A Research on the Additives and Regulatory Requirements for Pediatric Formulation

Year : 2024 | Volume :11 | Issue : 01 | Page : 28-45
By

Hamsa Priya M.

Chandana M

Darshan G

Shashank R

Srilekha M

Umesh Gr

Bharath B

Parina Mathema

  1. Student Aditya Bangalore Institute of Pharmacy Education and Research Karnataka India
  2. Student Aditya Bangalore Institute of Pharmacy Education and Research Karnataka India
  3. Student Aditya Bangalore Institute of Pharmacy Education and Research Karnataka India
  4. Student Aditya Bangalore Institute of Pharmacy Education and Research Karnataka India
  5. Student Aditya Bangalore Institute of Pharmacy Education and Research Karnataka India
  6. Student Aditya Bangalore Institute of Pharmacy Education and Research Karnataka India
  7. Student Aditya Bangalore Institute of Pharmacy Education and Research Karnataka India
  8. Associate Professor Aditya Bangalore Institute of Pharmacy Education and Research, Bangalore Karnataka India

Abstract

These days, pediatric considerations are incorporated early on in the creation of new medications. The guidelines and policies of European drug regulatory bodies served as the foundation for our investigation. The review comprehensively outlines excipients commonly found in pediatric medicine formulations. It identifies potentially harmful compounds flagged by scientific literature, stressing the necessity of rigorous safety checks, often involving toxicity studies. Excipients included in pediatric databases, like the STEP database, prioritize safety and toxicity considerations. This compilation ensures medications administered to children meet stringent safety standards. By emphasizing these factors, we aim to enhance the safety and efficacy of pediatric medications, advancing the field of pediatric medicine while safeguarding the well-being of young patients. Addressing the challenges surrounding diethylene glycol (DEG) and ethylene glycol (EG) as excipients encompasses understanding their complex physicochemical properties, navigating toxicity concerns, and adhering to stringent regulatory requirements. Emphasis is placed on implementing safety precautions to mitigate associated hazards. Moreover, compliance with legal mandates governing their use in medications is paramount. This multifaceted approach ensures the safe integration of DEG and EG into formulations, bolstering confidence in their efficacy and safety profiles. By tackling these challenges head-on and fostering compliance with regulatory standards, we strive to enhance the quality and safety of medications utilizing these excipients.

Keywords: Pediatric, Active pharmaceutical ingredients, Excipients, Medications, Dosage, FDA, EMA, Clinical studies.

[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production(rrjodfdp)]

How to cite this article: Hamsa Priya M., Chandana M, Darshan G, Shashank R, Srilekha M, Umesh Gr, Bharath B, Parina Mathema. A Research on the Additives and Regulatory Requirements for Pediatric Formulation. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2024; 11(01):28-45.
How to cite this URL: Hamsa Priya M., Chandana M, Darshan G, Shashank R, Srilekha M, Umesh Gr, Bharath B, Parina Mathema. A Research on the Additives and Regulatory Requirements for Pediatric Formulation. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2024; 11(01):28-45. Available from: https://journals.stmjournals.com/rrjodfdp/article=2024/view=143659





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Regular Issue Subscription Original Research
Volume 11
Issue 01
Received February 23, 2024
Accepted March 28, 2024
Published April 18, 2024