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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

799
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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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

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

406
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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In Vitro Drug Dissolution: Alternative Methods01:17

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

463
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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In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
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Contemporary Techniques and Prospects in Pharmaceutical Tablet Surface Analysis.

Matjaž Finšgar1

  • 1Faculty of Chemistry and Chemical Engineering, University of Maribor, 2000 Maribor, Slovenia.

ACS Measurement Science Au
|April 20, 2026
PubMed
Summary

Surface analysis techniques like ToF-SIMS and XPS offer detailed chemical characterization of pharmaceutical tablets. These methods provide spatially resolved insights crucial for formulation development and quality control.

Keywords:
3D-profilometryAFMToF-SIMSXPSpharmaceutical tabletsolid dosage forms

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Area of Science:

  • Pharmaceutical Sciences
  • Surface Chemistry
  • Analytical Chemistry

Background:

  • Solid pharmaceutical dosage forms require precise chemical characterization for efficacy and safety.
  • Conventional methods often lack the spatial resolution to analyze complex tablet surfaces and subsurface regions.

Purpose of the Study:

  • To demonstrate the application of complementary surface analysis techniques for the chemical characterization of pharmaceutical tablets.
  • To investigate the capabilities of ToF-SIMS, XPS, AFM, and 3D profilometry in analyzing tablet formulations.

Main Methods:

  • Utilized time-of-flight secondary ion mass spectrometry (ToF-SIMS) with tandem MS/MS for API marker definition.
  • Employed X-ray photoelectron spectroscopy (XPS) for elemental and chemical state quantification.
  • Applied atomic force microscopy (AFM) and 3D profilometry for surface topography and roughness analysis.
  • Integrated gas cluster ion beam (GCIB) sputtering for depth profiling and subsurface analysis.

Main Results:

  • ToF-SIMS provided molecularly specific maps and depth profiles, localizing active pharmaceutical ingredients (APIs) and excipients.
  • XPS offered quantitative elemental and chemical state information on the surface and subsurface.
  • Surface analytical techniques revealed API and excipient segregation and interfacial layering.
  • Demonstrated submicrometric imaging and large-area mapping capabilities.

Conclusions:

  • Surface analysis techniques provide spatially resolved insights essential for pharmaceutical formulation development, troubleshooting, and quality control.
  • These methods can confirm API/excipient localization, assess surface properties, detect contaminants, and compare batches.
  • Limited adoption is attributed to specialized equipment and expertise requirements.