Toxic additives in medication for preterm infants

Whittaker, Amy; Currie, Andrew; Turner, Mark A.; Field, David; Mulla, Hussain; Pandya, Hitesh

doi:10.1136/adc.2008.146035

Cited by 83 publications

(68 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…61 A number of recent studies in NICUs revealed systemic concentrations of excipients that were intolerable even in older age groups. 54,62,63 The urgent need to understand these safety concerns has led to a collaborative effort by the United States and the European Union to create a STEP (Safety and Toxicity of Excipients for Pediatrics) database. Its aim is to improve systematic data collection on excipient toxicity and tolerance in children.…”

Section: Potential Limitations Of Pediatric Drug Formulationsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

View full text Add to dashboard Cite

Children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is essential that pediatric medicines are formulated to best suit a child' s age, size, physiologic condition, and treatment requirements. To ensure adequate treatment of all children, different routes of administration, dosage forms, and strengths may be required. Many existing formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. New regulations, additional funding opportunities, and innovative collaborative research initiatives have resulted in some recent progress in the development of pediatric formulations. These advances include a paradigm shift toward oral solid formulations and a focus on novel preparations, including flexible, dispersible, and multiparticulate oral solid dosage forms. Such developments have enabled greater dose flexibility, easier administration, and better acceptance of drug formulations in children. However, new pediatric formulations address only a small part of all therapeutic needs in children; moreover, they are not always available. Five key issues need to be addressed to stimulate the further development of better medicines for children: (1) the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries; (2) a better use of existing data to facilitate pediatric formulation development; (3) innovative technologies in adults that can be used to develop new pediatric formulations; (4) clinical feedback and practice-based evidence on the impact of novel formulations; and (5) improved access to new pediatric formulations. Pediatrics

show abstract

Section: Potential Limitations Of Pediatric Drug Formulationsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

View full text Add to dashboard Cite

show abstract

“…One less excipients needed is beneficial, especially for new borns and babies, since for safety issues it is recommended to avoid components in formulations, unless strictly necessary [1,[37][38][39].…”

Section: Discussionmentioning

confidence: 99%

Taste acceptance of Captopril and Furosemide Extemporaneous Oral Pediatric Formulations among Hospitalized Children

Mdsg¹,

Garruti²,

Laa³

et al. 2016

J Pharma Care Health Sys

View full text Add to dashboard Cite

Many pediatric patients require medications that are not available in age appropriate formulations, especially those with cardiovascular diseases. The use of a suitable vehicle is critical for the preparation of extemporaneous formulations with the expected effect. Considering that palatability is essential to treatment adherence in children, we analyzed the acceptance of extemporaneous formulations of Captopril and Furosemide prepared using a developed vehicle in three flavors: neutral, strawberry and mint. Formulations were administered to hospitalized pediatric patients as prescribed. Acceptance was evaluated through the guardians using the hedonic scale and compared with the researcher's observation. Formulations in neutral and strawberry flavors were considered acceptable for both drugs. Correlation between results from both methods was moderate for Captopril and absent for Furosemide. Neutral taste results showed that the addition of flavoring agents did not improve acceptance. Since it is recommended to avoid components in formulations for infants and newborns, unless strictly necessary, it is important to identify excipients that are dispensable.

show abstract

“…For instance, solvents such as ethanol and propylene glycol that are commonly used for improving solubility were shown to have life-threatening intoxication and adverse events associated with cardiovascular, hepatic, respiratory and central nervous systems (Arulanantham and Genel 1978;Whittaker et al 2009). Preservatives like benzalkonium chloride and antioxidants such as sulfites were associated with paradoxical bronchospasm in asthmatic children using inhaled formulations (Koepke et al 1984).…”

Section: Introductionmentioning

confidence: 99%

Excipients in Pediatric Formulations: Biopharmaceutical and Toxicological Considerations

Vangara¹,

Yellepeddi

2015

Excipient Applications in Formulation Design and Drug Delivery

View full text Add to dashboard Cite

Excipients are commonly used in pharmaceutical formulations for a variety of applications such as solubility and stability enhancement, taste-masking, tablet compaction, etc. Excipients are also used in the preparation of pediatric formulations for purposes similar to that of adult formulations. However, excipients that are used in adult formulations may not be suitable for the development of formulations for pediatric use due to toxicity concerns. Toxicity of excipients in pediatric populations is mainly due to rapid developmental changes, slower metabolism and elimination, and varied organ and body composition. For example, solvents such as ethanol and propylene glycol that are commonly used in pediatric formulations as solubility enhancers, showed life-threatening adverse events. Therefore, it is apparent that the use of excipients in pediatric formulations requires additional risk assessment by practitioners to avoid potential toxicity issues. Regulatory agencies in the United States of America and Europe are working together to create and maintain a database of Safety and Toxicity of Excipients for Pediatrics (STEP). The purpose of this book chapter is to review the role of excipients and their toxicity in pediatric formulations along with strategies to mitigate the potential risks of toxicity associated with their use in pediatric patients.

show abstract

Toxic additives in medication for preterm infants

Abstract: Background: Little is known about exposure of preterm infants to excipients during routine clinical care. Objective: To document excipient exposure in vulnerable preterm babies in a single centre, taking into account chronic lung disease (CLD) as a marker of illness severity.

Cited by 83 publications

References 18 publications

Pediatric Drug Formulations: A Review of Challenges and Progress

Pediatric Drug Formulations: A Review of Challenges and Progress

Taste acceptance of Captopril and Furosemide Extemporaneous Oral Pediatric Formulations among Hospitalized Children

Excipients in Pediatric Formulations: Biopharmaceutical and Toxicological Considerations

Contact Info

Product

Resources

About