RESUMO
BACKGROUND: Cystinosis is a rare genetic disorder characterized by the accumulation of cystine crystals in several tissues and organs causing, among others, severe eye symptoms. The high instability of cysteamine eye drops makes it difficult to develop formulations with an acceptable shelf life to be prepared in hospital pharmacy departments. Previously, a new compounded formulation of cysteamine eye drops in hyaluronic acid (HA) packaged in innovative single-dose systems was developed. METHODS: Long-term stability at -20 °C of this formulation was studied considering the content of cysteamine, pH, osmolality, viscosity, and microbiological analysis. The oxygen permeability of single-dose containers was also studied and an ocular biopermanence study was conducted in healthy volunteers measuring lacrimal stability and volume parameters. RESULTS: Data confirm that cysteamine concentration remained above 90% for 120 days, all parameters remaining within the accepted range for ophthalmic formulations. The permeability of the containers was reduced over time, while ocular biopermanence was maintained despite the freezing process and storage time. CONCLUSIONS: 0.55% cysteamine hydrochloride formulation in HA and packaged in single-dose containers preserved at -20 °C is stable for 120 days protected from light, presenting high potential for its translation into clinical practice when commercial presentations are not available.
RESUMO
Cystinosis is a rare genetic disorder characterized by the accumulation of cystine crystals in different tissues and organs causing, among other symptoms, severe ocular manifestations. Cysteamine eye drops are prepared in hospital pharmacy departments to facilitate access to treatment, for which vehicles that provide adequate biopermanence, as well as adaptable containers that maintain its stability, are required. Difficulties related to cysteamine preparation, as well as its tendency to oxidize to cystamine, show the importance of conducting rigorous galenic characterization studies. This work aims to develop and characterize an ophthalmic compounded formulation of cysteamine prepared with hyaluronic acid and packaged in innovative single-dose systems. For this task, the effect of different storage temperatures and the presence/absence of nitrogen on the physicochemical stability of the formulation and its packaging was studied in a scaled manner, until reaching the optimal storage conditions. The results showed that 0.55% cysteamine, prepared with hyaluronic acid and packaged in single-dose containers, is stable for 30 days when stored at -20 °C. In addition, opening vials every 4 h at room temperature after 30 days of freezing maintains the stability of the cysteamine formulation for up to 16 h. Moreover, ocular biopermanence studies were conducted using molecular imaging, concluding that the biopermanence offered by the vehicle is not affected by the freezing process, where a half-life of 31.11 min for a hyaluronic acid formulation stored for 30 days at -20 °C was obtained, compared with 14.63 min for 0.9% sodium chloride eye drops.
RESUMO
Introducción. Se revisan los casos de artritis séptica en población pediátrica por Streptococcus pneumoniae en el Área Sanitaria de Santiago de Compostela. Material y métodos. Se realizó una revisión retrospectiva de los aislamientos de S. pneumoniae en líquidos articulares en niños el período de enero de 2005 a marzo de 2014. Resultados. De los 7.416 líquidos articulares recibidos en el Servicio de Microbiología, 77 pertenecían a pacientes pediátricos, y de ellos, solamente 8 tuvieron cultivo positivo. En total fueron tres casos positivos para S. pneumoniae, dos con cultivo positivo y un tercero con detección antigénica positiva en el líquido articular. En los tres pacientes (dos de ellos menores de 15 meses) la articulación afectada fue la cadera, se combinó el tratamiento antibiótico con el drenaje quirúrgico y la evolución fue favorable. Conclusiones. La artritis neumocócica es una entidad que debe ser tenida en cuenta ya que la mayoría de los cuadros de artritis en población pediátrica aparecen como complicación de una bacteriemia posterior a un cuadro catarral o una otitis. El mayor riesgo de secuelas se asocia a retrasos en el diagnóstico, por ello es imprescindible un diagnóstico precoz clínico y microbiológico (AU)
Introduction. Cases of septic arthritis in paediatric population by Streptococcus pneumoniae in the Health Area of Santiago de Compostela (Spain) were reviewed. Material and methods. A retrospective study from January 2005 to March 2014 was conducted for all S. pneumoniae isolates obtained from joint fluids in children. Results. From the 7,416 joint fluids received in the Microbiology Department, 77 belonged to paediatric patients, and of these, only 8 had positive culture. In total, there were three positive cases for S. pneumoniae, two with positive culture and a third with positive antigen detection. In the three patients (two of them under 15 months) the affected joint was hip, antibiotic treatment was combined with surgical drainage and evolution was favourable. Conclusions. We conclude that pneumococcal arthritis is an entity that must be taken into account since most cases of arthritis in paediatric population appear as a complication of bacteraemia after a common cold or an ear infection. The greatest risk of sequel is associated with delays in diagnosis, so it is essential clinical and microbiological early diagnosis (AU)
