Orally disintegrating tablet containing carbamazepine and levetiracetam: formulation and in vitro and in vivo characterization

References

• Raghavendra Rao NG, Patel T, Gandhi S. Development and evaluation of carbamazepine fast dissolving tablets prepared with a complex by direct compression technique. Asian J Pharm. 2009;3(2):97–103.
   Google Scholar
• Chandrasekaran P, Kandasamy R. Solid oral flexible formulations for pediatric and geriatric patients: age-appropriate formulation platforms. Indian J Pharm Sci. 2018;80:14–25.
   Web of Science ®Google Scholar
• Suñé Neģre JM, Roiģ Carreras M, García RF, et al. Chapter 5: SeDeM diagram: an expert system for preformation, characterization and optimization of tablets obtained by direct compression. In: Aguilar JE, editor. Formulation tools for pharmaceutical development. Cambridge: Woodhead Publishing; 2013. p. 109–135.
   Google Scholar
• Rai PK, Modi K. Orally disintegrating tablets: a novel approach for medication. Int J Med Health Res. 2019;5:84–91.
   Google Scholar
• Falco-Walter JJ, Scheffer IE, Fisher RS. The new definition and classification of seizures and epilepsy. Epilepsy Res. 2018;139:73–79.
   PubMed Web of Science ®Google Scholar
• Fisher RS, Van Emde Boas W, Blume W, et al. Epileptic seizures and epilepsy: definitions proposed by the International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE). Epilepsia. 2005;46(4):470–472.
   PubMed Web of Science ®Google Scholar
• WHO: epilepsy; 2019 [Internet] [cited 2019 Nov 7]. Available from: http://www.who.int/news-room/fact-sheets/detail/epilepsy#:∼:targetText=Epilepsy%20is%20a%20chronic%20noncommunicable,most%20common%20neurological%20diseases%20globally.&targetText=The%20risk%20of%20premature%20death,than%20for%20the%20general%20population
   Google Scholar
• Liu G, Slater N, Perkins A. Epilepsy: treatment options. Am Fam Physician. 2017;96(2):87–96.
   PubMed Web of Science ®Google Scholar
• Magiorkinis E, Diamantis A, Sidiropoulou K, et al. Highlights in the history of epilepsy: the last 200 years. Epilepsy Res Treat. 2014;2014:582039.
   PubMedGoogle Scholar
• Goldenberg MM. Overview of drugs used for epilepsy and seizures: etiology, diagnosis, and treatment. P T. 2010;35(7):392–415.
   PubMedGoogle Scholar
• Nadkarni S, La Joie J, Devinsky O. Current treatments of epilepsy. Neurology. 2005;64(12 Suppl. 3):S2–S11.
   PubMed Web of Science ®Google Scholar
• Willems LM, Bauer S, Rosenow F, et al. Recent advances in the pharmacotherapy of epilepsy: brivaracetam and perampanel as broad-spectrum antiseizure drugs for the treatment of epilepsies and status epilepticus. Expert Opin Pharmacother. 2019;20(14):1755–1765.
   PubMed Web of Science ®Google Scholar
• Tolou-Ghamari Z, Zare M, Habibabadi JM, et al. A quick review of carbamazepine pharmacokinetics in epilepsy from 1953 to 2012. J Res Med Sci. 2013;18(Suppl. 1):S81–S85.
   PubMed Web of Science ®Google Scholar
• Idkaidek NM. Interplay of biopharmaceutics, biopharmaceutics drug disposition and salivary excretion classification systems. Saudi Pharm J. 2014;22(1):79–81.
   PubMed Web of Science ®Google Scholar
• Kumar Gunda R, Suresh Kumar JN, Satyanarayana V, et al. Formulation development and evaluation of carbamazepine fast dissolving tablets. J Pharm Res. 2016;10:216–225.
   Google Scholar
• Brayfield AM. The complete drug reference. 38th ed. London: The Pharmaceutical Press; 2014.
   Google Scholar
• Swamy PV, Shahidulla SM, Shirsand SB, et al. Orodispersible tablets of carbamazepine prepared by direct compression method using 32 full factorial design. Dhaka Univ J Pharm Sci. 2008;7:1–5.
   Google Scholar
• Abou-Khalil B. Levetiracetam in the treatment of epilepsy. Neuropsychiatr Dis Treat. 2008;4(3):507–523.
   PubMedGoogle Scholar
• Lyseng-Williamson KA. Levetiracetam: a review of its use in epilepsy. Drugs. 2011;71(4):489–514.
   PubMed Web of Science ®Google Scholar
• Otoul C, De Smedt H, Stockis A. Lack of pharmacokinetic interaction of levetiracetam on carbamazepine, valproic acid, topiramate, and lamotrigine in children with epilepsy. Epilepsia. 2007;48(11):2111–2115.
   PubMed Web of Science ®Google Scholar
• Florek-Luszczki M, Wlaz A, Luszczki JJ. Interactions of levetiracetam with carbamazepine, phenytoin, topiramate and vigabatrin in the mouse 6Hz psychomotor seizure model – a type II isobolographic analysis. Eur J Pharmacol. 2014;723:410–418.
   PubMed Web of Science ®Google Scholar
• Kaminski RM, Matagne A, Patsalos PN, et al. Benefit of combination therapy in epilepsy: a review of the preclinical evidence with levetiracetam. Epilepsia. 2009;50(3):387–397.
   PubMed Web of Science ®Google Scholar
• European Directorate for the Quality of Medicines (EDQM). European Pharmacopoeia. 8th ed. Strasbourg: Council of Europe; 2013.
   Google Scholar
• Aslani A, Beigi M. Design, formulation, and physicochemical evaluation of montelukast orally disintegrating tablet. Int J Prev Med. 2016;7:120.
   PubMed Web of Science ®Google Scholar
• Kandilli B, Uğur AB, Çetin M, et al. A simple HPLC-UV method for simultaneous determination of levetiracetam and carbamazepine. Hacettepe Univ J Fac Pharm. 2018;38:58–64.
   Google Scholar
• Tekade NP, Bhajipale NS, Ganesan V, et al. Orodispersible tablets of lansoprazole: formulation, characterization and in vitro evaluation. Int J ChemTech Res. 2010;2:400–405.
   Google Scholar
• Velmurugan S, Vinushitha S. Orally disintegrating tablets: an overview. Int J Chem Pharm Sci. 2010;1:1–12.
   Google Scholar
• Harlalka SS, Chaware VJ, Deshmane SV, et al. Formulation and evaluation of orodispersible tablet containing amlodipine besylate. Dhaka Univ J Pharm Sci. 2014;6:38–41.
   Google Scholar
• Kandilli B, Ugur Kaplan AB, Cetin M, et al. Carbamazepine and levetiracetam-loaded PLGA nanoparticles prepared by nanoprecipitation method: in vitro and in vivo studies. Drug Dev Ind Pharm. 2020;46(7):1063–1072.
   PubMed Web of Science ®Google Scholar
• Ergul Erkec O, Arihan O. Pentylenetetrazol kindling epilepsy model. J Turk Epilepsi Soc. 2015;21:6–12.
   Web of Science ®Google Scholar
• Fischer W, Kittner H. Influence of ethanol on the pentylenetetrazol-induced kindling in rats. J Neural Transm. 1998;105(10–12):1129–1142.
   PubMed Web of Science ®Google Scholar
• Baysal M, Ilgin S, Kilic G, et al. Reproductive toxicity after levetiracetam administration in male rats: evidence for role of hormonal status and oxidative stress. PLOS One. 2017;12(4):e0175990.
   PubMed Web of Science ®Google Scholar
• Chi YC, Lin SP, Hou YC. A new herb–drug interaction of polygonum cuspidatum, a resveratrol-rich nutraceutical, with carbamazepine in rats. Toxicol Appl Pharmacol. 2012;263(3):315–322.
   PubMed Web of Science ®Google Scholar
• Tawfeek HM, Faisal W, Soliman GM. Enalapril maleate orally disintegrating tablets: tableting and in vivo evaluation in hypertensive rats. Pharm Dev Technol. 2018;23(5):496–503.
   PubMed Web of Science ®Google Scholar
• Comoglu T, Inal O, Kargili A, et al. Formulation, in vitro and in vivo evaluation of taste masked rasagiline orally fast disintegrating tablets (ODTS). Res Rev Pharm Pharm Sci. 2017;6:27–38.
   Google Scholar
• Gulsun T, Akdag Cayli Y, Izat N, et al. Development and evaluation of terbutaline sulfate orally disintegrating tablets by direct compression and freeze drying methods. J Drug Deliv Sci Technol. 2018;46:251–258.
   Web of Science ®Google Scholar
• Shirsand SB, Suresh S, Swamy PV, et al. Formulation design of fast disintegrating tablets using disintegrant blends. Indian J Pharm Sci. 2010;72(1):130–133.
   PubMed Web of Science ®Google Scholar
• Dixit M, Kini AG, Kulkarni PK. Enhancing the aqueous solubility and dissolution of olanzapine using freeze-drying. Braz J Pharm Sci. 2011;7:743–749.
   Google Scholar
• Gugulothu D, Desai P, Pandharipande P, et al. Freeze drying: exploring potential in development of orodispersible tablets of sumatriptan succinate. Drug Dev Ind Pharm. 2015;41(3):398–405.
   PubMed Web of Science ®Google Scholar
• Swain RP, Nagamani R, Panda S. Formulation, in vitro characterization and stability studies of fast dispersing tablets of diclofenac sodium. J Appl Pharm Sci. 2015;5:94–102.
   Google Scholar
• Mansouri S, Ataei ML, Hosseini M, et al. Tamoxifen mimics the effects of endogenous ovarian hormones on repeated seizures induced by pentylenetetrazole in rats. Exp Neurobiol. 2013;22(2):116–123.
   PubMedGoogle Scholar
• Bilgin Topçuoğlu Ö, Ağan K, Midi İ, et al. Politerapi kullanan epilepsi hastalarının monoterapi kullanan hastalardan farklılıkları. Marmara Med J. 2012;25:123–127.
   Google Scholar
• Kanemura H, Sano F, Ohyama T, et al. Efficacy of levetiracetam as first add-on therapy to carbamazepine and valproate sodium for children with epilepsy. J Pediatr Epilepsy. 2014;3:77–83.
   Google Scholar
• Luszczki JJ, Andres MM, Czuczwar P, et al. Pharmacodynamic and pharmacokinetic characterization of interactions between levetiracetam and numerous antiepileptic drugs in the mouse maximal electroshock seizure model: an isobolographic analysis. Epilepsia. 2006;47(1):10–20.
   PubMed Web of Science ®Google Scholar
• Bandigari V, Thadkala K, Devara RK, et al. Preparation and evaluation of orodispersable tablets of carbamazepine using different superdisintegrating agents. Int J PharmTech Res. 2015;7:438–447.
   PubMedGoogle Scholar
• Chonkar A, Hardikar S, Rao V, et al. Development and evaluation of orodispersible tablet of microwave generated co-processed material of carbamazepine. Adv Sci Lett. 2017;23(3):1899–1903.
   Google Scholar
• Ali W, Badawi A, Mahdy M, et al. Formulation and evaluation of carbamazepine 200 mg chewable tablets using cyclodextrins. Int J Pharm Pharm Sci. 2012;4:472–480.
   Google Scholar
• Saha SS, Nazmi M, Saha N, et al. Preparation and evaluation of carbamazepine sustained release tablets. Dhaka Univ J Pharm Sci. 2012;11:173–180.
   Google Scholar
• Spritam. Spritam – a new formulation of levetiracetam for epilepsy. Med Lett Drugs Ther. 2016;58:78–79.
   PubMed Web of Science ®Google Scholar
• Kumar YG, Reddy PG, Kumar VK. Formulation design and development of orodispersible tablets of levetiracetam. J Pharm Res. 2017;11:775–779.
   Google Scholar
• Dhandapani NV. Formulation and in vitro evaluation of sustained release matrix tablets of levetiracetam for better epileptic treatment. Int J Pharmacol Pharm Sci. 2016;10:573–577.
   Google Scholar
• Wang M, Wang M, Zhang Q, et al. Pharmacokinetics and safety of levetiracetam extended-release tablets and relative bioavailability compared with immediate-release tablets in healthy Chinese subjects. Eur J Drug Metab Pharmacokinet. 2018;43(4):405–413.
   PubMed Web of Science ®Google Scholar
• Patil H, Patil G, Jain V, et al. A review on mouth dissolving tablet. J Appl Pharm Res. 2017;5:9–15.
   Google Scholar
• Elkhodairy KA, Hassan MA, Afifi SA. Formulation and optimization of orodispersible tablets of flutamide. Saudi Pharm J. 2014;22(1):53–61.
   PubMed Web of Science ®Google Scholar
• Jain A, Jain S, Jain P, et al. Preparation and evaluation of zolmitriptan rapimelt tablet for migraine. EC Pharm Sci. 2018;3:1.
   Google Scholar
• Kumar Gunda R, Kumar JNS. Formulation development and evaluation of amisulpride fast dissolving tablets. Fabad J Pharm Sci. 2018;43:15–25.
   Google Scholar
• Wajid S, Yamsani VV, Alsaleh SS, et al. Formulation design and in vitro evaluation of orodispersible tablets of orlistat by direct compression method. Asian J Pharm. 2017;11:367–373.
   Web of Science ®Google Scholar
• Juanita T, Ditya F. Formulation of ibuprofen orally disintegrating tablets (ODTs) by lyophilization method using gelatin and mannitol. Int J PharmTech Res. 2014;6:996–1002.
   Google Scholar
• Saleem M, Shahin M, Srinivas B, et al. Evaluation of tablets by friability apparatus. Int J Res Pharm Chem. 2014;4:837–840.
   Google Scholar
• Badgujar BP, Mundada AS. The technologies used for developing orally disintegrating tablets: a review. Acta Pharm. 2011;61(2):117–139.
   PubMed Web of Science ®Google Scholar
• Vaucher LC, Paim CS, Lange AD, et al. Development and validation of a dissolution test for telithromycin in coated tablets. Quím Nova. 2009;32(5):1329–1333.
   Web of Science ®Google Scholar
• The United States Convention. United States Pharmacopeia (USP 36-NF 31); 2013.
   Google Scholar
• Mishra SM, Rohera BD. An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine. Pharm Dev Technol. 2017;22(7):889–903.
   PubMed Web of Science ®Google Scholar
• Gunda RK, Manchineni PR, Reddy CG, et al. Formulation development and in vitro evaluation of oral disintegrating tablets for newer anticonvulsant agent. J Anal Pharm Res. 2019;8(2):85–89.
   Google Scholar
• Sisodiya SM, Sander JWAS, Patsalos PN. Carbamazepine toxicity during combination therapy with levetiracetam: a pharmacodynamic interaction. Epilepsy Res. 2002;48(3):217–219.
   PubMed Web of Science ®Google Scholar