Street SE, Minneapolis, MN 55455, United States; Department of Neurology, 420 Delaware St. SE, University of Minnesota, Minneapolis, MN 55455, United States; MINCEP Epilepsy Care, 5775 Wayzata Boulevard, Minneapolis, MN 55416, United States. 4. Department of Neurology and Division of Women's Health at Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, United States. 5. MINCEP Epilepsy Care, 5775 Wayzata Boulevard, Minneapolis, MN 55416, United States. 6. Department of Medicinal Chemistry, 308 Harvard Street SE, University of Minnesota, Minneapolis 55455, MN, United States.
Abstract
PURPOSE: Intravenous (IV) formulations are useful when treating patients where oral administration is not possible and to study certain pharmacokinetic parameters such as bioavailability. We developed a stable-labeled IV formulation of lamotrigine (LTG) for studying pharmacokinetics in epilepsy patients. METHODS: Stable-labeled IV LTG was given to 20 persons with epilepsy (6 men; 14 women) with a mean age of 34.8 years (SD 11.7). A 50mg dose of LTG (stable labeled) was given intravenously and replaced 50mg of the regular morning oral dose of LTG (unlabeled, commercially available formulation). RESULTS: No significant changes in blood pressure, heart rate, or adverse events including rash were attributed to administration of a 50-mg dose of the intravenous LTG formulation. CONCLUSION: Our results show that LTG base that is complexed with 2-hydroxypropyl-β-cyclodextrin and stable-labeled can be given safely as a tracer replacement dose.
PURPOSE: Intravenous (IV) formulations are useful when treating patients where oral administration is not possible and to study certain pharmacokinetic parameters such as bioavailability. We developed a stable-labeled IV formulation of lamotrigine (LTG) for studying pharmacokinetics in epilepsypatients. METHODS: Stable-labeled IV LTG was given to 20 persons with epilepsy (6 men; 14 women) with a mean age of 34.8 years (SD 11.7). A 50mg dose of LTG (stable labeled) was given intravenously and replaced 50mg of the regular morning oral dose of LTG (unlabeled, commercially available formulation). RESULTS: No significant changes in blood pressure, heart rate, or adverse events including rash were attributed to administration of a 50-mg dose of the intravenous LTG formulation. CONCLUSION: Our results show that LTG base that is complexed with 2-hydroxypropyl-β-cyclodextrin and stable-labeled can be given safely as a tracer replacement dose.
Authors: Baralee Punyawudho; James C Cloyd; Ilo E Leppik; R Eugene Ramsay; Susan E Marino; Page B Pennell; James R White; Angela K Birnbaum Journal: Clin Pharmacokinet Date: 2009 Impact factor: 6.447
Authors: A H Guberman; F M Besag; M J Brodie; J M Dooley; M S Duchowny; J M Pellock; A Richens; R S Stern; E Trevathan Journal: Epilepsia Date: 1999-07 Impact factor: 5.864
Authors: Jeannine M Conway; James R White; Angela K Birnbaum; R Eugene Ramsay; Page B Pennell; John O Rarick; Luna Musib; Ilo E Leppik; James C Cloyd Journal: Epilepsy Res Date: 2009-03-18 Impact factor: 3.045
Authors: Anne M Clark; Robert L Kriel; Ilo E Leppik; James R White; Thomas R Henry; Richard C Brundage; James C Cloyd Journal: Epilepsia Date: 2013-04-15 Impact factor: 5.864
Authors: J E Ahn; J C Cloyd; R C Brundage; S E Marino; J M Conway; R E Ramsay; J R White; L C Musib; J O Rarick; A K Birnbaum; I E Leppik Journal: Neurology Date: 2008-07-01 Impact factor: 9.910
Authors: Vikram R Shinde; Makarand R Shelake; Sandeep S Shetty; Amit B Chavan-Patil; Yogesh V Pore; Sameer G Late Journal: J Pharm Pharmacol Date: 2008-09 Impact factor: 3.765
Authors: S E Marino; A K Birnbaum; I E Leppik; J M Conway; L C Musib; R C Brundage; R E Ramsay; P B Pennell; J R White; C R Gross; J O Rarick; U Mishra; J C Cloyd Journal: Clin Pharmacol Ther Date: 2012-01-25 Impact factor: 6.875
Authors: Akshanth R Polepally; Rory P Remmel; Richard C Brundage; Ilo E Leppik; John O Rarick; R Eugene Ramsay; Angela K Birnbaum Journal: J Clin Pharmacol Date: 2015-08-18 Impact factor: 3.126