Amoxicillin chewable tablets intended for pediatric use: formulation development, stability evaluation and taste assessment

References

• Adedara O, Taylor J. 2021. Roles of protein, starch and sugar in the texture of sorghum biscuits. LWT. 136:110323.
   Web of Science ®Google Scholar
• Aghazadeh A, Kazemifard G. 2001. Simultaneous determination of amoxycillin and clavulanic acid in pharmaceutical dosage forms by LC with amperometric detection. J Pharm Biomed Anal. 25(2):325–329.
   PubMed Web of Science ®Google Scholar
• Akhond M, Absalan G, Ershadifar H. 2015. Highly sensitive colorimetric determination of amoxicillin in pharmaceutical formulations based on induced aggregation of gold nanoparticles. Spectrochim Acta A Mol Biomol Spectrosc. 143:223–229.
   PubMed Web of Science ®Google Scholar
• Ampatzopoulos I, Kouskoura M, Markopoulou C. 2015. Coupling classical analytical methods with modeling in routine analysis tests - merits and drawbacks. Curr Anal Chem. 11:244–256.
   Web of Science ®Google Scholar
• Andrews D, Salunke S, Cram A, Bennett J, Ives RS, Basit AW, Tuleu C. 2021. Bitter-blockers as a taste masking strategy: a systematic review towards their utility in pharmaceuticals. Eur J Pharm Biopharm. 158:35–51.
   PubMed Web of Science ®Google Scholar
• Bellur Atici E, Yazar Y, Ağtaş Ç, Ridvanoğlu N, Karlığa B. 2017. Development and validation of stability indicating HPLC methods for related substances and assay analyses of amoxicillin and potassium clavulanate mixtures. J Pharm Biomed Anal. 136:1–9.
   PubMed Web of Science ®Google Scholar
• Bhattacharjee R, Akoroda M. 2018. Taxonomy and classification of cacao. Achieving sustainable cultivation of cacao. Cambridge: Burleigh Dodds Science Publishing; p. 3–18.
   Google Scholar
• Birrer M, Fusun A. 2021. Electrospun orally disintegrating film formulation of telmisartan. Pharm Dev Technol. 26:661–672.
   PubMed Web of Science ®Google Scholar
• Brahman PK, Dar RA, Vitae A, Pitre KS. 2013. Conducting polymer film based electrochemical sensor for the determination of amoxicillin in micellar media. Sen Actuators B. 176:307–314.
   Web of Science ®Google Scholar
• Cardea S, Sessa M, Reverchon E. 2011. Supercritical CO2 assisted formation of poly(vinylidenefluoride) aerogels containing amoxicillin, used as controlled release device. J. Supercritical Fluids. 59:149–156.
   Web of Science ®Google Scholar
• Dahiya J, Jalwal P, Singh B. 2015. Chewable tablets: a comprehensive review. Pharma Innov J. 4:100–105.
   Google Scholar
• Davies EH, Tuleu C. 2008. Medicines for children: a matter of taste. J Pediatr. 153(5):599–604.
   PubMed Web of Science ®Google Scholar
• [EMA] European Medicines Agency Reflection paper. 2012. Pharmaceutical development (EMA/CHMP/QWP/805880/2012) Rev. 2 Paediatric Committee (PDCO). 24.
   Google Scholar
• [EMEA] European Medicines Agency Reflection paper. 2006. Formulation of choice for the paediatric population (EMEA/CHMP/PEG/194810/2005). Eur Med Agency EMEA/CHMP. 1–45.
   Google Scholar
• [FDA] U.S. Food & Drug 2002. Food-additives-petitions/additional-information-about-high-intensity-sweeteners-permitted-use-food-united-states. Available from: https://www.fda.gov/food/food-additives-petitions/additional-information-about-high-intensity-sweeteners-permitted-use-food-united-states.
   Google Scholar
• [FDA] U.S. Food & Drug 2018. Quality attribute considerations for chewable tablets guidance for industry. Available from: https://www.fda.gov/files/drugs/published/Quality-Attribute-Considerations-for-Chewable-Tablets-Guidance-for-Industry.pdf.
   Google Scholar
• [FDA] U.S. Food & Drug, CFR-Code of federal regulation – title 21 2019. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=163.130.
   Google Scholar
• Gala U, Chauhan H. 2014. Taste masking techniques in the pharmaceutical industry. Am Pharm Rev. 17:1–7.
   Google Scholar
• Giannopoulou I, Saïs F, Thomopoulos R. 2015. Linked data annotation and fusion driven by data quality evaluation. Rev Des Nouv Technol l’Information E. 28:257–262.
   Google Scholar
• Gould J, Vieira J, Wolf B. 2013. Cocoa particles for food emulsion stabilisation. Food Funct. 4(9):1369–1375.
   PubMed Web of Science ®Google Scholar
• Guedes M, Marques M, Guedes P, Contri R, Guerreiro I. 2020. The use of electronic tongue and sensory panel on taste evaluation of pediatric medicines: a systematic review. Pharm Dev Technol. 26:119–137.
   PubMed Web of Science ®Google Scholar
• Hartesi B, Sriwidodo M, Abdassah M, Chaerunisaa AY. 2016. Starch as pharmaceutical excipient. Int J Pharm Sci Rev Res. 41:59–64.
   Google Scholar
• Hernandez M, Borrull F, Calull M. 1999. Determination of amoxicillin in plasma samples by capillary electrophoresis. J. Chromatogr. B. 731(2):309–315.
   PubMedGoogle Scholar
• Indrayanto G, Sa TK, Widjaja S. 2000. Simultaneous determination of amoxycillintrihydrate and clavulanate potassium in pharmaceutical preparations by thin - layer chromatography/densitometry. J AOAC Int. 83(6):1493–1496.
   PubMed Web of Science ®Google Scholar
• Margaritelis N, Markopoulou C, Koundourellis J. 2013. Setting up the chromatographic analysis of anthelmintics using crossedD-optimal experimental design methodology. Anal Methods. 5 (13):3334–3346.
   Web of Science ®Google Scholar
• Minekus M, Alminger M, Alvito P, Ballance S, Bohn T, Bourlieu C, Carrière F, Boutrou R, Corredig M, Dupont D, et al. 2014. A standardised static in vitro digestion method suitable for food-an international consensus. Food Funct. 5(6):1113–1124.
   PubMed Web of Science ®Google Scholar
• Mudasir A, Adil G, Ifra H, Qingrong H, Hassan S. 2020. Production and characterization of starch nanoparticles by mild alkali hydrolysis and ultra-sonication process. Sci Rep. 10:3533.
   PubMed Web of Science ®Google Scholar
• Nguyen T, Bhandari B, Cichero J, Prakash S. 2016. In vitro digestion of infant formulations with hydrolysed and non-hydrolysed proteins from dairy and soybean. Food Funct. 7(12):4908–4919.
   PubMed Web of Science ®Google Scholar
• Ostrowska-Ligęza E, Marzec A, Górska A, Wirkowska-Wojdyła M, Bryś J, Rejch A, Czarkowska K. 2019. A comparative study of thermal and textural properties of milk, white and dark chocolates. Thermochim. Acta. 671:60–69.
   Web of Science ®Google Scholar
• Paz-Yépez C, Peinado I, Heredia A, Andrés A. 2019. Lipids digestibility and polyphenols release under in vitro digestion of dark, milk and white chocolate. J Funct Food. 52:196–203.
   Web of Science ®Google Scholar
• Peltekis N, Markopoulou C. 2015. Crossed D-optimal experimental design methodology for the chromatographic separation of antihypertensive drugs. Anal Lett. 48(7):1070–1088.
   Web of Science ®Google Scholar
• Perissutti B, Rubessa F, Moneghini M, Voinovich D. 2003. Formulation design of carbamazepine fast-release tablets prepared by melt granulation technique. Pharmaceutics. 256(1-2):53–63.
   PubMed Web of Science ®Google Scholar
• [Ph. Eur.] European Pharmacopoeia v. 9 2020. 2.9.1. Disintegration of tablets and capsules, 2.9.7. Friability of uncoated tablets & 2.9.8. resistance to crushing of tablets.
   Google Scholar
• EC 2008. Regulation [EC] No 1901/2006 of the European Parliament and of the Council of 12 2006. December on medicinal products for paediatric use. Available at: https://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf. Accessed April 28, 2008.
   Google Scholar
• [SCF] Scientific Committee on Food 2002. Opinion of the Scientific Committee on Food: update on the safety of aspartame. 1–24.
   Google Scholar
• Shah A. 2015. Quality control management for tablets – Hardness test. Available from: https://[email protected].
   Google Scholar
• Sopyan I, Widya Sukma Santi NM, Virisy Berlian A, Erin Meilina N, Fauza Q, Amelia Apriyandi R. 2020. A review: pharmaceutical excipients of solid dosage forms and characterizations. Int J Res Pharm Sci. 11:1472–1480.
   Google Scholar
• [USP] Pharmacopeia 2018. Amoxicillin tablets.
   Google Scholar
• Walsh J, Cram A, Woertz K, Breitkreutz J, Winzenburg G, Turner R, Tuleu C, European Formulation Initiative 2014. Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients. Adv Drug Deliv Rev. 73:14–33.
   PubMed Web of Science ®Google Scholar
• Watson R. 2006. European Medicines Agency gives favourable ruling on NSAIDs. BMJ. 333(7574):873.
   PubMed Web of Science ®Google Scholar
• Wen A, Hang T, Chen S, Wang Z, Ding L, Tian Y, Zhang M, Xu X. 2008. Simultaneous determination of amoxicillin and ambroxol in human plasma by LC-MS/MS: Validation and application to pharmacokinetic study. J Pharm Biomed Anal. 48(3):829–834.
   PubMed Web of Science ®Google Scholar
• [WHO] World Health Organization 2001. WHO model prescribing information: drugs used for bacterial infections. World Health Organization. Available from: http://apps.who.int/iris/handle/10665/42372.
   Google Scholar
• [WHO] World Health Organization, Denmark. 2019. World health organization model list of essential medicines. p. 119–134.
   Google Scholar
• Yoon KH, Lee SY, Kim W, Park JS, Kim HS. 2004. Simultaneous determination of amoxicillin and clavulanic acid in human plasma by HPLC-ESI mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 813(1-2):121–127.
   PubMed Web of Science ®Google Scholar