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Key Technical Aspects Influencing the Accuracy of Tablet Subdivision
Maíra T Teixeira1, Lívia C L Sá-Barreto2, Taís Gratieri1
1Laboratory of Food, Drugs and Cosmetics (LTMAC), University of Brasília (UnB), 70910-900, Brasília, DF, Brazil.
AAPS Pharmscitech
|September 3, 2016
Summary
Tablet subdivision accuracy varies by drug formulation and tools used. Tablet splitters and specific tablet characteristics like scoring improve dose adjustment precision.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Formulation Science
Background:
- Tablet subdivision is a common practice for dose adjustment.
- Understanding factors influencing subdivision accuracy is crucial for patient safety and therapeutic efficacy.
Purpose of the Study:
- To investigate the impact of production techniques and subdivision methods on tablet accuracy.
- To compare the performance of tablet splitters versus kitchen knives for tablet subdivision.
- To evaluate the influence of tablet characteristics (score, shape, coating, diluents) and generic versus innovator products on subdivision accuracy.
Main Methods:
- Selected five commonly subdivided drugs, including innovator and generic products (scored and non-scored).
- Performed mechanical and physical tests, including image analysis of surface area, to assess subdivision accuracy.
- Compared subdivision methods (splitter vs. knife), tablet features (score, shape, coating), diluent composition, and generic vs. innovator products.
Main Results:
- Tablet splitters showed better results in weight loss and friability tests compared to knives.
- Oblong, coated, and scored tablets exhibited superior subdivision accuracy over round, uncoated, and non-scored tablets.
- Elastic diluents (starch, dibasic phosphate dehydrate) facilitated more accurate subdivision than plastic ones (microcrystalline cellulose, lactose).
- Significant differences in quality control assays of divided tablets were noted between generic and innovator products.
Conclusions:
- Tablet subdivision accuracy is significantly influenced by formulation, physical characteristics, and the subdivision tool employed.
- Health regulations should consider tablet subdivision performance during the marketing authorization of generic drug products.
- Image analysis serves as a valuable tool for evaluating tablet subdivision accuracy.
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