Blend uniformity replacement

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. 

In vinyl plasticized with various levels of a readily flammable ester, for example DOP, LOI will rise gradually with each part of antimony trioxide, up to about 5-7 parts, at which point it will tend to level off. At about 75 phr flammable plasticizer, this will limit compositions to about 25 percent LOI, usually sufficient to pass horizontal but not vertical flame tests. At 30-50 phr plasticizer, 5-7 phr antimony trioxide will provide an LOI of 30-35, adequate for simple vertical tests. Substitution of zinc borate for antimony trioxide in such systems will result uniformly in lower LOI, but use instead of a 1 1 blend will generally duplicate results with antimony trioxide alone because of their synergistic effect. Zinc borate does not appear to interfere with gas-phase action of antimony plus chlorine. One-third replacement of flammable plasticizer with chlorinated paraffin will result in a greater increase in LOI per part antimony trioxide added. The effects of replacement with FR phosphate plasticizers are discussed in Chapter 9. 

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