Testing Antacid Effectiveness

IR spectra did not show differences between the intermediate phase and the disordered cancrinite. Therefore, IR techniques fail when were used to identify these phases. One more effective way to identify disordered cancrinite and the intermediate phase is by using X-ray diffraction (XRD). Fig 1 shows the diffractogram of both tectosilicates. In the intermediate phase, the observed peaks correspond with those reported in the literature[4]. The main differences between both spectra correspond to those peaks placed between 25°<20<35°, which are more intense for the disordered cancrinite [9]. Likewise, the results of specific surface area for the intermediate phase (sample 5) and the disordered cancrinite (sample 6) were 35 and 41 m2/g respectively. The antacid capacity test was carried out with the samples 5 and 6. Fig. 2 shows the relationship between experimental pH versus the mass content of the tectosilicates. The neutralization capacity of these solids is related with its carbonate content which reacts with the synthetic gastric juice to neutralize it. In general, the behaviour of solids is similar the pH increases as the weight of the studied solid is increased. However, a less disordered cancrinite mass amount must be employed to reach a pH= 4 in comparison... 

This paper represents an effective study of the synthesis, characterization and antacid test of the disordered cancrinite and the intermediate phase. So, it was possible to synthesize the disordered cancrinite in soft temperature conditions. By XRD, IR and the BET surface area confirmed the synthesis of the disordered cancrinite and the intermediate phase. Neutralization tests indicated that disordered cancrinite was more effective than the intermediate phase. Furthermore, the disordered cancrinite was able to keep a pH plateau between 3 and 4 in higher extension than the intermediate phase. The enzymatic activity of pepsin was preserved when the tested solids were contact with it. Finally, these tectosilicates could be used as effective antacid drugs. 

Acid indigestion, also known as heartburn, is caused by the excess production of stomach acid. Eating a large meal may bring on acid indigestion. Commercial antacids contain basic salts that neutralize the excess acids. Design a titration experiment to test the effectiveness of various brands of antacids. 

As discussed, the manufacture of suspensions presents additional problems, particularly in the area of uniformity. The development data should address the key compounding and filling steps that ensure uniformity. The protocol should provide for the key in-process and finished product tests, along with their specifications. For oral solutions, bioequivalency studies may not always be needed. However, oral suspensions, with the possible exception of some of the over-the-counter antacids, usually require a bioequivalency or clinical study to demonstrate their effectiveness. Comparison of product batches with the biobatch is an important part of the validation process. Make sure there are properly written protocol and process validation reports and, if appropriate, data for comparing full-scale batches with biobatch available during FDA inspection. 

Design an experiment to test the neutralization effectiveness of various brands of antacid. Show your procedure, including... 

Food delays the absorption and decreases MPA C ax by 25% but has no effect on MPA At/C. As a result, prescribing information indicates that MMF should be taken on an empty stomach however, MMF is often given with food in chnical practice to minimize GI adverse effects. Administration with aluminum- and magnesium-containing antacids or cholestyramine, significantly decreases the At/C of MPA and should be avoided. It has been suggested that administration of iron may produce similar results, but this has not been tested. 

Suppose that you work for a consumer advocate organization and you want to test a company s advertising claims about the effectiveness of its antacid. The company claims that its product neutralizes ten times as much stomach acid per tablet as its nearest competitor. How would you test the validity of this claim ... 

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