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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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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Biowaiver monographs for immediate-release solid oral dosage forms: codeine phosphate.

Arik Dahan1, Omri Wolk, Moran Zur

  • 1Department of Clinical Pharmacology, School of Pharmacy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, 84105, Israel.

Journal of Pharmaceutical Sciences
|May 3, 2014
PubMed
Summary
This summary is machine-generated.

Codeine phosphate solid dosage forms can potentially bypass in vivo bioequivalence studies. This biowaiver approach is supported by codeine's high solubility, absorption, and permeability, with risks unrelated to dosage form.

Keywords:
absorptionbioavailabilitybioequivalencebiopharmaceutics classification system (BCS)codeine phosphatedissolutionpermeabilitysolubility

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Area of Science:

  • Pharmacokinetics and Biopharmaceutics
  • Drug Regulatory Affairs

Background:

  • Multisource immediate-release solid dosage forms require bioequivalence (BE) assessment for regulatory approval.
  • The biowaiver procedure allows for waiving in vivo BE studies based on in vitro data and drug properties.
  • Codeine phosphate is commonly formulated as immediate-release solid dosage forms.

Purpose of the Study:

  • To review available biopharmaceutical and clinical data for codeine phosphate.
  • To assess the suitability of codeine phosphate for the biowaiver procedure for immediate-release solid dosage forms.
  • To determine if in vivo bioequivalence studies can be waived for multisource codeine phosphate products.

Main Methods:

  • Review of solubility data against World Health Organization (WHO), European Medicines Agency (EMA), and United States Food and Drug Administration (US FDA) criteria.
  • Assessment of in vivo absorption data based on human urinary excretion studies.
  • Evaluation of drug permeability using Caco-2 cell monolayers and rat intestinal perfusion models.

Main Results:

  • Codeine meets the 'highly soluble' definition according to major regulatory agencies (WHO, EMA, US FDA).
  • Codeine exhibits high absorption in humans (fraction of dose absorbed >90%) and high permeability.
  • Key risks (CYP2D6 polymorphism-related toxicity, abuse potential) are independent of the dosage form and do not impact bioequivalence considerations.

Conclusions:

  • Codeine is classified as a Class 1 drug (high solubility, high permeability).
  • The drug possesses manageable risks that are not relevant for bioequivalence assessment.
  • Codeine phosphate is a suitable candidate for biowaiver of in vivo bioequivalence studies for immediate-release solid dosage forms.