ALUMINUM POTASSIUM SULFATE

Absorption

Potassium alum is found in its dodecahydrate form that produces a very large molecule. This large molecule cannot be absorbed through the skin when this substance is included as an astringent agent in topical OTC. If ingested, the aluminum salts are rapidly solubilized in the stomach and then they can generate aluminum hydroxide or poorly absorbed basic aluminum salts.

Toxicity

There is no evidence of potassium alum that demonstrates any suspicious for it to be a hazard for the consumers in the currently approved levels of use.

Chemical properties

white powder(s); absorbs atmospheric moisture [MER06]

Chemical properties

The PhEur 6.0 describes potassium alum as a granular powder, or colorless, transparent, crystalline masses. The JP XV describes it as colorless or white crystals or powder. Potassium alum is odorless and has a slightly sweet, strongly astringent taste.

The Uses of ALUMINUM POTASSIUM SULFATE

Astringent (topical).

Indications

Potassium alum is considered safe by the FDA and its use is in homepathic or OTC products. Due to its presence in several different drugs, the main indications for the use of potassium alum are:
-Constipation -Cosmetic or drug astringent, helping the shrinkage of tissues and the dry of secretions -Oral health care drug -Part of formulation in cleansing products, skin-care products, mosturizers, face powders and deodorants -Antiperspirant -Antifungal

Background

Potassium alum is considered by the FDA as a generally recognized as safe (GRAS) substance. It is an inorganic salt, also called potassium aluminum sulfate with a formula of AlK(SO4)2 that is predominantly produced in the dodecahydrate form (AlK(SO4)2 * 12H2O). Potassium alum is formed by large, transparent crystals that are used in different products like food or drugs as a buffer, neutralizing or forming agent.

Definition

ChEBI: A metal sulfate composed of potassium, aluminium and sulfate ions in the ration 1:1:2.

Production Methods

Potassium alum is manufactured by treating bauxite with sulfuric acid and then potassium sulfate. Alternatively, aluminum sulfate is reacted with potassium sulfate.

Flammability and Explosibility

Non flammable

Pharmaceutical Applications

Potassium alum precipitates proteins and is a powerful astringent. The ability to precipitate proteins is utilized in the manufacture of vaccines, where purified proteins are coprecipitated with and adsorbed onto potassium alum.
Potassium alum is often included in preparations used as mouthwashes or gargles and in dermatological preparations, and it may be used as a topical hemostatic, either as a solid or as a solution. Intravesical instillation of potassium alum, typically as a 1% solution, has been used for hemorrhagic cystitis.

Pharmacokinetics

The presence of potassium alum reduces swollen mucous membranes that result from inflammation of the nasal, gastrointestinal and urinary passages as well as in the presence of excessive secretions. The induction of the coagulation cascade will also stop bleeding.

Safety

Potassium alum is often included in preparations used as mouthwashes or gargles and in dermatological preparations.
Large doses of potassium alum act as an irritant and may be corrosive; gum necrosis and gastrointestinal hemorrhage have occurred. Acute encephalopathy has been reported following bladder irrigation with alum solutions in the treatment of bladder hemorrhage. Anecdotal evidence suggests that this practice should be avoided for patients with renal insufficiency.

Metabolism

Potassium alum does not go through a metabolic pathway. When ingested or absorbed, it will get rapidly dissolved and it will form ions that will later generate other salt derivatives.

storage

Store in a cool, dry place in tightly closed containers. Stable under normal temperatures and pressures. When kept for a long time at 60–65°C (or over sulfuric acid) potassium alum dodecahydrate loses water, which is reabsorbed on exposure to air. It becomes anhydrous at about 200°C.

Incompatibilities

Potassium alum is incompatible with strong oxidizing agents, aluminum, copper, steel, and zinc. When it is dispensed in powders with phenol, salicylates, or tannic acid, gray or green colors may be developed owing to traces of iron in the alum.

Regulatory Status

GRAS listed. Included in the FDA Inactive Ingredients Database (vaginal; suppository). Included in medicines licensed in the UK.