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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Establishment of a Clinic-based Biorepository
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BCS-based biowaivers: Extension to paediatrics.

J Martir1, T Flanagan2, J Mann3

  • 1Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|September 17, 2020
PubMed
Summary
This summary is machine-generated.

Extending Biopharmaceutics Classification System (BCS)-based biowaivers to pediatric drug formulations requires caution. Solubility changes in children mean BCS biowaivers may not apply, necessitating careful evaluation.

Keywords:
Biopharmaceutics classification systemBiowaiversDose numberIn vitro dissolutionPaediatrics

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Area of Science:

  • Pharmaceutical Sciences
  • Biopharmaceutics
  • Paediatric Drug Development

Background:

  • Biopharmaceutics Classification System (BCS)-based biowaivers simplify bioequivalence assessment for adult drug products.
  • Paediatric populations may exhibit different drug solubility and permeability compared to adults.
  • Extrapolation of adult BCS criteria to pediatric formulations requires careful consideration due to physiological differences.

Purpose of the Study:

  • To identify compounds whose solubility classification may change between adult and pediatric populations.
  • To assess the risks associated with applying BCS-based biowaiver criteria to pediatric drug products.
  • To evaluate the suitability of current biowaiver conditions for pediatric formulation assessment.

Main Methods:

  • Dissolution studies of amoxicillin, prednisolone, and amlodipine IR formulations were performed.
  • USP II (paddle) and mini-paddle apparatus were used across three pH conditions (1.2, 4.5, 6.8).
  • Three dissolution setups were tested: typical BCS biowaiver, adult bioequivalence (250 mL), and pediatric (50 mL) volumes.

Main Results:

  • Drug solubility classification can differ between adult and pediatric populations.
  • Scaling down volumes in dissolution testing does not automatically ensure the validity of BCS-based biowaivers for pediatric use.
  • BCS-based biowaivers are not recommended when a drug's solubility class may change from adult to pediatric populations.

Conclusions:

  • Extending BCS-based biowaivers to pediatric formulations is complex and not a simple volume adjustment.
  • The risk of altered drug solubility in pediatric populations necessitates a cautious approach to BCS biowaiver application.
  • Further research into the pediatric gastrointestinal environment is crucial for developing appropriate biopharmaceutical tools for pediatric drug formulation evaluation.