296
Views
0
CrossRef citations to date
0
Altmetric
Research Articles

Development of pediatric orally disintegrating mini-tablets containing atomoxetine hydrochloride-β-cyclodextrin inclusion complex using experimental design

ORCID Icon & ORCID Icon
Pages 667-681 | Received 16 Aug 2022, Accepted 29 Nov 2022, Published online: 15 Dec 2022

References

  • Comoglu T, Dilek Ozyilmaz E. Orally disintegrating tablets and orally disintegrating mini tablets – novel dosage forms for pediatric use. Pharm Dev Technol. 2019;24(7):902–914.
  • Tashan E, Karakucuk A, Celebi N. Development of nanocrystal ziprasidone orally disintegrating tablets: optimization by using design of experiment and in vitro evaluation. AAPS PharmSciTech. 2020;21(3):1–12.
  • Preis M. Orally disintegrating films and mini-tablets—innovative dosage forms of choice for pediatric use. AAPS PharmSciTech. 2015;16(2):234–241.
  • Batchelor HK, Marriott JF. Formulations for children: problems and solutions. Br J Clin Pharmacol. 2015;79(3):405–418.
  • Hirani JJ, Rathod DA, Vadalia KR. Orally disintegrating tablets: a review. Trop J Pharm Res. 2009;8(2):161–172.
  • Ercan ES, Çetin FÇ, Mukaddes NM, et al. Dikkat eksikliği hiperaktivite bozukluğu tedavisinde atomoksetin. Çocuk ve Gençlik Ruh Sağlığı Dergisi. 2009;16(2):113–118.
  • Vaughan B, Fegert J, Kratochvil CJ. Update on atomoxetine in the treatment of attention-deficit/hyperactivity disorder. Expert Opin Pharmacother. 2009;10(4):669–676.
  • Hammerness P, McCarthy K, Mancuso E, et al. Atomoxetine for the treatment of attention-deficit/hyperactivity disorder in children and adolescents: a review. Neuropsychiatr Dis Treat. 2009;5:215–226.
  • Nakano M, Witcher J, Satoi Y, et al. Pharmacokinetic profile and palatability of atomoxetine oral solution in healthy Japanese male adults. Clin Drug Investig. 2016;36(11):903–911.
  • Jasinski DR, Faries DE, Moore RJ, et al. Abuse liability assessment of atomoxetine in a drug-abusing population. Drug Alcohol Depend. 2008;95(1–2):140–146.
  • Al-Kasmi B, Alsirawan MB, Bashimam M, et al. Mechanical microencapsulation: the best technique in taste masking for the manufacturing scale—effect of polymer encapsulation on drug targeting. J Control Release. 2017;260:134–141.
  • Khor CM, Ng WK, Kanaujia P, et al. Hot-melt extrusion microencapsulation of quercetin for taste-masking. J Microencapsul. 2017;34(1):29–37.
  • Maniruzzaman M, Boateng JS, Snowden MJ, et al. A review of hot-melt extrusion: process technology to pharmaceutical products. Int Scholar Res Notices. 2012;2012:1–9.
  • Groll AH, Wood L, Roden M, et al. Safety, pharmacokinetics, and pharmacodynamics of cyclodextrin itraconazole in pediatric patients with oropharyngeal candidiasis. Antimicrob Agents Chemother. 2002;46(8):2554–2563.
  • Patel H, Suhagia B, Shah S, et al. Preparation and characterization of etoricoxib-β-cyclodextrin complexes prepared by the kneading method. Acta Pharm. 2007;57(3):351–359.
  • Kfoury M, Landy D, Auezova L, et al. Effect of cyclodextrin complexation on phenylpropanoids’ solubility and antioxidant activity. Beilstein J Org Chem. 2014;10(1):2322–2331.
  • Kamimura JA, Santos EH, Hill LE, et al. Antimicrobial and antioxidant activities of carvacrol microencapsulated in hydroxypropyl-beta-cyclodextrin. LWT Food Sci Technol. 2014;57(2):701–709.
  • Denadai ÂM, Santoro MM, Da Silva LH, et al. Self-assembly characterization of the β-cyclodextrin and hydrochlorothiazide system: NMR, phase solubility, ITC and QELS. J Incl Phenom Macrocycl Chem. 2006;55(1–2):41–49.
  • Ugoeze KC, Nwachukwu N. Disintegrant properties of a newly derived superdisintegrant from Lentinus tuber regium in paracetamol tablet formulation. Int J Appl Biol Pharm Technol. 2020;11(2):105–120.
  • United States Pharmacopeial Convention. The United States Pharmacopeia—the national formulary. United States Pharmacopeial Convention. Rockville, Maryland; 2008.
  • Li S, Zhang Y, Khan AR, et al. Quantitative prediction of the bitterness of atomoxetine hydrochloride and taste-masked using hydroxypropyl-β-cyclodextrin: a biosensor evaluation and interaction study. Asian J Pharm Sci. 2020;15(4):492–505.
  • Gao S, Liu Y, Jiang J, et al. Physicochemical properties and fungicidal activity of inclusion complexes of fungicide chlorothalonil with β-cyclodextrin and hydroxypropyl-β-cyclodextrin. J Mol Liq. 2019;293:111513.
  • Wang J, Guo Z, Xiong J, et al. Facile synthesis of chitosan-grafted beta-cyclodextrin for stimuli-responsive drug delivery. Int J Biol Macromol. 2019;125:941–947.
  • Cui H, Siva S, Lin L. Ultrasound processed cuminaldehyde/2-hydroxypropyl-β-cyclodextrin inclusion complex: preparation, characterization and antibacterial activity. Ultrason Sonochem. 2019;56:84–93.
  • Nejman A, Gromadzińska E, Kamińska I, et al. Assessment of thermal performance of textile materials modified with PCM microcapsules using combination of DSC and infrared thermography methods. Molecules. 2019;25(1):122.
  • Alopaeus JF, Göbel A, Breitkreutz J, et al. Investigation of hydroxypropyl-β-cyclodextrin inclusion complexation of two poorly soluble model drugs and their taste-sensation—effect of electrolytes, freeze-drying and incorporation into oral film formulations. J Drug Deliv Sci Technol. 2021;61:102245.
  • Katewongsa P, Lertsuphotvanit N, Phaechamud T. Cetirizine dihydrochloride, beta-cyclodextrin inclusion complex by ethanol kneading for taste masking. Pharm Sci. 2017;79(5):758–767.
  • He J, Guo F, Lin L, et al. Investigating the oxyresveratrol β-cyclodextrin and 2-hydroxypropyl-β-cyclodextrin complexes: the effects on oxyresveratrol solution, stability, and antibrowning ability on fresh grape juice. LWT. 2019;100:263–270.
  • Driscoll WC. Robustness of the ANOVA and Tukey–Kramer statistical tests. Comput Ind Eng. 1996;31(1–2):265–268.
  • Alalaiwe A, Fayed MH, Alshahrani SM, et al. Application of design of experiment approach for investigating the effect of partially pre-gelatinized starch on critical quality attributes of rapid orally disintegrating tablets. J Drug Deliv Sci Technol. 2019;49:227–234.
  • Sutthapitaksakul L, Thanawuth K, Dass CR, et al. Optimized taste-masked microparticles for orally disintegrating tablets as a promising dosage form for Alzheimer’s disease patients. Pharmaceutics. 2021;13(7):1046.
  • Farkas D, Madarász L, Nagy ZK, et al. Image analysis: a versatile tool in the manufacturing and quality control of pharmaceutical dosage forms. Pharmaceutics. 2021;13(5):685.
  • Ghourichay MP, Kiaie SH, Nokhodchi A, et al. Formulation and quality control of orally disintegrating tablets (ODTs): recent advances and perspectives. Biomed Res Int. 2021;2021:1–12.
  • Gulsun T, Cayli YA, 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.
  • Goto T, Hirata Y, Takita Y, et al. Efficacy and safety of atomoxetine hydrochloride in Asian adults with ADHD: a multinational 10-week randomized double-blind placebo-controlled Asian study. J Attent Disord. 2017;21(2):100–109.
  • United States Pharmacopeial Convention. USP 32: United States Pharmacopeia. Rockville: United States Pharmacopeial Convention; 2009. p. 1209–1210.
  • Wang Z, Li J, Hong X, et al. Taste masking study based on an electronic tongue: the formulation design of 3D printed levetiracetam instant-dissolving tablets. Pharm Res. 2021;38(5):831–842.
  • Guedes MDV, Marques MS, Guedes PC, et al. The use of electronic tongue and sensory panel on taste evaluation of pediatric medicines: a systematic review. Pharm Dev Technol. 2021;26(2):119–137.
  • European Medicines Agency. ICH topic Q 1 A (R2) stability testing of new drug substances and products. Burlington, MA, United States; 2003.
  • Sedat Ü, Yücel Ç, Serdar T, et al. Dosetakselin siklodekstrin türevleri ile farklı yöntemlerle kompleks oluşturması ve oluşan inklüzyon komplekslerinin karakterizasyonu. Sağlık Bilimleri Dergisi. 2017;26(2):119–125.
  • Jacob S, Nair AB. Cyclodextrin complexes: perspective from drug delivery and formulation. Drug Dev Res. 2018;79(5):201–217.
  • Bebawy G, Sokar M, Abdallaha OY. Novel risperidone orally disintegrating minitablets for pediatric use: patient acceptance and dose adjustment. Drug Dev Ind Pharm. 2021;47(4):542–551.
  • Prabowo I, Iskandarsyah  , Adriany R, Characterization and concentration optimization of Hibiscus rosa-sinensis L. mucilage powder as superdisintegrant. Int J Appl Pharm. 2021;13(Special Issue 2):49–52.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.