As will be seen from the foregoing table all the commercial products that were tested failed the USP enteric test. Enteric coated tablets of this invention made according to Example 2, not only pass this USP enteric test initially, but even after these tablets were stress tested for three and six days at 60° C./60% RH in an open petri dish and for six days at 60° C. in a glass jar with screw cap. In addition, the effect of the stress conditions on the dissolution time at pH (intestinal phase) is so slight to conclude that these enteric coated tablets are uneffected by stress storage conditions.
Dry granulation processes create granules by light compaction of the powder blend under low pressures. The compacts so-formed are broken up gently to produce granules (agglomerates). This process is often used when the product to be granulated is sensitive to moisture and heat. Dry granulation can be conducted on a tablet press using slugging tooling or on a roll press called a roller compactor. Dry granulation equipment offers a wide range of pressures to attain proper densification and granule formation. Dry granulation is simpler than wet granulation, therefore the cost is reduced. However, dry granulation often produces a higher percentage of fine granules, which can compromise the quality or create yield problems for the tablet. Dry granulation requires drugs or excipients with cohesive properties, and a 'dry binder' may need to be added to the formulation to facilitate the formation of granules.
I was prescribed a five-day course of Z-pak after developing a severe flu-like upper respiratory infection plus pain, a sore throat, diarrhea, muscle pain, nausea, and other symptoms. I had an infusion of Rituxan, and all of these symptoms began the next day. I have rheumatoid arthritis and, as my immune system is compromised, the dosage of Rituxan temporarily make it worse. Z-pak started working almost immediately, and two hours after my second 250 mg pill (the first one was 500 mg), I did not feel sick. My breasts are still a bit swollen, but that is bearable. I am impressed.