Formulation of Magnesium Trisilicate Suspension and Comparison to Bisodol Tablets

Introduction

Antacids are a crucial class of pharmaceuticals designed to alleviate the discomfort caused by symptoms of nausea and indigestion. They function by neutralizing the excess stomach acid responsible for these symptoms. Antacids come in various forms, including tablets, suspensions, and sachets, each with its unique advantages. Among the common active ingredients found in antacids are calcium carbonate and magnesium hydroxide. In this study, we focus on suspension antacids, which have a distinct advantage due to their higher dissolution rates, enabling faster relief as they are already pre-dissolved.

Methods

To prepare a 100ml magnesium trisilicate suspension, the following chemicals were used:

The preparation of the magnesium trisilicate suspension was meticulously carried out. Initially, a 100ml amber-glass bottle was calibrated. Next, 100ml of water was measured accurately using a pharmaceutical-grade conical flask before being gently poured into the calibrated bottle.

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The meniscus of the water level was carefully marked using a label to ensure precise measurement.

All solid chemicals, including magnesium trisilicate, sodium bicarbonate, and light magnesium carbonate, were accurately weighed using a class B balance. Subsequently, these solid components were combined in a mortar and pestle, ensuring thorough mixing. To this mixture, 50ml of double concentrated chloroform water was gradually added in 10ml increments while continuing to mix. The resulting homogeneous mixture was carefully poured into the previously prepared amber bottle, accompanied by the addition of 2.5ml of peppermint emulsion.

Finally, water was added to reach the calibrated guideline, and the bottle was securely sealed with a prescription label, adhering strictly to the guidelines outlined in the Medicines, Ethics, and Practice book.

For the subsequent pH testing, 50ml of 0.1M HCL was measured into a conical flask, and to facilitate pH measurement, 10 drops of a pH indicator were added. The magnesium trisilicate suspension was added gradually, in 5ml spoonfuls, until a visible change in pH was observed. This procedure was meticulously repeated using two Bisodol tablets as a substitute for the suspension.

Results

In order to obtain the necessary quantities of chemicals for preparing 100ml of magnesium trisilicate suspension (as the original method was designed for a 1000ml batch), a careful calculation was performed. Subsequently, the suspension was subjected to rigorous examination and validation by a qualified laboratory technician.

During the pH testing, it was observed that the magnesium trisilicate suspension required only 10ml to transition from a pH of 1 to a pH of 3. This remarkable change occurred in less than a minute with agitation assisting in the process.

For the magnesium trisilicate suspension, it can be concluded that:

5g in 100ml

500mg in 10ml

Conversely, the Bisodol tablets, when subjected to the same pH testing, required two tablets and a duration of 12 minutes to achieve the same pH transition.

Discussion

The significantly faster action of the magnesium trisilicate suspension in neutralizing acidity can be attributed to its form. In suspension form, the active ingredients are already dissolved, facilitating immediate neutralization upon contact with HCL. Furthermore, the agitation employed expedited the mixing of the active ingredients, enhancing the overall speed of the process. In contrast, the Bisodol tablets needed to dissolve first, and without agitation, the dispersion of the active ingredient would have taken considerably longer (Brouwers and Tytgat, 1978).

It is worth noting that the tablets might have demonstrated a faster reaction if they had been crushed before testing. Discussions with other research groups conducting similar experiments revealed that magnesium trisilicate suspension consistently outperformed crushed Bisodol tablets, achieving neutralization within a minute.

Additional research suggests that magnesium trisilicate may not be the most effective antacid in suspension form. Instead, light magnesium carbonate is considered the most effective antacid (Gaisford et al., 2004).

It is important to mention that Bisodol tablets contain calcium carbonate (522mg), light magnesium carbonate (68mg), and sodium bicarbonate (64mg) (Teva Ltd, 2018). In comparison to the dose of magnesium trisilicate suspension, the suspension contains higher quantities of light magnesium carbonate and sodium bicarbonate, potentially contributing to its quicker neutralization and potentially more effective results. Furthermore, if the suspension were left in contact with HCL for a longer period, it might have achieved even more extensive neutralization.

References

• Brouwers, J. R., & Tytgat, G. N. (1978). Biopharmaceutical properties of liquid and tablet antacids: in vivo studies using the intragastric pH-measurement technique. Journal of Pharmacy and Pharmacology, 30(2), 148-151. doi:10.1111/j.2042-7158.1978.tb13186.x
• Gaisford, S., Royall, P. G., & Greig, D. G. (2004). Solution calorimetry as a tool to study the neutralizing capacity of magnesium trisilicate mixture BP and its components. Thermochimica Acta, 417(2), 217-221.
• Teva Ltd. (2018). Bisodol Patient Information Leaflet. Retrieved from https://www.medicines.org.uk/emc/files/pil.9014.pdf