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Pharmaceutics
Special Issues
Pediatric Drug Formulations
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Pediatric Drug Formulations

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: closed (30 September 2023) | Viewed by 7332

Special Issue Editor

Dr. Sofia Mattsson

E-Mail Website
Guest Editor
Department of Integrative Medical Biology, Umeå University, SE-901 87 Umeå, Sweden
Interests: pharmaceutics; drug delivery; pediatric dosage forms; drug formulation; solid oral dosage forms; drug release; powder mixtures

Special Issue Information

Dear Colleagues,

There is an increasing demand for personalized medicines and treatments to be able to meet the needs of each patient and improve drug treatment. This includes drug treatments for the pediatric population. Consequently, there is a considerable need to develop medicines and dosage forms suitable for the pediatric population to ensure the safe and effective administration of drugs to children. The off-label use of drugs in pediatric patients is common but may require doses that differ from those of adults; furthermore, the administration of inappropriate dosage forms leads to unsafe drug use and decreased compliance. A suitable dosage form for children should possess convenient administration (including palatability and avoiding manipulation pre-administration), flexibility in dosing, and safety.

The aim of this Special Issue is to shed light on the development of pediatric drug formulations in the scientific community and to highlight the research in this important area.

Dr. Sofia Mattsson
Guest Editor

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

  • pediatric
  • children
  • drug formulation
  • dosage form
  • administration
  • safety
  • flexible dosing
  • compliance
  • excipients

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Published Papers (3 papers)

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Research

12 pages, 1119 KiB  
Article
Pharmacokinetic Evaluation of Oral Viscous Budesonide in Paediatric Patients with Eosinophilic Oesophagitis in Repaired Oesophageal Atresia
by Raffaele Simeoli, Sebastiano A. G. Lava, Alessandro Di Deo, Marco Roversi, Sara Cairoli, Renato Tambucci, Francesca Rea, Monica Malamisura, Giulia Angelino, Isabella Biondi, Alessandra Simonetti, Paola De Angelis, Carlo Dionisi Vici, Paolo Rossi, Giuseppe Pontrelli, Oscar Della Pasqua and Bianca Maria Goffredo
Pharmaceutics 2024, 16(7), 872; https://doi.org/10.3390/pharmaceutics16070872 - 28 Jun 2024
Viewed by 1855
Abstract
Eosinophilic oesophagitis is a long-term complication of oesophageal atresia (EA), an uncommon condition that affects approximately 1 in 3500 infants. An exploratory, open-label phase 2 clinical trial was conducted in paediatric eosinophilic oesophagitis after oesophageal atresia (EoE-EA) to assess the safety, pharmacokinetics, and [...] Read more.
Eosinophilic oesophagitis is a long-term complication of oesophageal atresia (EA), an uncommon condition that affects approximately 1 in 3500 infants. An exploratory, open-label phase 2 clinical trial was conducted in paediatric eosinophilic oesophagitis after oesophageal atresia (EoE-EA) to assess the safety, pharmacokinetics, and efficacy of oral viscous budesonide (OVB). In total, eight patients were enrolled in the study and assigned to a twice-daily dosing regimen of either 0.8 or 1 mg OVB, depending on age and height, administered for 12 weeks. OVB was safe and effective in the treatment of EoE-EA. The current investigation focuses on the pharmacokinetics of budesonide and the impact of an oral viscous formulation on its absorption and bioavailability. Using a non-linear mixed effects approach, two distinct absorption profiles were identified, despite marked interindividual variability in drug concentrations. Budesonide exposure was higher than previously reported in children following oral inhalation. Even though no significant effect has been observed on serum cortisol levels, future studies should consider exploring different doses, schedules, and/or treatment durations, as there may be an opportunity to reduce the risk of cortisol suppression. Full article
(This article belongs to the Special Issue Pediatric Drug Formulations)
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18 pages, 2835 KiB  
Article
Optimisation of the Manufacturing Process of Organic-Solvent-Free Omeprazole Enteric Pellets for the Paediatric Population: Full Factorial Design
by Khadija Rouaz-El-Hajoui, Encarnación García-Montoya, Andrea López-Urbano, Miquel Romero-Obon, Blanca Chiclana-Rodríguez, Alex Fraschi-Nieto, Anna Nardi-Ricart, Marc Suñé-Pou, Josep María Suñé-Negre and Pilar Pérez-Lozano
Pharmaceutics 2023, 15(11), 2587; https://doi.org/10.3390/pharmaceutics15112587 - 4 Nov 2023
Cited by 3 | Viewed by 2570
Abstract
Liquid formulations are mostly used in the paediatric population. However, with certain active pharmaceutical ingredients (APIs), it is very difficult to guarantee quality and stability; this is the case, for example, with omeprazole. Omeprazole is used as a model drug due to the [...] Read more.
Liquid formulations are mostly used in the paediatric population. However, with certain active pharmaceutical ingredients (APIs), it is very difficult to guarantee quality and stability; this is the case, for example, with omeprazole. Omeprazole is used as a model drug due to the lack of a paediatric formulation meeting gastro-resistance requirements, which remains a challenge today. In this experimental study, the development of enteric polymer-coated pellets is proposed. It is proposed to use aqueous coating dispersions without the use of organic solvents, which are commonly used in fluidised bed coatings. To do this, the design of experiments method is used as a statistical tool for experiment creation and the subsequent analysis of the responses. In particular, this study uses a randomised full factorial design. The mean weight increases of the protective layer and the enteric coating are chosen as factors. Each factor is assigned two levels. Therefore, the design of the used experiments is a 22 + 1 central point. Overall, the obtained pellets can be an alternative to the compounding formulas of omeprazole that are currently used in the paediatric population, which do not meet the gastro-resistance specifications necessary to guarantee the therapeutic efficacy of this active ingredient. Full article
(This article belongs to the Special Issue Pediatric Drug Formulations)
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14 pages, 1396 KiB  
Article
Effect of Food on the Pediatric Dispersible Tablet Formulations of TRIUMEQ and DOVATO in Healthy Adult Participants
by Hardik Chandasana, Ryan Marnoch, Michael McKenna, Julia Double, Ciara Seal, Gilda Bontempo, Allen Wolstenholme and Ann Buchanan
Pharmaceutics 2023, 15(5), 1470; https://doi.org/10.3390/pharmaceutics15051470 - 11 May 2023
Cited by 2 | Viewed by 2211
Abstract
This randomized food effect study in healthy adult participants examined dispersible tablet formulations of fixed-dose combinations of dolutegravir/abacavir/lamivudine (TRIUMEQ) and dolutegravir/lamivudine (DOVATO). While adult tablet formulations of these combinations are currently approved for the treatment of human immunodeficiency virus, alternate formulations for children [...] Read more.
This randomized food effect study in healthy adult participants examined dispersible tablet formulations of fixed-dose combinations of dolutegravir/abacavir/lamivudine (TRIUMEQ) and dolutegravir/lamivudine (DOVATO). While adult tablet formulations of these combinations are currently approved for the treatment of human immunodeficiency virus, alternate formulations for children are urgently needed to facilitate appropriate pediatric dosing for patients who may have difficulty swallowing a conventional tablet. This study compared the effect of a high-fat, high-calorie meal on the pharmacokinetics, safety, and tolerability of dispersible tablet (DT) formulations of the two-drug and three-drug regimens, with administration under fasting conditions. Both the two-drug and three-drug dispersible tablet formulations, administered under fasting conditions and following a high-fat, high-calorie meal, were well tolerated in healthy participants. There were no clinically relevant differences in drug exposure for either regimen when administered with a high-fat meal as compared to under fasting conditions. Safety observations were similar for both treatments, either in the fed or fasted state. Both TRIUMEQ DT and DOVATO DT formulations can be administer with or without food. Full article
(This article belongs to the Special Issue Pediatric Drug Formulations)
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