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A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Clinical Pharmaceutics".

Deadline for manuscript submissions: closed (30 April 2022) | Viewed by 41013

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Dr. Milan Grundmann

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Department of Clinical Pharmacology, Faculty of Medicine, University of Ostrava, Syllabova 19, 703 00 Ostrava, Czech Republic
Interests: therapeutic drug monitoring; clinical pharmacology; personalised medicine; drug metabolism; drug safety; pharmacodynamics; drug toxicity; multiplex sclerosis
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Dr. Ivana Kacirova

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1. Department of Clinical Pharmacology, Faculty of Medicine, University of Ostrava, Syllabova 19, 703 00 Ostrava, Czech Republic
2. Department of Clinical Pharmacology, Department of Laboratory Medicine, University Hospital Ostrava, 708 52 Ostrava, Czech Republic
Interests: therapeutic drug monitoring; pregnancy; breastfeeding; antiepileptic drugs; multiple sclerosis
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Women frequently take a variety of drugs during pregnancy and lactation, including prescription, over the counter, and herbal agents. It is well known that pregnancy induces significant changes in both pharmacokinetics and pharmacodynamics of most drugs with a high intra- and interpatient variability. Unfortunately, data on long-term safety of the prenatal and breastfed-exposed infants are still lacking for many drugs. For this reason, most medications do not include labelling information about their use during pregnancy and lactation. Choosing the appropriate drug dose for a pregnant and nursing woman is a difficult balancing act between optimal maternal treatment and minimal risk of fetal or breastfed infant harm. Therapeutic drug monitoring may be a useful tool for dose adjustment in this period, and analysis of the umbilical cord/maternal serum drug concentration ratio is the method recommended to assess transplacental transfer. Recognizing pregnant and lactating women as special populations is essential to obtain information about the safety and efficacy of drugs, which is of crucial importance. This Special Issue will include original and review articles.

Dr. Milan Grundmann
Dr. Ivana Kacirova
Guest Editors

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Keywords

• contraception/possible infertility related to the drug

• pharmacokinetics during pregnancy and lactation

• fetal and neonatal complications

• intrauterine therapy of fetal diseases

• umbilical cord serum drug concentrations

• drug interaction with placental transporters

• milk and breastfed infant serum drug concentrations

• the need for multidisciplinary teams and the additional complexity of treatment

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Related Special Issue

Drugs in Pregnancy and Lactation, 2nd Edition in Pharmaceutics (1 article)

Published Papers (11 papers)

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Research

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20 pages, 2842 KiB

Open AccessArticle

Prenatal Exposure to Δ9-Tetrahydrocannabinol Affects Hippocampus-Related Cognitive Functions in the Adolescent Rat Offspring: Focus on Specific Markers of Neuroplasticity

by Valentina Castelli, Gianluca Lavanco, Salvatore Feo, Cesare D’Amico, Vincenzo Micale, Martin Kuchar, Fulvio Plescia, Anna Brancato and Carla Cannizzaro

Pharmaceutics 2023, 15(2), 692; https://doi.org/10.3390/pharmaceutics15020692 - 17 Feb 2023

Cited by 11 | Viewed by 2686

Abstract

Previous evidence suggests that prenatal exposure to THC (pTHC) derails the neurodevelopmental trajectories towards a vulnerable phenotype for impaired emotional regulation and limbic memory. Here we aimed to investigate pTHC effect on hippocampus-related cognitive functions and markers of neuroplasticity in adolescent male offspring. Wistar rats were exposed to THC (2 mg/kg) from gestational day 5 to 20 and tested for spatial memory, object recognition memory and reversal learning in the reinforce-motivated Can test and in the aversion-driven Barnes maze test; locomotor activity and exploration, anxiety-like behaviour, and response to natural reward were assessed in the open field, elevated plus maze, and sucrose preference tests, respectively. The gene expression levels of NMDA NR1-2A subunits, mGluR5, and their respective scaffold proteins PSD95 and Homer1, as well as CB1R and the neuromodulatory protein HINT1, were measured in the hippocampus. pTHC offspring exhibited deficits in spatial and object recognition memory and reversal learning, increased locomotor activity, increased NR1-, decreased NR2A- and PSD95-, increased mGluR5- and Homer1-, and augmented CB1R- and HINT1-hippocampal mRNA levels. Our data shows that pTHC is associated with specific impairment in spatial cognitive processing and effectors of hippocampal neuroplasticity and suggests novel targets for future pharmacological challenges. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

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11 pages, 265 KiB

Open AccessArticle

A Pharmacokinetic Dose-Optimization Study of Cabotegravir and Bictegravir in a Mouse Pregnancy Model

by Haneesha Mohan, Kieran Atkinson, Birgit Watson, Chanson J. Brumme and Lena Serghides

Pharmaceutics 2022, 14(9), 1761; https://doi.org/10.3390/pharmaceutics14091761 - 24 Aug 2022

Cited by 3 | Viewed by 2118

Abstract

Animal pregnancy models can be useful tools to study HIV antiretroviral safety and toxicity and to perform mechanistic studies that are not easily performed in humans. Utilization of clinically relevant dosing in these models improves the relevance of the findings. Cabotegravir and bictegravir are new integrase strand transfer inhibitors (INSTIs), recently approved for the treatment of people living with HIV. Studies of these drugs in pregnancy are very limited. The objective of this study was to perform a dose-optimization study of cabotegravir and bictegravir in a mouse pregnancy model with the goal of determining the dose that would yield plasma drug concentrations similar those observed in humans. Pregnant mice were administered increasing doses of cabotegravir or bictegravir in combination with emtricitabine and tenofovir by oral gavage from gestational day 11.5 to 15.5. Drug concentrations in the maternal plasma at 1 h and 24 h post drug administration and in the amniotic fluid at 1 h post drug administration were determined using high-performance liquid chromatography coupled with tandem mass spectrometry. A review of cabotegravir and bictegravir human pharmacokinetic studies are also reported. We hope these data will encourage studies of HIV antiretroviral safety/toxicity and mechanistic studies in animal pregnancy models. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

9 pages, 887 KiB

Open AccessArticle

Associations of GNAS and RGS Gene Polymorphisms with the Risk of Ritodrine-Induced Adverse Events in Korean Women with Preterm Labor: A Cohort Study

by Eun-Jeong Jang, Young-Ju Kim, Han-Sung Hwang, Jeong Yee and Hye-Sun Gwak

Pharmaceutics 2022, 14(6), 1220; https://doi.org/10.3390/pharmaceutics14061220 - 8 Jun 2022

Cited by 1 | Viewed by 1852

Abstract

Ritodrine, a β2-adrenergic receptor agonist, is among most commonly prescribed tocolytic agents. This study aimed to evaluate the associations of single nucleotide polymorphisms in GNAS, RGS2, and RGS5 with the risk of ritodrine-induced adverse events (AEs) and develop a risk scoring system to identify high-risk patients. This is the prospective cohort study conducted at the Ewha Woman’s University Mokdong Hospital between January 2010 and October 2016. Pregnant women were included if they were treated with ritodrine for preterm labor with regular uterine contractions (at least 3 every 10 min) and cervical dilation. A total of 6, 3, and 5 single nucleotide polymorphisms (SNPs) of GNAS, RGS2, and RGS5 genes were genotyped and compared in patients with and without ritodrine-induced AEs. A total of 163 patients were included in this study. After adjusting confounders, GNAS rs3730168 (per-allele odds ratio (OR): 2.1; 95% confidence interval (95% CI): 1.0–4.3) and RGS2 rs1152746 (per-allele OR: 2.6, 95% CI: 1.1–6.5) were significantly associated with ritodrine-induced AEs. According to the constructed risk scoring models, patients with 0, 1, 2, 3, 4, and 5 points showed 0%, 13%, 19%, 31%, 46%, and 100% risks of AEs. This study suggested that GNAS and RGS2 polymorphisms could affect the risk of AEs in patients treated with ritodrine. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

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23 pages, 1892 KiB

Open AccessArticle

Application of a Physiologically Based Pharmacokinetic Model to Predict Cefazolin and Cefuroxime Disposition in Obese Pregnant Women Undergoing Caesarean Section

by Hanadi H. Alrammaal, Khaled Abduljalil, Victoria Hodgetts Morton, R. Katie Morris, John F. Marriott, Hsu P. Chong and Hannah K. Batchelor

Pharmaceutics 2022, 14(6), 1162; https://doi.org/10.3390/pharmaceutics14061162 - 30 May 2022

Cited by 6 | Viewed by 2964

Abstract

Intravenous (IV) cefuroxime and cefazolin are used prophylactically in caesarean sections (CS). Currently, there are concerns regarding sub-optimal dosing in obese pregnant women compared to lean pregnant women prior to CS. The current study used a physiologically based pharmacokinetic (PBPK) approach to predict cefazolin and cefuroxime pharmacokinetics in obese pregnant women at the time of CS as well as the duration that these drug concentrations remain above a target concentration (2, 4 or 8 µg/mL or µg/g) in plasma or adipose tissue. Cefazolin and cefuroxime PBPK models were first built using clinical data in lean and in obese non–pregnant populations. Models were then used to predict cefazolin and cefuroxime pharmacokinetics data in lean and obese pregnant populations. Both cefazolin and cefuroxime models sufficiently described their total and free levels in the plasma and in the adipose interstitial fluid (ISF) in non–pregnant and pregnant populations. The obese pregnant cefazolin model predicted adipose exposure adequately at different reference time points and indicated that an IV dose of 2000 mg can maintain unbound plasma and adipose ISF concentration above 8 µg/mL for 3.5 h post dose. Predictions indicated that an IV 1500 mg cefuroxime dose can achieve unbound plasma and unbound ISF cefuroxime concentration of ≥8 µg/mL up to 2 h post dose in obese pregnant women. Re-dosing should be considered if CS was not completed within 2 h post cefuroxime administration for both lean or obese pregnant if cefuroxime concentrations of ≥8 µg/mL is required. A clinical study to measure cefuroxime adipose concentration in pregnant and obese pregnant women is warranted. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

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12 pages, 2254 KiB

Open AccessArticle

In Vitro Nephrotoxicity and Permeation of Vancomycin Hydrochloride Loaded Liposomes

by Nicole Papp, Jeffin Panicker, John Rubino, Gwendolyn Pais, Alexander Czechowicz, Walter C. Prozialeck, Brooke Griffin, Volkmar Weissig, Marc Scheetz and Medha D. Joshi

Pharmaceutics 2022, 14(6), 1153; https://doi.org/10.3390/pharmaceutics14061153 - 28 May 2022

Cited by 8 | Viewed by 2272

Abstract

Drugs can be toxic to the fetus depending on the amount that permeates across the maternal–fetal barrier. One way to limit the amount which penetrates this barrier is to increase the molecular size of the drug. In this study, we have achieved this by encapsulating our model antibiotic (vancomycin hydrochloride, a known nephrotoxic agent) in liposomes. PEGylated and non-PEGylated liposomes encapsulating vancomycin hydrochloride were prepared using two different methods: thin-film hydration followed by the freeze–thaw method and the reverse-phase evaporation method. These liposomes were characterized by their hydrodynamic size and zeta potential measurements, CryoTEM microscopy, loading and encapsulation efficiency studies, in vitro release measurements and in vitro cytotoxicity assays using NRK-52 E rat kidney cells. We also determined the in vitro permeability of these liposomes across the human placental cell and dog kidney cell barriers. Vancomycin hydrochloride-loaded PEGylated liposomes (VHCL-lipo) of a size less than 200 nm were prepared. The VHCL-lipo were found to have the faster release of vancomycin hydrochloride and resulted in greater viability of NRK-52E cells. In vitro, the VHCL-lipo permeated the human placental cell and dog kidney cell barriers to a lesser extent than the free vancomycin hydrochloride. The data suggest a reduction in nephrotoxicity and permeability of vancomycin hydrochloride after encapsulation in PEGylated liposomes. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

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14 pages, 1865 KiB

Open AccessArticle

Comparison of the Effects of Three Dual-Nucleos(t)ide Reverse Transcriptase Inhibitor Backbones on Placenta Mitochondria Toxicity and Oxidative Stress Using a Mouse Pregnancy Model

by Kayode Balogun and Lena Serghides

Pharmaceutics 2022, 14(5), 1063; https://doi.org/10.3390/pharmaceutics14051063 - 15 May 2022

Cited by 4 | Viewed by 2549

Abstract

Nucleos(t)ide reverse transcriptase inhibitors (NRTIs) are the backbone of HIV antiretroviral therapy (ART). ART use in pregnancy has been associated with adverse birth outcomes, in part due to NRTI-induced mitochondrial toxicity. Direct comparison on the effects of commonly used dual-NRTI regimens on placental mitochondria toxicity in pregnancy is lacking. We compared zidovudine/lamivudine, abacavir/lamivudine, and tenofovir/emtricitabine using a mouse model and examined markers of placental mitochondrial function and oxidative stress. Zidovudine/lamivudine and abacavir/lamivudine were associated with lower fetal and placental weights compared to controls, whereas tenofovir/emtricitabine was associated with the least fetal and placental weight reduction, as well as lower resorption rates. Placental mitochondrial DNA content, as well as placental expression of cytochrome c-oxidase subunit-II, DNA polymerase gamma, and citrate synthase, was higher in tenofovir/emtricitabine-treated mice compared to other groups. Zidovudine/lamivudine-treated mice had elevated malondialdehyde levels (oxidative stress marker) compared to other groups and lower mRNA levels of manganese superoxide dismutase and peroxisome proliferator-activated receptor gamma coactivator 1-alpha in the placenta compared to tenofovir/emtricitabine-treated mice. We observed differences in effects between NRTI regimens on placental mitochondrial function and birth outcomes. Tenofovir/emtricitabine was associated with larger fetuses, increased mtDNA content, and higher expression of mitochondrial-specific antioxidant enzymes and mitochondrial biogenesis enzymes, whereas zidovudine/lamivudine was associated with markers of placental oxidative stress. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

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14 pages, 1712 KiB

Open AccessArticle

Morphine Perinatal Exposure Induces Long-Lasting Negative Emotional States in Adult Offspring Rodents

by Nair C. F. Castro, Izabelle S. Silva, Sabrina C. Cartágenes, Luanna M. P. Fernandes, Paula C. Ribera, Mayara A. Barros, Rui D. Prediger, Enéas A. Fontes-Júnior and Cristiane S. F. Maia

Pharmaceutics 2022, 14(1), 29; https://doi.org/10.3390/pharmaceutics14010029 - 24 Dec 2021

Cited by 2 | Viewed by 3755

Abstract

Psychoactive substances during pregnancy and lactation is a key problem in contemporary society, causing social, economic, and health disturbance. In 2010, about 30 million people used opioid analgesics for non-therapeutic purposes, and the prevalence of opioids use during pregnancy ranged from 1% to 21%, representing a public health problem. This study aimed to evaluate the long-lasting neurobehavioral and nociceptive consequences in adult offspring rats and mice exposed to morphine during intrauterine/lactation periods. Pregnant rats and mice were exposed subcutaneously to morphine (10 mg/kg/day) during 42 consecutive days (from the first day of pregnancy until the last day of lactation). Offspring were weighed on post-natal days (PND) 1, 5, 10, 15, 20, 30, and 60, and behavioral tasks (experiment 1) or nociceptive responses (experiment 2) were assessed at 75 days of age (adult life). Morphine-exposed female rats displayed increased spontaneous locomotor activity. More importantly, both males and female rats perinatally exposed to morphine displayed anxiety- and depressive-like behaviors. Morphine-exposed mice presented alterations in the nociceptive responses on the writhing test. This study showed that sex difference plays a role in pain threshold and that deleterious effects of morphine during pre/perinatal periods are nonrepairable in adulthood, which highlights the long-lasting clinical consequences related to anxiety, depression, and nociceptive disorders in adulthood followed by intrauterine and lactation morphine exposure. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

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12 pages, 2345 KiB

Open AccessArticle

Valproic Acid Concentrations in Mothers, Colostrum and Breastfed Infants during the Early Postpartum Period: Comparison with Concentrations Determined during Delivery and in the Mature Milk Period

by Ivana Kacirova, Milan Grundmann and Hana Brozmanova

Pharmaceutics 2021, 13(12), 2074; https://doi.org/10.3390/pharmaceutics13122074 - 3 Dec 2021

Cited by 4 | Viewed by 1839

Abstract

To obtain information on the transport of valproic acid from mothers to colostrum and breastfed infants, in this cohort study, valproic acid concentrations in maternal serum (90 subjects), colostrum and the serum of breastfed infants were analyzed in years 1993–2018, between the 2nd and 5th postnatal days. Valproic acid concentrations ranged from 4.3 to 66.5 mg/L (mean 31.2 ± 13.6 mg/L) in maternal serum, from 0.5 to 5.9 mg/L (mean 1.1 ± 1.2 mg/L) in milk, and from 0.5 to 42.9 mg/L (mean 15.4 ± 9.4 mg/L) in infant serum. The milk/maternal serum concentration ratio ranged from 0.01 to 0.22 (mean 0.04 ± 0.04), and the infant/maternal serum concentration ratio ranged from 0.01 to 1.61 (mean 0.51 ± 0.28). A significant correlation was found between serum concentrations of breastfed infants and milk concentrations, maternal serum concentrations, maternal daily dose, and dose related to maternal body weight. Valproic acid concentrations in milk and infant serum did not reach the lower limit of the reference range used for the general epileptic population, and three-quarters of the concentrations in milk were lower than the lower limit of quantification. Routine monitoring of serum concentrations of breastfed infants is not necessary. If signs of potential adverse reactions are noted, serum concentrations of the infants should be measured. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

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Review

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27 pages, 381 KiB

Open AccessReview

Herbal Medicines—Are They Effective and Safe during Pregnancy?

by Beata Sarecka-Hujar and Beata Szulc-Musioł

Pharmaceutics 2022, 14(1), 171; https://doi.org/10.3390/pharmaceutics14010171 - 12 Jan 2022

Cited by 25 | Viewed by 12055

Abstract

Since the teratogenicity of Thalidomide has been proven, herbal products are more commonly used in pregnancy to not only relieve morning sickness but also to fight infections. These products are frequently considered as natural and therefore harmless. However, herbs contain a number of active substances that, when used during pregnancy, can affect the development of the fetus. Often, pregnant women do not consult the usage of herbal medicines with a physician. The access to these products is easy and treatment of certain ailments with the use of herbs is common in many countries. The aim of the present literature review was to discuss available data regarding the efficacy and safety of cranberry, chamomile, Echinacea purpurea, garlic, ginger, Ginkgo biloba, and peppermint, which are used to counteract the most common ailments during pregnancy, i.e., infections and pregnancy-related ailments (e.g., nausea and vomiting, dizziness, and headache). Analysis of available data showed that ginger is one of the most extensively analyzed herbal remedies. The dose of ginger below 1000 mg per day may help to relief hypereremesis gravidarum, and such an amount of ginger did not increase frequency of adverse effects for either woman or developing fetus. Data regarding other herbs are most often heterogeneous and give conflicting results with no clear conclusions. However, all herbal products should be used with a special caution in pregnancy. Further high-quality human studies should be determined to confirm the safe doses of herbal products which could be used by pregnant or breast-feeding women. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

32 pages, 1770 KiB

Open AccessReview

Modelling Tools to Characterize Acetaminophen Pharmacokinetics in the Pregnant Population

by Sofie A. M. Brookhuis, Karel Allegaert, Lidwien M. Hanff, Marjolijn N. Lub-de Hooge, André Dallmann and Paola Mian

Pharmaceutics 2021, 13(8), 1302; https://doi.org/10.3390/pharmaceutics13081302 - 20 Aug 2021

Cited by 9 | Viewed by 3924

Abstract

This review describes acetaminophen pharmacokinetics (PK) throughout pregnancy, as analyzed by three methods (non-compartmental analyses (NCA), population PK, and physiologically based PK (PBPK) modelling). Eighteen studies using NCA were reported in the scientific literature. These studies reported an increase in the volume of distribution (3.5–60.7%) and an increase in the clearance (36.8–84.4%) of acetaminophen in pregnant women compared to non-pregnant women. Only two studies using population PK modelling as a technique were available in the literature. The largest difference in acetaminophen clearance (203%) was observed in women at delivery compared to non-pregnant women. One study using the PBPK technique was found in the literature. This study focused on the formation of metabolites, and the toxic metabolite N-acetyl-p-benzoquinone imine was the highest in the first trimester, followed by the second and third trimester, compared with non-pregnant women. In conclusion, this review gave an overview on acetaminophen PK changes in pregnancy. Also, knowledge gaps, such as fetal and placenta PK parameters, have been identified, which should be explored further before dosing adjustments can be suggested on an evidence-based basis. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

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30 pages, 1886 KiB

Open AccessSystematic Review

The Effect of Pregnancy and Inflammatory Bowel Disease on the Pharmacokinetics of Drugs Related to Inflammatory Bowel Disease—A Systematic Literature Review

by Thomas K. Wiersma, Marijn C. Visschedijk, Nanne K. de Boer, Marjolijn N. Lub-de Hooge, Jelmer R. Prins, Daan J. Touw and Paola Mian

Pharmaceutics 2022, 14(6), 1241; https://doi.org/10.3390/pharmaceutics14061241 - 11 Jun 2022

Cited by 4 | Viewed by 2579

Abstract

Due to ethical and practical reasons, a knowledge gap exists on the pharmacokinetics (PK) of inflammatory bowel disease (IBD)-related drugs in pregnant women with IBD. Before evidence-based dosing can be proposed, insight into the PK has to be gained to optimize drug therapy for both mother and fetus. This systematic review aimed to describe the effect of pregnancy and IBD on the PK of drugs used for IBD. One aminosalicylate study, two thiopurine studies and twelve studies with biologicals were included. Most drugs within these groups presented data over multiple moments before, during and after pregnancy, except for mesalazine, ustekinumab and golimumab. The studies for mesalazine, ustekinumab and golimumab did not provide enough data to demonstrate an effect of pregnancy on concentration and PK parameters. Therefore, no evidence-based dosing advice was given. The 6-thioguanine nucleotide levels decreased during pregnancy to 61% compared to pre-pregnancy levels. The potentially toxic metabolite 6-methylmercaptopurine (6-MMP) increased to maximal 209% of the pre-pregnancy levels. Although the PK of the thiopurines changed throughout pregnancy, no evidence-based dosing advice was provided. One study suggested that caution should be exercised when the thiopurine dose is adjusted, due to shunting 6-MMP levels. For the biologicals, infliximab levels increased, adalimumab stayed relatively stable and vedolizumab levels tended to decrease during pregnancy. Although the PK of the biologicals changed throughout pregnancy, no evidence-based dosing advice for biologicals was provided. Other drugs retrieved from the literature search were mesalazine, ustekinumab and golimumab. We conclude that limited studies have been performed on PK parameters during pregnancy for drugs used in IBD. Therefore, more extensive research to determine the values of PK parameters is warranted. After gathering the PK data, evidence-based dosing regimens can be developed. Full article

(This article belongs to the Special Issue Drugs in Pregnancy and Lactation)

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