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Buccal/Sublingual Drug Delivery for the Paediatric Population

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS,volume 11)

Abstract

Oral mucosal drug delivery has emerged as a potential route of drug administration which represents a strategy of maximising the availability of the oral route for easy administration without the need to swallow a dosage form whilst offering the possibility of local delivery and direct access to the systemic circulation thus avoiding first pass metabolism. However, changes in anatomical, physiological and biochemical functions that occur from birth to adolescence are required to be considered when designing such formulations. Currently marketed formulations include liquids, semi-solids and solid dosage forms; however, there is significant research in developing alternative dosage forms for oral mucosal delivery such as nanotablets, films, microparticles and mouth sprays which is partly due to problems (e.g., posology or excipients present in formulation) associated with using currently marketed products in children. Despite the development of novel technologies including NanoTabs and mucosal sprays, there still remains relatively few products approved for use in the paediatric population. This is likely explained by the fact that alongside the normal problems that need to be overcome during product development, additional issues including compliance, palatability, paediatric safety, the needs and capabilities of carers and the implications of global paediatric regulatory guidance need to be considered.

Keywords

  • Dosage Form
  • Solid Dosage Form
  • Pass Metabolism
  • Fentanyl Citrate
  • Buccal Tablet

These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. Breitkreutz J (2008) European perspectives on pediatric formulations. Clin Ther 30:2146–2154

    PubMed  CrossRef  Google Scholar 

  2. Dunne J (2007) The European regulations on medicines for paediatric use. Paediatr Respir Rev 8:177–183

    PubMed  CrossRef  Google Scholar 

  3. Rodriguez W, Selen A, Avant D et al (2008) Improving pediatric dosing through pediatric initiatives: what we have learned. Pediatrics 121:530–539

    PubMed  CrossRef  Google Scholar 

  4. Committee for Medicinal Products for Human Use (CHMP) Reflection paper: formulations of choice for the paediatric population. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf. Accessed 2 Dec 2011

  5. Patel VF, Lui F, Brown MB (2011) Advances in oral transmucosal drug delivery. J Control Release 153:106–116

    CAS  PubMed  CrossRef  Google Scholar 

  6. Costello I (2007) Paediatric pharmacokinetics and pharmacodynamics. In: Florence AT, Moffat AC (eds) Paediatric drug handling, 1st edn. Pharm Press, London

    Google Scholar 

  7. Leopold A, Wilson S, Weaver JS, Moursi AM (2002) Pharmacokinetics of lidocaine delivered from a transmucosal patch in children. Anesth Prog 49:82–87

    PubMed Central  PubMed  Google Scholar 

  8. Sonesson M, Eliasson L, Matsson L (2003) Minor salivary gland secretion in children and adults. Arch Oral Biol 48:535–539

    PubMed  CrossRef  Google Scholar 

  9. Williams DM, Cruchley AT (1994) Structural aspects of aging in the oral mucosa. In: Squier CA, Hill MW (eds) The effect of aging in oral mucosa and skin. CRC, Boca Raton, pp 65–74

    Google Scholar 

  10. Squier CA, Wertz PW, Williams DM, Cruchley AT (1994) Permeability of oral mucosa and skin with age. In: Squier CA, Hill MW (eds) The effect of aging in oral mucosa and skin. CRC, Boca Raton, pp 91–98

    Google Scholar 

  11. http://www.medilexicon.com/drugs-list/pediatrics.php. Accessed 15 July 2012

  12. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228. Accessed 14 Feb 2013

  13. Kaye JL (2011) Review of paediatric gastrointestinal physiology data relevant to oral drug delivery. Int J Clin Pharm 33:20–24

    PubMed  CrossRef  Google Scholar 

  14. Temgesic. www.medicines.org.uk. Accessed 14 June 2012

  15. Tephine. www.medicines.org.uk. Accessed 14 June 2012

  16. Buccolam. www.medicines.org.uk. Accessed 14 June 2012

  17. Daktarin oral gel. www.medicines.org.uk. Accessed 22 June 2012

  18. Daktarin Sugar free 2% oral gel. www.medicines.org.uk. Accessed 22 June 2012

  19. Anbesol Teething gel. www.medicines.org.uk. Accessed 14 June 2012

  20. Boots Dry Cough Relief Lozenges. www.medicines.org.uk. Accessed 14 June 2012

  21. Glyceryl Trinitrate, Paediatric Formulary Committee. BNF for Children (online). BMJ Group, Pharmaceutical Press, and RCPCH Publications, London. http://www.medicinescomplete.com. Accessed 18 Oct 2012

  22. Actiq. www.medicines.org.uk. Accessed 14 June 2012

  23. Fentanyl, Paediatric Formulary Committee. BNF for Children (online). BMJ Group, Pharmaceutical Press, and RCPCH Publications, London. http://www.medicinescomplete.com. Accessed 18 Oct 2012

  24. Camacho Parreño S, Prieto MF, Santana VM, Sanchez MTS (2012) Off-label oral transmucosal fentanyl citrate analgesia for bone fracture alignment in children. Eur J Hosp Pharm 19:103

    Google Scholar 

  25. Bartoshuk LM (2000) Comparing sensory experiences across individuals: recent psychophysical advances illuminate genetic variation in taste perception. Chem Senses 25:447–460

    CAS  PubMed  CrossRef  Google Scholar 

  26. Birch LL, Fisher JO (1998) Development of eating behaviors among children and adolescents. Pediatrics 1(Suppl 2):539–549

    Google Scholar 

  27. Beauchamp GK, Cowart BJ (1987) Development of sweet taste. In: Dobblng J (ed) Sweetness. Springer, New York

    Google Scholar 

  28. Beauchamp GK, Moran M (1984) Acceptance of sweet and salty tastes in 2-year-old children. Appetite 5:291–305

    CAS  PubMed  CrossRef  Google Scholar 

  29. KaJulra H, Cowart BJ, Beauchamp GK (1992) Early developmental change in bitter taste responses in human infants. Dev Psychobiol 25:375–386

    CrossRef  Google Scholar 

  30. Mennella JA, Peplno MY, Reed DR (2005) Genetic and environmental determinants of bitter perception and sweet preferences. Pediatrics 115:e216–e222

    PubMed Central  PubMed  CrossRef  Google Scholar 

  31. Bar-Shalom D (2011) Pediatric formulations – are we living in the past? Am Pharm Rev. http://www.americanpharmaceuticalreview.com. Accessed 27 Sept 2012

  32. Shojaei AH (1998) Buccal mucosa as a route for systemic drug delivery: a review. J Pharm Pharm Sci 1:15–30

    CAS  PubMed  Google Scholar 

  33. Spomer N, Klingmann V, Stoltenberg I, Lerch C, Meissner T, Breitkreutz J (2012) Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study. Arch Dis Child 97:283–286

    PubMed  CrossRef  Google Scholar 

  34. Limbachiya S, Nagar H, Dodiya H, Mehta D (2013) Development and characterization of fast dissolving mucoadhesive microsphere of nebivolol hydrochloride using modified methacrylate polymer. Int J Pharm Sci 3:136–141

    Google Scholar 

  35. De Matas M, Okwelogu C, York P (2009) Paediatric dosage forms: proposal of a versatile platform technology. Chim Oggi Chem 27:20–24

    Google Scholar 

  36. Onsolis. http://www.onsolis.com/pdf/onsolis_pi.pdf. Accessed 18 Feb 2013

  37. Striant. http://www.actientpharma.com/filebin/pdf/products/58816-10_Striant_full_PI_4pager.pdf. Accessed 18 Feb 2013

  38. Dixit RP, Puthli SP (2009) Oral strip technology: overview and future potential. J Control Release 139:94–107

    CAS  PubMed  CrossRef  Google Scholar 

  39. http://www.catalent.com/index.php/news-events/news/Catalent-Licenses-Technology-with-NJIT. Accessed 4 March 2013

  40. Novamist Technology. http://www.novadel.com/technology/index.htm. Accessed 18 Oct 2012

  41. Palmer P, Schreck T, Tzennis S, Hamel L, Poutiatine AI (2009) Drug formulations for oral transmucosal administration in pediatric patients. US 20090010992. www.uspto.gov. Accessed 24 July 2012

  42. ARX-01 Sufentanil NanoTab PCA System. http://www.acelrx.com/pipeline/index.html. Accessed 24 July 2012

  43. Schechter NL, Weisman SJ, Rosenblum M, Bernstein B, Conard PL (1995) The use of oral transmucosal fentanyl citrate for painful procedures in children. Pediatrics 95:335–339

    CAS  PubMed  Google Scholar 

  44. Gerrard SE, Baniecki ML, Sokal DC, Morris MK, Urdaneta-Hartmann S, Krebs FC, Wigdahl B, Abrams BF, Hanson CV, Slater NK, Edwards AD (2012) A nipple shield delivery system for oral drug delivery to breastfeeding infants: microbicide delivery to inactivate HIV. Int J Pharm 434:224–234

    CAS  PubMed  CrossRef  Google Scholar 

  45. http://justmilk.org/index.html. Accessed 5 Oct 2012

  46. http://www.lmana.com/pwpcontrol.php?pwpID=6358. Accessed 5 Aug 2012

  47. European Medicine Agency (2011) Draft guideline on pharmaceutical development of medicines for paediatric use. Committee for Medicinal Products for Human Use (CHMP). http://www.ema.europa.eu. Accessed 19 July 2012

  48. World Health Organization (2008) Report of the informal expert meeting on dosage forms of medicines for children. December 2008. http://www.who.int/selection_medicines/committees/expert/17/application/paediatric/Dosage_form_reportDEC2008.pdf. Accessed 5 Aug 2012

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Correspondence to Viralkumar F. Patel , Darragh Murnane or Marc B. Brown .

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© 2014 American Association of Pharmaceutical Scientists

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Patel, V.F., Murnane, D., Brown, M.B. (2014). Buccal/Sublingual Drug Delivery for the Paediatric Population. In: Bar-Shalom, D., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 11. Springer, New York, NY. https://doi.org/10.1007/978-1-4899-8011-3_15

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