Prednisolone sodium phosphate oral solution

PEDIAPRED (prednisolone sodium phosphate) oral solution is a dye-free, colorless to light-straw-colored, raspberry-flavored solution. Each 5 mL (teaspoonful) of PEDI- 

APRED contains 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle. 

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In prednisolone sodium phosphate oral solution (see Table 23.23) the main degradation reaction is hydrolysis of the corticosteroid-phosphate ester catalysed by hydrogen ions. The phosphate group is split off. At pH 7-8 this hydrolysis is minimal [28], therefore the... 

Prednisolone Sodium Phosphate Pediapred oral solution... 

In aqueous solution, prednisolone sodium phosphate and dexamethasone sodium phosphate are more stable than hydrocortisone sodium succinate. At a pH of about 8, the acid groups are sufficiently ionised to make the substance very soluble, while the phosphate ester is reasonably stable at this pH. Water soluble corticosteroids are mainly used in parenteral preparations, eye drops, oral mixtures and enemas. Examples are prednisolone oral mixtures and dexamethasone injections. 

It is possible to work with the standardised batch preparation instructions by correcting the amount of raw material to be weighed with a constant factor, corresponding with the most probable amount of impurities. So prednisolone sodium phosphate is allowed to contain up to 8 % water according to the Ph. Eur. In practice the water content is generally close to the 8 %. In the batch preparation instmctions for Prednisolone Oral solution (see Table 23.23) a surplus of 8 % of the active substance would then be included. However with this approach care should be taken to confirm that the level of impurity is within a specified level before the raw material is approved for use. 

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