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Pharmaceutical Manufacturing Handbook: Production and

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ing at punches <strong>and</strong> dies. Low product yield, low crushing force, <strong>and</strong> further tablet<br />

yams <strong>and</strong> chipping are other problems which have to be solved [33, 201] .<br />

High tablet weight variation can be reduced by using weight control systems.<br />

Further demixing of the tableted material has to be avoided, since demixing results<br />

in higher tablet weight variation <strong>and</strong> content uniformity can no longer be achieved.<br />

As already discussed, paddle feeders can be used to achieve mixing homogeneity<br />

for problematic products <strong>and</strong> further spectroscopic techniques can be used for<br />

control.<br />

The problem of capping <strong>and</strong> lamination can be solved by increasing RH or<br />

adding wetting agents. Further either external lubrication may help. Picking <strong>and</strong><br />

sticking of the tablets at punches <strong>and</strong> dies can be avoided by using lubricants as<br />

discussed above.<br />

A low product yield is caused by loss of material during fast production processes.<br />

On rotary tableting machines this problem is solved by slightly lowering the<br />

lower punches before the compression event starts.<br />

A low crushing force is often caused by the composition of the special formulation.<br />

If the formulation itself is not the reason for a low crushing force, compression<br />

force can easily be increased. Another possible explanation can be low humidity of<br />

the tableted product.<br />

Finally tablets yam <strong>and</strong> chipping can occur before the tablets leave the die table<br />

of a rotary machine. Usually the lower punches or the tablet scraper of the tableting<br />

machine are not properly adjusted. Another reason can be low crushing force.<br />

In conclusion, for smooth <strong>and</strong> perfect machine runs, product properties <strong>and</strong><br />

machine conditions have to be tightly controlled.<br />

6.4.13<br />

FUTURE OF TABLET PRODUCTION SYSTEMS<br />

In principle tablet production systems have remained the same throughout the last<br />

century. However, major improvements in instrumentation, data acquisition, <strong>and</strong><br />

analysis techniques have been made. Nowadays more sophisticated data acquisition<br />

<strong>and</strong> analysis techniques are available which facilitate <strong>and</strong> improve interpretation of<br />

tableting data.<br />

In order to facilitate scale - up, more sophisticated simulation systems can be<br />

thought of. They will be a real help for scale - up with small amounts of material as<br />

available in early development of formulations.<br />

Further quality control of the tablets during tableting or shortly after has become<br />

more important. Recent trends show improvements for production in a GMP environment<br />

by isolating the production unit from the machinery. For the near future<br />

the implementation of the PAT initiative of the FDA is conceivable.<br />

REFERENCES<br />

1.<br />

2.<br />

REFERENCES 1087<br />

Brockedon , W. ( 1843 ), Shaping pills, lozenges, <strong>and</strong> black lead by pressure in dies, British<br />

Patent 9977.<br />

Leuenberger , H. ( 1997 ), Research in solid dosage forms — An obsolete topic? Pharm.<br />

Dev. Technol. , 2 , vii – viii .

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