Lactose Free, Direct Compression Formulation Used to Produce Loratadine (10 mg) Tablets

Lactose Free, Direct Compression Formulation Used to Produce Loratadine (10 mg) Tablets

Loratadine is a popular over-the-counter, non sedating antihistamine used for the temporary relief of symptoms caused by hay fever or other upper respiratory allergies. Loratadine works by blocking the action of histamine, a natural substance in the body that is released by the immune system during an allergic reaction. Many marketed loratadine products use lactose as the main filler ingredient. Lactose, one of the most commonly used fillers in solid dosage formulations, is well known for producing tablets with high mechanical strength. However, its usage has been eroded by some relatively recent concerns, such as Bovine Spongiform Encephalopathy BSE, Variant Creutzfeldt-Jacob Disease (vCJD), and lactose intolerance. These concerns have led some formulators to evaluate other excipients in their formulations. In addition, the abrasiveness of lactose can cause a decrease in tooling life due to excess wear on tableting or capsule-filling equipment. To overcome abrasiveness, lubricantsmust be used, but high lubricant levels can cause a decrease in tablet mechanical strength and can affect disintegration and dissolution.

Keywords: Excipient, Loratadine, Colorcon, Starch 1500, Microcrystalline Cellulose, Colloidal Silicon Dioxide, Magnesium Stearate, Stearic Acid

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Lactose Free, Direct Compression Formulation Used to Produce Loratadine (10 mg) Tablets
Technical Data Direct Compression Loratadine Formulation
Colorcon 2005
ex_td_starch_loratadine2.pdf
Adobe Acrobat Document 67.9 KB

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