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Related Concept Videos

Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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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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Bioequivalence: Overview01:16

Bioequivalence: Overview

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

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Body:The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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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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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Multivariate analysis in the development of bioequivalent tablets containing bicalutamide.

Roman Goněc1, Aleš Franc2, Petr Doležel2

  • 1Masaryk Memorial Cancer Institute, Brno, Czechia.

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|October 30, 2020
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Summary

Micronization of poorly soluble bicalutamide significantly improves drug liberation and bioavailability. Statistical analysis confirmed optimal particle size distribution (PSD) for reproducible tablet production and bioequivalence to the originator drug.

Keywords:
Bicalutamidebioequivalencedissolutionmultivariate statisticsparticle size

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Area of Science:

  • Pharmaceutical Science
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Poorly soluble Active Pharmaceutical Ingredients (APIs) present significant challenges in drug formulation.
  • Developing effective strategies to enhance API liberation and bioavailability is crucial for the pharmaceutical industry.
  • Bicalutamide serves as a model compound for addressing poor solubility issues.

Purpose of the Study:

  • To investigate the impact of particle size reduction on the liberation of bicalutamide.
  • To identify optimal particle size distribution (PSD) parameters for improved tablet properties.
  • To statistically validate PSD limits for consistent laboratory and commercial-scale production.

Main Methods:

  • Particle size reduction (micronization) of bicalutamide.
  • Formulation of gelatinous capsules and subsequent granulation for tablet compression.
  • Comparative dissolution profiling against the originator product (Casodex 150 mg).
  • Multifactorial data analysis and statistical evaluation of PSD parameters (D(v,0.9), D[4,3]).

Main Results:

  • Micronization effectively improved API liberation and tablet properties.
  • Statistically determined PSD limits ensured reproducibility at both laboratory and commercial scales.
  • The formulated tablets demonstrated bioequivalence to the originator product (90% CI for ln AUC0-120: 99.8-111.9%; 90% CI for ln cmax: 101.1-112.9%).

Conclusions:

  • API micronization remains an efficient and cost-effective method for enhancing bioavailability.
  • Statistical multifactorial methods enhance the safety and reproducibility of pharmaceutical production.
  • Optimized PSD is critical for achieving bioequivalent generic drug products.