ArticlePharmaceutical research2016
Assessment of Age-Related Changes in Pediatric Gastrointestinal Solubility.
Article in Pharmaceutical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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Who cites it
23 citing papers in PubMed.
- PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.The AAPS journal · 2026Article
- Model-Informed Dose Optimization of Spironolactone in Neonates and Infants.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Assessing solubility of meloxicam in age-specific gastric and intestinal media relevant to adults and pediatric populations: implications for optimizing dosing in patients for postoperative pain.BMC pharmacology & toxicology · 2024Article
- Physiologically Based Pharmacokinetic Modeling in Neonates: Current Status and Future Perspectives.Pharmaceutics · 2023Review
- Article
- Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study.The AAPS journal · 2023Article
- Understanding the Impact of Age-Related Changes in Pediatric GI Solubility by Multivariate Data Analysis.Pharmaceutics · 2022Article
- Computational Models for Clinical Applications in Personalized Medicine-Guidelines and Recommendations for Data Integration and Model Validation.Journal of personalized medicine · 2022Review
- Performance Evaluation of Montelukast Pediatric Formulations: Part I-Age-Related In Vitro Conditions.The AAPS journal · 2022Article
- Evaluating pediatric and adult simulated fluids solubility: Abraham solvation parameters and multivariate analysis.Pharmaceutical research · 2021Article
- Development of an Age-Appropriate Mini Orally Disintegrating Carvedilol Tablet with Paediatric Biopharmaceutical Considerations.Pharmaceutics · 2021Article
- Predictive Performance of Physiology-Based Pharmacokinetic Dose Estimates for Pediatric Trials: Evaluation With 10 Bayer Small-Molecule Compounds in Children.Journal of clinical pharmacology · 2021Article
- Article
- Challenges of Dissolution Methods Development for Soft Gelatin Capsules.Pharmaceutics · 2021Review
- In Vivo Predictive Dissolution Testing of Montelukast Sodium Formulations Administered with Drinks and Soft Foods to Infants.AAPS PharmSciTech · 2020Article
- Availability of Authorizations from EMA and FDA for Age-Appropriate Medicines Contained in the WHO Essential Medicines List for Children 2019.Pharmaceutics · 2020Review
- Classification of WHO Essential Oral Medicines for Children Applying a Provisional Pediatric Biopharmaceutics Classification System.Pharmaceutics · 2019Article
- Potential prediction of formulation performance in paediatric patients using biopharmaceutical tools and simulation of clinically relevant administration scenarios of nifedipine and lorazepam.British journal of clinical pharmacology · 2019Article
- State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development.Clinical pharmacokinetics · 2019Review
- Biopharmaceutical optimization in neglected diseases for paediatric patients by applying the provisional paediatric biopharmaceutical classification system.British journal of clinical pharmacology · 2018Article
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3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeCompound solubility serves as a surrogate indicator of oral biopharmaceutical performance. Between infancy and adulthood, marked compositional changes in gastrointestinal (GI) fluids occur. This study serves to assess how developmental changes in GI fluid composition affects compound solubility.
methodsSolubility assessments were conducted in vitro using biorelevant media reflective of age-specific pediatric cohorts (i.e., neonates and infants). Previously published adult media (i.e., FaSSGF, FeSSGF, FaSSIF.v2, and FeSSIF.v2) were employed as references for pediatric media development. Investigations assessing age-specific changes in GI fluid parameters (i.e., pepsin, bile acids, pH, osmolality, etc.) were collected from the literature and served to define the composition of neonatal and infant media. Solubility assessments at 37 °C were conducted for seven BCS Class II compounds within the developed pediatric and reference adult media.
resultsFor six of the seven compounds investigated, solubility fell outside an 80-125% range from adult values in at least one of the developed pediatric media. This result indicates a potential for age-related alterations in oral drug performance, especially for compounds whose absorption is delimited by solubility (i.e., BCS Class II).
conclusionDevelopmental changes in GI fluid composition can result in relevant discrepancies in luminal compound solubility between children and adults.
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