General Description
Synonyms: Baking soda; E500; Effer-Soda; monosodium carbonate; natrii hydrogenocarbonas; Sal de Vichy; sodium acid carbonate; sodium hydrogen carbonate
Description: Sodium bicarbonate occurs as an odorless, white, crystalline powder with a saline, slightly alkaline taste. The crystal structure is monoclinic prisms. Grades with different particle sizes, from a fine powder to free-flowing uniform granules, are commercially available.
Chemical Name: Carbonic acid monosodium salt
Functions
Alkalizing agent; therapeutic agent.
Uses
Sodium bicarbonate is generally used in pharmaceutical formulations as a source of carbon dioxide in effervescent tablets and granules.
It is also widely used to produce or maintain an alkaline pH in a preparation.
In effervescent tablets and granules, sodium bicarbonate is usually formulated with citric and/or tartaric acid; combinations of citric and tartaric acid are often preferred in formulations as citric acid alone produces a sticky mixture that is difficult to granulate, while if tartaric acid is used alone, granules lose firmness.
When the tablets or granules come into contact with water, a chemical reaction occurs, carbon dioxide is evolved, and the product disintegrates.
Melt granulation in a fluidized bed dryer has been suggested as a one-step method for the manufacture of effervescent granules composed of anhydrous citric acid and sodium bicarbonate, for subsequent compression into tablets.
Tablets may also be prepared with sodium bicarbonate alone since the acid of gastric fluid is sufficient to cause effervescence and disintegration.
Sodium bicarbonate is also used in tablet formulations to buffer drug molecules that are weak acids, thereby increasing the rate of tablet dissolution and reducing gastric irritation.
The effects of tablet binders, such as polyethylene glycols, microcrystalline cellulose, silicified microcrystalline cellulose, pregelatinized starch, and povidone, on the physical and mechanical properties of sodium bicarbonate tablets have also been investigated.
Incompatibilities
Sodium bicarbonate reacts with acids, acidic salts, and many alkaloidal salts, with the evolution of carbon dioxide. Sodium bicarbonate can also intensify the darkening of salicylates. In powder mixtures, atmospheric moisture or water of crystallization from another ingredient is sufficient for sodium bicarbonate to react with compounds such as boric acid or alum. In liquid mixtures containing bismuth subnitrate, sodium bicarbonate reacts with the acid formed by hydrolysis of the bismuth salt.
Safety
Sodium bicarbonate is used in a number of pharmaceutical formulations including injections and ophthalmic, otic, topical, and oral preparations. Sodium bicarbonate is metabolized to the sodium cation, which is eliminated from the body by renal excretion, and the bicarbonate anion, which becomes part of the body’s bicarbonate store. Any carbon dioxide formed is eliminated via the lungs. Administration of excessive amounts of sodium bicarbonate may thus disturb the body’s electrolyte balance, leading to metabolic alkalosis or possibly sodium overload with potentially serious consequences. The amount of sodium present in antacids and effervescent formulations has been sufficient to exacerbate chronic heart failure, especially in elderly patients
Handling Precautions
Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and gloves are recommended.
Related Substances
Potassium bicarbonate.