Formulation Challenges and Strategies to Develop Pediatric Dosage Forms
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....
| Những tác giả chính: | , , , , |
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| Định dạng: | Bài viết |
| Ngôn ngữ: | English |
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MDPI AG
2022-04-01
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| Loạt: | Children |
| Những chủ đề: | |
| Truy cập trực tuyến: | https://www.mdpi.com/2227-9067/9/4/488 |
| _version_ | 1827621248606142464 |
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| author | Wedad A. Malkawi Enas AlRafayah Mohammad AlHazabreh Salam AbuLaila Abeer M. Al-Ghananeem |
| author_facet | Wedad A. Malkawi Enas AlRafayah Mohammad AlHazabreh Salam AbuLaila Abeer M. Al-Ghananeem |
| author_sort | Wedad A. Malkawi |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T11:00:57Z |
| format | Article |
| id | doaj.art-37d9dfd5bd0e4f48b5d0af8ca2f7d38b |
| institution | Directory Open Access Journal |
| issn | 2227-9067 |
| language | English |
| last_indexed | 2024-03-09T11:00:57Z |
| publishDate | 2022-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Children |
| spelling | doaj.art-37d9dfd5bd0e4f48b5d0af8ca2f7d38b2023-12-01T01:18:06ZengMDPI AGChildren2227-90672022-04-019448810.3390/children9040488Formulation Challenges and Strategies to Develop Pediatric Dosage FormsWedad A. Malkawi0Enas AlRafayah1Mohammad AlHazabreh2Salam AbuLaila3Abeer M. Al-Ghananeem4College of Art and Science, University of Louisville, Louisville, KY 40208, USACollege of Pharmacy, Jordan University of Science and Technology, Irbid 22110, JordanCollege of Pharmacy, Jordan University of Science and Technology, Irbid 22110, JordanCollege of Pharmacy, Jordan University of Science and Technology, Irbid 22110, JordanCollege of Pharmacy and Health sciences, Sullivan University, Louisville, KY 40205, USAThe 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.https://www.mdpi.com/2227-9067/9/4/488pediatricsdosage formformulation developmentoralbuccalregulatory |
| spellingShingle | Wedad A. Malkawi Enas AlRafayah Mohammad AlHazabreh Salam AbuLaila Abeer M. Al-Ghananeem Formulation Challenges and Strategies to Develop Pediatric Dosage Forms Children pediatrics dosage form formulation development oral buccal regulatory |
| title | Formulation Challenges and Strategies to Develop Pediatric Dosage Forms |
| title_full | Formulation Challenges and Strategies to Develop Pediatric Dosage Forms |
| title_fullStr | Formulation Challenges and Strategies to Develop Pediatric Dosage Forms |
| title_full_unstemmed | Formulation Challenges and Strategies to Develop Pediatric Dosage Forms |
| title_short | Formulation Challenges and Strategies to Develop Pediatric Dosage Forms |
| title_sort | formulation challenges and strategies to develop pediatric dosage forms |
| topic | pediatrics dosage form formulation development oral buccal regulatory |
| url | https://www.mdpi.com/2227-9067/9/4/488 |
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