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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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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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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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,...

Imperfections in Crystal Structure: Non-Stoichiometric Defects

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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...

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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Optimized Procedure for Determining the Adsorption of Phosphonates onto Granular Ferric Hydroxide using a Miniaturized Phosphorus Determination Method

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Elemental Impurities in Pharmaceutical Excipients.

Gang Li¹, Dave Schoneker², Katherine L Ulman³

¹U.S. Food and Drug Administration, Division of Pharmaceutical Analysis, St. Louis, Missouri 63110.

Journal of Pharmaceutical Sciences

|September 24, 2015

Summary

Pharmaceutical elemental impurity analysis is shifting to permitted daily exposures. A new survey of common excipients and drug substances shows relatively low elemental impurity levels, easing manufacturer concerns about regulatory changes.

Keywords:

Analytical Chemistry Global Health ICP-MS Mass Spectrometry Regulatory Science US FDA excipients microwave-assisted digestion trace elements trace metal

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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

Area of Science:

Pharmaceutical Analysis
Analytical Chemistry
Regulatory Science

Background:

Elemental impurity control in pharmaceuticals is transitioning from component concentration limits to permitted daily exposures (PDEs).
Manufacturers face uncertainty regarding the impact of these new regulations.
A lack of public data on elemental impurity levels in pharmaceutical excipients contributes to this uncertainty.

Purpose of the Study:

To survey elemental impurity levels in common pharmaceutical excipients and drug substances.
To provide data supporting the transition to PDE-based control strategies.
To assess the suitability of a new analytical method for elemental impurity determination.

Main Methods:

Development of a microwave-assisted digestion and inductively coupled plasma mass spectrometry (ICP-MS) method.
Analysis of 190 excipient samples and 15 drug substance samples.
Method validation for elements relevant to USP <232> and ICH Q3D guidelines.

Main Results:

The developed analytical procedure proved suitable for quantifying elemental impurities.
Survey results indicate generally low levels of elemental impurities in the tested pharmaceutical materials.
Data was collected from the International Pharmaceutical Excipient Council of the Americas.

Conclusions:

The study provides valuable data on elemental impurity profiles of common pharmaceutical excipients and drug substances.
The findings suggest that current pharmaceutical materials may comply with emerging PDE-based regulations.
The developed analytical method offers a robust approach for routine elemental impurity testing.