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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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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 products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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Authentication of pharmaceutical vials.

Klara Dégardin1, Marguerite Jamet1, Aurélie Guillemain1

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Talanta
|March 17, 2019
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Summary

Analytical tools effectively authenticate pharmaceutical vials by detecting counterfeit components and linking them. This aids investigations and informs the design of more secure, counterfeit-resistant packaging.

Keywords:
CounterfeitsIdentificationPackagingPharmaceuticalsVials

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Area of Science:

  • Pharmaceutical analysis
  • Forensic science
  • Materials science

Background:

  • Counterfeit injectable medicines pose a significant public health risk.
  • Pharmaceutical vials are frequently assembled from genuine and fake or manipulated parts, making visual authentication challenging.
  • Distinguishing subtle differences in individual vial components requires advanced analytical support.

Purpose of the Study:

  • To evaluate the efficacy of various analytical techniques in authenticating pharmaceutical vial packaging.
  • To identify counterfeit components within injectable medicine vials.
  • To establish links between counterfeit vials based on packaging composition.

Main Methods:

  • Analysis of 31 counterfeit vials using Raman spectroscopy and microscopy, X-ray fluorescence spectroscopy, Infrared spectroscopy, and optical microscopy.
  • Visual comparison of vial components against reference standards.
  • Chemical and elemental composition analysis of flip-off caps, aluminum crimping caps, stoppers, glass vials, and labels.

Main Results:

  • Multiple analytical tools successfully supported visual inspection for authenticating various vial components.
  • Eight counterfeit vials from different seizures were linked through the chemical or elemental composition of their parts.
  • The study demonstrated the capability to detect manipulations and understand counterfeiting methods.

Conclusions:

  • Analytical techniques are crucial for robust pharmaceutical packaging authentication, especially for injectable vials.
  • Linking counterfeit vials via packaging analysis provides valuable intelligence for ongoing investigations.
  • Understanding counterfeiting techniques through packaging analysis aids in developing more secure and counterfeit-resistant pharmaceutical packaging designs.