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Pharmaceuticals
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Advances in Perinatal Pharmacology
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Advances in Perinatal Pharmacology

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmacology".

Deadline for manuscript submissions: 25 February 2027 | Viewed by 5129

Editors

Dr. Khaled Abduljalil

E-Mail Website
Guest Editor
Simcyp Division, Certara UK Limited, Sheffield, UK
Interests: PBPK; pregnancy; neonate; pharmacology
Dr. Raj Badhan

E-Mail Website
Guest Editor
Pharmacy School, Aston University, Birmingham, UK
Interests: PBPK; pregnancy; neonate; pharmacy
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Understanding pharmacokinetic processes during the perinatal period is critical, as both the gestational and neonatal periods are marked by profound physiological changes that affect how drugs behave in the body.

Major physiological changes that impact drug pharmacokinetics include increased plasma volume and total body water, leading to altered drug distribution, reduced plasma albumin, affecting protein binding and free drug concentrations, changes in hepatic enzyme activity, notably CYP450 enzymes that can alter drug metabolism, and increased cardiac output as well as renal blood flow, which may accelerate the renal clearance of drugs.

At birth, neonatal drug exposure is influenced by ongoing organ growth and increase in their functions, including the maturation of absorption processes, drug-metabolising enzymes, and drug-binding components, and well as blood tissue perfusions.

Several intrinsic and extrinsic factors can play crucial roles in the variability in the exposure between individuals, including genetics, comedications, and comorbidities.

Over the past decade, significant advances in molecular biology and technology in in vitro and in silico systems, from cell lines to organ-on-a-chip, together with modelling in vivo data have enhanced our understanding of perinatal drug pharmacokinetics, improving drug safety and efficacy for both mothers and their babies. For example, recent research using physiologically based pharmacokinetic (PBPK) models allows for the prediction of how these changes influence drug disposition. Likewise, the application of population pharmacokinetics allows for the description of sparse PK/PD data and overcomes the barrier of rich sampling requirements. Such progress in perinatal research enables better dose optimization and improving patient care.

Dr. Khaled Abduljalil
Dr. Raj Badhan
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-anonymized peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceuticals is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • maternal
  • perinatal
  • neonatal
  • pharmacology
  • placenta
  • pregnancy

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Published Papers (4 papers)

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26 pages, 3158 KB  
Article
From Pharmacovigilance Signals to Mechanistic Phenotypes: Integrating ADMET, PK/PD, and Network Context to Interpret Antiviral Safety in Pregnancy
by Bárbara Costa and Nuno Vale
Pharmaceuticals 2026, 19(3), 450; https://doi.org/10.3390/ph19030450 - 11 Mar 2026
Viewed by 1097
Abstract
Background: Antiviral therapies are widely used during pregnancy and are generally considered safe, pregnancy-specific severe safety signals continue to be observed in post-marketing pharmacovigilance data. These signals are rarely interpreted within an integrated mechanistic framework. Methods: We analysed pregnancy-related EudraVigilance reports (2015–2025) using [...] Read more.
Background: Antiviral therapies are widely used during pregnancy and are generally considered safe, pregnancy-specific severe safety signals continue to be observed in post-marketing pharmacovigilance data. These signals are rarely interpreted within an integrated mechanistic framework. Methods: We analysed pregnancy-related EudraVigilance reports (2015–2025) using a previously network-based pharmacovigilance framework. Established ADR clusters were treated as fixed phenotypes and integrated with in silico ADMET liabilities, literature-derived pregnancy pharmacokinetic/pharmacodynamic (PK/PD) parameters, polypharmacy and co-medication network metrics, and exploratory statistical, machine-learning, and exposure–liability analyses for mechanistic prioritisation. Results: Phenotype membership explained 22.3% of the variance in composite ADMET risk (intraclass correlation coefficient = 0.223; p < 0.001), and all tested ADMET parameters differed significantly across phenotypes (FDR-adjusted p < 10−10). One phenotype showed pronounced enrichment, with 13 antivirals over-represented. Polypharmacy strongly modified seriousness, with odds of serious outcomes increasing by ~5% per additional co-reported active drug (OR 1.05, 95% CI 1.04–1.05). A composite mechanistic vulnerability index showed moderate concordance with empirical burden (Spearman’s ρ = 0.65), while regimen-level prioritisation of drug–drug interactions (DDIs) identified no high-priority combinations. Conclusions: Pregnancy-related antiviral ADRs cluster into reproducible phenotypes driven by mechanistic liability and system-level complexity, supporting mechanistically informed prioritisation and targeted pharmacometric follow-up. Full article
(This article belongs to the Special Issue Advances in Perinatal Pharmacology)
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25 pages, 3737 KB  
Article
Physiologically Based Pharmacokinetic Modelling of Hydroxyurea in Patients with Sickle Cell Disease: A Special Focus on Lactating Women and Breastfed Infants to Inform Safe Dosing and Breastfeeding Strategies
by Khaled Abduljalil, Neel Deferm, Anna Murphy and Iain Gardner
Pharmaceuticals 2026, 19(2), 220; https://doi.org/10.3390/ph19020220 - 27 Jan 2026
Cited by 1 | Viewed by 1548
Abstract
Background/Objectives: Hydroxyurea is currently the standard disease-modifying therapy for reducing sickle cell disease (SCD) complications; however, drug labels currently advise discontinuation of breastfeeding during hydroxyurea therapy due to limited human data on the risk of hydroxyurea exposure in breastfed neonates. Methods: [...] Read more.
Background/Objectives: Hydroxyurea is currently the standard disease-modifying therapy for reducing sickle cell disease (SCD) complications; however, drug labels currently advise discontinuation of breastfeeding during hydroxyurea therapy due to limited human data on the risk of hydroxyurea exposure in breastfed neonates. Methods: A physiologically based pharmacokinetic (PBPK) model for hydroxyurea was built and verified with data from non-lactating adult patients with SCD. The model was then extended to predict hydroxyurea in nursing and in paediatric populations. Predictions were compared to the observed data. Results: The PBPK model predictions for hydroxyurea pharmacokinetics described the observed data in both adult and paediatric subjects with SCD. Observed concentration profiles were within the 5th–95th prediction intervals, and predicted PK parameters were within 2-fold of the observed values. The predicted milk-to-plasma ratio was 0.8. Neonatal exposure to hydroxyurea via breast milk as a percentage of maternal exposure increased from 0.6% at 1 day to 10% at the 4th week postpartum before declining to 5%, 3%, and 2% at 6, 9, and 12 months postpartum, respectively. Conclusions: About 56% of total milk hydroxyurea exposure is within the first 3 h of post-maternal dose. Disposal of this early milk would reduce the exposure of breastfed children. The reduction in exposure is especially pronounced around the first 1 month postpartum. Lactation PBPK models offer a physiological approach to assess real-life scenarios that are difficult to investigate in clinical studies and provide useful results for future clinical study design and clinical recommendations. This was exemplified with hydroxyurea in the current work. Full article
(This article belongs to the Special Issue Advances in Perinatal Pharmacology)
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17 pages, 486 KB  
Article
The Impact of Maternal BMI on the Efficacy and Safety of Oral Misoprostol for Labor Induction
by Maciej W. Socha, Wojciech Flis, Julia Sowińska, Martyna Stankiewicz and Anita Kazdepka-Ziemińska
Pharmaceuticals 2025, 18(12), 1888; https://doi.org/10.3390/ph18121888 - 14 Dec 2025
Viewed by 1307
Abstract
Background: Maternal obesity may influence the efficacy and course of induction of labor (IoL). Misoprostol, a prostaglandin E1 analogue, is widely used for cervical ripening, but evidence regarding its effectiveness in obese women remains limited. This study aimed to evaluate the efficacy [...] Read more.
Background: Maternal obesity may influence the efficacy and course of induction of labor (IoL). Misoprostol, a prostaglandin E1 analogue, is widely used for cervical ripening, but evidence regarding its effectiveness in obese women remains limited. This study aimed to evaluate the efficacy and safety of oral misoprostol for IoL across different body mass index (BMI) categories. Methods: This prospective study was conducted at a tertiary center. Term singleton pregnancies with medical indications for IoL and an unfavorable cervix (Bishop score < 6) received oral misoprostol 50 μg every 4 h to a maximum of 200 μg. Primary outcomes were vaginal delivery (VD) rates. Secondary outcomes included cesarean section (CS) rate, oxytocin use, labor duration, analgesia, adverse events, and neonatal outcomes. Results: Among 291 participants (43.0% overweight; 40.2% obese), the Bishop score increased from 2.3 to 6.2 (p < 0.0001). VD occurred in 77.3%, and CS in 22.7%. Most women delivered within 48 h (96.6%). Higher BMI correlated with longer time to contractions, pain onset, and delivery, as well as with more misoprostol doses. Neonatal outcomes were uniformly favorable, with median Apgar scores of 10 at 1, 5, and 10 min, and mean umbilical pH values ranging from 7.2 to 7.3. Adverse events were infrequent, with tachysystole observed in 1.7% of cases. Conclusions: Oral misoprostol is an effective and safe IoL method across BMI categories, achieving high vaginal delivery rates and favorable neonatal outcomes. Obesity modestly prolongs induction and increases dose requirements, supporting individualized dosing and close monitoring. Full article
(This article belongs to the Special Issue Advances in Perinatal Pharmacology)
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20 pages, 10552 KB  
Systematic Review
Antenatal Corticosteroids: Short-Term Gains, Long-Term Questions—A Meta-Analysis
by Marharyta Sobczak, Barbara Wencka and Rafał Pawliczak
Pharmaceuticals 2026, 19(7), 1098; https://doi.org/10.3390/ph19071098 - 17 Jul 2026
Viewed by 498
Abstract
Background/Objectives: Antenatal corticosteroids (ACSs) form the basis of prenatal care for women at risk of preterm birth, primarily due to their proven benefits in reducing neonatal mortality and short-term morbidity. However, there are growing concerns about the potential long-term consequences of fetal [...] Read more.
Background/Objectives: Antenatal corticosteroids (ACSs) form the basis of prenatal care for women at risk of preterm birth, primarily due to their proven benefits in reducing neonatal mortality and short-term morbidity. However, there are growing concerns about the potential long-term consequences of fetal exposure to ACSs. The aim of the meta-analysis was to assess the relationship between exposure to corticosteroids administered during the prenatal period and long-term effects. Methods: PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials were searched for studies published up to 28 January 2026. Randomized controlled trials and observational studies reporting long-term outcomes after exposure to ACSs were included. A random effects model was used to calculate effect sizes. Results: Among the neurological disorders analyzed, our meta-analysis showed an increased risk of 17% of suspected neurocognitive disorder (RR = 1.17; 95% CI [1.13; 1.21]; p < 0.0001, I2 = 10%), 18% of hearing impairment (RR = 1.18; 95% CI [1.13; 1.24]; p < 0.0001, I2 = 41%), 3% of visual impairment (RR = 1.03; 95% CI [1.01; 1.05]; p = 0.0012, I2 = 0%), 25% of autism spectrum disorders (RR = 1.25; 95% CI [1.09; 1.42]; p = 0.001, I2 = 43%) and 25% of any mental or behavioral disorder (RR = 1.25; 95% CI [1.1; 1.43]; p = 0.0008, I2 = 77%). The results of other neurological disorders, as well as other analyzed outcomes, were not statistically significant (p > 0.05). Conclusions: Although this meta-analysis suggests an increased risk of certain long-term neurological outcomes following prenatal exposure to corticosteroids, these findings should be interpreted with caution in light of the well-documented short-term benefits for newborns and the need for a careful assessment of the benefit–risk ratio and further long-term observational studies. Full article
(This article belongs to the Special Issue Advances in Perinatal Pharmacology)
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