Modeling the physiological factors that affect drug delivery from a nipple shield delivery system to breastfeeding infants

Journal of Pharmaceutical Sciences

Volumn 102, Issue 10, 2013, Pages 3773-3783

  Gerrard, Stephen E ^a   Orlu Gul, Mine ^b   Tuleu, Catherine ^b   Slater, Nigel K H ^a  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Controlled release delivery; Drug delivery systems; in vitro models; Lactation; Nipple shield delivery system; Oral drug delivery; Pediatric

Indexed keywords

CROSCARMELLOSE SODIUM; LACTOSE; MAGNESIUM STEARATE; MILK FAT; SILICONE; STARCH GLYCOLATE SODIUM; SULFORHODAMINE B;

ARTICLE; BREAST FEEDING; BREAST MILK; BREAST PUMP; CRUSHING STRENGTH; DISPERSIBLE TABLET; DRUG DELIVERY SYSTEM; DRUG RELEASE; FAT CONTENT; FEEDING BEHAVIOR; FLOW RATE; HUMAN; INFANT FEEDING; LACTATION; LIPID COMPOSITION; MOTHER; NIPPLE; NIPPLE SHIELD DELIVERY SYSTEM; NUTRIENT; PERISTALTIC PUMP; PROTEIN CONTENT; PULSE RATE; SUCTION; TABLET;

CONTROLLED RELEASE/DELIVERY; DRUG DELIVERY SYSTEMS; IN VITRO MODELS; LACTATION; NIPPLE SHIELD DELIVERY SYSTEM; ORAL DRUG DELIVERY; PEDIATRIC;

BREAST FEEDING; CHEMISTRY, PHARMACEUTICAL; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; INFANT; LACTATION; MODELS, BIOLOGICAL; NIPPLES; RHODAMINES; TABLETS;

EID: 84883746382     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23688     Document Type: Article

References (38)

1. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. 2003. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med 349(12):1157-1167.
2. Knoppert DC. 2009. Pediatric formulations: International issues and potential solutions. Paediatr Drugs 11(1):55-56.
3. WHO. 2012. Priority live-saving medicines for women and children 2012. Accessed June 7, 2013, at: http://apps.who.int/medicinedocs/documents/s19290en/s19290en.pdf.
4. UNICEF, WHO. 2010. Sources and prices of selected medicines for children. Including therapeutic food, dietary vitamin and mineral supplementation. 2nd ed. Accessed June 7, 2013, at: http://www.unicef.org/supply/files/SOURCES_AND_PRICES_2010(2).pdf.
5. WHO. 2007. Promoting safety of medicines for children. Accessed June 7, 2013, at: http://www.who.int/medicines/publications/essentialmedicines/Promotion_safe_med_childrens.pdf.
6. Beggs S, Cranswick N, Reed M. 2005. Improving drug use for children in the developing world. Arch Dis Child 90(10):1091-1093.
7. Pandolfini C, Bonati M. 2005. A literature review on off-label drug use in children. Eur J Pediatr 164(9):552-558.
8. Stoltenberg I, Winzenburg G, Breitkreutz J. 2010. Solid oral dosage forms for children-Formulations, excipients and acceptance issues. J Appl Ther Res 7:141-146.
9. Sokal D, Gerrard S, Kneen E, Hubbard R, Galgon G, Banda T. 2009. Device and method for delivering an agent into breast milk while breastfeeding. Patent US8357117 B2.
10. 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(1-2):224-234.
11. Gerrard SE, Larson AM, Klibanov AM, Slater NK, Hanson CV, Abrams BF, Morris MK. 2013. Reducing infectivity of HIV upon exposure to surfaces coated with N, N-dodecyl, methyl-polyethylenimine. Biotechnol Bioeng 110(7):2058-2062.
12. Rusby JE, Brachtel EF, Michaelson JS, Koerner FC, Smith BL. 2007. Breast duct anatomy in the human nipple: Three-dimensional patterns and clinical implications. Breast Cancer Res Treat 106(2):171-179.
13. Zoppou C, Barry SI, Mercer GN. 1997. Dynamics of human milk extraction: A comparative study of breast feeding and breast pumping. Bull Math Biol 59(5):953-973.
14. Emmett PM, Rogers IS. 1997. Properties of human milk and their relationship with maternal nutrition. Early Hum Dev 49:S7-S28.
15. Riordan J. 2005. Breastfeeding and human lactation. 3rd ed. Burlington, Vermont: Jones & Bartlett Publishers, pp 103-110.
16. Goedhart AC, Bindels JG. 1994. The composition of human milk as a model for the design of infant formulas: Recent findings and possible applications. Nutr Res Rev 7:1-24.
17. Daly SEJ, Dirosso A, Owens RA, Hartmann PE. 1993. Degree of breast emptying explains changes in the fat-content, but not fatty-acid composition, of human-milk. Exp Physiol 78(6):741-755.
18. Kent JC, Mitoulas LR, Cregan MD, Ramsay DT, Doherty DA, Hartmann PE. 2006. Volume and frequency of breastfeedings and fat content of breast milk throughout the day. Pediatrics 117(3):e387-e395.
19. Khan S, Casadio YS, Lai CT, Prime DK, Hepworth AR, Trengove NJ, Hartmann PE. 2012. Investigation of short-term variations in casein and whey proteins in breast milk of term mothers. J Pediatr Gastroenterol Nutr 55(2):136-141.
20. Khan S, Hepworth AR, Prime DK, Lai CT, Trengove NJ, Hartmann PE. 2013. Variation in fat, lactose, and protein composition in breast milk over 24 hours: Associations with infant feeding patterns. J Hum Lact 29(1):81-89.
21. Hartmann PE, Prosser CG. 1984. Physiological basis of longitudinal changes in human milk yield and composition. Fed Proc 43(9):2448-2453.
22. Nommsen LA, Lovelady CA, Heinig MJ, Lönnerdal B, Dewey KG. 1991. Determinants of energy, protein, lipid, and lactose concentrations in human milk during the first 12 mo of lactation: The DARLING Study. Am J Clin Nutr 53(2):457-465.
23. Dewey KG, Lönnerdal B. 1983. Milk and nutrient intake of breast-fed infants from 1 to 6 months: Relation to growth and fatness. J Pediatr Gastroenterol Nutr 2(3):497-506.
24. Saarela T, Kokkonen J, Koivisto M. 2005. Macronutrient and energy contents of human milk fractions during the first six months of lactation. Acta Paediatr 94(9):1176-1181.
25. Kent JC, Ramsay DT, Doherty D, Larsson M, Hartmann PE. 2003. Response of breasts to different stimulation patterns of an electric breast pump. J Hum Lact 19(2):179-186.
26. Weber F, Woolridge MW, Baum JD. 1986. An ultrasonographic study of the organisation of sucking and swallowing by newborn infants. Dev Med Child Neurol 28(1):19-24.
27. Geddes DT, Kent JC, Mitoulas LR, Hartmann PE. 2008. Tongue movement and intra-oral vacuum in breastfeeding infants. Early Hum Dev 84(7):471-477.
28. Prieto CR, Cardenas H, Salvatierra AM, Boza C, Montes CG, Croxatto HB. 1996. Sucking pressure and its relationship to milk transfer during breastfeeding in humans. J Reprod Fertil 108(1):69-74.
29. Charoo NA, Shamsher AA, Zidan AS, Rahman Z. 2012. Quality by design approach for formulation development: A case study of dispersible tablets. Int J Pharm 423(2):167-178.
30. Wang CD, Chu PS, Mellen BG, Shenai JP. 1999. Creamatocrit and the nutrient composition of human milk. J Perinatol 19(5):343-346.
31. Bradford MM. 1976. A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. Anal Biochem 72(1):248-254.
32. Woolridge MW. 1986. The "anatomy" of infant sucking. Midwifery 2(4):164-171.
33. Costa P, Sousa Lobo JM 2001. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 13(2):123-133.
34. Kent JC, Mitoulas LR, Cregan MD, Geddes DT, Larsson M, Doherty DA, Hartmann PE. 2008. Importance of vacuum for breastmilk expression. Breastfeed Med 3(1):11-19.
35. Kent JC. 2007. How breastfeeding works. J Midwifery Womens Health 52(6):564-570.
36. Monaci G, Woolridge M. 2011. Ultrasound video analysis for understanding infant breastfeeding. In ICIP 2011: IEEE International Conference on Image Processing; Brussels, Belgium; September 11-14, 2011; 1765-1768.
37. Boyle RJ, Robins-Browne RM, Tang ML. 2006. Probiotic use in clinical practice: What are the risks? Am J Clin Nutr 83(6):1256-1264.
38. Abrahamsson B, Albery T, Eriksson A, Gustafsson I, Sjoberg M. 2004. Food effects on tablet disintegration. Eur J Pharm Sci 22(2-3):165-172.