Neonatal and pediatric oral drug delivery: Hopes and hurdles.

The neonatal and pediatric populations have long been neglected concerning the development of oral dosage forms. For close to two decades, caregivers have had to adjust the doses of the off-label medicines and drugs for adults to suit the neonatal and pediatric needs. This is due to the lack of rules and regulations regarding neonates and pediatrics clinical trials while pharmaceutical industries see this as a non-lucrative approach. Despite such limitations, the administration of solid and liquid dosage forms to neonates and pediatrics necessitates the development of new technologies and even new strategies to meet the needs. Current approaches have not only focused on the development of suitable dosage forms but also the advancement of devices to enhance drug administration to pediatrics and neonates. Though current approaches have significantly added to the number of pediatric and neonatal oral dosage formulations on the market, there is still more room for improvement(s). While novel dosage forms including multiparticulates, orodispersible tablets/films, and chewable tablets have extensively been researched, some administration devices (e.g., nipple shield, pill swallowing cup, and solid dosage pen) have also been explored. Although a few of these products are in the market, the concerted efforts of regulation administrative bodies, pharmaceutical industry settings, and scientists in academia have been oriented to address all issues and advance the neonatal and pediatric-centric pharmaceutical products.

Serum Hsp70 Antigen: Early Diagnosis Marker in Perinatal Asphyxia.

BACKGROUND: Perinatal asphyxia is an important cause of mortality and permanent neurological and developmental deficit. Early and accurate diagnosis would help to establish the likely prognosis and may also help in determining the most appropriate treatment. Studies in experimental animal models suggest that a protein called Hsp70 may be a good and potentially useful marker of cellular stress that may be clinically useful in determining the presence of neonatal asphyxia. OBJECTIVES: Regarding the importance of early and accurate diagnosis of asphyxia, we conducted this study, which is the first investigation of the comparison of the serum Hsp70 antigen level between asphyxiated and healthy infants. PATIENTS AND METHODS: In this observational study, the serum concentrations of Hsp70 antigen were compared between neonates suffering from perinatal asphyxia (n = 50) and normal neonates (n = 51). The inclusion criteria for the cases were neonates who had reached term and had at least two clinical criteria of asphyxia. Exclusion criteria were babies with gestational age < 37 weeks, infants with congenital abnormalities or positive blood culture. Exclusion criteria in this group were the requirement to hospital stay during first week of the life or babies whose mothers had difficulties during pregnancy or delivery. Term neonates without major anomalies who had asphyxia during delivery were enrolled in the first six hours after delivery, and control group consisted of healthy term neonates without problems and normal delivery process in the first week of life. The cord blood was taken during labor to measure Hsp70 antigen level by using an in-house ELISA (The enzyme-linked immunosorbent assay). RESULTS: The median values of serum anti Hsp70 titers were significantly higher in asphyxiated neonates compared with non-asphyxiated neonates (0.36 [0.04 - 1.14] vs 0.24 [0.01 - 0.63]). At cutoff point = 0.3125 ng/mL, sensitivity was 58% and specificity 76% based on ROC curve. CONCLUSIONS: A significant difference between the serum concentrations of Hsp70 of the control and patient group was observed in this study. It is inferred serum concentrations of Hsp70 antigen may be a useful marker for the early diagnosis of that prenatal hypoxia.