View Article

Abstract

Due to physiological, pharmacokinetic, and compliance-related considerations, pediatric medication formulations are very different from adult dose forms. Safety, effectiveness, palatability, and dose flexibility are the main considerations in the creation of pediatric marketed formulations. A variety of commercially available pediatric formulations, including syrups, suspensions, dry syrups, tablets, and innovative dosage forms, are highlighted in this review. Based on factors such stability, patient compliance, dosage accuracy, and convenience, a comparative analysis is provided. To improve therapeutic results in children, recent developments focus on taste-masked, preservative-free, and user-friendly formulations.

Keywords

Pediatric Formulations

Introduction

Pediatric patients are a diverse group with particular treatment requirements. Children's swallowing abilities, taste preferences, and metabolic variances make administering drugs to them difficult. There is a need for specially created pediatric preparations because many traditional adult formulas are inappropriate. Due to their greater acceptability and simplicity of administration, oral formulations make up the bulk of pediatric formulations. However, dose flexibility, stability, and palatability must be taken into account while designing a formulation.

2. Types of Pediatric Preparations on the Market

Pediatric formulations fall under the following general categories:

1. Formulations that are ready to use

Syrups

• Oral remedies

Suspensions

Chewable tablets

• ODTs, or oral disintegrating tablets

These formulations are easy to use right away and don't need to be altered before administration.

2. Formulations that need to be modified or reconstituted

• Dry syrups (powder for suspension)

• Oral suspension granules

• Tablets that disperse

• Oral solution powders

These formulations are recommended for stability concerns and need to be diluted or prepared before use.

3. Comparative Study of Paediatric Dosage Forms

Dosage Form

Advantages

Disadvantages

Examples (Marketed)

Syrups

Palatable, easy administration

High sugar content, microbial growth

Paracetamol syrup

Suspensions

Suitable for insoluble drugs, better stability

Sedimentation, shaking required

Ibuprofen suspension

Dry Syrups

Enhanced shelf-life, stability

Requires reconstitution, risk of dosing errors

Antibiotic dry syrups

Solutions

Uniform dosing, rapid absorption

Stability issues, taste masking needed

Vitamin solutions

Chewable Tablets

Convenient, portable

Not suitable for very young children

Multivitamin chewables

ODTs (Orally Disintegrating Tablets)

No need for water, fast action

Costly, fragile

Ondansetron ODT

4. Evaluation Parameters

4.1 Taste

Taste masking is essential since children's obedience is decreased by unpleasant taste.

4.2 Consistency

Liquid formulations are less stable.

• Dry formulations: more stable

Because they prolong shelf life by preventing deterioration, dry syrups are favored.

4.3 Accuracy of Dosage

• Liquids: adaptable but prone to measurement errors • Tablets: precise but less adaptable

5. Challenges in Paediatric Formulation Development

  • Dose adjustment based on body weight
  • Taste masking of bitter drugs
  • Stability of formulation
  • Selection of safe excipients
  • Lack of age-appropriate formulations

6. Current Developments in Pediatric Formulations

Current developments in pediatric preparations on the market include:

• Multiparticulate systems and mini-tablets • ODTs, or oral disintegrating tablets • Granules and powders based on sachets • Formulations without preservatives These developments enhance patient compliance, safety, and dose flexibility.

DISCUSSION

Comparative analysis indicates that no single dosage form is ideal for all paediatric patients. Liquid formulations are widely preferred for infants and young children, whereas solid dosage forms are gaining importance due to better stability and convenience. The choice depends on age, disease condition, drug properties, and patient compliance.

CONCLUSION

As pharmaceutical technology has advanced, pediatric marketed formulations have changed dramatically. The market is dominated by syrups and suspensions, but more recent dose forms including ODTs and mini-tablets are becoming more well-liked. For pediatric patients, the best course of treatment requires a balanced approach that takes stability, palatability, and dosage accuracy into account.

REFERENCES

  1. Ivanovska V, Rademaker CMA, van Dijk L, Mantel-Teeuwisse AK. Pediatric drug formulations: a review of challenges and progress. Pediatrics. 2014;134(2):361–372.
  2. Tuleu C, Breitkreutz J. Educational paper: formulation-related issues in pediatric clinical pharmacology. Clin Ther. 2013;35(11):1677–1688.
  3. Cornilă A, Iurian S, Tomuță I, Porfire A. Orally dispersible dosage forms for pediatric use. Pharmaceutics. 2022;14(8):1621.
  4. Wiedey R, Kokott M, Breitkreutz J. Orodispersible tablets for pediatric use. Expert Opin Drug Deliv. 2021;18(12):1873–1890.
  5. Comoglu T, Ozyilmaz ED. Mini-tablets for pediatric drug delivery. Pharm Dev Technol. 2019;24(7):902–914.
  6. Batchelor H, Marriott J. Paediatric pharmacotherapy: challenges and solutions. Br J Clin Pharmacol. 2015;79(3):405–417.
  7. Meyers RS. Oral dosage forms for pediatric patients. J Pediatr Pharmacol Ther. 2024;29(1):22–31.
  8. Jug ML, et al. Stability of pediatric oral liquids. Pharmaceutics. 2023;15(4):1023.
  9. Walsh J, et al. Pediatric oral formulations: challenges. Int J Pharm. 2018;536(2):547–558.
  10. Nunn T, Williams J. Formulation of medicines for children. Br J Clin Pharmacol. 2005;59(6):674–676.
  11. Breitkreutz J. Pediatric drug delivery systems. Eur J Pharm Biopharm. 2017; 113:1–3.
  12. Stoltenberg I, et al. Advances in pediatric drug delivery. J Control Release. 2021; 330:1–10.
  13. Thompson KC, et al. Pediatric dosage considerations. Pediatr Drugs. 2020;22(4):375–386.
  14. Liu F, et al. Patient-centered pharmaceutical design. Int J Pharm. 2014;469(1):109–122.
  15. van Riet-Nales DA, et al. Acceptability of oral dosage forms. Pediatrics. 2016;137(3): e20153162.
  16. Kozarewicz P. Regulatory perspectives on pediatric medicines. Eur J Pharm Sci. 2014; 57:151–154.
  17. World Health Organization. Development of paediatric medicines: points to consider. Geneva: WHO; 2012.
  18. US Food and Drug Administration. Pediatric Research Equity Act (PREA). FDA; 2020.

Reference

  1. Ivanovska V, Rademaker CMA, van Dijk L, Mantel-Teeuwisse AK. Pediatric drug formulations: a review of challenges and progress. Pediatrics. 2014;134(2):361–372.
  2. Tuleu C, Breitkreutz J. Educational paper: formulation-related issues in pediatric clinical pharmacology. Clin Ther. 2013;35(11):1677–1688.
  3. Cornilă A, Iurian S, Tomuță I, Porfire A. Orally dispersible dosage forms for pediatric use. Pharmaceutics. 2022;14(8):1621.
  4. Wiedey R, Kokott M, Breitkreutz J. Orodispersible tablets for pediatric use. Expert Opin Drug Deliv. 2021;18(12):1873–1890.
  5. Comoglu T, Ozyilmaz ED. Mini-tablets for pediatric drug delivery. Pharm Dev Technol. 2019;24(7):902–914.
  6. Batchelor H, Marriott J. Paediatric pharmacotherapy: challenges and solutions. Br J Clin Pharmacol. 2015;79(3):405–417.
  7. Meyers RS. Oral dosage forms for pediatric patients. J Pediatr Pharmacol Ther. 2024;29(1):22–31.
  8. Jug ML, et al. Stability of pediatric oral liquids. Pharmaceutics. 2023;15(4):1023.
  9. Walsh J, et al. Pediatric oral formulations: challenges. Int J Pharm. 2018;536(2):547–558.
  10. Nunn T, Williams J. Formulation of medicines for children. Br J Clin Pharmacol. 2005;59(6):674–676.
  11. Breitkreutz J. Pediatric drug delivery systems. Eur J Pharm Biopharm. 2017; 113:1–3.
  12. Stoltenberg I, et al. Advances in pediatric drug delivery. J Control Release. 2021; 330:1–10.
  13. Thompson KC, et al. Pediatric dosage considerations. Pediatr Drugs. 2020;22(4):375–386.
  14. Liu F, et al. Patient-centered pharmaceutical design. Int J Pharm. 2014;469(1):109–122.
  15. van Riet-Nales DA, et al. Acceptability of oral dosage forms. Pediatrics. 2016;137(3): e20153162.
  16. Kozarewicz P. Regulatory perspectives on pediatric medicines. Eur J Pharm Sci. 2014; 57:151–154.
  17. World Health Organization. Development of paediatric medicines: points to consider. Geneva: WHO; 2012.
  18. US Food and Drug Administration. Pediatric Research Equity Act (PREA). FDA; 2020.

Photo
Shivam
Corresponding author

Ch. Sughar Singh Pharmacy College, Jaswantnagar, Etawah, India

Photo
Saurav Singh Sikarwar
Co-author

Ch. Sughar Singh Pharmacy College, Jaswantnagar, Etawah, India

Photo
Pradeep Kumar
Co-author

Ch. Sughar Singh Pharmacy College, Jaswantnagar, Etawah, India

Shivam*, Saurav Singh Sikarwar, Pradeep Kumar, A Comparative Study of Marketed Pediatric Formulations, Int. J. Med. Pharm. Sci., 2026, 2 (5), 172-174. https://doi.org/10.5281/zenodo.20041836

More related articles
A Review on Occular Inserts and Implants...
Abbineni Anusha, Pasam Jyothirmayi, Dr. N. Srinivasa Rao, K. Chin...
A Review on Biomarkers for Early Detection of Live...
Mulla Samir Ismail, Sunil Dangre, ...
Formulation and Characterization of Opipramol Dihydrochloride Loaded Fast Dissol...
Aman Savita, Dr. Avinash Kondalkar, Muraree Lal, Shankar , Jogendra Singh, ...
Formulation and Evaluation of Mefenamic Acid Emulgel for Topical Delivery...
Pradnya Patil, H. Doddayya, Charulatha, Saniya Samreen, Chetan Kumar G., ...
Related Articles
Formulation And Evaluation of Herbal Nutritional Cookies...
Vaishnavi Chitalkar, Gauri Kulkarni, Ganesh Barkade, ...
Nephroprotective Activity of Manilkara Zapota Nano-Suspension Formulation on Gen...
Sahana Shailesh Vajramatti, Salma Bhanu, Marigouda Patil, Lingaraj Anawal, Sanjay Havaragi, Chandras...
A COMPREHENSIVE REVIEW ON PICRORHIZAKURROA (KUTKI): PHYTOCHEMISTRY, PHARMACOLOGY...
Minakshi Khairnar, Yogeshwari Soanwane, Rohit Thakare, Darshan Sonawane, Siddhesh Nandan, Rakesh Jad...
More related articles
A Review on Occular Inserts and Implants...
Abbineni Anusha, Pasam Jyothirmayi, Dr. N. Srinivasa Rao, K. Chinababu, Akula Lavanya, L. Bhandhavya...
A Review on Occular Inserts and Implants...
Abbineni Anusha, Pasam Jyothirmayi, Dr. N. Srinivasa Rao, K. Chinababu, Akula Lavanya, L. Bhandhavya...