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Pharmaceutics
Special Issues
Paediatric Dosage Forms: New Approaches to Old Challenges
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Paediatric Dosage Forms: New Approaches to Old Challenges

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: closed (20 May 2023) | Viewed by 8561

Special Issue Editors

Dr. Sara Hanning

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Guest Editor
Faculty of Medical and Health Sciences, University of Auckland, Auckland 1023, New Zealand
Interests: paediatric formulations; extemporaneous compounding; medicines for children
Prof. Dr. Catherine Tuleu

E-Mail Website
Guest Editor
Department of Pharmaceutics, UCL School of Pharmacy, London WC1N 1AX, UK
Interests: pharmaceutics; formulation; patient centric; children; acceptability; palatability; taste masking

Special Issue Information

Dear Colleagues,

The paediatric population ranges from neonates to adolescents, with distinct differences in size, body composition, bodily function and sensory maturity across this age range. Many medicines for adults have potential applications for children but lack the dosing flexibility and demonstration of safety and efficacy through clinical trials to support use across the paediatric spectrum. Young children, especially neonates, handle drugs and excipients differently to older children and adults. With this in mind, a range of methods have been investigated to develop suitable patient-centric paediatric formulations.

The aim of this Special Issue of Pharmaceutics is to highlight new methodology related to paediatric product research and development. We invite researchers to publish their original research or review articles regarding the reformulation of off-patent drugs, novel excipients, administration devices and sensory pharmaceutics, with a focus on paediatrics.

Dr. Sara Hanning
Prof. Dr. Catherine Tuleu
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 100 words) can be sent to the Editorial Office for announcement on this website.

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-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics 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

  • paediatric/pediatric
  • neonate
  • off-patent reformulation
  • novel excipients
  • administration devices
  • sensory pharmaceutics
  • paediatric product research and development

Published Papers (5 papers)

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Research

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17 pages, 2418 KiB  
Article
Responsive Sensory Evaluation to Develop Flexible Taste-Masked Paediatric Primaquine Tablets against Malaria for Low-Resource Settings
by Sejal R. Ranmal, Marc Lavarde, Elodie Wallon, Samar Issa, Walter R. Taylor, Julie L. A. Nguyen Ngoc Pouplin, Catherine Tuleu and Anne-Marie Pensé-Lhéritier
Pharmaceutics 2023, 15(7), 1879; https://doi.org/10.3390/pharmaceutics15071879 - 04 Jul 2023
Cited by 2 | Viewed by 1206
Abstract
Primaquine is an important antimalarial drug for malaria transmission blocking and radical cure, but it is not currently available in child-friendly formulations in appropriate doses. Adult-strength tablets are often crushed and dissolved in water to obtain the required dose, which exposes the drug’s [...] Read more.
Primaquine is an important antimalarial drug for malaria transmission blocking and radical cure, but it is not currently available in child-friendly formulations in appropriate doses. Adult-strength tablets are often crushed and dissolved in water to obtain the required dose, which exposes the drug’s bitter taste. As part of the developing paediatric primaquine (DPP) project, this study adopted a responsive sensory pharmaceutics approach by integrating real-time formulation development and pre-clinical taste assessment to develop palatable, flavour-infused primaquine tablets. A design of experiment (DoE) approach was used to screen different taste-masking agents and excipient blends with trained, expert sensory assessors, with quinine hydrochloride as a model bitter tastant. The taste-masking efficacy of selected prototype formulation blends was validated with naïve assessors using the highest 15 mg primaquine dose. The mean bitterness intensity rating, measured on a discrete 11-point scale, was halved from 7.04 for the unflavoured control to 2.74–3.70 for the formulation blends. Sucralose had the biggest impact on bitterness suppression and improving palatability. Two different flavouring systems have been developed, and their acceptability in paediatric patients will be assessed as part of upcoming validation field clinical trials in Africa. Full article
(This article belongs to the Special Issue Paediatric Dosage Forms: New Approaches to Old Challenges)
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15 pages, 2950 KiB  
Article
Rectal Bioavailability of Amoxicillin from Hollow-Type Suppositories: Effect of Chemical Form of Amoxicillin
by Trusha J. Purohit, Satya Amirapu, Zimei Wu and Sara M. Hanning
Pharmaceutics 2023, 15(7), 1865; https://doi.org/10.3390/pharmaceutics15071865 - 01 Jul 2023
Viewed by 2067
Abstract
Rectal drug administration could offer advantages in the delivery of medicines for children by avoiding swallowability issues, improving stability and enabling administration by caregivers. This study aimed to evaluate the rectal bioavailability of hollow-type suppositories (HTS) and understand the effect of two chemical [...] Read more.
Rectal drug administration could offer advantages in the delivery of medicines for children by avoiding swallowability issues, improving stability and enabling administration by caregivers. This study aimed to evaluate the rectal bioavailability of hollow-type suppositories (HTS) and understand the effect of two chemical forms of amoxicillin: amoxicillin sodium (AS) or amoxicillin trihydrate (AMT). HTS were prepared by incorporating a lipophilic core containing the antibiotic with a polyethylene glycol (PEG) shell. Formulations were characterised in vitro, and the absolute bioavailability was determined in a rabbit model, while drug–base interactions were evaluated using X-ray diffraction crystallography (XRD), differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy. The in vitro amoxicillin release from AMT HTS was delayed, taking 27.3 ± 4.9 h to release 50% drug compared with 1.7 h for the AS HTS, likely due to solubility differences between AMT and AS. The presence of orthorhombic AMT and anhydrous AS crystals in respective HTS was confirmed via XRD and DSC. PEG shells were able to protect the drug chemical stability when stored at 25 °C/60% RH. Despite the difference in their in vitro release rates, a similar rectal bioavailability was found in both forms of amoxicillin (absolute bioavailability 68.2 ± 6.6% vs. 72.8 ± 32.2% for AMT HTS and AS HTS, respectively; p = 0.9682). Both HTS formulations showed little or no irritation to the rectal mucosa following a single dose. Full article
(This article belongs to the Special Issue Paediatric Dosage Forms: New Approaches to Old Challenges)
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16 pages, 2860 KiB  
Article
Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study
by Juliane Münch, Isabelle Sessler, Hans Martin Bosse, Manfred Wargenau, Janine D. Dreesen, Giulio Loforese, Nicholas J. A. Webb, Rama Sivasubramanian, Sibylle Reidemeister, Philipp Lustenberger and Viviane Klingmann
Pharmaceutics 2023, 15(6), 1729; https://doi.org/10.3390/pharmaceutics15061729 - 14 Jun 2023
Cited by 1 | Viewed by 1095
Abstract
Mini-tablets are advantageous over liquid formulations in overcoming challenges related to stability, taste, and dosage. This open-label, single-dose, cross-over study investigated the acceptability and safety of drug-free, film-coated mini-tablets in children aged 1 month–6 years (stratified: 4–6 years, 2–<4 years, 1–<2 years, 6–<12 [...] Read more.
Mini-tablets are advantageous over liquid formulations in overcoming challenges related to stability, taste, and dosage. This open-label, single-dose, cross-over study investigated the acceptability and safety of drug-free, film-coated mini-tablets in children aged 1 month–6 years (stratified: 4–6 years, 2–<4 years, 1–<2 years, 6–<12 months, and 1–<6 months), and their preference for swallowing either a high quantity of 2.0 mm or a low quantity of 2.5 mm diameter mini-tablets. The primary endpoint was acceptability derived from swallowability. The secondary endpoints were investigator-observed palatability, acceptability as a composite endpoint derived from both swallowability and palatability, and safety. Of 320 children randomized, 319 completed the study. Across all tablet sizes, quantities and age groups, acceptability rates based on swallowability were high (at least 87%). Palatability was rated as “pleasant/neutral” in 96.6% of children. The acceptability rates as per the composite endpoint were at least 77% and 86% for the 2.0 mm and 2.5 mm film-coated mini-tablets, respectively. No adverse events or deaths were reported. Recruitment in the 1–<6-months group was stopped early due to coughing—evaluated as “choked on” in three children. Both 2.0 mm and 2.5 mm film-coated mini-tablets are suitable formulations for young children. Full article
(This article belongs to the Special Issue Paediatric Dosage Forms: New Approaches to Old Challenges)
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Review

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12 pages, 273 KiB  
Review
Paediatric Medicinal Formulation Development: Utilising Human Taste Panels and Incorporating Their Data into Machine Learning Training
by Okhee Yoo, Britta S. von Ungern-Sternberg and Lee Yong Lim
Pharmaceutics 2023, 15(8), 2112; https://doi.org/10.3390/pharmaceutics15082112 - 09 Aug 2023
Cited by 1 | Viewed by 1022
Abstract
This review paper explores the role of human taste panels and artificial neural networks (ANNs) in taste-masking paediatric drug formulations. Given the ethical, practical, and regulatory challenges of employing children, young adults (18–40) can serve as suitable substitutes due to the similarity in [...] Read more.
This review paper explores the role of human taste panels and artificial neural networks (ANNs) in taste-masking paediatric drug formulations. Given the ethical, practical, and regulatory challenges of employing children, young adults (18–40) can serve as suitable substitutes due to the similarity in their taste sensitivity. Taste panellists need not be experts in sensory evaluation so long as a reference product is used during evaluation; however, they should be screened for bitterness taste detection thresholds. For a more robust evaluation during the developmental phase, considerations of a scoring system and the calculation of an acceptance value may be beneficial in determining the likelihood of recommending a formulation for further development. On the technological front, artificial neural networks (ANNs) can be exploited in taste-masking optimisation of medicinal formulations as they can model complex relationships between variables and enable predictions not possible previously to optimise product profiles. Machine learning classifiers may therefore tackle the challenge of predicting the bitterness intensity of paediatric formulations. While advancements have been made, further work is needed to identify effective taste-masking techniques for specific drug molecules. Continuous refinement of machine learning algorithms, using human panellist acceptability scores, can aid in enhancing paediatric formulation development and overcoming taste-masking challenges. Full article
(This article belongs to the Special Issue Paediatric Dosage Forms: New Approaches to Old Challenges)
35 pages, 1894 KiB  
Review
Exploring the Potential of Nanotechnology in Pediatric Healthcare: Advances, Challenges, and Future Directions
by Hossein Omidian and Kwadwo Mfoafo
Pharmaceutics 2023, 15(6), 1583; https://doi.org/10.3390/pharmaceutics15061583 - 24 May 2023
Cited by 6 | Viewed by 2651
Abstract
The utilization of nanotechnology has brought about notable advancements in the field of pediatric medicine, providing novel approaches for drug delivery, disease diagnosis, and tissue engineering. Nanotechnology involves the manipulation of materials at the nanoscale, resulting in improved drug effectiveness and decreased toxicity. [...] Read more.
The utilization of nanotechnology has brought about notable advancements in the field of pediatric medicine, providing novel approaches for drug delivery, disease diagnosis, and tissue engineering. Nanotechnology involves the manipulation of materials at the nanoscale, resulting in improved drug effectiveness and decreased toxicity. Numerous nanosystems, including nanoparticles, nanocapsules, and nanotubes, have been explored for their therapeutic potential in addressing pediatric diseases such as HIV, leukemia, and neuroblastoma. Nanotechnology has also shown promise in enhancing disease diagnosis accuracy, drug availability, and overcoming the blood–brain barrier obstacle in treating medulloblastoma. It is important to acknowledge that while nanotechnology offers significant opportunities, there are inherent risks and limitations associated with the use of nanoparticles. This review provides a comprehensive summary of the existing literature on nanotechnology in pediatric medicine, highlighting its potential to revolutionize pediatric healthcare while also recognizing the challenges and limitations that need to be addressed. Full article
(This article belongs to the Special Issue Paediatric Dosage Forms: New Approaches to Old Challenges)
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