Development of a Novel Controlled-Release Tablet of Pregabalin: Formulation Variation and Pharmacokinetics in Dogs and Humans

References

• BianF, LiZ, OffordJ, et al. Calcium channel alpha2-delta type 1 subunit is the major binding protein for pregabalin in neocortex, hippocampus, amygdala, and spinal cord: an ex vivo autoradiographic study in alpha2-delta type 1 genetically modified mice. Brain Res. 2006;1075(1):68–80. doi:10.1016/j.brainres.2005.12.08416460711
   PubMed Web of Science ®Google Scholar
• GeeNS, BrownJP, DissanayakeVU, OffordJ, ThurlowR, WoodruffGN. The novel anticonvulsant drug, gabapentin (Neurontin), binds to the alpha2delta subunit of a calcium channel. J Biol Chem. 1996;271(10):5768–5776. doi:10.1074/jbc.271.10.57688621444
   PubMed Web of Science ®Google Scholar
• JackC, WilliamA, YunhuiHW. Application of the biopharmaceutical classification system in clinical drug development – an industrial view. AAPS J. 2008;10(2):306–310. doi:10.1208/s12248-008-9036-518500563
   PubMed Web of Science ®Google Scholar
• ChewML, AlveyCW, PlotkaA, et al. Pregabalin controlled-release pharmacokinetics in healthy volunteers. Clin Drug Investig. 2014;34(9):627–637. doi:10.1007/s40261-014-0221-2
   PubMed Web of Science ®Google Scholar
• ChewML, PlotkaA, AlveyCW, et al. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014;34(9):617–626. doi:10.1007/s40261-014-0211-4
   PubMed Web of Science ®Google Scholar
• BockbraderHN, RadulovicLL, PosvarEL, et al. Clinical pharmacokinetics of pregabalin in healthy volunteers. J Clin Pharmacol. 2010;50(8):941–950. doi:10.1177/009127000935208720147618
   PubMed Web of Science ®Google Scholar
• PiyapolrungrojN, LiC, BockbraderH, LiuG, FleisherD. Mucosal uptake of gabapentin (neurontin) vs. pregabalin in the small intestine. Pharm Res. 2001;18(8):1126–1130. doi:10.1023/A:101097080909011587483
   PubMed Web of Science ®Google Scholar
• FrenchJA, KuglerAR, RobbinsJL, KnappLE, GarofaloEA. Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures. Neurology. 2003;60(10):1631–1637. doi:10.1212/01.WNL.0000068024.20285.6512771254
   PubMed Web of Science ®Google Scholar
• ColemanCI, LimoneB, SobierajDM, et al. Dosing frequency and medication adherence in chronic disease. J Manag Care Pharm. 2012;18(7):527–539. doi:10.18553/jmcp.2012.18.7.52722971206
   PubMed Web of Science ®Google Scholar
• SrivastavaK, AroraA, KatariaA, CappelleriJC, SadoskyA, PetersonAM. Impact of reducing dosing frequency on adherence to oral therapies: a literature review and meta-analysis. Patient Prefer Adherence. 2013;7:419–434. doi:10.2147/PPA.S4464623737662
   PubMed Web of Science ®Google Scholar
• MaL, DengL, ChenJ. Applications of poly(ethylene oxide) in controlled release tablet systems: a review. Drug Dev Ind Pharm. 2014;40(7):845. doi:10.3109/03639045.2013.83143824001212
   PubMed Web of Science ®Google Scholar
• HuangX, BrazelCS. On the importance and mechanisms of burst release in matrix-controlled drug delivery systems. J Control Release. 2001;73(2–3):121–136. doi:10.1016/S0168-3659(01)00248-611516493
   PubMed Web of Science ®Google Scholar
• ColomboP, ConteU, GazzanigaA, et al. Drug release modulation by physical restriction of matrix swelling. Int J Pharm. 1990;63(1):43–48.
   Web of Science ®Google Scholar
• ConteU, MaggiL, TorreML, GiunchediP, La MannaA. Press-coated tablets for time-programmed release of drugs. Biomaterials. 1993;14(13):1017–1023. doi:10.1016/0142-9612(93)90195-88286668
   PubMed Web of Science ®Google Scholar
• ConteU, MaggiL, ColomboP, La MannaA. Multi-layered hydrophilic matrices as constant release devices (Geomatrix Systems). J Control Release. 1993;26(1):39–47.
   Web of Science ®Google Scholar
• ParkJS, ShimJY, ParkJS, ChoiYW, JeongSH. A novel three-layered tablet for extended release with various layer formulations and in vitro release profiles. Drug Dev Ind Pharm. 2011;37(6):664–672. doi:10.3109/03639045.2010.53521121449708
   PubMed Web of Science ®Google Scholar
• HodgesLA, SimeKA, CreechLA, et al. Pharmacoscintigraphy confirms consistent tamsulosin release from a novel triple-layered tablet. Int J Pharm. 2013;454(1):41–46. doi:10.1016/j.ijpharm.2013.06.06523834829
   PubMed Web of Science ®Google Scholar
• WagnerJG. The Wagner-Nelson method applied to a multicompartment model with zero order input. Biopharm Drug Dispos. 1983;4(4):359–373. doi:10.1002/bdd.25100404086661514
   PubMed Web of Science ®Google Scholar
• MaL, DengL, ChenJ. Applications of poly (ethylene oxide) in controlled release tablet systems: a review. Drug Dev Ind Pharm. 2014;40(7):845–851. doi:10.3109/03639045.2013.83143824001212
   PubMed Web of Science ®Google Scholar
• ParkJS, ShimJY, NguyenKV, et al. A pharma-robust design method to investigate the effect of PEG and PEO on matrix tablets. Int J Pharm. 2010;393(1–2):79–87. doi:10.1016/j.ijpharm.2010.04.00920399261
   PubMed Web of Science ®Google Scholar
• Choi DuH, KimKH, ParkJS, JeongSH, ParkK. Evaluation of drug delivery profiles in geometric three-layered tablets with various mechanical properties, in vitro-in vivo drug release, and Raman imaging. J Control Release. 2013;172(3):763–772. doi:10.1016/j.jconrel.2013.08.30124035977
   PubMed Web of Science ®Google Scholar
• BockbraderHN, WescheD, MillerR, ChapelS, JaniczekN, BurgerP. A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Clin Pharmacokinet. 2010;49(10):661–669. doi:10.2165/11536200-000000000-0000020818832
   PubMed Web of Science ®Google Scholar
• KanwarN, KumarR, SarwalA, SinhaVR. Preparation and evaluation of floating tablets of pregabalin. Drug Dev Ind Pharm. 2016;42(4):654–660. doi:10.3109/03639045.2015.106289526146770
   PubMed Web of Science ®Google Scholar
• BockbraderHN, ChoYH, SantiagoSD, et al. (Warner-Lambert Co LLC., USA). Solid pharmaceutical compositions containing pregabalin. US Patent 9,144,559 B2. 2015 9 29.
   Google Scholar
• SakoK, NakashimaH, SawadaT, FukuiM. Relationship between gelation rate of controlled-release acetaminophen tablets containing polyethylene oxide and colonic drug release in dogs. Pharm Res. 1996;13(4):594–598. doi:10.1023/A:10160064236018710752
   PubMed Web of Science ®Google Scholar
• YogeshJ, DavidM, HosseinO. Enhanced bioavailability via extended gastric retention. J Develop Drugs. 2013;2(1):105–109.
   Google Scholar
• SuttonSC. Companion animal physiology and dosage form performance. Adv Drug Deliv Rev. 2004;56(10):1383–1398. doi:10.1016/j.addr.2004.02.01315191788
   PubMed Web of Science ®Google Scholar