Pulmonary delivery of an ultra-fine oxytocin dry powder formulation: Potential for treatment of postpartum haemorrhage in developing countries

PLoS ONE

Volumn 8, Issue 12, 2013, Pages

  Prankerd, Robert J ^a   Nguyen, Tri Hung ^a   Ibrahim, Jibriil P ^a   Bischof, Robert J ^a   Nassta, Gemma C ^a   Olerile, Livesey D ^a   Russell, Adrian S ^a   Meiser, Felix ^b   Parkington, Helena C ^a   Coleman, Harold A ^a   Morton, David A V ^a   McIntosh, Michelle P ^a  

^a MONASH UNIVERSITY   (Australia)

^b UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ADMINISTRATION, INHALATION; ANIMALS; DESICCATION; DEVELOPING COUNTRIES; DRUG DELIVERY SYSTEMS; ELECTROMYOGRAPHY; EXCIPIENTS; FEMALE; GLYCINE; HUMANS; LEUCINE; LUNG; MANNITOL; OXYTOCICS; OXYTOCIN; PARTICLE SIZE; POSTPARTUM HEMORRHAGE; POSTPARTUM PERIOD; POWDERS; PREGNANCY; SHEEP, DOMESTIC; UTERUS;

EID: 84893436237     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0082965     Document Type: Article

References (39)

1. WHO (2012) WHO Recommendations for the prevention and treatment of postpartum haemorrhage. Geneva: WHO.
2. Khan KS, Wojdyla D, Say L, Gülmezoglu AM, Van Look PFA (2006) WHO analysis of causes of maternal death: a systematic review. Lancet 367: 1066-1074. doi:10.1016/S0140-6736(06)68397-9. PubMed: 16581405.
3. Prendiville WJ, Harding JE, Elbourne DR, Stirrat GM (1988) The Bristol third stage trial: active versus physiological management of third stage of labour. BMJ 297: 1295. doi:10.1136/bmj.297.6659.1295. PubMed: 3144366.
4. Rogers J, Wood J, McCandlish R, Ayers S, Truesdale A et al. (1998) Active versus expectant management of third stage of labour: the Hinchingbrooke randomised controlled trial. Lancet 351: 693-699. doi: 10.1016/S0140-6736(97) 09409-9. PubMed: 9504513.
5. WHO (2011) FINAL Report of the 18th Expert Committee on the Selection and Use of Essential Medicines (WHO TRS 965).
6. Hawe A, Poole R, Romeijn S, Kasper P, van der Heijden R et al. (2009) Towards Heat-stable Oxytocin Formulations: Analysis of Degradation Kinetics and Identification of Degradation Products. Pharm Res 26: 1679-1688. doi:10.1007/s11095-009-9878-2. PubMed: 19343484.
7. Hogerzeil HV, Walker GJ, De Goeje MJ (1994) Managing the third stage of labour. Oxytocin more stable in tropical climates. BMJ 308: 59. doi:10.1136/bmj.308.6920.59.
8. Hogerzeil HV, Walker GJA (1996) Instability of (methyl)ergometrine in tropical climates: an overview. European Journal of Obstetrics en Amp; Gynecology and Reproductive Biology 69: 25-29. PubMed: 8909953.
9. Deepak NN, Mirzabagi E, Koski A, Tripathi V (2013) Knowledge, Attitudes, and Practices Related to Uterotonic Drugs during Childbirth in Karnataka, India: A Qualitative Research Study. PLOS ONE 8: e62801. doi:10.1371/journal.pone. 0062801. PubMed: 23638148.
10. Gülmezoglu AM, Villar J, Ngoc NTN, Piaggio G, Carroli G et al. (2001) WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. Lancet 358: 689-695. doi:10.1016/S0140-6736(01)05835-4. PubMed: 11551574.
11. Althabe F, Mazzoni A, Cafferata ML, Gibbons L, Karolinski A et al. (2011) Using Uniject to increase the use of prophylactic oxytocin for management of the third stage of labor in Latin America. Int J Gynaecol Obstet 114: 184-189. doi:10.1016/j.ijgo.2011.05.003. PubMed: 21693378.
12. Tsu VD, Luu HTT, Mai TTP (2009) Does a novel prefilled injection device make postpartum oxytocin easier to administer? Results from midwives in Vietnam. Midwifery 25: 461-465. doi:10.1016/j.midw.2007.10.010. PubMed: 18281131.
13. Tsu VD, Sutanto A, Vaidya K, Coffey P, Widjaya A (2003) Oxytocin in prefilled Uniject™ injection devices for managing third-stage labor in Indonesia. International Journal Gynecology en Amp; Obstetrics 83: 103-111. doi:10.1016/S0020-7292(03)00186-3.
14. Vivien Davis T (2004) New and underused technologies to reduce maternal mortality. Lancet 363: 75-76. doi:10.1016/S0140-6736(03)15180-X.
15. Oladapo OT, Fawole B, Blum J, Abalos E (2012) Advance misoprostol distribution for preventing and treating postpartum haemorrhage. The Cochrane Library CD009336.pub2
16. Winikoff B, Dabash R, Durocher J (2010) Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, noninferiority trial. Lancet 375: 210 - 216. doi:10.1016/S0140-6736(09)61924-3. PubMed: 20060161.
17. Alfirevic Z, Blum J, Walraven G, Weeks A, Winikoff B (2007) Prevention of postpartum hemorrhage with misoprostol. International Journal Gynecology en Amp; Obstetrics 99, Supplement 2: S198-S201. doi: 10.1016/j.ijgo.2007.09.012. PubMed: 17961574.
18. Tunçalp Ö, Hofmeyr GJ, Gülmezoglu AM (2012) Prostaglandins for prevention of postpartum haemorrhage. Cochrane database of systematic reviews (Online): CD000494
19. Villar J, Gülmezoglu AM, Hofmeyr GJ, Forna F (2002) Systematic Review of Randomized Controlled Trials of Misoprostol to Prevent Postpartum Hemorrhage. Obstet Gynecol 100: 1301-1312. PubMed: 12468178.
20. Ruis H, Rolland R, Doesburg W, Broeders G, Corbey R (1981) Oxytocin enhances onset of lactation among mothers delivering prematurely. Br Med J (Clin Res Ed) 283: 340-342. doi:10.1136/bmj.283.6287.340. PubMed: 6788318.
21. Parkington HC, Harding R, Sigger JN (1988) Co-ordination of electrical activity in the myometrium of pregnant ewes. J Reprod Fertil 82: 697-705. doi:10.1530/jrf.0.0820697. PubMed: 3361503.
22. Parkington HC (1985) Some properties of the circular myometrium of the sheep throughout pregnancy and during labour. J Physiol 359: 1-15. PubMed: 3999034.
23. Parkington HC, Tonta MA, Brennecke SP, Holman ME, Coleman HA (1998) Prostaglandin hyperpolarize and suppress spontaneous contractions in human uterine smooth muscle. Journal of Physiology 507: 68P.
24. Meeusen EN, Snibson KJ, Hirst SJ, Bischof RJ (2009) Sheep as a model species for the study and treatment of human asthma and other respiratory diseases. Drug Discovery Today: Disease Models 6: 101-106.
25. Labiris NR, Dolovich MB (2003) Pulmonary drug delivery. Part I: Physiological factors affecting therapeutic effectiveness of aerosolized medications. Br J Clin Pharmacol 56: 588-599. doi:10.1046/j.1365-2125.2003. 01892.x. PubMed: 14616418.
26. Irngartinger M, Camuglia V, Damm M, Goede J, Frijlink HW (2004) Pulmonary delivery of therapeutic peptides via dry powder inhalation: effects of micronisation and manufacturing. Eur J Pharm Biopharm 58: 7-14. doi:10.1016/j.ejpb.2004.03.016. PubMed: 15207532.
27. Mihalko P, Schreier H, Abra R (1988) Liposomes: a pulmonary perspective. In: G Gregoriadis. Liposomes as Drug Carriers. New York: John Wiley. pp. 679-694.
28. Patton JS (1996) Mechanisms of macromolecule absorption by the lungs. Advanced Drug Delivery Reviews 19: 3-36. doi: 10.1016/0169-409X(95)00113-L.
29. Yamahara H, Morimoto K, Lee VL, Kim K-J (1994) Effects of Protease Inhibitors on Vasopressin Transport Across Rat Alveolar Epithelial Cell Monolayers. Pharm Res 11: 1617-1622. doi:10.1023/A:1018918022865. PubMed: 7870680.
30. Hastings RH, Grady M, Sakuma T, Matthay MA (1992) Clearance of different-sized proteins from the alveolar space in humans and rabbits. J Appl Physiol (1985) 73: 1310-1316. PubMed: 1447074.
31. Folkesson HG, Weström BR, Dahlbäck M, Lundin S, Karlsson BW (1992) Passage of Aerosolized BSA and the Nona-peptide dDAVP via the Respiratory Tract in Young and Adult Rats. Exp Lung Res 18: 595-614. doi:10.3109/ 01902149209031697. PubMed: 1396409.
32. Folkesson HG, Weström BR, Pierzynowski SG, Svendsen J, Karlsson BW (1993) Lung to blood passage of albumin and a nona-peptide after intratracheal instillation in the young developing pig. Acta Physiol Scand 147: 173-178. doi:10.1111/j.1748-1716.1993.tb09486.x. PubMed: 8475743.
33. Sou T, Kaminskas LM, Nguyen T-H, Carlberg R, McIntosh MP et al. (2012) The effect of amino acid excipients on morphology and solid-state properties of multi-component spray-dried formulations for pulmonary delivery of biomacromolecules. European Journal of Pharmaceutics and Biopharmaceutics 83: 234-243. doi:10.1016/j.ejpb. 2012.10.015. PubMed: 23183447.
34. Weers JG, Tarara TE, Clark AR (2007) Design of fine particles for pulmonary drug delivery. Expert Opin Drug Deliv 4: 297-313. doi: 10.1517/17425247.4.3.297. PubMed: 17489656.
35. Kimura T, Takemura M, Nomura S, Nobunaga T, Kubota Y et al. (1996) Expression of oxytocin receptor in human pregnant myometrium. Endocrinology 137: 780-785. doi:10.1210/en.137.2.780. PubMed: 8593830.
36. Wu WX, Verbalis JG, Hoffman GE, Derks JB, Nathanielsz PW (1996) Characterization of oxytocin receptor expression and distribution in the pregnant sheep uterus. Endocrinology 137: 722-728. doi:10.1210/en. 137.2.722. PubMed: 8593823.
37. Lalonde A (2012) Prevention and treatment of postpartum hemorrhage in low-resource settings. Int J Gynaecol Obstet 117: 108-118. doi: 10.1016/j.ijgo.2012.03.001. PubMed: 22502595.
38. Aronsson A, Bygdeman M, Gemzell-Danielsson K (2004) Effects of misoprostol on uterine contractility following different routes of administration. Hum Reprod 19: 81-84. doi:10.1093/oxfordjournals.humrep.a002332. PubMed: 14688161.
39. Davis SS (1999) Delivery of peptide and non-peptide drugs through the respiratory tract. Pharmaceutical Science & Technology. Today 2: 450-456. Available online at: PubMed: 10542391