Lodotra^™ – Delayed Release Technology

Lodotra^™ has been co-developed with SkyePharma and utilizes SkyePharma’s proprietary GeoClockTM technology (based on SkyePharma’s GeoMatrixTM technology) for which Nitec holds an exclusive worldwide license for the delivery of glucocorticoids. Lodotra^™ is comprised of an active core containing prednisone, which is encapsulated by an inactive porous shell. The inactive shell acts as a barrier between the product’s active core and a patient’s gastrointestinal fluids. Following ingestion of Lodotra^™, water in the digestive tract diffuses through the shell to the active core which expands, leading to a weakening and breakage of the shell allowing a release of prednisone from the core tablet. This proprietary technology is able to define the period of delay between ingestion and dissolution of the active core by the patient’s gastrointestinal fluids. In the case of Lodotra^™, this period is approximately four hours. Importantly, studies have shown that the blood concentration of prednisone from Lodotra^™ is similar to standard oral prednisone except for a time shift of approximately four hours.

The following animation shows this delayed release process in action:


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Figure: Bioavailability: Mean plasma levels of prednisone after a single dose of 5 mg prednisone administered as Lodotra^™ 5 mg or an immediate release prednisone tablet (A) 5 mg immediate release prednisone tablet (fasted, intake at 2 am), (B) Lodotra^™ 5 mg (2.5 hours after a light evening meal) and (C) Lodotra^™ 5 mg (immediately after a full evening meal). The tablet’s unique delivery system ensures immediate release of the prednisone from the tablet core about 4 hours after ingestion. The administration of 5 mg Lodotra^™ provides equivalent AUC and Cmax to a 5 mg standard prednisone formulation.