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Review

Extended-release drug formulations for the treatment of epilepsy

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Pages 843-850 | Received 29 Nov 2016, Accepted 12 Apr 2018, Published online: 19 Apr 2018

References

  • Fröscher W, Blankenhorn V, May TW, et al. Pharmakotherapie der epilepsien. 4 ed. Stuttgart: Schattauer; 2008. p. 422 p.
  • Leucuta SE. Drug delivery systems with modified release for systemic and biophase bioavailability. Curr Clin Pharmacol. 2012 Nov;7(4):282–317. PubMed PMID: 22794159.
  • Perucca E. Extended-release formulations of antiepileptic drugs: rationale and comparative value. Epilepsy Curr. 2009 Nov-Dec;9(6):153–157. PubMed PMID: 19936129. Pubmed Central PMCID: 2778358.
  • May TW, Brandt C, Helmer R, et al. Comparison of lacosamide concentrations in cerebrospinal fluid and serum in patients with epilepsy. Epilepsia. 2015 Jul;56(7):1134–1140. PubMed PMID: 25988882.
  • Sattler A, Schaefer M, May TW, et al. Fluctuation of lacosamide serum concentrations during the day and occurrence of adverse drug reactions–first clinical experience. Epilepsy Res. 2011 Aug;95(3):207–212. PubMed PMID: 21543186. Epub 2011/05/06. .
  • Specht U, Elsner H, May TW, et al. Postictal serum levels of antiepileptic drugs for detection of noncompliance. Epilepsy Behav. 2003 Oct;4(5):487–495. PubMed PMID: 14527489.
  • May TW, Berkenfeld R, Dennig D, et al. Patients’ perspectives on management and barriers of regular antiepileptic drug intake. Epilepsy & Behavior: E&B. 2017 Dec 29;79:162–168. PubMed PMID: 29291547. Epub 2018/01/02. eng.
  • Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001 Aug;23(8):1296–1310. PubMed PMID: 11558866.
  • Gollwitzer S, Kostev K, Hagge M, et al. Nonadherence to antiepileptic drugs in Germany: a retrospective, population-based study. Neurology. 2016 Aug 2;87(5):466–472. PubMed PMID: 27371490.
  • Brandt C, May TW. Therapeutic drug monitoring of newer antiepileptic drugs. LaboratoriumsMedizin. 2011;35(3): 161–169. PubMed PMID: WOS:000293164300005. .
  • Brandt C, Baumann P, Eckermann G, et al. “Therapeutic drug monitoring” in epileptologie und psychiatrie. [Therapeutic drug monitoring in epileptology and psychiatry]. Nervenarzt. 2008 Feb;79(2):167–174. PubMed PMID: 17701390. Epub 2007/ 08/19.
  • Crawford P. Best practice guidelines for the management of women with epilepsy. Epilepsia. 2005;46:117–124.
  • Nau H. Teratogenic valproic acid concentrations: infusion by implanted minipumps vs conventional injection regimen in the mouse. Toxicol Appl Pharmacol. 1985 Sep 15;80(2):243–250. PubMed PMID: 3927520.
  • Mawhinney E, Campbell J, Craig J, et al. Valproate and the risk for congenital malformations: is formulation and dosage regime important? Seizure. 2012 Apr;21(3):215–218. PubMed PMID: 22364656.
  • Ficker DM, Privitera M, Krauss G, et al. Improved tolerability and efficacy in epilepsy patients with extended-release carbamazepine. Neurology. 2005 Aug 23;65(4):593–595. PubMed PMID: 16116122.
  • Mirza WU, Rak IW, Thadani VM, et al. Six-month evaluation of Carbatrol (extended-release carbamazepine) in complex partial seizures. Neurology. 1998 Dec;51(6):1727–1729. PubMed PMID: 9855533.
  • Miller AD, Krauss GL, Hamzeh FM. Improved CNS tolerability following conversion from immediate- to extended-release carbamazepine. Acta Neurol Scand. 2004 Jun;109(6):374–377. PubMed PMID: 15147458.
  • Persson LI, Ben-Menachem E, Bengtsson E, et al. Differences in side effects between a conventional carbamazepine preparation and a slow-release preparation of carbamazepine. Epilepsy Res. 1990 Jul;6(2):134–140. PubMed PMID: 2201541.
  • Canger R, Altamura AC, Belvedere O, et al. Conventional vs controlled-release carbamazepine: a multicentre, double-blind, cross-over study. Acta Neurol Scand. 1990 Jul;82(1):9–13. PubMed PMID: 2239143.
  • Sivenius J, Heinonen E, Lehto H, et al. Reduction of dosing frequency of carbamazepine with a slow-release preparation. Epilepsy Res. 1988 Jan-Feb;2(1):32–36. PubMed PMID: 3197677.
  • Garnett WR, Levy B, McLean AM, et al. Pharmacokinetic evaluation of twice-daily extended-release carbamazepine (CBZ) and four-times-daily immediate-release CBZ in patients with epilepsy. Epilepsia. 1998 Mar;39(3):274–279. PubMed PMID: 9578044.
  • Wolf P, May T, Tiska G, et al. Steady state concentrations and diurnal fluctuations of carbamazepine in patients after different slow release formulations. Arzneimittel-Forschung. 1992 Mar;42(3):284–288. PubMed PMID: 1497685.
  • McKee PJ, Blacklaw J, Carswell A, et al. Double dummy comparison between once and twice daily dosing with modified-release carbamazepine in epileptic patients. Br J Clin Pharmacol. 1993 Sep;36(3):257–261. PubMed PMID: 9114913. Pubmed Central PMCID: 1364647.
  • Brodie MJ, Mintzer S, Pack AM, et al. Enzyme induction with antiepileptic drugs: cause for concern? Epilepsia. 2013 Jan;54(1):11–27. PubMed PMID: 23016553. Epub 2012/ 09/29.
  • Gordi T, Hou E, Kasichayanula S, et al. Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive- extended-release and immediate-release tablets: a randomized, open-label, multiple-dose, three-way crossover, exploratory study in healthy subjects. Clin Ther. 2008 May;30(5):909–916. PubMed PMID: 18555937.
  • Chen C, Cowles VE, Hou E. Pharmacokinetics of gabapentin in a novel gastric-retentive extended-release formulation: comparison with an immediate-release formulation and effect of dose escalation and food. J Clin Pharmacol. 2011 Mar;51(3):346–358. PubMed PMID: 20484610.
  • Zaccara G, Perucca E. Interactions between antiepileptic drugs, and between antiepileptic drugs and other drugs. Epileptic Disorders: International Epilepsy Journal with Videotape. 2014 Dec;16(4):409–431. PubMed PMID: 25515681.
  • Naritoku DK, Warnock CR, Messenheimer JA, et al. Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology. 2007 Oct 16;69(16):1610–1618. PubMed PMID: 17938371.
  • Biton V, Di Memmo J, Shukla R, et al. Adjunctive lamotrigine XR for primary generalized tonic-clonic seizures in a randomized, placebo-controlled study. Epilepsy Behav. 2010 Nov;19(3):352–358. PubMed PMID: 20937567.
  • French JA, Temkin NR, Shneker BF, et al. Lamotrigine XR conversion to monotherapy: first study using a historical control group. Neurotherapeutics. 2012 Jan;9(1):176–184. PubMed PMID: 22139591. Pubmed Central PMCID: 3271149.
  • Biton V, Shneker BF, Naritoku D, et al. Long-term tolerability and safety of lamotrigine extended-release: pooled analysis of three clinical trials. Clin Drug Investig. 2013 May;33(5):359–364. PubMed PMID: 23475541.
  • Tompson DJ, Ali I, Oliver-Willwong R, et al. Steady-state pharmacokinetics of lamotrigine when converting from a twice-daily immediate-release to a once-daily extended-release formulation in subjects with epilepsy (The COMPASS Study). Epilepsia. 2008 Mar;49(3):410–417. PubMed PMID: 17825077.
  • Polepally AR, Remmel RP, Brundage RC, et al. Steady-state pharmacokinetics and bioavailability of immediate-release and extended-release formulations of lamotrigine in elderly epilepsy patients: use of stable isotope methodology. J Clin Pharmacol. 2015 Oct;55(10):1101–1108. PubMed PMID: 25903807. Pubmed Central PMCID: 4558201.
  • Chen C, Wright J, Gidal B, et al. Assessing impact of real-world dosing irregularities with lamotrigine extended-release and immediate-release formulations by pharmacokinetic simulation. Ther Drug Monit. 2013 Apr;35(2):188–193. PubMed PMID: 23503444.
  • Nielsen KA, Dahl M, Tommerup E, et al. Diurnal lamotrigine plasma level fluctuations: clinical significance and indication of shorter half-life with chronic administration. Epilepsy Behav. 2008 Oct;13(3):470–473. PubMed PMID: 18611447.
  • Ramey P, Osborn M, Abou-Khalil B. Conversion from immediate-release to extended-release lamotrigine improves seizure control. Epilepsy Res. 2014 Nov;108(9):1637–1641. PubMed PMID: 25205163.
  • May TW, Rambeck B, Jurgens U. Serum concentrations of Levetiracetam in epileptic patients: the influence of dose and co-medication. Ther Drug Monit. 2003 Dec;25(6):690–699. PubMed PMID: 14639055.
  • Peltola J, Coetzee C, Jimenez F, et al. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406–414. PubMed PMID: 19317886.
  • Chung S, Ceja H, Gawlowicz J, et al. Levetiracetam extended release conversion to monotherapy for the treatment of patients with partial-onset seizures: a double-blind, randomised, multicentre, historical control study. Epilepsy Res. 2012 Aug;101(1–2):92–102. PubMed PMID: 22516508.
  • Richy FF, Banerjee S, Brabant Y, et al. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240–245. PubMed PMID: 19699156.
  • Rouits E, Burton I, Guenole E, et al. Pharmacokinetics of levetiracetam XR 500mg tablets. Epilepsy Res. 2009 Apr;84(2–3):224–231. PubMed PMID: 19264451.
  • French JA, Baroldi P, Brittain ST, et al. Efficacy and safety of extended-release oxcarbazepine (Oxtellar XR) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial. Acta Neurol Scand. 2014 Mar;129(3):143–153. PubMed PMID: 24359313. Pubmed Central PMCID: 4033571.
  • Chung SS, Johnson JK, Brittain ST, et al. Long-term efficacy and safety of adjunctive extended-release oxcarbazepine (Oxtellar XR) in adults with partial-onset seizures. Acta Neurol Scand. 2015 Aug 6. doi:10.1111/ane.12467. [Epub ahead of print]. PubMed PMID: 26248506.
  • Steinhoff BJ, Wendling AS. Short-term impact of the switch from immediate-release to extended-release oxcarbazepine in epilepsy patients on high dosages. Epilepsy Res. 2009 Dec;87(2–3):256–259. PubMed PMID: 19850448.
  • Steinhoff BJ, Stefan H, Schulze-Bonhage A, et al. Retardiertes vs. schnell freisetzendes Oxcarbazepin bei therapierefraktarer fokaler Epilepsie: eine offene multizentrische, randomisierte kontrollierte Studie. [Slow release versus immediate release oxcarbazepine in difficult-to-treat focal epilepsy: a multicenter, randomized, open, controlled, parallel group phase III study]. Nervenarzt. 2012 Oct;83(10):1292–1299. PubMed PMID: 22850688.
  • Sattler A, Schaefer M, May TW. Relationship between mono-hydroxy-carbazepine serum concentrations and adverse effects in patients on oxcarbazepine monotherapy. Seizure. 2015 Sep;31:149–154. PubMed PMID: 26362393.
  • Bialer M, Soares-da-Silva P. Pharmacokinetics and drug interactions of eslicarbazepine acetate. Epilepsia. 2012;53(6):935–946.
  • Perucca E, Elger C, Halász P, et al. Pharmacokinetics of eslicarbazepine acetate at steady-state in adults with partial-onset seizures. Epilepsy Res. 2011;96(1–2):132–139.
  • Rojanasthien N, Chaichana N, Teekachunhatean S, et al. Effect of doses on the bioavailability of phenytoin from a prompt-release and an extended-release preparation: single dose study. J Med Assoc Thai. 2007 Sep;90(9):1883–1893. PubMed PMID: 17957935.
  • Boehme V, Rambeck B, May TW, et al. Fluctuation of pregabalin serum concentrations during the day. Epilepsia. 2007;48(Suppl. 3):38–39.
  • French J, Brandt C, Friedman D, et al. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: A double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Jun 24;55:1220–1228. PubMed PMID: 24962242.
  • Brandt C, Schoendienst M, Trentowska M, et al. Efficacy and safety of pregabalin in refractory focal epilepsy with and without comorbid anxiety disorders - results of an open-label, parallel group, investigator-initiated, proof-of-concept study. Epilepsy Behav. 2013 Nov;29(2):298–304. PubMed PMID: 24012505.
  • Chung SS, Fakhoury TA, Hogan RE, et al. Once-daily USL255 as adjunctive treatment of partial-onset seizures: randomized phase III study. Epilepsia. 2014 Jul;55(7):1077–1087. PubMed PMID: 24902983. Pubmed Central PMCID: 4143954.
  • Hogan RE, Blatt I, Lawson B, et al. Efficacy of once-daily extended-release topiramate (USL255): a subgroup analysis based on the level of treatment resistance. Epilepsy Behav. 2014 Dec;41:136–139. PubMed PMID: 25461205.
  • May TW, Rambeck B, Jurgens U. Serum concentrations of topiramate in patients with epilepsy: influence of dose, age, and comedication. Ther Drug Monit. 2002 Jun;24(3):366–374. PubMed PMID: 12021627.
  • Clark AM, Halvorsen MB, Braun TL, et al. USL255 extended-release topiramate: dose-proportional pharmacokinetics and tolerability in healthy volunteers. Epilepsia. 2014 Jul;55(7):1069–1076. PubMed PMID: 24861853. Pubmed Central PMCID: 4283972.
  • Bialer M, Shekh-Ahmad T, Braun TL, et al. Comparative steady-state pharmacokinetic evaluation of immediate-release topiramate and USL255, a once-daily extended-release topiramate formulation. Epilepsia. 2013 Aug;54(8):1444–1452. PubMed PMID: 23692553.
  • Lambrecht LJ, Shekh-Ahmad T, Todd WM, et al. Comparative pharmacokinetic analysis of USL255, a new once-daily extended-release formulation of topiramate. Epilepsia. 2011 Oct;52(10):1877–1883. PubMed PMID: 21770925.
  • Brittain ST, Wheless JW. Pharmacokinetic simulations of topiramate plasma concentrations following dosing irregularities with extended-release vs. immediate-release formulations. Epilepsy Behav. 2015 Nov;52(Pt A):31–36. PubMed PMID: 26409125.
  • Pierre-Louis SJ, Brannegan RT, Evans AT. Seizure control and side-effect profile after switching adult epileptic patients from standard to extended-release divalproex sodium. Clin Neurol Neurosurg. 2009 Jun;111(5):437–441. PubMed PMID: 19181439.
  • Imaizumi T, Izumi T, Fukuyama Y. A comparative clinical and pharmacokinetic study of a new slow-release versus conventional preparations of valproic acid in children with intractable epilepsy. Brain Dev. 1992;14(5):304–308.
  • Thibault M, Blume WT, Saint-Hilaire JM, et al. Divalproex extended-release versus the original divalproex tablet: results of a randomized, crossover study of well-controlled epileptic patients with primary generalized seizures. Epilepsy Res. 2002 Aug;50(3):243–249. PubMed PMID: 12200215.
  • Verrotti A, Nanni G, Agostinelli S, et al. Effects of the abrupt switch from solution to modified-release granule formulation of valproate. Acta Neurol Scand. 2012 Mar;125(3):e14–8. PubMed PMID: 21707552.
  • Dutta S, Reed RC. Divalproex to divalproex extended release conversion. Clin Drug Investig. 2004;24(9): 495–508. PubMed PMID: 17523712.
  • Sommerville KW, Dutta S, Biton V, et al. Bioavailability of a divalproex extended-release formulation versus the conventional divalproex formulation in adult patients receiving enzyme-inducing antiepileptic drugs. Clin Drug Investig. 2003;23(10): 661–670. PubMed PMID: 17535081.
  • Reed RC, Dutta S. Predicted serum valproic acid concentrations in patients missing and replacing a dose of extended-release divalproex sodium. Am J Health Syst Pharm. 2004 Nov 1;61(21):2284–2289. PubMed PMID: 15552636.
  • Dutta S, Reed RC. Effect of delayed and/or missed enteric-coated divalproex doses on valproic acid concentrations: simulation and dose replacement recommendations for the clinician. J Clin Pharm Ther. 2006 Aug;31(4):321–329. PubMed PMID: 16882100.
  • Dulac O, Alvarez JC. Bioequivalence of a new sustained-release formulation of sodium valproate, valproate modified-release granules, compared with existing sustained-release formulations after once- or twice-daily administration. Pharmacotherapy. 2005 Jan;25(1):35–41. PubMed PMID: 15767218.
  • Reed RC, Dutta S, Cavanaugh JH, et al. Every-12-hour administration of extended-release divalproex in patients with epilepsy: impact on plasma valproic acid concentrations. Epilepsy Behav. 2006 Mar;8(2):391–396. PubMed PMID: 16473558.
  • Brandt C, May TW, Bien CG. Brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy: the current evidence base. Ther Adv Neurol Disord. 2016 Nov 1;9(6):474–482.

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