Breakability of tablets and film-coated dragees
Spang, R.
Pharmaceutica Acta Helvetiae 57(4): 99-111
1982
ISSN/ISBN: 0031-6865 PMID: 7089019 Document Number: 5047
Several marketed tablets and film-coated tablets (round shaped) were tested for their breakability, both manually and mechanically. The resulting halves were analyzed for their weight variation. A correlation was seen between hardness and manual breakability, hardness and mechanical breaking force, and- consequently- between mechanical breaking force and manual breakability. In general, the halves from plain tablets varied with respect to weight to a larger extent than those from film-coated tablets. With three CibaGeigy products it was demonstrated that a deepened score facilitated manual breaking and reduced weight variation of the halves. In addition, the investigation demonstrated an influence of the manual breaking method on the weight variation of the tablet halves. Some properties such as the angle of the score and the sharpness of the score edge as obtained from different punches turned out to be of little importance for tablet breakability. A correlation between the cross section below the score and manual breakability or mechanical breaking force, respectively, could be established only by introducing a quotient of mechanical force and tensile strength (with empirical modification of the equation). It was concluded that the only possibility to assure a good manual breakability of plain and film-coated tablets at this point is to establish limits for the breaking force based on mechanical measurements.
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