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Pharmaceutical Manufacturing Handbook: Production and

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982 TABLET DESIGN<br />

E: This ensures that the bore of the die is fi lled with as exact volume of the<br />

material to be used, <strong>and</strong> the next stage can begin.<br />

2. Compression Pressure is applied to form the granule into a solid (Figure<br />

4 b ):<br />

F: The upper punch is lowered into the bore of the die.<br />

G: Precompression gives the powder an initial “ punch ” to remove excess<br />

air.<br />

H: The powder is fully compressed.<br />

I: The correct pressure is reached.<br />

J: The upper punch is lifted out of the way ready for tablet ejection.<br />

3. Ejection The tablet is ejected <strong>and</strong> the next tablet will be formed (Figure<br />

4 c ):<br />

K: The lower punch begins to rise in the bore of the die lifting the tablet until<br />

step L is reached.<br />

L: Its base is level with the tap of the die.<br />

M: The tablet is pushed aside into the take - off chute by passing under a static<br />

blade.<br />

N: The lower punch moves to its lowest position ready for fi lling ( O ), similar<br />

to A <strong>and</strong> the entire cycle is repeated.<br />

Guidance on compression levels for each tablet type (series 1, 2, <strong>and</strong> 3) <strong>and</strong> maximum<br />

punch pressures are given in Table 1 :<br />

Series 1 : Flat fl ace, normal concave, shallow concave tablets<br />

Series 2 : Double radius, bevel <strong>and</strong> concave tablets<br />

Series 3 : Flat beveled edge, deep concave, ball or pill<br />

In Figure 4 the tablets progress from start to fi nish from left to right. On an actual<br />

machine this will be determined by the direction in which the entire turret rotates<br />

in relation to the fi xed item, such as the fi ll hopper precompressions <strong>and</strong> compression<br />

rollers. It is important to note that this direction may vary from machine to<br />

machine, but as a general rule, British, American, <strong>and</strong> some Asian machines<br />

rotate in a clockwise direction while European machines rotate anticlockwise<br />

(see Figure 5 ).<br />

6.3.3<br />

LIMITATIONS FOR DIRECT COMPRESSION<br />

In tablet formulation, a range of excipient materials are normally required along<br />

with the active ingredient in order to give the tablet the desired properties. For<br />

example, the reproducibility <strong>and</strong> dose homogeneity of tablets are dependent on the<br />

properties of the powder mass. The tablet should also be suffi ciently strong to<br />

withst<strong>and</strong> h<strong>and</strong>ling but should disintegrate after intake to facilitate drug release.<br />

The choice of excipients will affect all these properties:<br />

1. Filler illers are used to make tablets of suffi cient size for easy h<strong>and</strong>ling by<br />

the patient <strong>and</strong> to facilitate production. Tablets containing a very potent active

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