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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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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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Related Experiment Video

Updated: May 30, 2026

Utilization of Capsules for Negative Staining of Viral Samples within Biocontainment
08:22

Utilization of Capsules for Negative Staining of Viral Samples within Biocontainment

Published on: July 19, 2017

Capsule shells adulterated with tadalafil.

Bastiaan J Venhuis1, Jing Tan, Marjo J Vredenbregt

  • 1RIVM-National Institute for Public Health and the Environment, Bilthoven, The Netherlands. Bastiaan.Venhuis@rivm.nl

Forensic Science International
|August 5, 2011
PubMed
Summary
This summary is machine-generated.

A food supplement capsule shell was found to contain tadalafil, an erectile dysfunction drug. This discovery highlights that capsule shells can be used to hide undeclared pharmaceutical substances.

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Area of Science:

  • Pharmaceutical Analysis
  • Forensic Chemistry
  • Material Science

Background:

  • Food supplements are sometimes suspected of adulteration with synthetic drug substances.
  • Analysis of a suspicious food supplement initially focused on its contents, not the capsule shell.

Purpose of the Study:

  • To investigate the adulteration of a food supplement suspected of containing synthetic drugs.
  • To identify the method used for adulterating the food supplement.

Main Methods:

  • High-Performance Liquid Chromatography with Diode Array Detection (HPLC-DAD)
  • High-Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS)
  • Microscopy
  • RAMAN Spectroscopy

Main Results:

  • The capsule shell, not the content, was found to contain 2.85 mg of tadalafil, an erectile dysfunction drug.
  • Tadalafil was detected throughout the gelatin matrix of the capsule shell, both as particles and dissolved.
  • The adulteration likely occurred during manufacturing by incorporating tadalafil powder into the gelatin jelly.

Conclusions:

  • Capsule shells can serve as a vehicle for concealing pharmaceutical substances.
  • The manufacturing process of capsule shells presents a potential route for drug adulteration.
  • Forensic analysis of capsule shells is crucial for detecting hidden drug substances in supplements.