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Pharmaceutical Manufacturing Handbook: Production and

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950 ROLE OF PREFORMULATION IN DEVELOPMENT OF SOLID DOSAGE FORMS<br />

FIGURE 9 Measurement techniques for powder fl ow. ( a ) Angle of repose is determined<br />

by pouring a powder through a funnel <strong>and</strong> noting the angle that the powder heap makes with<br />

the horizontal surface. ( b ) Carr ’ s index is measured by pouring a known weight of the powder<br />

into a graduated cylinder <strong>and</strong> tapping it on a hard surface until the powder is consolidated.<br />

( c ) Carr ’ s index is measured as percent, while angle of repose is measured in degrees,<br />

<strong>and</strong> both methods show good correlation. Powder fl ow is classifi ed based on either of the<br />

measurement methods.<br />

available for preformulation testing, either method may be used to estimate the<br />

powder fl ow property. Poor fl owing powders may require glidants to improve their<br />

fl ow property. Compressibility is studied by compressing the drug in a hydraulic or<br />

IR press, <strong>and</strong> such experiments give early warnings to the formulator about capping<br />

<strong>and</strong> lamination issues in tablets. Altogether, these preformulation tests give valuable<br />

information to the formulator in deciding excipients <strong>and</strong> processes.<br />

6.2.3<br />

(a) (b)<br />

Carr’s index (%)<br />

5–15<br />

12–16<br />

18–21<br />

23–35<br />

33–38<br />

>40<br />

Powder flow<br />

Excellent<br />

Good<br />

Fair to<br />

passable<br />

Poor<br />

Very poor<br />

Extremely<br />

poor<br />

(c)<br />

SOLUBILITY CHARACTERISTICS<br />

Bulk volume<br />

Volume after tapping<br />

Angle of repose (deg)<br />

Drug solubility is one of the physicochemical parameters that receives lots of attention<br />

during preformulation testing. In the initial stages, solubility studies are usually<br />

kinetically determined, where the drug is placed in contact with the solvents <strong>and</strong><br />

then the solubility is assessed using turbidometric methods almost instantaneously.<br />

40<br />

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