Unmet technological demands in orodispersible films for age-appropriate paediatric drug delivery

Watts G. WHO launches campaign to make drugs safer for children. BMJ 2007;335:1227. https://doi.org/10.1136/bmj.39423.581042.DB.

WHO Technical Report Series, Development of paediatric medicines: points to consider in formulation, in: Tech. Reports No. 970, 2012: pp. 197–225.

Qiu Y, He X, Zhu L, Chen B. Product and process development of solid oral dosage forms, in: Dev. Solid Oral Dos. Forms Pharm. Theory Pract. Second Ed., Academic Press, 2017: pp. 555–591. https://doi.org/10.1016/B978-0-12-802447-8.00020-0.

Borges AF, Silva C, Coelho JFJ, Simões S. Oral films: current status and future perspectives: I-Galenical development and quality attributes. J Control Release. 2015;206:1–19. https://doi.org/10.1016/j.jconrel.2015.03.006.

Article  PubMed  CAS  Google Scholar 

Liew KB, Tan YT, Peh KK. Characterization of oral disintegrating film containing donepezil for Alzheimer Disease, AAPS PharmSciTech. 2012;13:134. https://doi.org/10.1208/S12249-011-9729-4.

Abdelbary A, Bendas ER, Ramadan AA, Mostafa DA. Pharmaceutical and pharmacokinetic evaluation of a novel fast dissolving film formulation of flupentixol dihydrochloride. AAPS PharmSciTech. 2014;15:1603–10. https://doi.org/10.1208/s12249-014-0186-8.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Gerrard SE, Walsh J, Bowers N, Salunke S, Hershenson S. Hershenson, Innovations in pediatric drug formulations and administration technologies for low resource settings. Pharmaceutics. 2019;11. https://doi.org/10.3390/pharmaceutics11100518.

Belayneh A, Tadese E, Molla F. Safety and biopharmaceutical challenges of excipients in off-label pediatric formulations. Int J Gen Med. 2020;13:1051–66. https://doi.org/10.2147/IJGM.S280330.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Van Riet-Nales DA, Kozarewicz P, Aylward B, de Vries R, Egberts TCG, Rademaker CMA, Schobben AFAM. Paediatric drug development and formulation design—a european perspective. AAPS PharmSciTech. 2017;18:241–9. https://doi.org/10.1208/s12249-016-0558-3.

Article  PubMed  CAS  Google Scholar 

Slavkova M, Breitkreutz J. Orodispersible drug formulations for children and elderly. Eur J Pharm Sci. 2015;75:2–9. https://doi.org/10.1016/j.ejps.2015.02.015.

Article  PubMed  CAS  Google Scholar 

Van Riet-Nales DA, Schobben AFAM, Vromans H, Egberts TCG, Rademaker CMA. safe and effective pharmacotherapy in infants and preschool children: importance of formulation aspects. Arch Dis Child. 2016;101:662–9. https://doi.org/10.1136/archdischild-2015-308227.

Article  PubMed  Google Scholar 

Irfan M, Rabel S, Bukhtar Q, Qadir MI, Jabeen F, Khan A. Orally disintegrating films: a modern expansion in drug delivery system. Saudi Pharm J. 2016;24:537–46. https://doi.org/10.1016/j.jsps.2015.02.024.

Article  PubMed  Google Scholar 

Karavasili C, Gkaragkounis A, Fatouros DG. Patent landscape of pediatric-friendly oral dosage forms and administration devices. Expert Opin Ther Pat. 2021;31:663–86. https://doi.org/10.1080/13543776.2021.1893691.

Article  PubMed  CAS  Google Scholar 

EMA. Guideline on pharmaceutical development of medicines for paediatric use. 2013.

Harris D, Hermans E, Klein S, Wagner-Hattler L, Walsh J. Age-appropriate solid oral formulations for pediatric applications with a focus on multiparticulates and minitablets: summary of September 2019 EuPFI workshop. In: Eur J Pharm Biopharm., Eur J Pharm Biopharm. 2020; pp. 222–225. https://doi.org/10.1016/j.ejpb.2020.06.012.

Klingmann V, Seitz A, Meissner T, Breitkreutz J, Moeltner A, Bosse HM. Acceptability of uncoated mini-tablets in neonates—a randomized controlled trial. J Pediatr. 2015;167:893-896.e2. https://doi.org/10.1016/j.jpeds.2015.07.010.

Article  PubMed  Google Scholar 

Klingmann V, Pohly CE, Meissner T, Mayatepek E, Möltner A, Flunkert K, Breitkreutz J, Bosse HM. Acceptability of an orodispersible film compared to syrup in neonates and infants: a randomized controlled trial. Eur J Pharm Biopharm. 2020;151:239–45. https://doi.org/10.1016/J.EJPB.2020.03.018.

Article  PubMed  CAS  Google Scholar 

Liang AC, Chen LIH. Fast-dissolving intraoral drug delivery systems. Expert Opin Ther Pat. 2001;11:981–6. https://doi.org/10.1517/13543776.11.6.981.

Article  CAS  Google Scholar 

Hoffmann EM, Breitenbach A, Breitkreutz J. Advances in orodispersible films for drug delivery. Expert Opin Drug Deliv. 2011;8:299–316. https://doi.org/10.1517/17425247.2011.553217.

Article  PubMed  CAS  Google Scholar 

WHO. Unedited Draft Annex To 46Th Report of the Who Expert Committee on specifications for pharmacetical preparations. 2020.

Walsh J, Schaufelberger D, Iurian S, Klein S, Batchelor H, Turner R, Gizurarson S, Boltri L, Alessandrini E, Tuleu C. Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper. Br J Clin Pharmacol. 2021. https://doi.org/10.1111/bcp.14989.

Article  PubMed  Google Scholar 

Hoppu K. Time to change the paradigm of children’s medicines from liquid formulations to flexible solid oral dosage forms, Ceylon. Med J. 2016;61:93–5. https://doi.org/10.4038/cmj.v61i3.8340.

Article  CAS  Google Scholar 

O’Brien F, Clapham D, Krysiak K, Batchelor H, Field P, Caivano G, Pertile M, Nunn A, Tuleu C. Making medicines baby size: the challenges in bridging the formulation gap in neonatal medicine. Int J Mol Sci. 2019;20:2688. https://doi.org/10.3390/ijms20112688.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Purswani MU, Radhakrishnan J, Irfan KR, Walter-Glickman C, Hagmann S, Neugebauer R. Infant acceptance of a bitter-tasting liquid medication: a randomized controlled trial comparing the rx medibottle with an oral syringe. Arch Pediatr Adolesc Med. 2009;163:186–8. https://doi.org/10.1001/archpediatrics.2008.541.

Article  PubMed  Google Scholar 

European Medicines Agency. Reflection paper: formulation of choice for the paediatric population. Eur Med Agency. EMEA/CHMP/. 2006;1–45.

Mistry P, Batchelor H. Evidence of acceptability of oral paediatric medicines: a review. J Pharm Pharmacol. 2017;69:361–76. https://doi.org/10.1111/jphp.12610.

Article  PubMed  CAS  Google Scholar 

Walsh J, Cram A, Woertz K, Breitkreutz J, Winzenburg G, Turner R, Tuleu C. Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients. Adv Drug Deliv Rev. 2014;73:14–33. https://doi.org/10.1016/j.addr.2014.02.012.

Article  PubMed  CAS  Google Scholar 

Asiri A, Hofmanová J, Batchelor H. A review of in vitro and in vivo methods and their correlations to assess mouthfeel of solid oral dosage forms. Drug Discov Today. 2021;26:740–53. https://doi.org/10.1016/j.drudis.2020.12.015.

Article  PubMed  CAS  Google Scholar 

Venables R, Stirling H, Batchelor H, Marriott J. Problems with oral formulations prescribed to children: a focus group study of healthcare professionals. Int J Clin Pharm. 2015;37:1057–67. https://doi.org/10.1007/s11096-015-0152-x.

Article  PubMed  Google Scholar 

Orlu M, Ranmal SR, Sheng Y, Tuleu C, Seddon P. Acceptability of orodispersible films for delivery of medicines to infants and preschool children. Drug Deliv. 2017;24:1243–8. https://doi.org/10.1080/10717544.2017.1370512.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Sohi H, Sultana Y, Khar RK. Taste masking technologies in oral pharmaceuticals: recent developments and approaches. Drug Dev Ind Pharm. 2004;30:429–48. https://doi.org/10.1081/ddc-120037477.

Article  PubMed  CAS  Google Scholar 

Batchelor HK, Marriott JF. Paediatric pharmacokinetics: key considerations. Br J Clin Pharmacol. 2015;79:395–404. https://doi.org/10.1111/bcp.12267.

Article  PubMed  PubMed Central  CAS  Google Scholar 

Turner-Bowker DM, An Haack K, Krohe M, Yaworsky A, Vivas N, Kelly M, Chatterjee G, Chaston E, Mann E, Reaney M. Development and content validation of the pediatric oral medicines acceptability questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures. J Patient Rep Outcomes. 2020;4:80. https://doi.org/10.1186/s41687-020-00246-1.

Gillis J, Loughlan P. Not just small adults: the metaphors of paediatrics. Arch Dis Child. 2007;92:946–7. https://doi.org/10.1136/adc.2007.121087.

Article  PubMed  PubMed Central  Google Scholar 

Visser JC, Woerdenbag HJ, Hanff LM, Frijlink HW. Personalized medicine in pediatrics: the clinical potential of orodispersible films. AAPS PharmSciTech. 2017;18:267–72. https://doi.org/10.1208/s12249-016-0515-1.

Article  PubMed  CAS  Google Scholar 

Gijsen M, Vlasselaers D, Spriet I, Allegaert K. Pharmacokinetics of antibiotics in pediatric intensive care: fostering variability to attain precision medicine. Antibiotics. 2021;10. https://doi.org/10.3390/antibiotics10101182.

He M, Zhu L, Yang N, Li H, Yang Q. Recent advances of oral film as platform for drug delivery. Int J Pharm. 2021;604:1–13. https://doi.org/10.1016/j.ijpharm.2021.120759.

Article  CAS  Google Scholar 

Krampe R, Visser JC, Frijlink HW, Breitkreutz J, Woerdenbag HJ, Preis M. Oromucosal film preparations: points to consider for patient centricity and manufacturing processes. Expert Opin Drug Deliv. 2015;13:493–506. https://doi.org/10.1517/17425247.2016.1118048.

Article  PubMed  CAS  Google Scholar 

Zhang L, Li Y, Abed M, Davé RN. Incorporation of surface-modified dry micronized poorly water-soluble drug powders into polymer strip films. Int J Pharm. 2018;535:462–72. https://doi.org/10.1016/j.ijpharm.2017.11.040.

Article  PubMed  CAS  Google Scholar 

Woertz C, Kleinebudde P. Development of orodispersible polymer films containing poorly water soluble active pharmaceutical ingredients with focus on different drug loadings and storage stability. Int J Pharm. 2015;493:134–45. https://doi.org/10.1016/j.ijpharm.2015.07.032.

Article  PubMed  CAS  Google Scholar 

Beck C, Sievens-Figueroa L, Gärtner K, Jerez-Rozo JI, Romañach RJ, Bilgili E, Davé RN. Effects of stabilizers on particle redispersion and dissolution from polymer strip films containing liquid antisolvent precipitated griseofulvin particles. Powder Technol. 2013;236:37–51. https://doi.org/10.1016/j.powtec.2012.05.047.

Article  CAS  Google Scholar 

Steiner D, Finke JH, Kwade A. Efficient production of nanoparticle-loaded orodispersible films by process integration in a stirred media mill. Int J Pharm. 2016;511:804–13.

留言 (0)

沒有登入
gif