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Exploring paediatric oral suspension development: Challenges, requirements, and formulation advancements
Sachin S Gaikwad1, Javier O Morales2, Narayan B Lande3
1Department of Pharmaceutics, Sanjivani College of Pharmaceutical Education and Research, Savitribai Phule Pune University, At Sahajanandnagar, Post-Shinganapur, Tal-Kopargaon, Ahmednagar, Maharashtra 423603, India; Department of Pharmaceutics, MET's Institute of Pharmacy, Affiliated to Savitribai Phule Pune University, Bhujbal Knowledge City, Adgaon, Nashik 422003, India.
Developing safe and effective paediatric oral suspensions is crucial due to challenges with solid medications. This review highlights key considerations for formulation, excipient selection, and characterization to ensure successful paediatric therapies.
Area of Science:
- Pharmaceutical Sciences
- Paediatric Drug Delivery
Background:
- Oral suspensions are preferred for paediatric patients due to difficulties with solid dosage forms.
- Challenges include swallowing issues, bitter taste, poor bioavailability, and physiological variations in children.
- Ensuring successful treatment requires safe and effective paediatric oral suspensions.
Purpose of the Study:
- To review essential aspects of paediatric oral suspension development.
- To analyze considerations for selecting safe and effective excipients and preservatives.
- To address challenges in formulating stable, age-appropriate paediatric suspensions.
Main Methods:
- Literature review focusing on paediatric oral suspension formulation.
- Analysis of excipient and preservative selection criteria.
- Examination of factors influencing drug release and bioavailability in paediatric populations.
Main Results:
- Excipient selection is critical for safety, efficacy, and stability of paediatric oral suspensions.
- Drug release kinetics significantly impact oral absorption and bioavailability, especially for BCS class II drugs.
- Formulating a single, stable suspension for the diverse paediatric age group presents formulation challenges.
Conclusions:
- Careful selection of excipients and preservatives is paramount for paediatric oral suspension development.
- Optimizing drug release profiles can enhance bioavailability and minimize adverse effects in children.
- Further research is needed to address formulation stability and age-specific pharmacokinetic considerations.
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