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Terminology challenges: defining modified release dosage forms in veterinary medicine
Marilyn N Martinez1, Danielle Lindquist, Sanja Modric
1Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, Maryland 20855, USA. marilyn.martinez@fda.hhs.gov
Journal of Pharmaceutical Sciences
|March 10, 2010
Summary
Veterinary medicine needs clear dosage form release terms. This study proposes definitions for veterinary pharmaceuticals, addressing confusion stemming from human drug standards and species-specific needs.
Area of Science:
- Veterinary Pharmacology
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Established terminologies for pharmaceutical dosage form release (immediate, modified, extended, delayed release) are well-accepted for human use by regulatory bodies like the FDA, ICH, and USP.
- Confusion persists in veterinary medicine regarding these release characteristic terms, unlike in human pharmaceuticals.
- Differences in veterinary vs. human dosage forms (e.g., parenteral vs. oral extended release) and interspecies physiological variations contribute to this confusion.
Purpose of the Study:
- To propose standardized terminologies for describing dosage form release characteristics specifically for veterinary pharmaceuticals.
- To address the existing ambiguity in the veterinary community regarding drug release definitions.
- To provide a foundation for clearer communication and application of drug release principles in veterinary medicine.
Main Methods:
- Review of existing human pharmaceutical release terminology standards (FDA, ICH, USP).
- Analysis of differences between human and veterinary dosage forms and their physiological implications.
- Development of suggested definitions tailored for veterinary applications.
Main Results:
- Identified specific challenges in applying human pharmaceutical release terms to veterinary medicine.
- Highlighted the need for distinct considerations due to interspecies differences in physiology and administration routes.
- Proposed initial definitions to bridge the gap in veterinary drug release terminology.
Conclusions:
- Standardized and appropriate terminology for veterinary drug release is crucial for safe and effective pharmaceutical use in animals.
- Existing human pharmaceutical definitions require adaptation to accurately reflect veterinary drug formulation and application.
- Further development and adoption of these proposed veterinary-specific terms are recommended to resolve current confusion.
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