A Review on Tablet Scoring: Background, History and Current Regulatory Considerations

Trivedi, Maitri; Patel, H.; Dave, Rutesh H.

doi:10.9734/jpri/2017/39027

Cited by 1 publication

(3 citation statements)

References 8 publications

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“…The FDA guidance as it is written is similar to that of unscored tablets with added requirements to prevent risks associated with drug exposures upon administration [130].…”

Section: Tablet Splitting: Regulatory Guidancementioning

confidence: 99%

“…Tablet physical properties such as size, curvature and thickness, and the form and deepness of the score line as well as scoring techniques can affect the effectiveness of tablet splitting [118]. To facilitate tablet splitting, recent studies have suggested the use of compression molding [130]. Compression Molding is a semi-manual operation where tablets are formed by forcing the wet granulated blend into a mold to achieve tablets of desired shapes and sizes [131].…”

mentioning

confidence: 99%

“…Tablet weights and uniformity of dose are interdependent. Uneven scored tablets can pose great clinical risk, especially when targeting a narrow therapeutic-toxic range [130]. By contrast, tablets with wider therapeutic indices and longer half-life are more forgiving to uneven splitting.…”

mentioning

confidence: 99%

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Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps

Jacques

Alexandridis

2019

Applied Sciences

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Oral solid dosage formulations and/or tablets have remained the preferred route of administration by both patients and health care practitioners. Oral tablets are easy to administer, they are non-invasive and cause less risk adversity. Because of the lack of commercially available tablet dose options, tablets are being split or partitioned by users. Tablet scoring refers to the breakage of a tablet to attain a desired efficacy dose and is an emerging concept in the pharmaceutical industry. The primary reason for the tablet scoring practice is to adjust the dose: dose tapering or dose titrating. Other reasons for tablet partitioning are to facilitate dose administration, particularly among the pediatric and the geriatric patient population, and to mitigating the high cost of prescription drugs. The scope of this review is to: (1) evaluate the advantages and inconveniences associated with tablet scoring/portioning, and (2) identify factors in the formulation and the manufacturing of tablets that influence tablet splitting. Whereas tablet partitioning has been a common practice, there is a lack of understanding regarding the fundamentals underpinning the performance of tablets with respect to splitting. Several factors can influence tablet partitioning: tablet size, shape, and thickness. A requirement has recently been set by the European Pharmacopoeia and the U.S. Food and Drug Administration for the uniformity of mass of subdivided tablets. For breaking ease, an in-vivo reference test and a routinely applicable in-vitro test need to be established.

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“…The FDA guidance as it is written is similar to that of unscored tablets with added requirements to prevent risks associated with drug exposures upon administration [130].…”

Section: Tablet Splitting: Regulatory Guidancementioning

confidence: 99%

mentioning

confidence: 99%