Formulation Examples for Direct Compression

Spray-dried lactose in the formulation may be replaced by spray-dried mannitol such as Pearlitol SD100. Also, the ratio of the lactose to Avicel PH 102 should be optimized for required product quality attributes including blending uniformity, content uniformity, potency, drug release, and breaking strength. 

The unit formula of example 3 is listed in Table 7.14. The batch size manufactured was 10 kg. The API was preblended with Avicel PH101 using a Patterson-Kelly tumble bin blender equipped with an intensifier bar (0.5 ft3, Fig. 7.6) at 15 rpm with the intensifier bar speed of 2000 rpm for 15 min. The preblend was mixed with lactose, sodium starch glycolate and colloidal silicon dioxide in a 1 ft3 tumble 

The author wish to thank Dr David Moeckly at Eli Lilly and Company for review of the manuscript. Special thanks are expressed to Ms Karen Boleyn for help with preparation of the manuscript. 

Shangraw RF, Demarest DA Jr. 1993. A survey of current industrial practices in the formulation and manufacture of tablets and capsules. Pharm. Technol. 17(1) 32-44. 

Johnson MCR. 1972. Particle size distribution of the active ingredient for solid dosage forms of low dosage. Pharm. Acta Helv. 47 546-559. 

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