Pharmaceutical Excipient Exposure in a Neonatal Intensive Care Unit

Sara, Nasrollahi; Meera, Neelathahalli Kasturirangan; Boregowda, Sunil

doi:10.1007/s13312-020-1956-x

Cited by 4 publications

(6 citation statements)

References 12 publications

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“…India has the largest adolescent (10 to 19 years) population in the world of around 253 million, with every fifth individual falling in this age group [73][74][75]. Another statistic depicted that, from 2009 to 2019, around one-fourth of the population in India fell in the age group of 0 to 14 years, whereas two-thirds were in the 15 to 64 years category [76].…”

Section: India 261 Current State and Challenges In Excipients Regulationmentioning

confidence: 99%

“…As a research study on excipients' use in pharmaceutical products, Nasrollahi conducted a study on excipient exposure, among neonates, in a neonatal intensive care unit [74]. The total number of prescribed drugs was 5535, that composed 77 different drugs.…”

Section: Ongoing Effortsmentioning

confidence: 99%

“…Furthermore, Ponceau 4R, which is concerning possible allergic reactions in the EU and must state a warning label, was used as a colorant. Due to its effect on neurocognitive development and behavior, Ponceau 4R is banned to use in some countries [74]. These excipients, in their adult dose, also have limited quantitative permissibility, which becomes even more stringent when developing a pediatric dosage form.…”

Section: Ongoing Effortsmentioning

confidence: 99%

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The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region

et al. 2022

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A major hurdle in pediatric formulation development is the lack of safety and toxicity data on some of the commonly used excipients. While the maximum oral safe dose for several kinds of excipients is known in the adult population, the doses in pediatric patients, including preterm neonates, are not established yet due to the lack of evidence-based data. This paper consists of four parts: (1) country-specific perspectives in different parts of the world (current state, challenges in excipients, and ongoing efforts) for ensuring the use of safe excipients, (2) comparing and contrasting the country-specific perspectives, (3) past and ongoing collaborative efforts, and (4) future perspectives on excipients for pediatric formulation. The regulatory process for pharmaceutical excipients has been developed. However, there are gaps between each region where a lack of information and an insufficient regulation process was found. Ongoing efforts include raising issues on excipient exposure, building a region-specific database, and improving excipient regulation; however, there is a lack of evidence-based information on safety for the pediatric population. More progress on clear safety limits, quantitative information on excipients of concern in the pediatric population, and international harmonization of excipients’ regulatory processes for the pediatric population are required.

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Section: India 261 Current State and Challenges In Excipients Regulationmentioning

confidence: 99%

Section: Ongoing Effortsmentioning

confidence: 99%

Section: Ongoing Effortsmentioning

confidence: 99%

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The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region

et al. 2022

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“…Several reports suggest that potentially harmful excipients (PHEs) are included in drugs prescribed for neonates [ 4 , 7 – 13 ]. The safety of PHEs, such as benzyl alcohol, ethanol, parabens, and propylene glycol, for pediatric patients, including neonates, has been investigated [ 14 – 16 ].…”

Section: Introductionmentioning

confidence: 99%

Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan

Saito

Nadatani

Makoto

et al. 2021

J Pharm Health Care Sci

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Background A multicenter investigation of neonate exposure to potentially harmful excipients (PHEs) in neonatal intensive care units (NICUs) in Japan has not been conducted. Methods A multicenter nationwide observational study was conducted. Neonate patient demographic data and information on all medicines prescribed and administered during hospitalization on 1 day between November 2019 and March 2021 were extracted from the medical records. Nine PHEs, paraben, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol, benzalkonium chloride, and aspartame, were selected. PHEs were identified from the package insert and the Interview Form. The quantitative daily exposure was calculated if quantitative data were available for each product containing the PHE. Results Prescription data was collected from 22 NICUs in Japan. In total, 343 neonates received 2360 prescriptions for 426 products containing 228 active pharmaceutical ingredients. PHEs were found in 52 (12.2%) products in 646 (27.4%) prescriptions for 282 (82.2%) neonates. Benzyl alcohol, sodium benzoates, and parabens were the most common PHEs in parenteral, enteral, and topical formulations, respectively. Quantitative analysis showed that 10 (10%), 38 (42.2%), 37 (94.9%), and 9 (39.1%) neonates received doses exceeding the acceptable daily intake of benzyl alcohol, polysorbate 80, propylene glycol, and sorbitol, respectively. However, due to the lack of quantitative information for all enteral and topical products, accurate daily PHE exposure could not be quantified. Conclusions Neonates admitted to NICUs in Japan were exposed to PHEs, and several of the most commonly prescribed medicines in daily clinical practice in NICUs contained PHEs. Neonate PHE exposure could be reduced by replacing these medicines with available PHE-free alternatives.

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“…Преимуществом Мексидола перед Мексипримом и другими генериками является и тот факт, что в его состав входит стабилизатор/консервант -натрия метабисульфит, обладающий, как и активное вещество, антиоксидантными свойствами [51] и позволяющий сохранять фармакологическую активность препарата на протяжении всего заявленного срока годности. Напротив, генерики, не имеющие в составе стабилизатор, могут терять активность при хранении, что часто сопровождается изменением цвета раствора и приводит к периодическим изъятиям из обращения определенных серий этих препаратов.…”

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Generic drugs: benefit/risk ratio

Ушкалова

Zyryanov

Gopienko

2021

RJTAO

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The review discusses the interchangeability of medications, approaches to the registration of original and generic drugs, and types of their equivalence, as well as problems with generics in clinical practice. Results of pharmacoepidemiological studies, which have been widely carried out recently, speak of insufficient understanding of the impact of generics on remote outcomes of chronic diseases, including mortality. The longterm economic prospects of generic drug administration continue to remain unclear. Among the primary differences between generics and brandname drugs are the differences in active ingredient synthesis methods and the composition of adjuvants and additives. Comparative studies on the therapeutic equivalence of generics with their originals or between themselves are rarely conducted. They are often affected by methodological flaws, which cannot ensure their comparable efficacy and safety. In this regard, automatic replacement of drugs containing the same active ingredient should be avoided without the participation of the attending physician.

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Pharmaceutical Excipient Exposure in a Neonatal Intensive Care Unit

Cited by 4 publications

References 12 publications

The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region

The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region

Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan

Generic drugs: benefit/risk ratio

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