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

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, lubricants must be used, but high lubricant levels can cause a decrease in tablet mechanical strength and can affect disintegration and dissolution.