Diluents dibasic dihydrate

Calcium phosphate dibasic dihydrate (diluent) 21% w/w as di hydrate water Decomposes below 100°C with loss of water 7.4 Practically insoluble in water 19%w/w... 

The most widely used inorganic direct compression diluent is calcium phosphate. It is available in several forms, but the immilled (i.e., coarse) dibasic dihydrate (CaHP04 2H2O) is the most frequently used. It has good flow and binding properties. Consolidation is... 

Diluents, although commonly presumed inert, do have the ability to influence the stability or bioavailability of the dosage form. For example, dibasic calcium phosphate (both anhydrous and dihydrate forms) is the most common inorganic salt used as a filler-binder for direct compression. It is particularly useful in vitamin products as a source of both calcium and phosphorous. Milled material is typically used in wet-granulated or roller-compacted formulations. The coarse-grade material is typically used in direct compression formulations. It is insoluble in water, but its surface is alkaline and it is therefore incompatible with drugs sensitive to alkaline pFI. Additionally, it may interfere with the absorption of tetracyclines [7]. 

Each vial contains either 74, 118.4, 177.6, or 222 p.g of PEG-intron, and 1.11 mg of dibasic sodium phosphate anhydrous, 1.11 mg of monobasic sodium phosphate dihydrate, 59.2 mg of sucrose, and 0.074 mg of polysorbate 80. Following reconstitution with 0.7 mL of the supplied diluent (SWFI, USP), each vial contains peginterferon at strengths of either 100, 160, 240, or 300 p,g/mL. 

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