title: Microbiological quality of pediatric oral liquid formulations.
abstract: The oral administration of drugs to the pediatric population involves the extemporaneous preparation of liquid formulations. These formulations have studies on their physicochemical stability, but they often lack microbiological studies. The objective of this study is to check the microbiological quality of five oral liquid formulations prepared with different excipients, which represent five major combinations, in two conditions: kept unopened until the day of the test, and in a multi-dose vial opened daily. The formulations were prepared according to standard operating procedures. Half of each batch was packaged in vials that remained closed until the day of testing, and the other half in a single container which was opened daily. Both the vials and the containers had been previously sterilized. Microbiological tests were performed weekly during the first month of the study, and then every two weeks, until the expiration date. The microbiological quality of oral liquid formulations is determined by the Royal Spanish Pharmacopoeia. The conclusion was that none of the formulations prepared that were packaged in sterilized containers became contaminated, either in unopened vials or in multi-dose containers when they were opened daily.
authors: Servei de Farmàcia, Àrea Maternoinfantil.. mjcabana@vhebron.net.
authors: Maria Josep
authors: MJ
authors: Cabañas Poy
authors: Servei de Farmàcia, Àrea Maternoinfantil.. mjcabana@vhebron.net.
authors: Carme
authors: C
authors: Cañete Ramírez
authors: Servei de Microbiologia i Parasitologia Clíniques. Hospital Universitari Vall d'Hebron, Barcelona. Spain.. mjcabana@vhebron.net.
authors: Sabina X
authors: SX
authors: González di Lauro
authors: Servei de Microbiologia i Parasitologia Clíniques. Hospital Universitari Vall d'Hebron, Barcelona. Spain.. mjcabana@vhebron.net.
authors: Virginia
authors: V
authors: Rodríguez Garrido
authors: Servei de Microbiologia i Parasitologia Clíniques. Hospital Universitari Vall d'Hebron, Barcelona. Spain.. mjcabana@vhebron.net.
authors: Gloria
authors: G
authors: Roig Carbajosa
authors: Servei de Farmàcia, Àrea Maternoinfantil.. mjcabana@vhebron.net.
authors: Aurora
authors: A
authors: Fernández-Polo
authors: Servei de Farmàcia, Àrea Maternoinfantil.. mjcabana@vhebron.net.
authors: Susana
authors: S
authors: Clemente Bautista
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D058491:Bacterial Load; D002648:Child; D004339:Drug Compounding; D004340:Drug Contamination; D006801:Humans; D010372:Pediatrics / Q000592:standards*; D019999:Pharmaceutical Solutions / Q000592:standards*; D011785:Quality Assurance, Health Care
chemical_list: D019999:Pharmaceutical Solutions