Evaluating Solubility of Celecoxib in Age-Appropriate Fasted- and Fed-State Gastric and Intestinal Biorelevant Media Representative of Adult and Pediatric Patients: Implications on Future Pediatric Biopharmaceutical Classification System

Shawahna, Ramzi; Zyoud, Ahed; Haj-Yahia, Aseel; Taya, Raheek

doi:10.1208/s12249-021-01958-3

Cited by 4 publications

(22 citation statements)

References 69 publications

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“…Additionally, the use of computers, robots, bar-codes, double-check standards, improving storage layout, and labeling of vials/ampoules might also help minimize medication errors that occur while preparing/diluting/storing the medication in neonatal intensive care units [ 16 ]. It has been suggested that using age-appropriate pre-filled and pre-labeled doses can eliminate the need for the preparation or dilution of medication doses [ 40 , 43 ]. This would ultimately minimize medication errors.…”

Section: Discussionmentioning

confidence: 99%

Medication errors in neonatal intensive care units: a multicenter qualitative study in the Palestinian practice

et al. 2022

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Background Neonatal intensive care units are high-risk settings where medication errors can occur and cause harm to this fragile segment of patients. This multicenter qualitative study was conducted to describe medication errors that occurred in neonatal intensive care units in Palestine from the perspectives of healthcare providers. Methods This exploratory multicenter qualitative study was conducted and reported in adherence to the consolidated criteria for reporting qualitative research checklist. Semi-structured in-depth interviews were conducted with healthcare professionals (4 pediatricians/neonatologists and 11 intensive care unit nurses) who provided care services for patients admitted to neonatal intensive care units in Palestine. An interview schedule guided the semi-structured in-depth interviews. The qualitative interpretive description approach was used to thematically analyze the data. Results The total duration of the interviews was 282 min. The healthcare providers described their experiences with 41 different medication errors. These medication errors were categorized under 3 categories and 10 subcategories. Errors that occurred while preparing/diluting/storing medications were related to calculations, using a wrong solvent/diluent, dilution errors, failure to adhere to guidelines while preparing the medication, failure to adhere to storage/packaging guidelines, and failure to adhere to labeling guidelines. Errors that occurred while prescribing/administering medications were related to inappropriate medication for the neonate, using a different administration technique from the one that was intended, and administering a different dose from the one that was intended. Errors that occurred after administering the medications were related to failure to adhere to monitoring guidelines. Conclusion In this multicenter study, pediatricians/neonatologists and neonatal intensive care unit nurses described medication errors occurring in intensive care units in Palestine. Medication errors occurred in different stages of the medication process: preparation/dilution/storage, prescription/administration, and monitoring. Further studies are still needed to quantify medication errors occurring in the neonatal intensive care units and investigate if the designed strategies could be effective in minimizing the medication errors.

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Section: Discussionmentioning

confidence: 99%

Medication errors in neonatal intensive care units: a multicenter qualitative study in the Palestinian practice

et al. 2022

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“…Therefore, biowaiver decisions can reduce the costs of developing IRSODFs, accelerate regulatory processing and approval, and reduce the regulatory burden [ 7 ]. It is important to note that the principles guiding IVBESs in pediatrics were not developed [ 6 , 8 – 11 ]. Additionally, there are recognizable variabilities in the quantities and qualities of the gastrointestinal fluids between adult and pediatric populations [ 6 , 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

“…It is important to note that the principles guiding IVBESs in pediatrics were not developed [ 6 , 8 – 11 ]. Additionally, there are recognizable variabilities in the quantities and qualities of the gastrointestinal fluids between adult and pediatric populations [ 6 , 11 , 12 ]. Moreover, the volume and composition of the gastrointestinal fluids vary by age, development, and maturation.…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, the volume and composition of the gastrointestinal fluids vary by age, development, and maturation. Therefore, pediatrics can be divided into subpopulations that include: neonates, infants, children, and adolescents [ 6 , 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

“…The permeability and solubility of APIs can vary by age, developmental status, and maturation. Recently, there has been a growing interest in studying how the permeability and solubility of APIs can change using age-specific criteria for the volume and constituents of the gastrointestinal fluids [ 8 – 11 , 13 – 18 ]. Previous studies have classified the drugs listed by the WHO as essential drugs for adults and children into provisional BCS classes [ 6 , 9 , 19 – 23 ].…”

Section: Introductionmentioning

confidence: 99%

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Solubility of lamotrigine in age-specific biorelevant media that simulated the fasted- and fed-conditions of the gastric and intestinal environments in pediatrics and adults: implications for traditional, re-formulated, modified, and new oral formulations

Shawahna,

Saba’aneh,

Daraghmeh

et al. 2023

BMC Biotechnol

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Background Lamotrigine is an effective antiseizure medication that can be used in the management of focal and generalized epilepsies in pediatric patients. This study was conducted to quantify and compare the solubility of lamotrigine in age-specific biorelevant media that simulated the fasted and fed conditions of the gastric and intestinal environments in pediatrics and adults. Another aim was to predict how traditional, re-formulated, modified, and new oral formulations would behave in the gastric and intestinal environments across different age groups. Methods Solubility studies of lamotrigine were conducted in 16 different age-specific biorelevant media over the pH range and temperature specified by the current biopharmaceutical classification system-based criteria. The age-specific biorelevant media simulated the environments in the stomach and proximal gastrointestinal tract in both fasted and fed conditions of adults and pediatric sub-populations. The solubility of lamotrigine was determined using a pre-validated HPLC-UV method. Results Lamotrigine showed low solubility in the 16 age-specific biorelevant media as indicated by a dose number of > 1. There were significant age-specific variabilities in the solubility of lamotrigine in the different age-specific biorelevant media. Pediatric/adult solubility ratios of lamotrigine fell outside the 80-125% range in 6 (50.0%) and were borderline in 3 (25.0%) out of the 12 compared media. These ratios indicated that the solubility of lamotrigine showed considerable differences in 9 out of the 12 (75.0%) of the compared media. Conclusion Future studies are still needed to generate more pediatric biopharmaceutical data to help understand the performances of oral dosage forms in pediatric sub-populations.

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Characterization of neonatal and infant enterostomy fluids - part II: Drug solubility

Waal

Brouwers

Rayyan

et al. 2023

International Journal of Pharmaceutics

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Evaluating Solubility of Celecoxib in Age-Appropriate Fasted- and Fed-State Gastric and Intestinal Biorelevant Media Representative of Adult and Pediatric Patients: Implications on Future Pediatric Biopharmaceutical Classification System

Cited by 4 publications

References 69 publications

Medication errors in neonatal intensive care units: a multicenter qualitative study in the Palestinian practice

Medication errors in neonatal intensive care units: a multicenter qualitative study in the Palestinian practice

Solubility of lamotrigine in age-specific biorelevant media that simulated the fasted- and fed-conditions of the gastric and intestinal environments in pediatrics and adults: implications for traditional, re-formulated, modified, and new oral formulations

Characterization of neonatal and infant enterostomy fluids - part II: Drug solubility

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