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Children
Special Issues
Advances in Pediatric Formulations Update
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Advances in Pediatric Formulations Update

A special issue of Children (ISSN 2227-9067). This special issue belongs to the section "Global Pediatric Health".

Deadline for manuscript submissions: 15 November 2024 | Viewed by 20938

Special Issue Editor

Dr. Hassan Almoazen

E-Mail Website
Guest Editor
College of Pharmacy, University of Tennessee Health Science Center, 881 Madison Ave, Rm 661, Memphis, TN 38163, USA
Interests: paediatric formulations; enhancing drug solubility; enhancing drug stability; enhancing drug permeability; design of prodrugs
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

In the past several years, we have witnessed a remarkable interest and encouragement from the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the National Institute of Health (NIH) toward pediatric formulations. Despite all incentives offered by the above governmental agencies, however, there are still many therapeutic agents lacking pediatric-friendly drug delivery systems.

One of the major challenges that academic scientists have traditionally faced in this area is lack of funding and support for this line of research, with most of the governmental funding going toward the advancement of novel drug delivery systems with little impact on the pediatric population. Many novel and targeted drug delivery systems have faced many challenges when it comes to translation into pediatric patients. Some of these challenges include excipients’ toxicity and limited stability and shelf life, but the major limitation has been pursuing the most invasive drug delivery route (parenteral delivery). It is generally accepted that translational drug delivery systems are friendlier, easier to use, and can impact the safety and prosperity of children as well as profoundly prolong their adherence to medication when designed properly. Due to the lack of funding in this area, however, very few academician scientists have taken on the challenge and pursued this area for a career.

The purpose of this Special Issue of Children is to draw attention to the importance of pediatric formulations and to provide scientists with a platform to publish their novel research work in this area. 

This Special Issue seeks novel topics pertaining to “Advances in Pediatric Formulations”. Original research as well as reviews will be considered for publication.

We look forward to receiving your contributions.

Dr. Hassan Almoazen
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. Children 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 2400 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 formulations
  • drug stability
  • drug solubility
  • drug permeability
  • prodrug design
  • sublingual absorption
  • oral absorption
  • transdermal delivery
  • pulmonary delivery
  • fast dissolving tablets
  • fast dissolving films
  • microneedles
  • oral niosomes

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Published Papers (4 papers)

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Research

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16 pages, 4753 KiB  
Article
Application of Galenic Strategies for Developing Gastro-Resistant Omeprazole Formulation for Pediatrics
by Khadija Rouaz-El-Hajoui, Encarnación García-Montoya, Marc Suñé-Pou, Josep María Suñé-Negre and Pilar Pérez-Lozano
Children 2024, 11(8), 945; https://doi.org/10.3390/children11080945 - 5 Aug 2024
Viewed by 788
Abstract
Objectives: This study addresses a critical need in pediatric pharmacotherapy by focusing on the development of an enteric formulation of omeprazole for pediatric use. Omeprazole, a widely used proton pump inhibitor, is essential for treating various gastrointestinal disorders in children. The main objective [...] Read more.
Objectives: This study addresses a critical need in pediatric pharmacotherapy by focusing on the development of an enteric formulation of omeprazole for pediatric use. Omeprazole, a widely used proton pump inhibitor, is essential for treating various gastrointestinal disorders in children. The main objective is to design a compounding formula that can be prepared in hospital pharmacy services without the need for industrial equipment, which is often unavailable in these settings. Methods: The research applied different galenic strategies to overcome the challenges of omeprazole’s instability in acidic environments and its complex pharmacokinetic and physicochemical properties. The experiments were conducted sequentially, employing salting out, ionic gelation, and matrix granulation strategies. Based on the results obtained, the control conditions and parameters for the various trials were established. Results: Among the techniques used, wet granulation proved to be the most promising, achieving a gastro-resistance level of 44%. In contrast, the ionic gelation and salting-out techniques did not yield satisfactory results. Conclusions: The findings of this study underscore the need to adopt alternative formulation strategies to ensure the stability of omeprazole. This goal requires a multidisciplinary approach and continuous effort to design omeprazole formulations that meet quality standards and appropriate gastro-resistance requirements. Full article
(This article belongs to the Special Issue Advances in Pediatric Formulations Update)
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Review

Jump to: Research, Other

12 pages, 1100 KiB  
Review
Formulation Challenges and Strategies to Develop Pediatric Dosage Forms
by Wedad A. Malkawi, Enas AlRafayah, Mohammad AlHazabreh, Salam AbuLaila and Abeer M. Al-Ghananeem
Children 2022, 9(4), 488; https://doi.org/10.3390/children9040488 - 1 Apr 2022
Cited by 22 | Viewed by 7450
Abstract
The development of pediatric-specific dose forms is particularly difficult due to a variety of factors relating to pediatric population differences from adult populations. The buccal dosage form is considered a good alternative to oral dosage form if the latter cannot be used in [...] Read more.
The development of pediatric-specific dose forms is particularly difficult due to a variety of factors relating to pediatric population differences from adult populations. The buccal dosage form is considered a good alternative to oral dosage form if the latter cannot be used in pediatric patients. Both oral and buccal dosage formulations uphold great application qualities for pediatric patients. This review sheds light on both oral and buccal, as they are the most convenient dosage forms for pediatrics. The use of adult drugs to treat children is a legislation concern, as it may result in incorrect dose, safety, and efficacy. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are two key pieces of legislation that encourage and regulate pediatric medication research. Both contribute to a well-balanced approach to emphasizing critical safety and efficacy warnings for the of medications within pediatric populations. These contributions are what enable companies to continue making significant investments in pediatric drug developments. Despite the importance of investigating medicines for children, there is still a demand for pediatric-specific formulations and dosage forms. Many formulations and dosage forms can be designed, among which the buccal drug delivery seems a good modality for pediatric-friendly dosage forms. The main issues associated with these pediatric dosage forms development, particularly clinical and physiological factors, are discussed in this review. In addition, formulation developments and regulatory expectations are highlighted. In turn, suggestions are made to potentially improve future pediatric formulation development. Full article
(This article belongs to the Special Issue Advances in Pediatric Formulations Update)
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28 pages, 3258 KiB  
Review
An Update on Pharmaceutical Strategies for Oral Delivery of Therapeutic Peptides and Proteins in Adults and Pediatrics
by Nirnoy Dan, Kamalika Samanta and Hassan Almoazen
Children 2020, 7(12), 307; https://doi.org/10.3390/children7120307 - 19 Dec 2020
Cited by 35 | Viewed by 8851
Abstract
While each route of therapeutic drug delivery has its own advantages and limitations, oral delivery is often favored because it offers convenient painless administration, sustained delivery, prolonged shelf life, and often lower manufacturing cost. Its limitations include mucus and epithelial cell barriers in [...] Read more.
While each route of therapeutic drug delivery has its own advantages and limitations, oral delivery is often favored because it offers convenient painless administration, sustained delivery, prolonged shelf life, and often lower manufacturing cost. Its limitations include mucus and epithelial cell barriers in the gastrointestinal (GI) tract that can block access of larger molecules including Therapeutic protein or peptide-based drugs (TPPs), resulting in reduced bioavailability. This review describes these barriers and discusses different strategies used to modify TPPs to enhance their oral bioavailability and/or to increase their absorption. Some seek to stabilize the TTPs to prevent their degradation by proteolytic enzymes in the GI tract by administering them together with protease inhibitors, while others modify TPPs with mucoadhesive polymers like polyethylene glycol (PEG) to allow them to interact with the mucus layer, thereby delaying their clearance. The further barrier provided by the epithelial cell membrane can be overcome by the addition of a cell-penetrating peptide (CPP) and the use of a carrier molecule such as a liposome, microsphere, or nanosphere to transport the TPP-CPP chimera. Enteric coatings have also been used to help TPPs reach the small intestine. Key efficacious TPP formulations that have been approved for clinical use will be discussed. Full article
(This article belongs to the Special Issue Advances in Pediatric Formulations Update)
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Other

Jump to: Research, Review

13 pages, 478 KiB  
Opinion
How Compounding Pharmacies Fill Critical Gaps in Pediatric Drug Development Processes: Suggested Regulatory Changes to Meet Future Challenges
by Robert B. MacArthur, Lisa D. Ashworth, Keming Zhan and Richard H. Parrish II
Children 2022, 9(12), 1885; https://doi.org/10.3390/children9121885 - 1 Dec 2022
Cited by 4 | Viewed by 3072
Abstract
Drugs administered to children in the United States fall into two broad categories: (1) those that have followed the US Food and Drug Administration (US-FDA) pediatric drug approval process and are marketed as finished dosage forms with pediatric labeling; and (2) all others, [...] Read more.
Drugs administered to children in the United States fall into two broad categories: (1) those that have followed the US Food and Drug Administration (US-FDA) pediatric drug approval process and are marketed as finished dosage forms with pediatric labeling; and (2) all others, many of which are used “off-label”. The use of most drug products in pediatrics is still off label, often requiring special preparation, packaging, and, in some cases, compounding into preparations. The latter category includes compounded preparations that incorporate either a US-FDA approved finished dosage form (e.g., a sterile solution, sterile powder, nonsterile capsules, oral solution, crushed tablets, etc.), or rely on bulk active pharmaceutical ingredients (APIs). Compounded preparations are prepared for individual patients in 503A pharmacies, or on a larger scale and not just for specific patients, in licensed 503B establishments. Critical gaps in the current drug approval process for finished dosage forms have created a proverbial “Gordian knot” that needs to be untangled thoughtfully to facilitate increased production and approval of vitally needed medications for pediatric patients. This opinion will describe current regulatory processes pertaining to pediatrics-only drug approval in the United States. Additionally, discussed are steps required for a product to acquire pediatric labeling. Gaps in regulatory approval pathways for both manufactured and compounded pediatric drugs will be identified, especially those that complicate and slow development and availability to patients. Finally, suggestions for regulatory modifications that may enhance pediatric product development strategies for both manufacturers and compounders are suggested. Full article
(This article belongs to the Special Issue Advances in Pediatric Formulations Update)
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