Inactive Ingredients in Loratadine

Inactive Ingredients in Loratadine
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Loratadine is the active drug in Claritin, a nonprescription antihistamine medication used for the treatment of common seasonal allergies. The FDA first approved Claritin for prescription use in 1993 and subsequently approved it for over-the-counter use in 2002. Claritin is available in tablet, orally dissolving tablet, capsule, oral solution and syrup formulations. All formulations include a number of inactive ingredients, or excipients, which may differ across brand-name and generic products.

Inactive Ingredients in Tablets

In addition to the active ingredient loratadine, the 2007 product labeling for Claritin listed the following inactive ingredients included with a 10 milligram dose of the tablet form of the active drug: corn starch, lactose, and magnesium stearate. The excipient magnesium stearate is used as a lubricant during the manufacturing process of the tablet; it is biologically inert and does not affect a person's body functions. Lactose is a form of sugar that is used to sweeten the taste of a tablet, whereas corn starch is often used as a binder for all ingredients.

Inactive Ingredients in Orally Disintegrating Tablets

Certain excipients enable drug tablets to rapidly dissolve in the mouth and therefore accelerate the body's ability to absorb the drug. Maltodextrin, mannitol, microcrystalline cellulose, crospovidone and modified food starch are all excipients that enable the rapid dissolving of loratadine in the mouth, and each is found in Alavert Allergy, the orally disintegrating form of loratadine . Other excipients that may be found in this kind of formulation include anhydrous citric acid, the noncaloric sweetener aspartame, butylated hydroxyanisole, colloidal silicon dioxide, corn syrup solids, dextrin, ferric oxides, magnesium stearate, both natural and artificial flavor,s and sodium bicarbonate.

Inactive Ingredients in Capsules

According to the package labeling for Claritin Liqui-Gels, this capsule formulation of loratadine includes the inactive ingredients caprylic/capric acid, the inert food coloring agent F D & C blue #1, gelatin, glycerin, pharmaceutical ink, polysorbate 80, sorbitol, povidone, and water. Solubilizing agents such as polysorbate 80 make a drug more easily dissolvable. Sorbitol is often used as a bulk sweetening agent in both food and drug products, and according to the Calorie Control Council, has one-third the calories of regular table sugar.

Inactive Ingredients in Syrup

The syrup formulation of Claritin includes the following inactive ingredients: citric acid, the antioxidant preservative edetate disodium or EDTA, artificial flavor, the natural sweetener glycerin, propylene glycol, sodium benzoate, sugar, and water.

Inactive Ingredients in Oral Solution

According to the package insert for a generic oral solution of loratadine by Major Pharmaceuticals, the following inactive ingredients were included in the formulation: citric acid, the preservative edetate disodium or EDTA, flavor, glycerin, propylene glycol, sodium benzoate, sugar, and water.

References

Article reviewed by Alva Dane Last updated on: Sep 28, 2010

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