title: Novel formulation and drug delivery strategies for the treatment of pediatric poverty-related diseases.
abstract: BACKGROUND
  Due to a lack of approved drugs and formulations, children represent the most vulnerable patients. Magistral, unlicensed formulations obtained by the manipulation of solid forms should undergo clinical evaluation to ensure bioequivalence. The development of new pediatric medicines is complex and faces technological, economic and ethical challenges. This phenomenon has contributed to the emergence of an adult-children gap. To improve the situation, the World Health Organization launched the global campaign 'Make medicines child size' and a number of international initiatives have been established. The situation is more critical in the case of poverty-related diseases (PRDs) that mainly affect poor countries.
  
  
  METHODS
  This review critically discusses different strategies to develop pediatric formulations and drug delivery systems (DDS) in PRDs and their potential implementation in the current market. Readers will gain an updated perspective on the development of pediatric medicines for the treatment of PRDs and the proximate challenges and opportunities faced to ensure an effective pharmacotherapy.
  
  
  CONCLUSIONS
  There is an urgent need for the development of innovative, scalable and cost-viable formulations to ensure pediatric patients have access to appropriate medications for PRDs. The guidelines of the International Conference on Harmonisation constitute a very good orientation tool, as they emphasize physiological and developmental aspects that need to be considered in pediatric research. It is important to consider cultural, economic and ethical aspects that make developing nations facing PRDs different from the developed world. Thus, the best strategy would probably be to conceive and engage similar initiatives in the developing world, to address unattended therapeutic niches.
authors.affiliation: University of Buenos Aires, Faculty of Pharmacy and Biochemistry, Department of Pharmaceutical Technology, The Group of Biomaterials and Nanotechnology for Improved Medicines, 956 Junín St., Buenos Aires CP1113, Argentina. alesosnik@gmail.com
authors.forename: Alejandro
authors.initials: A
authors.lastname: Sosnik
authors.forename: Katia P
authors.initials: KP
authors.lastname: Seremeta
authors.forename: Julieta C
authors.initials: JC
authors.lastname: Imperiale
authors.forename: Diego A
authors.initials: DA
authors.lastname: Chiappetta
mesh_terms: D000962:Antimalarials / Q000008:administration & dosage; D000995:Antitubercular Agents / Q000008:administration & dosage; D000998:Antiviral Agents / Q000008:administration & dosage; D002626:Chemistry, Pharmaceutical / Q000191:economics* / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D003906:Developing Countries / Q000191:economics*; D004333:Drug Administration Routes; D016503:Drug Delivery Systems / Q000191:economics* / Q000379:methods*; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy; D008288:Malaria / Q000188:drug therapy; D053769:Nanocapsules; D010372:Pediatrics / Q000191:economics*; D011203:Poverty; D013607:Tablets / Q000191:economics; D013678:Technology, Pharmaceutical / Q000191:economics; D014376:Tuberculosis / Q000188:drug therapy
chemical_list: D000962:Antimalarials; D000995:Antitubercular Agents; D000998:Antiviral Agents; D053769:Nanocapsules; D013607:Tablets