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Pharmaceuticals
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Advances in Pediatric Drug Formulations
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Advances in Pediatric Drug Formulations

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

Deadline for manuscript submissions: 25 February 2025 | Viewed by 3758

Special Issue Editors

Dr. Sonia M. Iurian

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Guest Editor
Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, 41 V. Babes Street, 400012 Cluj-Napoca, Romania
Interests: orodispersible dosage forms; pediatric dosage forms; freeze-drying; quality by design drug development; product/process optimization; design of experiments; texture analysis in pharmaceutical product characterization
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Ioan Tomuță

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Guest Editor
Department of Pharmaceutical Technology and Biopharmacy, University of Medicine and Pharmacy “Iuliu Hațieganu”, 41 Victor Babeș Street, 400012 Cluj-Napoca, Romania
Interests: innovative dosage forms; drug delivery systems; quality by design (QbD); process analytical technology (PAT); multivariate data analysis (MVDA); 3D printing in pharmaceutics; novel methods of drugs manufacturing; pharmaceutical process optimization
Special Issues, Collections and Topics in MDPI journals
Dr. Catalina Bogdan

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Guest Editor
Department of Dermopharmacy and Cosmetics, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, 12 I. Creanga Street, 400010 Cluj-Napoca, Romania
Interests: development and characterization of solid and semisolid dosage forms; texture analysis; development and optimization of cosmetic products based on nanocarriers or herbal extracts
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The low availability of appropriate pediatric medications remains a focal point for researchers and pharmaceutical manufacturing companies. Although efforts have been made to stimulate the authorization of pediatric medications, the needs of patients are still far away from being fulfilled. Lately, new solid dosage forms, such as orodispersibles, minitablets, thin films, and 3D-printed dosage forms, have been proposed as alternatives to liquids for different age groups, along with novel devices that ease pediatric drug administration. However, this field requires further research and innovation in terms of the appropriate excipients, product and process development, taste masking, and quality assessment methods. Also, understanding end-user perception and acceptability is needed to guide product formulation and grant treatment adherence. While pediatric drug availability, as well as details on preparation, manipulation, administration practices, and preferences, have long been documented in developed countries, data coming from developing regions are scarce.

We extend an invitation to all stakeholders, including academia, pharmaceutical companies, hospital/community pharmacies, patient associations, and regulatory authorities, to share their results in the aforementioned matters and bridge the knowledge gaps that currently limit the development of pediatric drugs.

Dr. Sonia M. Iurian
Prof. Dr. Ioan Tomuță
Dr. Catalina Bogdan
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. 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

  • pediatric dosage forms
  • child-friendly dosage forms
  • age-appropriate dosage forms
  • acceptability
  • administration devices
  • taste-masking
  • compounded pediatric formulations

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Published Papers (3 papers)

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Research

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17 pages, 1865 KiB  
Article
Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug
by Clément Boisseillier, Lucas Demange-Labriet, Dulanjalee Kariyawasam, Pauline Marchadour, Anne-Sophie Fauqueur, Maxime Annereau, Lucas Denis, Camille Cotteret, Salvatore Cisternino and Arnaud Schweitzer-Chaput
Pharmaceuticals 2025, 18(1), 86; https://doi.org/10.3390/ph18010086 - 13 Jan 2025
Viewed by 555
Abstract
Orodispersible thin film (ODF) is an innovative dosage form that allows for adjustable dosing and improved patient compliance. It is administered by mouth, where it dissolves, making it suitable for children. Objectives: The aim of the study was to develop and characterize an [...] Read more.
Orodispersible thin film (ODF) is an innovative dosage form that allows for adjustable dosing and improved patient compliance. It is administered by mouth, where it dissolves, making it suitable for children. Objectives: The aim of the study was to develop and characterize an optimal ODF formulation containing equivalent hydrocortisone at 0.5 mg/cm2 using the solvent-casting method. A stability-indicating assay for the simultaneous quantification of hydrocortisone and hydrocortisone 21-hemissucinate (HMS) was developed. ODFs were characterized by organoleptic properties and by testing for uniformity of mass, content, stability, thickness, and dissolution. Results: When optimized, ODF is thin, flexible, and transparent, making it suitable for production in hospital pharmacies using standard equipment. In contrast to the water-insoluble hydrocortisone, the HMS-loaded cast gel successfully satisfied the tests, including content uniformity. Disintegration appeared acceptable as compared to the commercial grade ondansetron ODF (Setofilm®). The physicochemical stability of the active ingredients (i.e., HMS, hydrocortisone) contained in the ODF at 0.5 mg/cm2 is demonstrated for at least 84 days at 23 °C. Conclusion: The ODF formulated with the water-soluble hydrocortisone prodrug HMS allows accurate drug level to be achieved, thus opening up new opportunities for use in pediatric patients. Full article
(This article belongs to the Special Issue Advances in Pediatric Drug Formulations)
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20 pages, 8678 KiB  
Article
Exploring Vacuum Compression Molding as a Preparation Method for Flexible-Dose Pediatric Orodispersible Films
by Dana Hales, Cătălina Bogdan, Lucia Ruxandra Tefas, Andreea Cornilă, Maria-Andreea Chiver, Ioan Tomuță, Tibor Casian, Rareș Iovanov, Gábor Katona, Rita Ambrus and Sonia Iurian
Pharmaceuticals 2024, 17(7), 934; https://doi.org/10.3390/ph17070934 - 12 Jul 2024
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Abstract
In recent years, solid dosage forms have gained interest in pediatric therapy because they can provide valuable benefits in terms of dose accuracy and stability. Particularly for orodispersible films (ODFs), the literature evidences increased acceptability and dose flexibility. Among the various available technologies [...] Read more.
In recent years, solid dosage forms have gained interest in pediatric therapy because they can provide valuable benefits in terms of dose accuracy and stability. Particularly for orodispersible films (ODFs), the literature evidences increased acceptability and dose flexibility. Among the various available technologies for obtaining ODFs, such as solvent casting, hot-melt extrusion, and ink printing technologies, the solvent-free preparation methods exhibit significant advantages. This study investigated Vacuum Compression Molding (VCM) as a solvent-free manufacturing method for the preparation of flexible-dose pediatric orodispersible films. The experimental approach focused on selecting the appropriate plasticizer and ratios of the active pharmaceutical ingredient, diclofenac sodium, followed by the study of their impacts on the mechanical properties, disintegration time, and drug release profile of the ODFs. Additional investigations were performed to obtain insights regarding the solid-state properties. The ODFs obtained by VCM displayed adequate quality in terms of their critical characteristics. Therefore, this proof-of-concept study shows how VCM could be utilized as a standalone method for the production of small-scale ODFs, enabling the customization of doses to meet the individual needs of pediatric patients. Full article
(This article belongs to the Special Issue Advances in Pediatric Drug Formulations)
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Review

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15 pages, 271 KiB  
Review
Analgosedation in Pediatric Emergency Care: A Comprehensive Scoping Review
by Lorenzo Ciavola, Francesco Sogni, Benedetta Mucci, Eleonora Alfieri, Angela Tinella, Elena Mariotti Zani and Susanna Esposito
Pharmaceuticals 2024, 17(11), 1506; https://doi.org/10.3390/ph17111506 - 8 Nov 2024
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Abstract
Effective management of pain and anxiety in pediatric emergency room is crucial for ensuring both the physical and emotional well-being of young patients. Analgosedation, a combination of analgesia and sedation, is commonly used to facilitate various procedures in children. However, selecting the optimal [...] Read more.
Effective management of pain and anxiety in pediatric emergency room is crucial for ensuring both the physical and emotional well-being of young patients. Analgosedation, a combination of analgesia and sedation, is commonly used to facilitate various procedures in children. However, selecting the optimal agent and administration route remains challenging due to the unique pharmacological profiles and side effects of available drugs. This scoping review aims to provide a comprehensive analysis of the pharmacological agents used for procedural analgosedation in pediatric emergency settings, focusing on their efficacy, safety, administration routes, and potential side effects. A systematic review of the literature was conducted, focusing on key agents such as ketamine, midazolam, dexmedetomidine, fentanyl, and nitrous oxide. Studies were included based on their relevance to pediatric procedural sedation, particularly in emergency settings. Literature analysis showed that ketamine and fentanyl are effective for managing moderate to severe pain, with a rapid onset of action. Fentanyl is preferred for acute pain management following fractures and burns, while ketamine and midazolam are commonly used for emergency analgosedation. Dexmedetomidine, which induces sedation similar to natural sleep, is particularly effective in preventing pain and agitation during procedures and is well tolerated in children, especially those with developmental disorders. Nitrous oxide, when used in a 50% oxygen mixture, offers a valuable option for conscious sedation during mildly to moderately painful procedures, maintaining respiratory and airway reflexes. No single drug is ideal for all pediatric patients and procedures and the choice of agent should be tailored to the specific clinical scenario, considering both the sensory and affective components of pain. Future research should prioritize large-scale comparative studies, the exploration of combination therapies, and the development of non-pharmacological adjuncts to enhance the safety and efficacy of pediatric analgosedation. Full article
(This article belongs to the Special Issue Advances in Pediatric Drug Formulations)
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