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Original Research

Formulation and Evaluation of Baclofen-Meloxicam Orally Disintegrating Tablets (ODTs) Using Co-Processed Excipients and Improvement of ODTs Performance Using Six Sigma Method

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Pages 4383-4402 | Published online: 16 Oct 2021

References

  • NeuprezA, NeuprezAH, KurthW, GilletP, BruyèreO, ReginsterJY. Profile of osteoarthritic patients undergoing hip or knee arthroplasty, a step toward a definition of the “need for surgery.”. Aging Clin Exp Res. 2018;30(4):315–321. doi:10.1007/s40520-017-0780-128560544
  • SamvelyanHJ, HughesD, StevensC, StainesKA. Models of osteoarthritis: relevance and new insights. Calcif Tissue Int. 2020;1–14. doi:10.1007/s00223-020-00670-x
  • MobasheriA, Bay-JensenA-C, Van SpilWE, LarkinJ, LevesqueMC. Osteoarthritis year in review 2016: biomarkers (biochemical markers). Osteoarthr Cartil. 2017;25(2):199–208. doi:10.1016/j.joca.2016.12.016
  • MachadoGC, Abdel-ShaheedC, UnderwoodM, DayRO. Non-steroidal anti-inflammatory drugs (NSAIDs) for musculoskeletal pain. BMJ. 2021;372. doi:10.1136/bmj.n104
  • IbrahimM, SarhanHA, NaguibYW, AbdelkaderH. Design, characterization and in vivo evaluation of modified release baclofen floating coated beads. Int J Pharm. 2020;582:119344. doi:10.1016/j.ijpharm.2020.11934432315750
  • MagniA, AgostoniP, BonezziC, et al. Management of osteoarthritis: expert opinion on NSAIDs. Pain Ther. 2021:1–26. doi:10.1007/s40122-021-00260-1.33247827
  • PatelHD, UppinRB, NaiduAR, RaoYR, KhandarkarS, GargA. Efficacy and safety of combination of NSAIDs and muscle relaxants in the management of acute low back pain. Pain Ther. 2019;8(1):121–132. doi:10.1007/s40122-019-0112-630652262
  • RaniS, KumarS, JoytiVP, LambaD, SainiR. To compare the efficacy and safety of eperisone with thiocolchicoside in patients with acute lower backache associated with muscle spasm. Indian J Pharm Pharmacol. 2016;3(2):79. doi:10.5958/2393-9087.2016.00018.2
  • KarneevAN, SolovyovaEY, FedinAI. Efficacy and tolerability of the combined therapy with mesipol and baclosan in chronic recurrent vertebrogenic pain syndrome. Zhurnal Nevrol I Psihiatr Im SS Korsakova. 2008;108(9):48–51.
  • KumarJNS, GundaRK. Design, formulation and evaluation of pravastatin fast dissolving tablets. Pharm Methods. 2017;9(1):16–23. doi:10.5530/phm.2018.1.4
  • SinghK, SharmaS. Development of nifedipine orodispersible tablets by different techniques using natural and synthetic superdisintegrants. Res J Pharm Technol. 2021;14(2):715–724. doi:10.5958/0974-360x.2021.00125.6
  • EdwardsP, ShihabN, ScottHW. Treatment of a case of feline baclofen toxicosis with intravenous lipid therapy. Vet Rec Case Rep. 2014;2(1):e000059. doi:10.1136/vetreccr-2014-000059
  • YoonS, LeeSH, YuKS, YimSV, KimBH. Pharmacokinetic comparison and bioequivalence evaluation of two 10-mg baclofen formulations in healthy male subjects. Int J Clin Pharmacol Ther. 2017;55(2):194–200. doi:10.5414/CP20276027879195
  • EmamMF, TahaNF, MursiNM, EmaraLH. Preparation, characterization and in-vitro/in-vivo evaluation of meloxicam extruded pellets with enhanced bioavailability and stability. Drug Dev Ind Pharm. 2021;47(1):163–175. doi:10.1080/03639045.2020.186217533297790
  • KhanKU, MinhasMU, SohailM, et al. Synthesis of PEG-4000-co-poly (AMPS) nanogels by cross-linking polymerization as highly responsive networks for enhancement in meloxicam solubility. Drug Dev Ind Pharm. 2021;47(3):465–476. doi:10.1080/03639045.2021.189273833651645
  • NamburuK, KolapalliVRM, YalavarthiPR, VadlamudiHC, PeesaJP. Pharmacokinetic profiling and bioavailability assessment of meloxicam solid dispersion tablets. Jordan J Pharm Sci. 2018;11(2):85–92.
  • ParekhVJ, DesaiND, ShaikhMS, ShindeUA. Self nanoemulsifying granules (SNEGs) of meloxicam: preparation, characterization, molecular modeling and evaluation of in vivo anti-inflammatory activity. Drug Dev Ind Pharm. 2017;43(4):600–610. doi:10.1080/03639045.2016.127566528005437
  • GulsunT, Akdag CayliY, IzatN, CetinM, OnerL, SahinS. 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. doi:10.1016/j.jddst.2018.05.014
  • GangurdeA, PatoleRK, SavAK, AminPD. A novel directly compressible co-processed excipient for sustained release formulation. J Appl Pharm Sci. 2013;3(9):89–97. doi:10.7324/JAPS.2013.3917
  • ConceiçãoJ, AdeoyeO, Cabral-MarquesH, ConcheiroA, Alvarez-LorenzoC, Sousa LoboJM. Orodispersible carbamazepine/Hydroxypropyl-β-cyclodextrin tablets obtained by direct compression with five-in-one co-processed excipients. AAPS PharmSciTech. 2020;21(2):1–10. doi:10.1208/s12249-019-1579-5
  • DraškovićM, DjurišJ, IbrićS, ParojčićJ. Functionality and performance evaluation of directly compressible co-processed excipients based on dynamic compaction analysis and percolation theory. Powder Technol. 2018;326:292–301. doi:10.1016/j.powtec.2017.12.021
  • ThulluruA, MadhaviC, NandiniK, SirishaS, SpandanaD. Co-processed excipients: new era in pharmaceuticals. Asian J Res Pharm Sci. 2019;9(1):1. doi:10.5958/2231-5659.2019.00001.8
  • HaleemRM, SalemMY, FatahallahFA, AbdelfattahLE. Quality in the pharmaceutical industry - A literature review. Saudi Pharm J. 2015;23(5):463–469. doi:10.1016/j.jsps.2013.11.00426594110
  • ChuganiN, KumarV, Garza-ReyesJA, Rocha-LonaL, UpadhyayA. Investigating the green impact of lean, six sigma and lean six sigma: a systematic literature review. Int J Lean Six Sigma. 2017;8(1):7–32. doi:10.1108/IJLSS-11-2015-0043
  • SharmaOP, GuptaV, RathoreGS, SainiNK, SachdevaK. Six sigma in pharmaceutical industry and regulatory affairs: a review. J Nat Conscientia. 2011;2(1):273–293.
  • CarleysmithSW, DuftonA, AltriaK. Implementing Lean Sigma in pharmaceutical research and development: a review by practitioners. RD Manag. 2009;39(1):95–106. doi:10.1111/j.1467-9310.2008.00542.x
  • JeevanandhamS, DhachinamoorthiD, Chandra SekharKBC, MuthukumaranM, SriramN, JoysarubyJ. Formulation and evaluation of naproxen sodium orodispersible tablets - A sublimation technique. Asian J Pharm. 2010;4(1):48–51. doi:10.4103/0973-8398.63985
  • United States Pharmacopeial Convention. General chapter <905> uniformity of dosage unit In: USP 39-NF 34. Rockville, MD USA: United States Pharmacopeial Convention. Vol. 1; 2016:736. ISBN ISBN-13: 978-3769265606.
  • ThakurRR, KashiM. An unlimited scope for novel formulations as orally disintegrating systems: present and future prospects. J Appl Pharm Sci. 2011;1(1):13–19.
  • BhardwajS, JainV, JatRC, MangalA, JainS. Formulation and evaluation of fast dissolving tablet of aceclofenac. Int J Drug Deliv. 2010;2(1):93–97. doi:10.5138/ijdd.2010.0975.0215.02017
  • Bashiri-ShahroodiA, NassabPR, Szabó-RévészP, RajkóR. Preparation of a solid dispersion by a dropping method to improve the rate of dissolution of meloxicam. Drug Dev Ind Pharm. 2008;34(7):781–788. doi:10.1080/0363904080192573518612916
  • SrinivasanK, MuthuS, DevadasanSR, SugumaranC. Six Sigma through DMAIC phases: a literature review. Int J Product Qual Manag. 2016;17(2):236–257. doi:10.1504/IJPQM.2016.074462
  • RimanthoD, RahmanTA, CahyadiB, Tina HernawatiS. Application of six sigma and AHP in analysis of variable lead time calibration process instrumentation. AIP Conference Proceedings. AIP Publishing LLC; 2017:40004. doi:10.1063/1.4975969.
  • GuresN, ArslanS, Yucel TunS. Customer expectation, satisfaction and loyalty relationship in Turkish airline industry. Int J Mark Stud. 2014;6(1):66. doi:10.5539/ijms.v6n1p66
  • GijoEV, AntonyJ. Reducing patient waiting time in outpatient department using lean six sigma methodology. Qual Reliab Eng Int. 2014;30(8):1481–1491. doi:10.1002/qre.1552
  • UllahM, HussainI, SunCC. The development of carbamazepine-succinic acid cocrystal tablet formulations with improved in vitro and in vivo performance. Drug Dev Ind Pharm. 2016;42(6):969–976. doi:10.3109/03639045.2015.109628126460090
  • WeynaDR, CheneyML, ShanN, et al. Improving solubility and pharmacokinetics of meloxicam via multiple-component crystal formation. Mol Pharm. 2012;9(7):2094–2102. doi:10.1021/mp300169c22642304
  • PrianoL, ZaraGP, El-AssawyN, et al. Baclofen-loaded solid lipid nanoparticles: preparation, electrophysiological assessment of efficacy, pharmacokinetic and tissue distribution in rats after intraperitoneal administration. Eur J Pharm Biopharm. 2011;79(1):135–141. doi:10.1016/j.ejpb.2011.02.00921352914
  • DukovaOA, KrasnovEA, EfremovAA. Development of an HPLC method for determining baclofen. Pharm Chem J. 2015;48(10):687–689. doi:10.1007/s11094-015-1172-5
  • BaeJW, KimMJ, JangCG, LeeSY. Determination of meloxicam in human plasma using a HPLC method with UV detection and its application to a pharmacokinetic study. J Chromatogr B Anal Technol Biomed Life Sci. 2007;859(1):69–73. doi:10.1016/j.jchromb.2007.09.004
  • SharmaD, SinghM, KumarD, SinghG, RathoreMS. Formulation development and evaluation of fast disintegrating tablets of Ambroxol hydrochloride for pediatrics- a novel approach for drug delivery. Indian J Pharm Educ Res. 2014;48(4):40–48. doi:10.5530/ijper.48.4s.6
  • YadavAK, SharmaA, SaxenaS, KesarwaniA. Mouth dissolving tablets: general overview and formulation aspects. Bull Pharm Res. 2014;4(1):43–57.
  • El-NabarawiMA, TeaimaMH, HamidMMA, ShomanNA, MohamedAI, El-SaharA. Formulation, evaluation and antioxidant activity of caffeine fast melt tablets. Res J Pharm Technol. 2018;11(7):3131–3138. doi:10.5958/0974-360X.2018.00575.9
  • MoqbelHA, ElMeshadAN, El-NabarawiMA. A pharmaceutical study on chlorzoxazone orodispersible tablets: formulation, in-vitro and in-vivo evaluation. Drug Deliv. 2016;23(8):2998–3007. doi:10.3109/10717544.2016.113834026828616
  • TayelSA, El NabarawiMA, AminMM, AbouGhalyMHH. Comparative study between different ready-made orally disintegrating platforms for the formulation of sumatriptan succinate sublingual tablets. AAPS PharmSciTech. 2017;18(2):410–423. doi:10.1208/s12249-016-0517-z27038484
  • KhairnarDA, AnantwarSP, ChaudhariCS, ShelkePA. Superdisintegrants: an emerging paradigm in orodispersible tablets. Int J Biopharm. 2014;5(2):119–128.
  • NaguibMJ, MakhloufAIA. Scalable flibanserin nanocrystal-based novel sublingual platform for female hypoactive sexual desire disorder: engineering, optimization adopting the desirability function approach and in vivo pharmacokinetic study. Drug Deliv. 2021;28(1):1301–1311. doi:10.1080/10717544.2021.193875534176378
  • DobettiL. Fast-melting tablets: developments and technologies. Pharm Technol Eur. 2000;12(9):32–42.
  • FouadSA, MalaakFA, El-NabarawiMA, ZeidKA. Development of orally disintegrating tablets containing solid dispersion of a poorly soluble drug for enhanced dissolution: in-vitro optimization/in-vivo evaluation. PLoS One. 2020;15(1212):e0244646. doi:10.1371/journal.pone.024464633382789
  • JacobS, ShirwaikarA, JosephA, SrinivasanK. Novel co-processed excipients of mannitol and microcrystalline cellulose for preparing fast dissolving tablets of glipizide. Indian J Pharm Sci. 2007;69(5):633–639. doi:10.4103/0250-474x.38467
  • BrniakW, MaślakE, JachowiczR. Orodispersible films and tablets with prednisolone microparticles. Eur J Pharm Sci. 2015;75:81–90. doi:10.1016/j.ejps.2015.04.00625889975
  • ChangSI, YenDC, ChouCC, WuHC, LeeHP. Applying six Sigma to the management and improvement of production planning procedure’s performance. Total Qual Manag Bus Excell. 2012;23(3–4):291–308. doi:10.1080/14783363.2012.65738743
  • ErbiyikH, SaruM. Six sigma implementations in supply chain: an application for an automotive subsidiary industry in bursa in turkey. Procedia - Soc Behav Sci. 2015;195:2556–2565. doi:10.1016/j.sbspro.2015.06.447
  • GawasSM, DevA, DeshmukhG, RathodS. 65 ©Pharmaceutical and biological evaluations current approaches in buccal drug delivery system. Pharm Biol Eval. 2016;3(2):165–177.
  • BhusnureO, NandgaveA, GholveSB, ThonteSS, ShindeCA, ShindeN. Formulation and evaluation of fast dissolving tablet on montelukast sodium by using QbD approach. Indo Am J Pharm Sci. 2015;5:1092.
  • GundaRK, KumarJ, JayakumariS, VijayalakshmiA, SatyanarayanaV. Formulation development and evaluation of risperidone fast dissolving tablets. J Pharm Res. 2016;2016:10.
  • KhanN, AslamM, AhmadL, JunCH. A control chart for gamma distributed variables using repetitive sampling scheme. Pakistan J Stat Oper Res. 2017;13(1):47–61. doi:10.18187/pjsor.v13i1.1390
  • Giner-BoschV, TranKP, CastagliolaP, KhooMBC. An EWMA control chart for the multivariate coefficient of variation. Qual Reliab Eng Int. 2019;35(6):1515–1541. doi:10.1002/qre.2459