Novel formulation and drug delivery strategies for the treatment of pediatric poverty-related diseases

Expert Opinion on Drug Delivery

Volumn 9, Issue 3, 2012, Pages 303-323

  Sosnik, Alejandro ^a,b   Seremeta, Katia P ^a,b   Imperiale, Julieta C ^a   Chiappetta, Diego A ^a,b  

^a UNIVERSIDAD DE BUENOS AIRES   (Argentina)

^b Facultad de Ciencias Naturales e Instituto M Lillo   (Argentina)

Author keywords

Pediatric drug delivery and formulations; Pharmacotherapy of poverty related diseases

Indexed keywords

ANTIRETROVIRUS AGENT; ARTEMETHER PLUS BENFLUMETOL; CETIRIZINE; CHYLOMICRON; CIPROFLOXACIN; DIDANOSINE; EFAVIRENZ; ETHAMBUTOL; EUDRAGIT; EXCIPIENT; FAMCICLOVIR; INDINAVIR; ISONIAZID; ISONIAZID PLUS PYRAZINAMIDE PLUS RIFAMPICIN; ISONIAZID PLUS RIFAMPICIN; LAMIVIR S; LAMIVUDINE PLUS STAVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LEVOFLOXACIN; LINEZOLID; LOPINAVIR PLUS RITONAVIR; MACROGOL; MONTELUKAST; NANOCARRIER; NEVIRAPINE; ORASWEET; POLYMER; POLYPROPYLENE OXIDE; PYRAZINAMIDE; RIFAMPICIN; STAVUDINE; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ALLERGY; ASTHMA; BITTER TASTE; CHEWABLE TABLET; CHILD; CHILDHOOD DISEASE; COLLOID; DRUG BIOAVAILABILITY; DRUG CAPSULE; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG RESEARCH; GROUPS BY AGE; HEALTH CARE COST; HERPES SIMPLEX; HERPES ZOSTER; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MALARIA; MICELLE; MICROENCAPSULATION; NANOSUSPENSION; NANOTECHNOLOGY; ORAL LIQUID PREPARATION; ORAL STRIP TECHNOLOGY; ORODISPERSIBLE TABLET; PILL; POVERTY; REVIEW; SELF NANOEMULSIFYING DRUG DELIVERY SYSTEM; SUSPENSION; TABLET FORMULATION; TRANSDERMAL PATCH; TUBERCULOSIS;

ANTIMALARIALS; ANTITUBERCULAR AGENTS; ANTIVIRAL AGENTS; CHEMISTRY, PHARMACEUTICAL; CHILD; CHILD, PRESCHOOL; DEVELOPING COUNTRIES; DRUG ADMINISTRATION ROUTES; DRUG DELIVERY SYSTEMS; HIV INFECTIONS; HUMANS; INFANT; INFANT, NEWBORN; INFANT, NEWBORN, DISEASES; MALARIA; NANOCAPSULES; PEDIATRICS; POVERTY; TABLETS; TECHNOLOGY, PHARMACEUTICAL; TUBERCULOSIS;

EID: 84857610934     PISSN: 17425247     EISSN: 17447593     Source Type: Journal    
DOI: 10.1517/17425247.2012.655268     Document Type: Review

References (190)

1. Nahata MC. Lack of pediatric drug formulations. Pediatrics 1999;104(Suppl 3):607-9 (Pubitemid 29426630)
2. Nahata MC, Allen LV Jr. Extemporaneous drug formulations. Clin Ther 2008;30:2112-19
3. Wilson JT. An update on the therapeutic orphan. Pediatrics 1999;104:585-90 (Pubitemid 29426624)
4. van Riet-Nales DA, Schobben AF, Egberts TC, et al. Effects of the pharmaceutical technologic aspects of oral pediatric drugs on patient-related outcomes: a systematic literature review. Clin Ther 2010;32:924-38
5. Neubert A, Wong IC, Bonifazi A, et al. Defining off-label and unlicensed use of medicines for children: results of a Delphi survey. Pharmacol Res 2008;58:316-22
6. Tuleu C, Arenas-Lopez S, Robinson C, et al. 'Poppy seeds' in stomach aspirates: is oral omeprazole extemporaneous dispersion bioavailable? Eur J Pediatr 2008;167:823-5 (Pubitemid 351733503)
7. Kairuz TE, Gargiulo D, Bunt C, et al. Quality, safety and efficacy in the 'off-label' use of medicines. Curr Drug Saf 2007;2:89-95 (Pubitemid 46723173)
8. Conroy S. Extemporaneous (magistral) preparation of oral medicines for children in European hospitals. Acta Paediatr 2003;92:408-11
9. Standing JF, Tuleu C. Paediatric formulations - getting to the heart of the problem. Int J Pharm 2005;300:56-66 (Pubitemid 41112167)
10. Choonara I, Conroy S. Unlicensed and off-label drug use in children: implications for safety. Drug Saf 2002;25:1-5 (Pubitemid 34208327)
11. Nunn T, Williams J. Formulation of medicines for children. Br J Clin Pharmacol 2005;59:674-6 (Pubitemid 40835500)
12. Schirm E, Tobi H, de Vries TW, et al. Lack of appropriate formulations of medicines for children in the community. Acta Paediatr 2003;92:1486-9 (Pubitemid 38114502)
13. Milne CP, Bruss JB. The economics of pediatric formulation development for off-patent drugs. Clin Ther 2008;30:2133-45
14. Zisowsky J, Krause A, Dingemanse J. Drug development for pediatric populations: regulatory aspects. Pharmaceutics 2010;2:364-88
15. Kearns GL, Abdel-Rahman SM, Alander SW. Developmental pharmacology - Drug disposition, action, and therapy in infants and children. N Engl J Med 2003;349:1157-67 (Pubitemid 37122329)
16. ICH E 11 Clinical investigation of medicinal products in the paediatric population. Published in the UK in: EU: note for guidance on clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99). London, 2000; and in the US in: US: International Conference on Harmonisation. Guidance on E 11 clinical investigation of medicinal products in pediatric population; Notice. Fed Regist 2000;65:78493-4
17. Bowles A, Keane J, Ernest T, et al. Specific aspects of gastro-intestinal transit in children for drug delivery design. Int J Pharm 2010;395:37-43
18. Formulations of choice for the paediatric population, committee for medicinal products for human use, EMA (London 23 June 2005 EMEA/CHMP/PEG/ 194810/2005). Available from: http:// www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500003782.pdf [Last accessed 25 November 2011]
19. Draft Guideline on pharmaceutical development of medicines for paediatric use, EMA (London 19 May 2011 EMA/ CHMP/QWP/180157/2011). Available from: http://www.ema.europa.eu/docs/ en-GB/document-library/Scientific-guideline/2011/ 06/WC500107908.pdf [Last accessed 25 November 2011]
20. Sosnik A, Carcaboso AM, Glisoni RJ, et al. New old challenges in tuberculosis: potentially effective nanotechnologies in drug delivery. Adv Drug Deliv Rev 2010;62:547-59
21. Sosnik A, Chiappetta DA, Carcaboso AM. Drug delivery systems in HIV pharmacotherapy: what has been done and the challenges standing ahead. J Control Release 2009;138:2-15
22. das Neves J, Amiji MM, Bahia MF, Sarmento B. Nanotechnology-based systems for the treatment and prevention of HIV/AIDS. Adv Drug Deliv Rev 2010;62:458-77
23. Romero EL, Morilla MJ. Nanotechnological approaches against Chagas disease. Adv Drug Deliv Rev 2010;62:576-88
24. Make medicines child size. World Health Organization, 2007. Available from: www.who.int/childmedicines/en/ [Last accessed 10 October 2011]
25. Osuntokun B. Clinical trials in pediatrics: the drug delivery dimension. Adv Drug Deliv Rev 2006;58:90-105
26. Chappuy H, Doz F, Blanche S, et al. Parental consent in paediatric clinical research. Arch Dis Child 2006;91:112-16 (Pubitemid 43362514)
27. Gans-Brangs KR, Plourde PV. The evolution of legislation to regulate pediatric clinical trials: present and continuing challenges. Adv Drug Deliv Rev 2006;58:106-15
28. Pal V, Nahata ME. Need for extemporaneous formulations in pediatric patients. J Pediatr Pharmacol Ther 2001;6:107-19
29. Stoyanova-Beninska VV, Wohlfarth T, Isaac M, et al. The EU paediatric regulation: effects on paediatric psychopharmacology in Europe. Eur Neuropsychopharmacol 2011;21:565-70
30. Zwaan CM, Kearns P, Caron H, et al. The role of the 'innovative therapies for children with cancer' (ITCC) European consortium. Cancer Treat Rev 2010;36:328-34
31. Jacqz-Aigrain E. Drug policy in Europe Research and funding in neonates: current challenges, future perspectives, new opportunities. Early Hum Dev 2011;87:S27-30
32. Breitkreutz J. European perspectives on pediatric formulations. Clin Ther 2008;30:2146-54
33. Strickley RG, Iwata Q, Wu S, et al. Pediatric drugs - review of commercially available oral formulations. J Pharm Sci 2008;97:1731-74
34. Zuccotti GV, Fabiano V. Safety issues with ethanol as an excipient in drugs intended for pediatric use. Expert Opin Drug Saf 2011;10:499-502
35. Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clin Ther 2008;30:2097-101
36. European Paediatric Formulation Initiative. Available from: www.eupfi.org [Last accessed 10 October 2011]
37. Cram A, Breitkreutz J, Desset-Brethes S, et al. Challenges of developing palatable oral paediatric formulations. Int J Pharm 2009;365:1-3
38. Neonatal European Information System. Available from: www.euroneostat.org [Last accessed 10 October 2011]
39. Lavelle EC, Sharif S, Thomas NW, et al. The importance of gastrointestinal uptake of particles in the design of oral delivery systems. Adv Drug Deliv Rev 1995;18:5-22
40. AIDS epidemic update 2007, World Health Organization. Available from: www.who.int/hiv/epiupdates/en/index. html [Last accessed 11 November 2010]
41. Giaquinto C, Morelli E, Fregonese F, et al. Current and future antiretroviral treatment options in paediatric HIV infection. Clin Drug Investig 2008;28:375-97 (Pubitemid 351695404)
42. Hazra R, Siberry GK, Mofenson LM. Growing up with HIV: children, adolescents, and young adults with perinatally acquired HIV infection. Annu Rev Med 2010;61:169-85
43. Sosnik A, Amiji M. Nanotechnology solutions for infectious diseases in developing nations. Adv Drug Deliv Rev 2010;62:375-7
44. Sosnik A. Nanotechnology contributions to the pharmacotherapy of pediatric HIV: a dual scientific and ethical challenge and a still pending agenda. Nanomedicine (UK) 2010;5:833-7
45. Waning B, Diedrichsen E, Jambert E, et al. The global pediatric antiretroviral market: analyses of product availability and utilization reveal challenges for development of pediatric formulations and HIV/AIDS treatment in children. BMC Pediatr 2010;10:74
46. Chang R, Guo X, Burnside B, et al. A review of fast dissolving tablets. Pharm Tech 2000;12:52-8
47. Siddiqui N, Garg G, Sharma PK. Fast dissolving tablets: preparation, characterization and evaluation: an overview. Int J Pharm Sci Rev Res 2010;4:87-96
48. Hirani JJ, Rathod DA, Vadalia KR. Orally disintegrating tablets: a review. Trop J Pharm Res 2009;8:161-72
49. Sumiya K, Baba Y, Inomata S, et al. Preparation and clinical evaluation of orally-disintegrating clonidine hydrochloride tablets for preanesthetic medication. Yakugaku Zasshi 2000;120:652-6 (Pubitemid 30457172)
50. Homma M, Sumiya K, Kambayashi Y, et al. Assessment of clonidine orally disintegrating tablet for pre-anesthetic medication in pediatric surgery. Biol Pharm Bull 2006;29:321-3 (Pubitemid 43200904)
51. Singh J, Philip AK, Pathak K. Optimization studies on design and evaluation of orodispersible pediatric formulation of indomethacin. AAPS PharmSciTech 2008;9:60-6
52. Patil C, Das S. Effect of various superdisintegrants on the drug release profile and disintegration time of lamotrigine orally disintegrating tablets. Afr J Pharm Pharmacol 2011;5:76-82
53. Thakur RR, Casi M. An unlimited scope for novel formulations as orally disintegrating systems: present and future prospects. J Appl Pharm Sci 2011;1:13-19
54. Akbari BV, Dholakiya RB, Shiyani BG, et al. Design, development and characterization of mouth dissolving tablets of cinnarizine using super-disintegrants. Int J PharmTech Res 2010;2:97-105
55. Gandhi GS, Mundhada DR, Bhaskaran S. Levocetirizine orodispersible tablet by direct compression method. J Appl Pharm Sci 2011;5:145-50
56. Bowen A, Palasanthiran P, Sohn AH. Global challenges in the development and delivery of paediatric antiretrovirals. Drug Discov Today 2008;13:530-5
57. Kayitare E, Vervaet C, Ntawukulilyayo JD, et al. Development of fixed dose combination tablets containing zidovudine and lamivudine for paediatric applications. Int J Pharm 2009;370:41-6
58. Padmavathi Y, Madhava Reddy B, Amareswar P. Development of fixed dose combination dispersible tablets containing stavudine, lamivudine and nevirapine for paediatric applications. Int J Pharm Technol 2011;3:2343-52
59. Pensi T. Fixed-dose combination of lamivudine, stavudine and nevirapine in the treatment of pediatric HIV-infection: a preliminary report. Indian Pediatr 2007;44:519-21 (Pubitemid 47076838)
60. Stoltenberg I, Winzenburg G, Breitkreutz J. Solid oral dosage forms for children - Formulations, excipients and acceptance issues. Eur Ind Pharm 2011;8:4-7
61. Badgujar BP, Mundada AS. The technologies used for developing orally disintegrating tablets: a review. Acta Pharm 2011;61:117-39
62. Siewert M, Dressman J, Brown CK, et al. FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms. AAPS PharmSciTech 2003;4:E7
63. Dixit RP, Puthli SP. Oral strip technology: overview and future potential. J Control Release 2009;139:94-107
64. Gavaskar B, Kumar SV, Sharan G, et al. Overview on fast dissolving films. Int J Pharm Pharm Sci 2010;2:29-33
65. Rabinow BE. Nanosuspensions in drug delivery. Nat Rev Drug Discov 2004;3:785-96 (Pubitemid 39242830)
66. Chan H-K, Kwok PCL. Production methods for nanodrug particles using the bottom-up approach. Adv Drug Deliv Rev 2011;63:406-16
67. Sharma P, Garg S. Non-polymeric nano-carriers in HIV/AIDS drug delivery and targeting. Adv Drug Deliv Rev 2010;62:491-502
68. Van Gyseghem E, Pendela M, Baert L, et al. Powder for reconstitution of the anti-HIV-1 drug TMC278 - Formulation development, stability and animal studies. Eur J Pharm Biopharm 2008;70:853-60
69. Sosnik A, Carcaboso AM, Chiappetta DA. Polymeric nanocarriers: new endeavors for the optimization of the technological aspects of drugs. Recent Pat Biomed Eng 2010;1:43-59
70. Chiappetta DA, Sosnik A. Poly(ethylene oxide)-poly(propylene oxide) block copolymer micelles as drug delivery agents: improved hydrosolubility, stability and bioavailability of drugs. Eur J Pharm Biopharm 2007;66:303-17 (Pubitemid 46756232)
71. Gaucher G, Satturwar P, Jones MC, et al. Polymeric micelles for oral drug delivery. Eur J Pharm Biopharm 2010;76:147-58
72. Brichard B, Van der Linden D. Clinical practice treatment of HIV infection in children. Eur J Pediatr 2009;168:387-92
73. Rabel SR, Patel M, Sun S. Electronic and resonance effects on the ionization of structural analogues of efavirenz. AAPS PharmSci 2001;3:E28
74. Gao JZh, Hussain MA, Motheram R, et al. Investigation of human pharmacoscintigraphic behavior of two tablets and a capsule formulation of a high dose, poorly water soluble/highly permeable drug (Efavirenz). J Pharm Sci 2007;96:2970-7 (Pubitemid 350221197)
75. Friedland G, Khoo S, Jack C, et al. Administration of efavirenz (600 mg/day) with rifampicin results in highly variable levels but excellent clinical outcomes in patients treated for tuberculosis and HIV. J Antimicrob Chemother 2006;58:1299-302 (Pubitemid 44884158)
76. Fabbiani M, Di Giambenedetto S, Bracciale L, et al. Pharmacokinetic variability of antiretroviral drugs and correlation with virological outcome: 2 years of experience in routine clinical practice. J Antimicrob Chemother 2009;64:109-17
77. ter Heine R, Scherpbier HJ, Crommentuyn KM, et al. A pharmacokinetic and pharmacogenetic study of efavirenz in children: dosing guidelines can result in subtherapeutic concentrations. Antiv Ther 2008;13:779-87
78. Csajka C, Marzolini C, Fattinger K, et al. Population pharmacokinetics and effects of efavirenz in patients with human immunodeficiency virus infection. Clin Pharmacol Ther 2003;73:20-30 (Pubitemid 36158483)
79. Bahal SM, Romansky JM, Alvarez FJ. Medium chain triglycerides as vehicle for palatable oral liquids. Pharm Dev Technol 2003;8:111-15 (Pubitemid 36337485)
80. Sellers RS, Antman M, Phillips J, et al. Effects of Miglyol 812 on rats after 4 weeks of gavage as compared with methylcellulose/Tween 80. Drug Chem Toxicol 2005;28:423-32 (Pubitemid 41572101)
81. Breitkreutz J, Boos J. Paediatric and geriatric drug delivery. Expert Opin Drug Deliv 2007;4:37-45 (Pubitemid 46117485)
82. Fabiano V, Mameli C, Zuccotti GV. Paediatric pharmacology: remember the excipients. Pharmacol Res 2011;63:362-5
83. Medecins Sans Frontieres. Essential Medicines List, 17th WHO Meeting. Letter to WHO Expert Committee on Essential Medicine Selection. Geneva 2009. Available from: www.who.int/selection-medicines/committees/expert/17/en/index. html [Last accessed 8 August 2011]
84. Sosnik A, Chiappetta DA, Hocht C. Composiciones farmaceuticas en forma de soluciones acuosas destinadas a la administracion oral de agentes antirretrovirales. AR072715; 2009
85. Chiappetta DA, Hocht C, Taira C, et al. Efavirenz-loaded polymeric micelles for pediatric anti-HIV pharmacotherapy with significantly higher oral bioavailaibility. Nanomedicine (UK) 2010;5:11-23
86. Chiappetta DA, Hocht C, Taira C, et al. Oral pharmacokinetics of the anti-HIV efavirenz encapsulated within polymeric micelles. Biomaterials 2011;32:2379-87
87. Chiappetta DA, Hocht C, Sosnik A. A highly concentrated and taste-improved aqueous formulation of efavirenz for a more appropriate paediatric management of the anti-HIV therapy. Curr HIV Res 2010;8:223-31
88. Saez-Llorens X, Yogev R, Arguedas A, et al. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother 2009;53:1912-20
89. Blumer J, Rodriguez A, Sanchez PJ, et al. Single-dose pharmacokinetics of famciclovir in infants and population pharmacokinetic analysis in infants and children. Antimicrob Agents Chemother 2010;54:2032-41
90. Limayem Blouza I, Charcosset C, Sfar S, et al. Preparation and characterization of spironolactone-loaded nanocapsules for paediatric use. Int J Pharm 2006;325:124-31 (Pubitemid 44608215)
91. Shafiq S, Shakeel F, Talegaonkar S, et al. Development and bioavailability assessment of ramipril nanoemulsion formulation. Eur J Pharm Biopharm 2007;66:227-43 (Pubitemid 46667230)
92. Mishra B, Sahoo BL, Mishra M, et al. Design of a controlled release liquid formulation of lamotrigine. DARU 2011;19:126-37
93. Maurer BJ, Kalous O, Yesair DW, et al. Improved oral delivery of N-(4-hydroxyphenyl)retinamide with a novel LYM-X-SORB organized lipid complex. Clin Cancer Res 2007;13:3079-86 (Pubitemid 46849585)
94. Schiffman SS, Zervakis J, Heffron S, et al. Effect of protease inhibitors on the sense of taste. Nutrition 1999;15:767-72 (Pubitemid 29461023)
95. Dhoka MV, Nimbalkar UA, Pande A. Preparation of Cefpodoxime Proxetil-polymeric microspheres by the emulsion solvent diffusion method for taste masking. Int J PharmTech Res 2011;3:411-19
96. Martinez BL, Riordan FAI. Novel strategies in the use of lopinavir/ritonavir for the treatment of HIV infection in children. HIV/AIDS - Res Palliative Care 2010;2:59-67
97. Akbari BV, Patel BP, Dholakiya RB, et al. Development and evaluation of taste masked suspension of prokinetic agent by using ion exchange resin. Int J PharmTech Res 2010;2:240-5
98. Chiappetta DA, Carcaboso AM, Bregni C, et al. Indinavir-loaded pH-sensitive microparticles for taste masking: toward extemporaneous paediatric HIV/AIDS liquid formulations with improved patient compliance. AAPS PharmSciTech 2009;10:1-6
99. Matsui D. Assessing the palatability of medications in children. Paediatr Perinat Drug Ther 2007;8:55-60 (Pubitemid 47621484)
100. Woertz K, Tissen C, Kleinebudde P, et al. Rational development of taste masked oral liquids guided by an electronic tongue. Int J Pharm 2010;400:114-23
101. WHO. WHO expert working group meeting to determine preferred ARV medicines for treating and preventing HIV infection in younger children. Geneva. October 23-25, 2006. Available from: www.who.int/hiv/events/ paediatricmeetingreport.pdf [Last accessed 25 November 2009]
102. Kaufmann SH, McMichael AJ. Annulling a dangerous liaison: vaccination strategies against AIDS and tuberculosis. Nat Med 2005;11:S33-44 (Pubitemid 40562302)
103. Frieden TR, Sterling TR, Munsiff SS, et al. Tuberculosis (Seminar). Lancet 2003;362:887-99
104. Onyebujoh P, Zumla A, Ribeiro I, et al. Treatment of tuberculosis: present status and future prospects. Bull World Health Organ 2005;83:857-65 (Pubitemid 41624872)
105. WHO, Treatment of tuberculosis: guidelines for national programmes. 3rd edition. World Health Organization; Geneva: 2003
106. Dye C. Global epidemiology of tuberculosis. Lancet 2006;367:938-40
107. Brewer T, Heymann S. Long time due: reducing tuberculosis mortality in the 21st century. Arch Med Res 2005;36:617-21 (Pubitemid 41436230)
108. WHO list of prequalified medicinal products. Available from: http://apps. who.int/prequal/query/ProductRegistry. aspx?list=tb [Last accessed 22 November 2011]
109. Shukla V, Nanjawade BK, Manvi FV, et al. Effect of different superdisintegrants on release behavior of rifampicin dispersible tablets for oral treatment of tuberculosis. Int J Pharm Sci 2010;2:871-83
110. Shukla V, Manvi FV. Effect of Kollidon Cl on release behavior of isoniazid and rifampicin combination dispersible tablets for oral treatment of tuberculosis. Int J Drug Devel Res 2010;2:892-906
111. Reverchon E, De Marco I, Della Porta G. Rifampicin microparticles production by supercritical antisolvent precipitation. Int J Pharm 2002;243:83-91
112. Moretton MA, Glisoni RJ, Chiappetta DA, Sosnik A. Molecular implications in the nanoencapsulation of the antituberculosis drug rifampicin within flower-like polymeric micelles. Colloids Surf B Biointerfaces 2010;79:467-79
113. Moretton MA, Chiappetta DA, Sosnik A. Cryoprotection-lyophilisation and physical stabilization of rifampicin-loaded flower-like polymeric micelles. J Royal Soc-Interface; doi: 10.1098/rsif.2011.0414
114. Moretton MA, Chiappetta DA, Sosnik A. Molecular implications of the encapsulation and chemical stabilization of rifampicin in flower-like polymeric micelles. I Argentine Symposium of Nanomedicines; October 2011; Buenos Aires, Argentina
115. Pandey R, Zahoor A, Sharma S. Nanoparticle encapsulated antitubercular drugs as a potential oral drug delivery system against murine tuberculosis. Tuberculosis 2003;83:373-8 (Pubitemid 37464042)
116. Pandey R, Sharma S, Khuller GK. Oral solid lipid nanoparticle-based antitubercular chemotherapy. Tuberculosis 2005;85:415-20 (Pubitemid 41617396)
117. Swai H, Semete B, Kalombo L, et al. Potential of treating tuberculosis with a polymeric nano-drug delivery system. J Control Release 2008;132:e48
118. Santos-Magalhaes NS, Mosqueira VC. Nanotechnology applied to the treatment of malaria. Adv Drug Deliv Rev 2010;62:560-75
119. Malaria fact sheet. World Health Organization. Available from: www.who. int/mediacentre/factsheets/fs094/en/index. html [Last accessed 12 July 2011]
120. Kurth F, Belard S, Adegnika AA, et al. Do paediatric drug formulations of artemisinin combination therapies improve the treatment of children with malaria? A systematic review and meta-analysis. Lancet Infect Dis 2010;10:125-32
121. WHO. World Malaria Report 2008. Geneva: World Health Organization, 2008. Available from: http://www.who. int/malaria/publications/atoz/ 9789241563697/en/index.html [Last accessed 22 Dec 2009]
122. Salah MT, Faroug M, Magzoub MM, et al. Efficacy of artemether-lumfantrine (Co-Artesiane®) suspension in the treatment of uncomplicated Plasmodium falciparum malaria among children under 5 years in eastern Sudan. Trop J Pharm Res 2006;5:551-5
123. Abdulla S, Sagara I, Borrmann S, et al. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single- blind, multicentre trial. Lancet 2008;372:1819-27
124. Juma EA, Obonyo CO, Akhwale WS, et al. A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya. Malar J 2008;7:262
125. Ramharter M, Kurth F, Schreier AC, et al. Fixed-dose pyronaridine- artesunate combination for treatment of uncomplicated falciparum malaria in pediatric patients in Gabon. J Infect Dis 2008;198:911-19
126. Bouyou-Akotet MK, Ramharter M, Ngoungou EB, et al. Efficacy and safety of a new pediatric artesunate-mefloquine drug formulation for the treatment of uncomplicated falciparum malaria in Gabon. Wien Klin Wochenschr 2010;122:173-8
127. Bouyou-Akotet MK, Ramharter M, Ngoungou EB, et al. Efficacy and safety of a new pediatric artesunate-mefloquine drug formulation for the treatment of uncomplicated falciparum malaria in Gabon. Wien Klin Wochenschr 2010;122:173-8
128. Abdulla S, Sagara I. Dispersible formulation of artemether/lumefantrine: specifically developed for infants and young children. Malar J 2009;8(Suppl 1):S7
129. Abdulla S, Amuri B, Kabanywanyi A, et al. Early clinical development of artemether-lumefantrine dispersible tablet: palatability of three flavours and bioavailability in healthy subjects. Malar J 2010;9:253-61
130. Krause J, Thommes M, Breitkreutz J. Immediate release pellets with lipid binders obtained by solvent-free cold extrusion. Eur J Pharm Biopharm 2009;71:138-44
131. Breitkreutz J, Bornhoft M, Woll F, et al. Pediatric drug formulations of sodium benzoate: I. Coated granules with a hydrophilic binder. Eur J Pharm Biopharm 2003;56:247-53 (Pubitemid 37072109)
132. Breitkreutz J, El-Saleh F, Kiera C, et al. Pediatric drug formulations of sodium benzoate: II. Coated granules with a lipophilic binder. Eur J Pharm Biopharm 2003;56:255-60 (Pubitemid 37072110)
133. Kayumba PC, Huyghebaert N, Cordella C, et al. Quinine sulphate pellets for flexible pediatric drug dosing: formulation development and evaluation of taste-masking efficiency using the electronic tongue. Eur J Pharm Biopharm 2007;66:460-5 (Pubitemid 46756222)
134. Brewster ME, Loftsson T. Cyclodextrins as pharmaceutical solubilizers. Adv Drug Deliv Rev 2007;59:645-66 (Pubitemid 47299263)
135. Stella VJ, He Q. Cyclodextrins. Toxicol Pathol 2008;36:30-42
136. Shah PP, Mashru RC. Palatable reconstitutable dry suspension of artemether for flexible pediatric dosing using cyclodextrin inclusion complexation. Pharm Dev Technol 2010;15:276-85
137. Shah PP, Mashru RC. Formulation and evaluation of taste masked oral reconstitutable suspension of primaquine phosphate. AAPS PharmSciTech 2008;9:1025-30
138. Shabir A, Mohammed A. Exploring the use of cyclodextrins as carriers in paediatric formulations. British J Clin Pharm 2010;2:275-8
139. Pareek A, Nandy A, Kochar D, et al. Efficacy and safety of beta-arteether and alpha/beta-arteether for treatment of acute Plasmodium falciparum malaria. Am J Trop Med Hyg 2006;75:139-42 (Pubitemid 351627582)
140. Tripathi R, Khanna M, Dwivedi AK. Efficacy of novel oral formulations of alpha/beta arteether against multidrug-resistant malaria in mice. Chemother 2010;56:178-83
141. Semwal R, Semwal DK, Badoni R. Chewing gum: a novel approach for drug delivery. J Appl Res 2010;10:124-33
142. Rassing MR. Chewing gum as a drug delivery system. Adv Drug Deliv Rev 1994;13:89-121 (Pubitemid 24032043)
143. Sjogren K, Birkhed D, Persson LG, et al. Salivary fluoride clearance after a single intake of fluoride tablets and chewing gums in children, adults, and dry mouth patients. Scand J Dent Res 1993;101:274-8 (Pubitemid 23289925)
144. Stallergenes. Available from: http://www.stallergenes.com/fileadmin/ images/ corporate/gallery/Documents-pdf/2009-11-26-pil-oralair-300-en-clean.pdf [Last accessed 12 October 2011]
145. American Academy of Pediatrics. Committee on drugs. Alternative routes of drug administration - advantages and disadvantages. Pediatrics 1997;100:143-52
146. Pires A, Fortuna A, Alves G, et al. Intranasal drug delivery: how, why and what for? J Pharm Pharm Sci 2009;12:288-311
147. Mistry A, Stolnik S, Illum L. Nanoparticles for direct nose-to-brain delivery of drugs. Int J Pharm 2009;379:146-57
148. Dhuria SV, Hanson LR, Frey WH II. Intranasal delivery to the central nervous system: mechanisms and experimental considerations. J Pharm Sci 2010;99:1654-73
149. Illum L. Is nose-to-brain transport of drugs in man a reality? J Pharm Pharmacol 2004;56:3-17 (Pubitemid 38195323)
150. Mainardes RM, Khalil NM, Daflon Gremiao MO. Intranasal delivery of zidovudin by PLA and PLA - PEG blend nanoparticles. Int J Pharm 2010;395:266-71
151. Touitou E, Waknine JH, Godin B, et al. Treatment of malaria in a mouse model by intranasal drug administration. Int J Parasitol 2006;36:1493-8 (Pubitemid 44751744)
152. Vivithanaporn P, Gill MJ, Power C. Impact of current antiretroviral therapies on neuroAIDS. Expert Rev Anti Infect Ther 2011;9:371-4
153. Grovit-Ferbas K, Harris-White ME. Thinking about HIV: the intersection of virus, neuroinflammation and cognitive dysfunction. Immunol Res 2010;48:40-58
154. Van Rie A, Mupuala A, Dow A. Children in Kinshasa, Democratic Republic of the Congo, Impact of the HIV/AIDS epidemic on the neurodevelopment of preschool-aged. Pediatrics 2008;122:e123
155. Chiappetta DA, Hocht C, Opezzo JAW, et al. Intranasal administration of antiretroviral-loaded micelles for anatomical targeting to the brain in HIV. Submitted
156. American Association for Respiratory Care (AARC) Clinical Practice Guideline. Selection of an aerosol delivery device for neonatal and pediatric patients. Respir Care 1995;40:1325-35
157. NICE Technology Appraisal Guidance No. 10: Guidance on the use of inhaler systems (devices) in children under the age of 5 years with chronic asthma. Nice: London 2000. Available from: http:// www.nice.org.uk/nicemedia/pdf/ NiceINHALERguidance.pdf [Last accessed 30 November 2011]
158. NICE Technology Appraisal Guidance No. 38: Inhaler devices for routine treatment of chronic asthma in older children (aged 5-15 years). Nice: London 2002. Available from: http://www.nice.org.uk/nicemedia/live/11450/32338/ 32338.pdf [Last accessed 30 November 2011]
159. Guideline in the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary diseases (COPD). Available from: http://www.emea.europa.eu/docs/ en-GB/document-library/Scientific-guideline/ 2009/09/ WC500003551.pdf [Last accessed 12 October 2011]
160. Mathias NR, Hussain MA. Non-invasive systemic drug delivery: developability considerations for alternate routes of administration. J Pharm Sci 2010;99:1-20
161. Sharma A, Sharma S, Khuller GK. Lectin-functionalized poly (lactide-co-glycolide) nanoparticles as oral/aerosolized antitubercular drug carriers for treatment of tuberculosis. J Antimicrob Chemother 2004;54:761-6 (Pubitemid 39386728)
162. Deol P, Khuller GK. Lung specific liposomes: stability, biodistribution and toxicity of liposomal antitubercular drugs in mice. Biochem Biophys Acta 1997;1334:161-72 (Pubitemid 27117518)
163. Pandey R, Khuller GK. Antitubercular inhaled therapy: opportunities, progress and challenges. J Antimicrob Chemother 2005;55:430-5 (Pubitemid 40542580)
164. Sharma R, Saxena D, Dwivedi AK, et al. Inhalable microparticles containing drug combinations to target alveolar macrophages for treatment of pulmonary tuberculosis. Pharm Res 2001;18:1405-10 (Pubitemid 32977245)
165. Mizoe T, Ozeki T, Okada H. Application of a four-fluid nozzle spray drier to prepare inhalable rifampicin-containing mannitol microparticles. AAPS PharmSciTech 2008;9:755-61
166. Emami J, Hamishehkar H, Najafabadi AR, et al. Particle size design of PLGA microspheres for potential pulmonary drug delivery using response surface methodology. J Microencapsul 2009;26:1-8
167. Tsifansky MD, Yeo Y, Evgenov OV, et al. Microparticles for inhalational delivery of antipseudomonal antibiotics. AAPS J 2008;10:254-60
168. Muttil P, Kaur J, Kumar K, et al. Inhalable microparticles containing large payload of anti-tuberculosis drugs. Eur J Pharm Sci 2007;32:140-50 (Pubitemid 47285721)
169. Ohashi K, Kabasawa T, Ozeki T, et al. One-step preparation of rifampicin/poly (lactic-co-glycolic acid) nanoparticle-containing mannitol microspheres using a four-fluid nozzle spray drier for inhalation therapy of tuberculosis. J Control Release 2009;135:19-24
170. Ojewole E, Mackraj I, Naidoo P, et al. Exploring the use of novel drug delivery systems for antiretroviral drugs. Eur J Pharm Biopharm 2008;70:697-710
171. Taki H, Ogawa K, Nikai T. Pharmaceutical study of suppository formulations for improved in vivo kinetics of rifampicin. Kekkaku 2008;83:451-6
172. Looareesuwan S, Wilairatana P, Vanijanonta S, et al. Efficacy and tolerability of a sequential, artesunate suppository plus mefloquine, treatment of severe falciparum malaria. Ann Trop Med Parasitol 1995;89:469-75
173. WHO: Guidelines for the treatment of malaria, second edition, 2010. Available from: http://www.who.int/malaria/publications/atoz/9789241547925/ en/index.html [Last accessed 11 October 2011]
174. Hinton RL, Auwun A, Pongua G, et al. Caregivers' acceptance of using artesunate suppositories for treating childhood malaria in Papua New Guinea. Am J Trop Med Hyg 2007;76:634-40 (Pubitemid 351627699)
175. Barnes KI, Mwenechanya J, Tembo M, et al. Efficacy of rectal artesunate compared with parenteral quinine in initial treatment of moderately severe malaria in African children and adults: a randomised study. Lancet 2004;363:1598-605 (Pubitemid 38625662)
176. Pengsaa K, Sirivichayakul C, Na-Bangchang K, et al. Life-saving rectal artesunate for complicated malaria in children. Southeast Asian J Trop Med Public Health 2005;36:597-601 (Pubitemid 41316779)
177. Gaudin K, Barbaud A, Boyer C, et al. In vitro release and stability of an artesunate rectal gel suitable for pediatric use. Int J Pharm 2008;353:1-7
178. The removable ADHD patch for children and adolescents. Available from: http://www.daytrana.com/about-daytrana/adhd-patch-children. aspx [Last accessed 12 October 2011]
179. Dubey V, Mishra D, Nahar M, et al. Enhanced transdermal delivery of an anti-HIV agent via ethanolic liposomes. Nanomedicine 2010;6:590-6
180. Romero EL, Morilla MJ. Drug delivery systems against leishmaniasis? Still an open question. Expert Opin Drug Deliv 2008;5:805-23
181. Prausnitz MR, Langer R. Transdermal drug delivery. Nat Biotechnol 2008;26:1261-8
182. Arora A, Prausnitz MR, Mitragotri S. Micro-scale devices for transdermal drug delivery. Int J Pharm 2008;364:227-36
183. Shah UU, Roberts M, Orlu Gul M, et al. Needle-free and microneedle drug delivery in children: a case for disease-modifying antirheumatic drugs (DMARDs). Int J Pharm 2011;416:1-11
184. Cazares-Delgadillo J, Ganem-Rondero A, Kalia YN. Human growth hormone: new delivery systems, alternative routes of administration, and their pharmacological relevance. Eur J Pharm Biopharm 2011;78:278-88
185. Dorr HG, Zabransky S, Keller E, et al. Are needle-free injections a useful alternative for growth hormone therapy in children? Safety and pharmacokinetics of growth hormone delivered by a new needle-free injection device compared to a fine gauge needle. J Pediatr Endocrinol Metab 2003;16:383-92 (Pubitemid 37259124)
186. True AL, Chiu YY, Demasi RA, et al. Pharmacokinetic bioequivalence of enfuvirtide using a needle-free device versus standard needle administration. Pharmacotherapy 2006;26:1679-86 (Pubitemid 44885324)
187. Jørgensen JT. A challenging drug development process in the era of personalized medicine. Drug Discov Today 2011;16:891-7
188. Salunke S, Hempenstall J, Kendall R, et al. European Paediatric Formulation Initiative's (EuPFI) 2nd conference commentary - formulating better medicines for children. Int J Pharm 2011;419:235-9
189. Collins S. The antiretroviral pipeline. 2011 pipeline report, 2nd Edition, i-Base/The Treatment Action Group, pages 17-37. Available from: http://www.treatmentactiongroup.org/sites/tagone.drupalgardens.com/files/ 2011pipeline-0.pdf [Last accessed 5 December 2011]
190. Clayden P. The pediatric antiretroviral pipeline. 2011 pipeline report, 2nd Edition, i-Base/The Treatment Action Group, pages 38-53. Available from: http://www.treatmentactiongroup.org/sites/tagone.drupalgardens.com/files/ 2011pipeline-0.pdf [Last accessed 5 December 2011]