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Minimize Tablet Bisect Risk: Part II

The new pill-cutting reality requires an understanding of bisect functionality


By Fred Rowley, Solid Dosage Training, Inc.

L ast month, we presented a current


problem facing the pharmaceutical
Industry: What to do about tablet bisects
OPTIMIZED BISECT
EFFECTIVENESS
Bisect options may differ both in terms of
does not consider either of these changes
signicant, as long as there is no change
in the code itself. Each manufacturer
that should break the tablet cleanly into width and depth. Selecting an appro- must determine which bisect best ts the
two portions. In reaction to the HMO priate bisect depends in part on tablet product. The TSM offers more detailed
practice of dispensing drugs with pill size, shape and weight. Once the size information concerning the differences
cutters, a more functional bisect will be and shape have been determined, the between standard concave, deep concave
needed in the future. The phrase this position of the bisect becomes impor- and at faced bevel edged tablets.
tablet may be split into two parts for con- tant. In pharmaceuticals, the bisect must Especially important is the position
venient administration, once placed in compete with the letters and numbers of the bisect on the top of the tablet.
the patient information, now takes a more identifying the drug. In the past, the Improper placement may cause
serious and perhaps a higher legal posi- letters and numbers took priority and unnecessary injury at the ejection station.
tion. Facing this, how does one choose an the bisect was sometimes even added as For example, in Figure 2, a C-type
optimized bisect and on what basis? an afterthought. In some instances, they bisect has been placed on both sides
were added to the wrong side of the tab- of the tablet, a practice that we do not
BISECTS AND SCORES let to make room. Today, with the bisect recommend.
The purpose of the bisect is to produce a taking a more important role, placement For new products not yet fully
desired dosage by dividing the tablet into of the bisect is important. specied, we recommend avoiding
two or more equal parts. A decision to For example, with concave tablets it is E-, B -and H- type bisects. For different
place a bisect on a tablet is not straight- especially important to avoid placing the products, one may select either the D, C
forward. The bisect may be affected by bisect on the lower punch, since doing or A types, but the A type may not be the
the tablet cup depth, band thickness so may cause damage when the tablet suitable for brittle active ingredients.
and the intended tablet hardness. As the is ejected from the die. Unfortunately, Tablet bisects have become a new
tablet size increases or changes, so do there is no equal tradeoff when reviewing issue in designing effective tablets.
the size and type of bisects that may be these considerations. In the future, the As HMOs drive the need for clean,
placed. Generally, there are seven types identication of the tablet may require effective tablet cutting, pharmaceutical
of bisect lines. One may conveniently smaller letters/numbers to allow for a companies, pharmacists and patients
review these bisect types by reading the larger, deeper and optimized bisect [2]. must be aware of both the advantages

Figure 1 (left and center) An A-type and an E-type bisect are not engineered to perform the same way. Figure 2 (right) An example of a C-type
decreasing bisect on both the upper and lower faces of the tablet.

Tablet Specication Manual (The TSM), CHANGING BISECTS and disadvantages of this practice.
published by the American Association of Many existing tablets feature an E-Type
Pharmaceutical Scientists [1]. or standard bisect, but may not split References:
The seven types range from the most evenly when an individual attempts 1. Tableting Specications Manual, 7th edition,
functional bisect, called a G-type, which to diide them into equal doses [3]. In APhA Tableting Specication Steering Commit-
is very sensitive to pressure placed on such cases, the rm will need to explore tee, AphA Publishing, 2005.
it by humans, to the least functional or moving to either a C-, D- or G- type. 2. Pharmaceutical Dosage Forms, Vol. 2, 2nd Ed.
H-Type which is considered a cosmetic One needs to recognize that making this New York: Marcel Dekker, Inc. 1989.
bisect. Figures 1 and 2 illustrate the change may result in the need to change 3. Wiggins, L: Cutting Pills in Half Saves Money,
apparent differences between an A-type the size of the letters or numbers. but is it Always Safe?, Gwinnett County Ga-
and a E-Type bisect. Under existing guidelines, the FDA zette, Feb. 8, 2006, gwinnettdailypost.com

Pharmaceutical Manufacturing www.pharmamanufacturing.com November/December 2006 33

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