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Development of ARV FDC for Pediatric Use: Challenges and Considerations

Pediatric formulation development for antiretroviral drugs presents unique challenges, including diverse dosage needs, limited patient populations for efficacy studies, and potential metabolic differences compared to adults. Key considerations include taste preferences, chemical stability, and packaging compatibility. Successful formulations must balance stability, preservative efficacy, and palatability to ensure adherence. Notable formulations available include pediatric oral solutions for abacavir, lamivudine, and lopinavir/ritonavir, among others. Addressing these complexities is essential for improving pediatric patient outcomes.

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Development of ARV FDC for Pediatric Use: Challenges and Considerations

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  1. Development of ARV FDC for Pediatric use Alan Parr, Pharm.D., Ph.D. GlaxoSmithKline Research Triangle Park, NC

  2. Presentation Outline • Introduction • Physical/Chemical considerations • Formulation consideration • Packaging considerations • Conclusions E://presentations/WHO110304a

  3. Introduction • Development of formulations for pediatric population is very challenging for the following reasons: • Requires a wide range of doses (not achievable using solid dosage forms) • Limited patient populations to evaluate efficacy of compound/product • Difficulty in doing studies in this patient population • Potential biological differences (e.g., metabolic differences) between pediatric patients and adult patients E://presentations/WHO110304a

  4. Overall Formulation considerations for Pediatric Formulations • Need to be aware of taste preference which differ significantly around the world • Need to be aware of sweetness preferences which differ from around the world • Need to be aware of the limit of inactive ingredients administered per the dosing regimen E://presentations/WHO110304a

  5. Physical/Chemical considerations for Pediatric formulations • Solubility of drug substance • Stability of the drug substance in solution • Compatibility of drug substance with excipients (e.g., flavors, sweeteners, preservatives) • Stability of multiple drug substances in a given formulation E://presentations/WHO110304a

  6. Formulation consideration for Pediatric formulations (Chemical basis) • Chemical stability of the drug substance • Chemical stability of the preservative system • Chemical stability of flavor and sweetening system • Impact of the buffering system on drug substance stability E://presentations/WHO110304a

  7. Formulation consideration for Pediatric formulations (Physical basis) • Loss of taste (e.g., sweetness and flavor) • pH of the product • Viscosity of the product • Change of color of the product • Mouth feel E://presentations/WHO110304a

  8. Packaging considerations for Pediatric formulations • Compatibility of packaging components with: • The drug substance • The preservatives • The flavors and sweeteners • The pH and buffering system • Absorption or adsorption of drug and inactive ingredients • Amount and type of leachables • Headspace in the container E://presentations/WHO110304a

  9. Conclusions • Development of a pediatric formulation is very challenging and complex • It requires a balance between a number of different variables to ensure a consistent product with appropriate stability, preservative system, and acceptable taste E://presentations/WHO110304a

  10. Back-up Slides E://presentations/WHO110304a

  11. Available Formulations that could be used in Pediatric Patients • Abacavir (Ziagen®) Pediatric Oral Solution (GSK) • Didanosine (Videx®) Pediatric Powder (BMS) • Lamivudine (Epivir®) Oral Solution (GSK) • Stavudine (Zerit®) Oral Solution (BMS) • Zidovudine (Retrovir®) Syrup (GSK) • Nevirapine (Viramune®) Suspension (BI) • Amprenavir (Agenerase®) Pediatric Oral Solution (GSK) • Fosamprenavir (Lexiva®) Suspension* (GSK) • Lopinavir/Ritonavir (Kaletra®) Pediatric Oral Solution (Abbott) • Nelfinavir (Viracept®) Powder for Oral Suspension (Agouron/Pfizer) • Ritonavir (Norvir®) Oral Solution (Abbott) * Under development E://presentations/WHO110304a

  12. Formulation Options for Pediatric patients • Oral solutions • Oral suspensions • Sachets • Note: need to re-constitute with a specific volume of liquid to dose on a mg/kg or mg/m2 E://presentations/WHO110304a

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