Formulation Of Effervescent Tablets

By: Pharma Tips | Views: 17084 | Date: 08-May-2011

Effervescence is the reaction (in water) of acids and bases producing carbon dioxide. Typical acids used in this reaction are citric, malic, tartaric, adipic, and fumaric. Citric acid is the most commonly used, and it imparts a citrus-like taste to the product. Malic acid can be used in effervescent formulas for a smoother aftertaste, but the price of malic acid is higher than that of citric acid. Tartaric, adipic, and fumaric acids are used sparingly because of their low water solubilities.

                          
                         Effervescence is the reaction (in water) of acids and bases producing carbon dioxide. Typical acids used in this reaction are citric, malic, tartaric, adipic, and fumaric. Citric acid is the most commonly used, and it imparts a citrus-like taste to the product. Malic acid can be used in effervescent formulas for a smoother aftertaste, but the price of malic acid is higher than that of citric acid. Tartaric, adipic, and fumaric acids are used sparingly because of their low water solubilities. Typical bases used in the effervescent reaction are sodium bicarbonate, potassium bicarbonate, sodium carbonate, and potassium carbonate. Sodium bicarbonate is very common in effervescent formulas and produces a clear solution after tablet disintegration. When sodium levels are a concern, potassium bicarbonate is used. Both types of carbonates are used mainly as desiccants. Binders are normally necessary in effervescent tablets to bring the tablet hardness to a point where handling is possible. These binders should be water-soluble and include dextrose, sorbitol, xyitol, and lactose. A binder should be used very cautiously because binders can carry free moisture into the tablet, which is undesirable and can increase disintegration times when used in large quantities. The ideal amount of binder is one that makes the tablet hard enough to handle, but soft enough to disintegrate (the harder the tablet, the slower the disintegration) and dry enough to be stable.  Lubrication of effervescent tablets has historically been the main stumbling block to an acceptable, marketable product. Typical lubricants such as magnesium stearate are not useful due to their insolubility in water.

Most formulators have to use water-soluble lubricants such as sodium benzoate, polyethylene glycol, and adipic acid. These are minimally effective, and depend heavily on the type of granulation they are used in.

There are tablet presses that use lubrication spray on the punches so that the formula does not require lubrication. Depending on the product, formulators can use color (artificial or natural), sweeteners (acesulfame potassium,
Sodium saccharin, aspartame, and surcalose), and flavors (artificial or natural) to enhance a product or to mask off-notes derived from the active ingredients.

Reaction

Effervescence is the evolution of gas bubbles from a liquid, as the result of a chemical reaction. The most common reaction for pharmaceutical purpose is the acid base reaction between sodium bicarbonate and citric acid. Acid-base reactions between alkali metal bicarbonates and citric or tartaric acid have been used for many years to produce pharmaceutical preparations that effervesce as soon as water is added.

3NaHCO3(aq) + H3C6H5O7(aq) 3H2O+CO2 + 3Na3C6H5O7(aq)

Production

Effervescent tablets and powders are produced in much the same manner as conventional tablets and powders, but production must occur in very low humidity areas. Effervescent granulations can be mixed in conventional blending equipment, such as ribbon, twin-cone, and V-type blenders. All equipment should be well grounded and should allow you to make it completely and absolutely dry after wash-down. Any traces of moisture in the equipment will give erratic granulation results and most likely result in lost batches of product. Figure 1 shows a tablet press making an effervescent dosage. Wet granulation of the effervescent base can be performed by carefully adding 0.1 to 1.0 percent water (weight-to-weight basis) to the chosen blending equipment. The granulation steps must be precisely timed and the ingredients mixed thoroughly to distribute the solvent or binder solution evenly in the blend. The mix is then quickly discharged to drying ovens. It must constantly monitor the operational parameters of all equipment, especially drying equipment, as variations in drying times and temperatures can affect the finished product. While stable granulations will ultimately be made, vast differences in tablet hardness and disintegration times can result from over- or under-reacting the granulation. After drying, the granulation is sized, and a final mix is performed. Fluid-bed dryers have been used for many years to make effervescent granulations. Basically, the water or binder solution is sprayed onto the effervescent mixture while it is suspended in a stream of hot, dry air. The humidity and temperature of the air serve to stop the effervescent reaction quickly and uniformly.

To ensure that you produce a free-flowing granulation, chose the particle sizes carefully and monitor all systems closely. Vacuum granulators have also been used to make effervescent granulations. This equipment gives you a very controlled granulation of the product and allows a dust free environment. The equipment also generally requires less power and less operating space than other types of granulators. In operation, the water or binder solution is sprayed onto the effervescent mixture during blending. Drying occurs by placing the granulation under vacuum and heating it via a thermal jacket. Effervescent products normally require tablet presses that can deliver high compression forces. If the tablets are to be wrapped in foil or placed into a tube, give careful attention to the tablet parameters during compression. Monitor the tablet thickness to ensure the wrapping or packaging equipment can handle the tablets. Strict control of temperature and humidity in all areas is a must (65 to 75ºF, relative humidity of 10 percent), or the formulation will begin a chemical reaction after it’s packaged. In essence, the tablet will self-destruct because the byproducts of an effervescent reaction are water and carbon dioxide. The best way to stabilize an effervescent product is to produce it in an environment where humidity is under strict control and to package it in a suitable moisture barrier. All ingredients in the formulation must be anhydrous. Your contractor should test for free moisture before packaging.


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