croscarmellose sodium 9 00 hydroxypropylcellulose ef 1 75 sodium lauryl sulfate 0 70 35 00 outside powders microcrystalline cellulose granular 102 37 50 croscarmellose sodium 7 00 magnesium stearate vegetable 1 25 total 250 mg film coat approximately 11 25 purified water usp is used in the manufacture of the tablets the water is removed during processing and minimal levels remain in the finished product tablets are manufactured using a wet granulation process a step by step description of the process is as follows the drug and excipients to be granulated are security sieved the selective pde5 inhibitor is dry blended with lactose monohydrate spray dried hydroxypropylcellulose croscarmellulose sodium and lactose monohydrate the resulting powder blend is granulated with an aqueous solution of hydroxypropylcellulose and sodium lauryl sulfate using a powrex or other suitable high shear granulator additional water can be added to reach the desired endpoint a mill can be used to delump the wet granulation and facilitate drying the wet granulation is dried using either a fluid bed dryer or a drying oven once the material is dried it can be sized to eliminate any large agglomerates microcrystalline cellulose croscarmellose sodium and magnesium stearate are security sieved and added to the dry sized granules these excipients and the dry granulation are mixed until uniform using a tumble bin ribbon mixer or other suitable mixing equipment the mixing process can be separated into two phases the microcrystalline cellulose croscarmellose sodium and the dried granulation are added to the mixer and blended during.