The STEP database through the end-users eyes—USABILITY STUDY

Salunke, Smita; Tuleu, Catherine

doi:10.1016/j.ijpharm.2015.06.016

Cited by 19 publications

(16 citation statements)

References 25 publications

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“…There are some general guidelines—for example, ‘Excipients in the label and package leaflet of medicinal products for human use’9 or ‘Guideline on the investigation of medicinal products in the term and preterm neonate’,7 and pharmaceutical excipients handbooks describing general safety data 8. Probably, the European Study of Neonatal Exposure to Excipients (ESNEE) project14 and the database of ‘Safety and Toxicity of Excipients for Paediatrics’15 will improve this situation. The ESNEE project was created in order to provide information about the safety of excipients in neonatal medicines.…”

Section: Introductionmentioning

confidence: 99%

A retrospective and observational analysis of harmful excipients in medicines for hospitalised neonates in Latvia

Sviestiņa

Mozgis

2017

Eur J Hosp Pharm

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BackgroundMedicines used in neonates contain different excipients, which may not be safe in this age group.ObjectiveTo analyse the frequency at which hospitalised neonates are exposed to harmful excipients (HEs) and to identify substitution possibilities for medicines containing HEs.Materials and methodsRetrospective, observational study at a university paediatric hospital from 1 September 2015 till 29 February 2016. All hospitalised neonates who received a prescription for medicines containing an HE were included. Neonates were divided into four groups according to gestational age (<28 weeks; 28 to <32 weeks; 32 to <37 weeks and ≥37 weeks). The following excipients were analysed: parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride. Excipients were identified from the Summaries of Product Characteristics.Results296 (102(34.5%) preterm) neonates included in the study received 1472 prescriptions for 106 medicines. The most often used formulations were intravenous (48/106; 45.3%) and oral solid formulations (20; 18.9%). The total number of different excipients was 169. In total, 29/106 (27.4%) medicines contained at least one HE. In total 82/102 (80.4%) preterm and 118/194 (60.8%) term neonates received medications with at least one HE. Substitution was possible for 9/29 (31.0%) HE-containing medicines.ConclusionsUse of HEs can be reduced by using HE-free products available on the European market. However, medicine substitution was possible in only a small number of cases. Therefore the main focus should be on information and education of the hospital specialists about HEs used in medicines and their adverse reactions.

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Section: Introductionmentioning

confidence: 99%

A retrospective and observational analysis of harmful excipients in medicines for hospitalised neonates in Latvia

Sviestiņa

Mozgis

2017

Eur J Hosp Pharm

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“…However, as discussed by a recent multinational panel [47], assessing the safety of excipients in children is particularly challenging, primarily due to the lack of comprehensive safety data and standardized guidelines for acceptable risk-benefit profiles of pediatric excipient use. Ideally, safety data will exist in the literature and in databases, such as the Safety & Toxicity of Excipients for Pediatrics (STEP) database [48]. Recent initiatives [40], such as the Safe Excipient Exposure in Neonates and Small Children (SEEN) project [49], are compiling and quantifying excipient use among neonates and young pediatric patients to guide clinicians toward medications with the best risk-benefit profile, which will depend heavily on context, i.e., the condition that is being treated and the anticipated outcome.…”

Section: Regulation Of Ps Use In the Pediatric Populationmentioning

confidence: 99%

Pediatric Safety of Polysorbates in Drug Formulations

et al. 2019

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Polysorbates 20 and 80 are the most frequently used excipients in biotherapeutics, the safety data for which have been well documented in adults. The polysorbate content in therapeutic formulations that are administered to children, however, has been less clearly regulated or defined with regard to safety. In pediatric patients, excessive amounts of polysorbate in biotherapeutics have been linked to hypersensitivity and other toxicity-related effects. To determine safe levels of polysorbates for young patients, we have developed the progressive pediatric safety factor (PPSF), an age- and weight-based tool that estimates the amount of parenterally administered polysorbates 20 and 80 in formulations that will avoid excipient-related adverse events. Compared with existing modalities for calculating maximum acceptable doses of excipients for initial clinical trials in pediatrics, the PPSF is far more conservative, thus constituting an added margin of safety for excipient exposure in the most sensitive subpopulations—i.e., neonates and infants. Further, the PPSF may be applied to any relevant excipient, aiding pharmaceutical developers and regulatory authorities in conservatively estimating the safety assessment of a biotherapeutic’s formulation, based on excipient levels.

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“…The need to integrate the existing safety and toxicity information of excipients from disparate resources under one umbrella was recognized by European Paediatric Formulations Initiative (EuPFI) and drove the collaborative development of the Safety and Toxicity of Excipients for Paediatrics (STEP) database with the USPFI. The database is a publicly accessible evidence base of safety and toxicity information of excipients for the pharmaceutical industry, academics, pharmacists, clinicians and regulators to help make informed decisions and thus expedite pediatric drug development (Salunke et al, 2012, 2013; Salunke and Tuleu, 2015). Participants emphasized that, in addition to referring to existing information sources (such as the STEP database), data collected as part of nonclinical toxicity reports from the pharmaceutical, food, and cosmetics industries could hopefully identify a broader set of established excipients qualified by extensive safety data in animals and humans.…”

Section: Key Considerations and Recommendationsmentioning

confidence: 99%

“…The first step in safety assessment of excipients involves comprehensive and critical review of all existing data to acquire a depth of understanding and breadth of knowledge beyond that of a single stakeholder (i.e., excipient maker or formulator alone). Before choosing an excipient, literature and databases such as the STEP database (Salunke et al, 2012, 2013; Salunke and Tuleu, 2015) should be searched to determine 1 if safety has been established and in what context, 2 what gaps exist in the data, and 3 the necessity of any additional studies to assess safety of the excipient. However, the information is currently scattered amongst numerous sources making it difficult for the users to systematically review the existing information.…”

Section: Introductionmentioning

confidence: 99%

Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients

Buckley

Salunke²,

Thompson

et al. 2018

International Journal of Pharmaceutics

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A public workshop entitled “Challenges and strategies to facilitate formulation development of pediatric drug products” focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement.

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The STEP database through the end-users eyes—USABILITY STUDY

Cited by 19 publications

References 25 publications

A retrospective and observational analysis of harmful excipients in medicines for hospitalised neonates in Latvia

A retrospective and observational analysis of harmful excipients in medicines for hospitalised neonates in Latvia

Pediatric Safety of Polysorbates in Drug Formulations

Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients

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