Novel bioequivalent oral disintegrating tablet of aripiprazole prepared by direct compression technique with shortened disintegration time

References

• Abdelbary G, Prinderre P, Eouani C, Joachim J, Reynier JP, Piccerelle P. 2004. The preparation of orally disintegrating tablets using a hydrophilic waxy binder. Int J Pharm. 278(2):423–433. doi: 10.1016/j.ijpharm.2004.03.023.
   PubMedGoogle Scholar
• Abu Fara D, Al-Hmoud L, Rashid I, Chowdhry BZ, Badwan A. 2020. Understanding the performance of a novel direct compression excipient comprising roller compacted chitin. Mar Drugs. 18(2):115. doi: 10.3390/md18020115.
   PubMed Web of Science ®Google Scholar
• Bartram LA, Lozano J, Coury DL. 2019. Aripiprazole for treating irritability associated with autism spectrum disorders. Expert Opin Pharmacother. 20(12):1421–1427. doi: 10.1080/14656566.2019.1626825.
   PubMed Web of Science ®Google Scholar
• Bhavana P, Reddy MS, Bhavana P, Reddy MS. 2023. A review on co-processed excipients used in direct compression of tablet dosage form. GSC Biol Pharm Sci. 23(1):212–219. doi: 10.30574/gscbps.2023.23.1.0100.
   Google Scholar
• Chattoraj S, Daugherity P, McDermott T, Olsofsky A, Roth WJ, Tobyn M. 2018. Sticking and picking in pharmaceutical tablet compression: an IQ Consortium review. J Pharm Sci. 107(9):2267–2282. doi: 10.1016/j.xphs.2018.04.029.
   PubMed Web of Science ®Google Scholar
• Chen S, Hanning S, Falconer J, Locke M, Wen J. 2019. Recent advances in non-ionic surfactant vesicles (niosomes): fabrication, characterization, pharmaceutical and cosmetic applications. Eur J Pharm Biopharm. 144:18–39. doi: 10.1016/j.ejpb.2019.08.015.
   PubMed Web of Science ®Google Scholar
• Conceição J, Adeoye O, Cabral-Marques H, Concheiro A, Alvarez-Lorenzo C, Sousa Lobo JM. 2020. Orodispersible carbamazepine/hydroxypropyl-β-cyclodextrin tablets obtained by direct compression with five-in-one co-processed excipients. AAPS PharmSciTech. 21(2):39. doi: 10.1208/s12249-019-1579-5.
   PubMed Web of Science ®Google Scholar
• Cox JH, Cavanna AE. 2021. Aripiprazole for the treatment of Tourette syndrome. Expert Rev Neurother. 21(4):381–391. doi: 10.1080/14737175.2021.1893693.
   PubMed Web of Science ®Google Scholar
• Cuomo A, Beccarini Crescenzi B, Goracci A, Bolognesi S, Giordano N, Rossi R, Facchi E, Neal SM, Fagiolini A. 2019. Drug safety evaluation of aripiprazole in bipolar disorder. Expert Opin Drug Saf. 18(6):455–463. doi: 10.1080/14740338.2019.1617847.
   PubMed Web of Science ®Google Scholar
• Dembélé M, Hudon S, Simard J-S, Abatzoglou N, Gosselin R. 2022. A multivariate data analysis approach to tablet sticking on an industrial scale: a qualitative case study of an ibuprofen-based formulation. Pharm Dev Technol. 27(10):1093–1109. doi: 10.1080/10837450.2022.2153866.
   PubMed Web of Science ®Google Scholar
• Desai C, Prabhakar B. 2015. Development and evaluation of orally disintegrating tablets of cilostazol-β-cyclodextrin inclusion complexes. Drug Dev Ind Pharm. 41(10):1589–1607. doi: 10.3109/03639045.2014.972413.
   PubMed Web of Science ®Google Scholar
• Dhiman J, Dev D, Prasad DN. 2022. Superdisintegrants: brief review. J Drug Delivery Ther. 12(1):170–175. doi: 10.22270/jddt.v12i1.5155.
   Google Scholar
• Floryanzia S, Ramesh P, Mills M, Kulkarni S, Chen G, Shah P, Lavrich D. 2022. Disintegration testing augmented by computer vision technology. Int J Pharm. 619:121668. doi: 10.1016/j.ijpharm.2022.121668.
   PubMedGoogle Scholar
• Fouad SA, Malaak FA, El-Nabarawi MA, Abu Zeid K. 2020. Development of orally disintegrating tablets containing solid dispersion of a poorly soluble drug for enhanced dissolution: in-vitro optimization/in-vivo evaluation. PLoS ONE. 15(12):e0244646. doi: 10.1371/journal.pone.0244646.
   PubMed Web of Science ®Google Scholar
• Ghourichay MP, Kiaie SH, Nokhodchi A, Javadzadeh Y. 2021. Formulation and quality control of orally disintegrating tablets (ODTs): recent advances and perspectives. Biomed Res Int. 2021:6618934–6618912. doi: 10.1155/2021/6618934.
   PubMed Web of Science ®Google Scholar
• Gittings S, Turnbull N, Roberts CJ, Gershkovich P. 2014. Dissolution methodology for taste masked oral dosage forms. J Control Release. 173:32–42. doi: 10.1016/j.jconrel.2013.10.030.
   PubMed Web of Science ®Google Scholar
• Irshad A, Yousuf RI, Shoaib MH, Qazi F, Saleem MT, Siddiqui F, Ahmed FR, Rehman R, Jabeen S, Farooqi S, et al. 2023. Effect of starch, cellulose and povidone based superdisintegrants in a QbD-based approach for the development and optimization of Nitazoxanide orodispersible tablets: physicochemical characterization, compaction behavior and in-silico PBPK modeling of its active metabolite Tizoxanide. J Drug Deliv Sci Technol. 79:104079. doi: 10.1016/j.jddst.2022.104079.
   Web of Science ®Google Scholar
• Jeon S-W, Park J-H, Kim J-E, Park Y-J. 2023. Design of experiment (DoE)-based formulation design of bepotastine sustained-release tablet and in vitro-in vivo pharmacokinetic correlation. J Pharm Investig. 53(3):407–416. doi: 10.1007/s40005-023-00611-4.
   Web of Science ®Google Scholar
• Jire DS, Gosavi NS, Badhe RB, Jagdale DH. 2021. Mouth dissolving tablet: a novel drug delivery system. AJPR. 11(3):180–186. doi: 10.52711/2231-5691.2021.00033.
   Google Scholar
• Jung E-A, Park Y-J, Kim J-E. 2023. Application of continuous manufacturing for solid oral dosage forms. J Pharm Investig. 53(4):457–474. doi: 10.1007/s40005-023-00619-w.
   Web of Science ®Google Scholar
• Kabi AK, Gujjarappa R, Garg A, Sahoo A, Roy A, Gupta S, Malakar CC. 2022. Overview on diverse biological activities of benzisoxazole derivatives. In Mukherjee K, Layek RK, De D, editors. Tailored Functional Materials. Singapore: Springer Nature; p. 81–98. doi: 10.1007/978-981-19-2572-6_6.
   Google Scholar
• Kang DW, Cho S, Choi G-W, Cho H-Y. 2022. Strategies for developing Alzheimer’s disease treatments: application of population pharmacokinetic and pharmacodynamic models. J Pharm Investig. 52(5):519–538. doi: 10.1007/s40005-022-00579-7.
   Web of Science ®Google Scholar
• Kayes SKMY, Islam MM, Hamidur RM, Nazmus S, Kayes SKMY, Islam MM, Hamidur RM, Nazmus S. 2019. A comparative study on naproxen sodium tablets formulating with different super disintegrants. GSC Biol Pharm Sci. 9(3):076–084. doi: 10.30574/gscbps.2019.9.3.0234.
   Google Scholar
• Kim J-S, Park H, Kang K-T, Ha E-S, Kim M-S, Hwang S-J. 2022. Micronization of a poorly water-soluble drug, fenofibrate, via supercritical-fluid-assisted spray-drying. J Pharm Investig. 52(3):353–366. doi: 10.1007/s40005-022-00565-z.
   Web of Science ®Google Scholar
• Kneller LA, Zubiaur P, Koller D, Abad-Santos F, Hempel G. 2021. Influence of CYP2D6 phenotypes on the pharmacokinetics of aripiprazole and dehydro-aripiprazole using a physiologically based pharmacokinetic approach. Clin Pharmacokinet. 60(12):1569–1582. doi: 10.1007/s40262-021-01041-x.
   PubMed Web of Science ®Google Scholar
• Kumar RS, Sankar BN. 2019. Fast dissolving tablets: better option for pediatrics and geriatrics. J Drug Deliv Ther. 9(4-A):831–834. doi: 10.22270/jddt.v9i4-A.3689.
   Google Scholar
• Kumar RS, Kumari A. 2019. Superdisintegrant: crucial elements for mouth dissolving tablets. J Drug Delivery Ther. 9(2):461–468. doi: 10.22270/jddt.v9i2.2480.
   Google Scholar
• Lee J-H, Park C, Song I-O, Lee B-J, Kang C-Y, Park J-B. 2022. Investigation of patient-centric 3D-printed orodispersible films containing amorphous aripiprazole. Pharmaceuticals. 15(7):895. doi: 10.3390/ph15070895.
   Web of Science ®Google Scholar
• Lee SC, Kim M, Kim D, Jeon EK, Lee EH. 2022. Development of a patient-centric formulation of tegoprazan, a novel potassium-competitive acid blocker, using modified-release drug-coated pellets. J Pharm Investig. 52(5):623–638. doi: 10.1007/s40005-022-00582-y.
   Web of Science ®Google Scholar
• Lee TJ, Kim D, Kim JC, Ro SW, Na DH. 2023. Formulation development and pharmacokinetic evaluation of enteric-coated dexrabeprazole tablets. J Pharm Investig. 53(2):323–331. doi: 10.1007/s40005-022-00602-x.
   Web of Science ®Google Scholar
• Mallikaarjun S, Salazar DE, Bramer SL. 2004. Pharmacokinetics, tolerability, and safety of aripiprazole following multiple oral dosing in normal healthy volunteers. J Clin Pharmacol. 44(2):179–187. doi: 10.1177/0091270003261901.
   PubMed Web of Science ®Google Scholar
• McFall H. 2016. Preparation and evaluation of aripiprazole-loaded pH-modulated solid dispersion via hot-melt extrusion technology (Undergraduate thesis). https://egrove.olemiss.edu/hon_thesis/364/.
   Google Scholar
• Mohapatra S, Jena P, Mishra A, Nayak S. 2023. Preparation and evaluation of orodispersible tablet of Aripiperazole. Eur J Mol Clin Med. 10(3):260–284.
   Google Scholar
• Nagar P, Singh K, Chauhan I, Verma M, Yasir M, Khan A, Sharma R, Gupta N. 2011. Orally disintegrating tablets : formulation, preparation techniques and evaluation. J App Pharm Sci. 1(4):35–45.
   Google Scholar
• Nikolic K, Filijović ND, Maričić B, Agbaba D. 2013. Development of a novel RP-HPLC method for the efficient separation of aripiprazole and its nine impurities. J Sep Sci. 36(19):3165–3175. doi: 10.1002/jssc.201300477.
   PubMed Web of Science ®Google Scholar
• Olah I, Lasher J, Regdon G, Pintye-Hodi K, Baki G, Sovany T. 2019. Evaluating superdisintegrants for their performance in orally disintegrating tablets containing lysozyme enzyme. J Drug Deliv Sci Technol. 49:396–404. doi: 10.1016/j.jddst.2018.12.012.
   Web of Science ®Google Scholar
• Piazzini V, Landucci E, Urru M, Chiarugi A, Pellegrini-Giampietro DE, Bilia AR, Bergonzi MC. 2020. Enhanced dissolution, permeation and oral bioavailability of aripiprazole mixed micelles: in vitro and in vivo evaluation. Int J Pharm. 583:119361. doi: 10.1016/j.ijpharm.2020.119361.
   PubMedGoogle Scholar
• Preda A, Shapiro BB. 2020. A safety evaluation of aripiprazole in the treatment of schizophrenia. Expert Opin Drug Saf. 19(12):1529–1538. doi: 10.1080/14740338.2020.1832990.
   PubMed Web of Science ®Google Scholar
• Rani A, Aslam M, Pandey G, Pant BN. 2023. A review on synthesis of FDA-approved antipsychotic drugs. Tetrahedron. 138:133430. doi: 10.1016/j.tet.2023.133430.
   Web of Science ®Google Scholar
• Rathore A, Asati V, Mishra M, Das R, Kashaw V, Kashaw SK. 2022. Computational approaches for the design of novel dopamine D2 and serotonin 5-HT2A receptor dual antagonist towards schizophrenia. In Silico Pharmacol. 10(1):7. doi: 10.1007/s40203-022-00121-5.
   PubMedGoogle Scholar
• Ravinder S, Bapuji AT, Mukkanti K, Raju DR, Ravikiran HLV, Reddy DC. 2012. Development and validation of an LC–ESI-MS method for quantitative determination of aripiprazole in human plasma and an application to pharmacokinetic study. J Chromatogr Sci. 50(10):893–901. doi: 10.1093/chromsci/bms087.
   PubMed Web of Science ®Google Scholar
• Rybakowski JK. 2023. Mood stabilizers of first and second generation. Brain Sci. 13(5):741. doi: 10.3390/brainsci13050741.
   PubMed Web of Science ®Google Scholar
• Scheil J, Power D. 2023. What is the risk of extrapyramidal symptoms in patients taking aripiprazole? EBPR. 26(2):28–29. doi: 10.1097/EBP.0000000000001733.
   Google Scholar
• Sekar V, Chellan VR. 2008. Immediate release tablets of telmisartan using superdisintegrant-formulation, evaluation and stability studies. Chem Pharm Bull (Tokyo). 56(4):575–577. doi: 10.1248/cpb.56.575.
   PubMed Web of Science ®Google Scholar
• Sichert V, Volz H-P. 2021. Rapid efficacy of aripiprazole in the treatment of catatonic depression/catatonia with consideration of the drug’s unique receptor profile: a case report. Fortschr Neurol Psychiatr. 89(4):178–181. doi: 10.1055/a-1183-3887.
   PubMedGoogle Scholar
• Singh J, Walia M, Harikumar SL. 2014. Formulation and evaluation of fast oral dissolving tablets of rosuvastatin. J Drug Deliv Ther. 4(5):173–181. doi: 10.22270/jddt.v4i5.947.
   Google Scholar
• Srinivasan S, Elumalai K, Cherian BV, Ramanujam SK. 2023. Formulation and characterization of metformin hydrochloride orodispersible tablets with super disintegrants. Intelligent Pharmacy. 1(3):162–166. doi: 10.1016/j.ipha.2023.06.006.
   Google Scholar
• Taylor D. 2003. Aripiprazole: a review of its pharmacology and clinical use. Int J Clin Pract. 57(1):49–54. doi: 10.1111/j.1742-1241.2003.tb11397.x.
   PubMed Web of Science ®Google Scholar
• Xiang J, Xu N, Wang X, Li S, Yu Q, Liang M, Nan F, Shu S, Yan R, Zhu Y, et al. 2021. Bioequivalence of 2 aripiprazole orally disintegrating tablets in healthy chinese volunteers under fasting and fed conditions. Clin Pharmacol Drug Dev. 10(8):840–849. doi: 10.1002/cpdd.954.
   PubMed Web of Science ®Google Scholar
• Yoo S-D, Kim JY, Han S-K, Lee B-H, Choi DH, Park E-S. 2023. Development of prediction model with machine learning in continuous twin screw granulation. J Pharm Investig. 53(5):707–722. doi: 10.1007/s40005-023-00625-y.
   Web of Science ®Google Scholar
• Zuo X, Wang F, Xu P, Zhu R, Li H. 2006. LC–ESI–MS for rapid and sensitive determination of aripiprazole in human plasma. Chroma. 64(7–8):387–391. doi: 10.1365/s10337-006-0037-1.
   Web of Science ®Google Scholar