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

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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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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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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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Drug Dissolution: Requirements and Profile Comparison01:14

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Transitioning Amiodarone Tablet Manufacturing: A Comparative Study of Batch and Continuous Wet Granulation.

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QbD-Based Formulation Development of Amiodarone Hydrochloride Tablet.

Chae-Won Jeon1, Ju-Hyun Yoon1, Joo-Eun Kim2

  • 1Department of Biopharmaceutical Chemistry, Kookmin University, Seoul 02707, Republic of Korea.

Pharmaceutics
|February 27, 2026
PubMed
Summary

This study developed a generic amiodarone tablet, ensuring a stable supply of this essential orphan drug. The new formulation demonstrates pharmaceutical equivalence to the reference drug, improving accessibility and potentially lowering healthcare costs.

Keywords:
amiodarone hydrochloridedesign of experimentdissolutionflowabilityquality by design

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Formulation Science

Background:

  • Amiodarone, an essential orphan drug, faces supply instability due to limited profitability.
  • A stable domestic supply chain is crucial for this medication.
  • Current market instability necessitates the development of a generic equivalent.

Purpose of the Study:

  • To develop a generic amiodarone tablet with pharmaceutical equivalence to the reference product.
  • To establish a stable supply chain for amiodarone.
  • To reduce national healthcare costs through improved drug accessibility.

Main Methods:

  • Utilized a Quality by Design (QbD) approach with factorial design.
  • Employed Design of Experiments (DoE) to identify Critical Material Attributes (CMAs).
  • Optimized formulation by adjusting lactose monohydrate addition and granulation parameters.

Main Results:

  • Achieved excellent powder flowability (Carr's Index 15.8%) by modifying formulation process.
  • Identified optimal povidone K25 (5.71%) and purified water (40 mg/T) levels.
  • Demonstrated dissolution and bioequivalence (PK profile) matching the reference drug across various pH buffers.

Conclusions:

  • The developed generic amiodarone tablet formulation ensures a stable domestic supply.
  • The formulation is bioequivalent and pharmaceutically equivalent to the reference drug.
  • Findings support continuous manufacturing implementation and reduced healthcare expenditures.