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Related Concept Videos

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

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

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

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...
In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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

In Vitro Drug Dissolution: Compendial Testing Models II

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, maintaining...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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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Related Experiment Video

Updated: Jun 1, 2026

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
09:24

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

Published on: August 22, 2017

Content uniformity studies in tablets by NIR-CI.

J Cruz1, M Blanco

  • 1Unitat de Química Analítica, Facultat de Ciencies, Universitat Autònoma de Barcelona, 08193 Bellaterra, Barcelona, Spain.

Journal of Pharmaceutical and Biomedical Analysis
|June 4, 2011
PubMed
Summary
This summary is machine-generated.

Near infrared chemical imaging (NIR-CI) analyzed acetylsalicylic acid (ASA) tablets from four brands. This pharmaceutical analysis confirmed all brands meet European Pharmacopoeia specifications for ASA content and distribution.

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Area of Science:

  • Pharmaceutical Analysis
  • Chemical Imaging
  • Spectroscopy

Background:

  • Near infrared chemical imaging (NIR-CI) offers rich data from single samples.
  • NIR-CI is increasingly used for pharmaceutical analysis, including quantitative composition and distribution studies.
  • Acetylsalicylic acid (ASA) is a common pharmaceutical agent analyzed using these techniques.

Purpose of the Study:

  • To analyze the quantitative composition and distribution of ASA in commercial tablets from different brands.
  • To evaluate the performance of NIR-CI and Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) for pharmaceutical quality control.
  • To determine if the analyzed tablets meet European Pharmacopoeia standards.

Main Methods:

  • Analysis of commercial ASA tablets from four different brands.
  • Application of quantitative algorithms to hyperspectral images using Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS).
  • Pixel-wise quantitation to generate concentration maps without prior calibration.

Main Results:

  • ASA concentration in tablets ranged from 71-82%, with variations in size and composition between brands.
  • MCR-ALS successfully quantified API content and homogeneity distribution.
  • Quantitation results aligned closely with nominal content, enabling determination of Accepted Value (AV).

Conclusions:

  • All analyzed ASA tablet brands meet the European Pharmacopoeia specifications.
  • NIR-CI combined with MCR-ALS is a robust method for pharmaceutical quality assessment.
  • The technique provides accurate quantitation and distribution analysis without requiring reference data.