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Pharmaceutics
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Formulation Strategies for Suitable and Effective Drug Delivery Systems in...
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Formulation Strategies for Suitable and Effective Drug Delivery Systems in Pediatrics

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Delivery and Controlled Release".

Deadline for manuscript submissions: closed (20 December 2024) | Viewed by 8315

Special Issue Editor

Dr. Marzia Cirri

E-Mail Website
Guest Editor
Department of Chemistry, University of Florence, Via Schiff 6, Sesto Fiorentino, 50019 Florence, Italy
Interests: cyclodextrins; drug delivery systems; drug-in-cyclodextrin-in-nanolipid carriers; oral administration; pediatric formulations; topical delivery
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The development of pediatric drug formulations is challenging since they must be adapted to children’s needs depending on their age, requiring constant dosing adjustments according to their weight and physiological conditions, as well as requiring different administration routes and dosage forms. The lack of specific formulations results in a large use of extemporaneous preparations leading to poor dosing accuracy and the need to develop suitable dosage forms.

Acceptability, namely, the ability and willingness of the patient to use and their caregiver to administer the medicine as intended, is the main issue to consider in the development of pediatric formulations to assure adherence to therapy. Other critical issues are the stability of the formulations and the choice of suitable excipients for a safe and effective treatment.

Original research papers, communication papers and review articles focused on formulation strategies for the development of suitable and effective pediatric formulations are welcome in this Special Issue.

Dr. Marzia Cirri
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 formulation
  • children
  • dosage form
  • pediatric drug delivery systems
  • formulation strategies
  • dosing accuracy
  • acceptability
  • safety
  • stability
  • excipients

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Published Papers (4 papers)

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Research

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25 pages, 2670 KiB  
Article
The Development of an Age-Appropriate Fixed Dose Combination for Tuberculosis Using Physiologically-Based Pharmacokinetic Modeling (PBBM) and Risk Assessment
by Xavier J. H. Pepin, Juliana Johansson Soares Medeiros, Livia Deris Prado and Sandra Suarez Sharp
Pharmaceutics 2024, 16(12), 1587; https://doi.org/10.3390/pharmaceutics16121587 - 12 Dec 2024
Cited by 1 | Viewed by 1114
Abstract
Background/Objectives: The combination of isoniazid (INH) and rifampicin (RIF) is indicated for the treatment maintenance phase of tuberculosis (TB) in adults and children. In Brazil, there is no current reference listed drug for this indication in children. Farmanguinhos has undertaken the development of [...] Read more.
Background/Objectives: The combination of isoniazid (INH) and rifampicin (RIF) is indicated for the treatment maintenance phase of tuberculosis (TB) in adults and children. In Brazil, there is no current reference listed drug for this indication in children. Farmanguinhos has undertaken the development of an age-appropriate dispersible tablet to be taken with water for all age groups from birth to adolescence. The primary objective of this work was to develop and validate a physiologically-based biopharmaceutics model (PBBM) in GastroPlusTM, to link the product’s in vitro performance to the observed pharmacokinetic (PK) data in adults and children. Methods: The PBBM was developed based on measured or predicted physico-chemical and biopharmaceutical properties of INH and RIF. The metabolic clearance was specified mechanistically in the gut and liver for both parent drugs and acetyl-isoniazid. The model incorporated formulation related measurements such as dosage form disintegration and dissolution as inputs and was validated using extensive literature as well as in house clinical data. Results: The model was used to predict the exposure in children across the targeted dosing regimen for each age group using the new age-appropriate formulation. Probabilistic models of efficacy and safety versus exposure, combined with real world data on children, were utilized to assess drug efficacy and safety in the target populations. Conclusions: The model predictions (systemic exposure) along with clinical data from the literature linking systemic exposure to clinical outcomes confirmed that the proposed dispersible pediatric tablet and dosing regimen are anticipated to be as safe and as effective as adult formulations at similar doses. Full article
(This article belongs to the Special Issue Formulation Strategies for Suitable and Effective Drug Delivery Systems in Pediatrics)
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21 pages, 2588 KiB  
Article
Utilization of the Drug–Polymer Solid Dispersion Obtained by Ball Milling as a Taste Masking Method in the Development of Orodispersible Minitablets with Hydrocortisone in Pediatric Doses
by Monika Trofimiuk, Katarzyna Olechno, Emil Trofimiuk, Anna Czajkowska-Kośnik, Patrycja Ciosek-Skibińska, Klaudia Głowacz, Joanna Lenik, Anna Basa, Halina Car and Katarzyna Winnicka
Pharmaceutics 2024, 16(8), 1041; https://doi.org/10.3390/pharmaceutics16081041 - 4 Aug 2024
Cited by 1 | Viewed by 2688
Abstract
The objective of the conducted research was to design 2 mm orodispersible minitablets of pediatric doses of hydrocortisone (0.5 mg; 1.0 mg) with desirable pharmaceutical properties and eliminate the sensation of a bitter taste using preparation of solid dispersion by ball mill. Hydrocortisone [...] Read more.
The objective of the conducted research was to design 2 mm orodispersible minitablets of pediatric doses of hydrocortisone (0.5 mg; 1.0 mg) with desirable pharmaceutical properties and eliminate the sensation of a bitter taste using preparation of solid dispersion by ball mill. Hydrocortisone was selected as the model substance, as it is widely utilized in the pediatric population. ODMTs were prepared by compression (preceded by granulation) in a traditional single-punch tablet machine and evaluated using pharmacopoeial tests, DSC, and FTIR analysis. The methods used to evaluate the effectiveness of the taste-masking effect included in vivo participation of healthy volunteers, in vitro drug dissolution and utilization of an analytical device—“electronic tongue”. The research employed a preclinical animal model to preliminary investigate the bioequivalence of the designed drug dosage form in comparison to reference products. The study confirmed the possibility of manufacturing good-quality hydrocortisone ODMTs with a taste-masking effect owing to the incorporation of a solid dispersion in the tablet mass. Full article
(This article belongs to the Special Issue Formulation Strategies for Suitable and Effective Drug Delivery Systems in Pediatrics)
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15 pages, 2284 KiB  
Article
Questionnaire Study to Investigate the Preferences of Children, Parents, and Healthcare Professionals for Different Formulations of Oral Medicinal Products
by Manfred Wargenau, Felicitas Baase, Kristin Eckardt, Lucas-Sebastian Spitzhorn, Sibylle Reidemeister, Ingrid Klingmann and Viviane Klingmann
Pharmaceutics 2024, 16(4), 515; https://doi.org/10.3390/pharmaceutics16040515 - 8 Apr 2024
Cited by 1 | Viewed by 1410
Abstract
Since the acceptability of a medicine can significantly impact therapeutic outcomes, this study aimed to determine and compare the preferences of children, parents, and healthcare professionals for the most commonly used pediatric oral medicine formulations (syrup, mini-tablets, oblong tablets, round tablets) addressing all [...] Read more.
Since the acceptability of a medicine can significantly impact therapeutic outcomes, this study aimed to determine and compare the preferences of children, parents, and healthcare professionals for the most commonly used pediatric oral medicine formulations (syrup, mini-tablets, oblong tablets, round tablets) addressing all pediatric age groups, 0–<18 years (y). This survey study employed sex-, age-, and participant group-adapted questionnaires for eight cohorts of participants, i.e., children 6–<12 y, adolescents 12–<18 y, parents of children in four age groups (0–<2 y, 2–<6 y, 6–<12 y, and 12–<18 y), nurses, and pediatricians. Descriptive statistics were used for data analysis. In the age groups 0–<2 y and 2–<6 y, mini-tablets were preferred over syrup by all participants. In the age group 6–12 y, solid dosage forms were also preferred over syrup by all participants. In the age group 12–<18 y, healthcare professionals preferred solid dosage forms over syrup. Parents preferred higher amounts of mini-tablets and syrup compared to round and oblong tablets, while adolescents’ preferences did not differentiate between these formulations. Based on the study results and in contrast to current practice, it is suggested to consider solid dosage forms for future age-appropriate medicinal products already for younger age groups. Full article
(This article belongs to the Special Issue Formulation Strategies for Suitable and Effective Drug Delivery Systems in Pediatrics)
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Review

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34 pages, 498 KiB  
Review
Leading Paediatric Infectious Diseases—Current Trends, Gaps, and Future Prospects in Oral Pharmacotherapeutic Interventions
by Penelope N. Rampedi, Modupe O. Ogunrombi and Oluwatoyin A. Adeleke
Pharmaceutics 2024, 16(6), 712; https://doi.org/10.3390/pharmaceutics16060712 - 26 May 2024
Cited by 2 | Viewed by 2368
Abstract
Paediatric infectious diseases contribute significantly to global health challenges. Conventional therapeutic interventions are not always suitable for children, as they are regularly accompanied with long-standing disadvantages that negatively impact efficacy, thus necessitating the need for effective and child-friendly pharmacotherapeutic interventions. Recent advancements in [...] Read more.
Paediatric infectious diseases contribute significantly to global health challenges. Conventional therapeutic interventions are not always suitable for children, as they are regularly accompanied with long-standing disadvantages that negatively impact efficacy, thus necessitating the need for effective and child-friendly pharmacotherapeutic interventions. Recent advancements in drug delivery technologies, particularly oral formulations, have shown tremendous progress in enhancing the effectiveness of paediatric medicines. Generally, these delivery methods target, and address challenges associated with palatability, dosing accuracy, stability, bioavailability, patient compliance, and caregiver convenience, which are important factors that can influence successful treatment outcomes in children. Some of the emerging trends include moving away from creating liquid delivery systems to developing oral solid formulations, with the most explored being orodispersible tablets, multiparticulate dosage forms using film-coating technologies, and chewable drug products. Other ongoing innovations include gastro-retentive, 3D-printed, nipple-shield, milk-based, and nanoparticulate (e.g., lipid-, polymeric-based templates) drug delivery systems, possessing the potential to improve therapeutic effectiveness, age appropriateness, pharmacokinetics, and safety profiles as they relate to the paediatric population. This manuscript therefore highlights the evolving landscape of oral pharmacotherapeutic interventions for leading paediatric infectious diseases, crediting the role of innovative drug delivery technologies. By focusing on the current trends, pointing out gaps, and identifying future possibilities, this review aims to contribute towards ongoing efforts directed at improving paediatric health outcomes associated with the management of these infectious ailments through accessible and efficacious drug treatments. Full article
(This article belongs to the Special Issue Formulation Strategies for Suitable and Effective Drug Delivery Systems in Pediatrics)
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