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Pharmaceutical Manufacturing Handbook: Production and

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1082 TABLET PRODUCTION SYSTEMS<br />

[78, 84, 83] . Most recently, partial melting of drugs could be analyzed for materials<br />

whose melting temperature is as high as 94 ° C [87] , <strong>and</strong> the reversible transgression<br />

of a glass transition temperature of 80 ° C was determined [162] .<br />

All results indicated that temperature increase depends on the material. Further<br />

temperature increase during tableting can contribute to slight changes in material<br />

structure [85] .<br />

6.4.9<br />

ANALYSIS OF FINAL TABLET FORMATION<br />

This characterization of the process of tablet formation has to be completed by<br />

analyzing the changes induced by tableting.<br />

Most important is the elastic recovery of the tablets which starts during decompression<br />

<strong>and</strong> is fi nished dependent on the material after several days. Elastic recovery<br />

can be defi ned as [163] .<br />

Ht−H ER ( % ) = 100 ×<br />

H<br />

where H min is the minimum height of the tablet under load <strong>and</strong> H t the height of the<br />

tablet at different times t after tableting.<br />

Elastic recovery gives information on the remaining elasticity of the materials<br />

which is only slowly released. Further it can indicate structural changes inside the<br />

materials <strong>and</strong> tablets. Structural changes induced by tableting have to be analyzed<br />

by physicochemical techniques, such as spectroscopic <strong>and</strong> thermoanalytical methods,<br />

X - ray diffraction, scanning electron microscopy, <strong>and</strong> transmission electron microscopy<br />

[35, 36, 85, 164 – 166] . The analyzed changes will help to better underst<strong>and</strong> the<br />

process of tablet formation <strong>and</strong> identify the reasons for compactibility of materials.<br />

However, these changes are not the subject of this chapter.<br />

6.4.10 COMPLETE DESCRIPTION OF PROCESS<br />

OF TABLET FORMATION<br />

On the whole, the process of tablet formation can fully be described by combining<br />

the analysis of the tableting process with the fi nal formation of the tablets. The<br />

methods which gives most detailed information of the whole process <strong>and</strong> simultaneously<br />

is a fast method is the 3D modeling technique in combination loith calculating<br />

the elastic recovery of the tablets. In addition, by combining both these methods<br />

<strong>and</strong> calculating general plasticity P from time plasticity d , pressure plasticity e , twisting<br />

angle ω , <strong>and</strong> elastic recovery ER, a more general tool for analysis of the process<br />

of tablet formation is available [3, 4] .<br />

Finally the crushing force of the tablets after relaxation gives information on<br />

the formed bonds inside the material <strong>and</strong> the compactibility. Compactibility has<br />

been described by Leuenberger [167] . For the future it can be expected that a<br />

prediction of compactibility as a result of the process of tablet formation is<br />

possible.<br />

min<br />

min<br />

(2)

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