RESUMEN
Oral Thin Film (OTF) is a newly emerging drug delivery system which has many benefits for patients. Although there has been some formulation of OTF products, these have mainly been as confectionary or dental health products. The most significant benefit of this dosage format will only be realised once more pharmaceutical products become available. Within this paper, OTF strips containing Diclofenac Sodium were prepared using the solvent casting method and then characterised to ensure the method could conform to acceptable levels of uniformity, the mean (SD) diclofenac sodium content was 25.43 (1.39) mg, range 22.84-27.44â¯mg. Bioburden was tested against coliforms, yeasts and moulds and all results were confirmed to beâ¯<10â¯CFU/g, also similar dissolution profile when compared to a commercial product to ensure biowaiver. An acceptable level of uniformity of mass was produced. K-F titration was employed to reduce the water content of the strips and it was found to be acceptable, this represented a level of water which would not be viable for microbial growth. The technique employed here in the production of OTF resulted in high quality products and amenability to being up scaled. Furthermore, the characterisation method was also sufficient to assess the quality of the products and may be used for future analysis of OTF pharmaceuticals.
Asunto(s)
Diclofenaco/química , Sistemas de Liberación de Medicamentos/métodos , Administración Oral , Diclofenaco/administración & dosificación , Diclofenaco/análisis , Diclofenaco/farmacología , Contaminación de Medicamentos/estadística & datos numéricos , Liberación de FármacosRESUMEN
UNLABELLED: Adequate phosphate intake is important for the prevention of metabolic bone disease in preterm infants. The European Society for Paediatric Gastroenterology, Hepatology and Nutrition recommends a daily phosphate intake of 184-230 mg/kg/day, which should be met by standard feed volumes of either commercially fortified breast milk or preterm formulae. We sought to investigate whether our local practise of providing supplemental oral phosphate for all infants born before 32 weeks' gestation continues to be necessary. Details of parenteral and milk feeding and both oral and parenteral phosphate supplementation from birth until 8 weeks of age were collected retrospectively from the case notes of 31 preterm infants. Routinely collected biochemical markers of bone mineral status were also recorded. Mean (SD) plasma phosphate concentration was higher when oral phosphate supplementation was given [2.10 (0.38) versus 1.92(0.50) mM/L without supplement (p < 0.001)]. A minimum average phosphate intake of 184 mg/kg/day was achieved by 47 and 77 % of babies in weeks 1 and 2, respectively, and by 84-100 % of infants from week 3. The percentage of plasma phosphate measurements below the minimum target of 1.8 mM/L was greater amongst unsupplemented babies (45 versus 18 %). CONCLUSION: A majority of infants <32 weeks' gestation did not achieve the recommended phosphate intake during the first week of life. Despite achieving the recommended phosphate intake from week 3, many infants did not have plasma phosphate concentrations within the accepted normal range. Additional oral supplementation may help to achieve blood phosphate concentrations within this target range.