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LIALDA demonstrates prolonged release of mesalamine in an in vitro study using a simulated colon
Date:10/17/2007

arance and the first appearance of cracks on the outer tablet coating. This demonstrates that very little drug is released in the simulated stomach and small intestine and suggests that the majority of mesalamine is released in the simulated colon, said Dr. Tenjarla.

LIALDA with Multi Matrix System (MMX) Technology combines a pH-dependent gastro-resistant coating, which delays the release of the medication to the colon, with a tablet core containing mesalamine with hydrophilic and lipophilic excipients. LIALDA is the only ulcerative colitis treatment that utilizes MMX Technology.

In two pivotal phase III clinical studies, LIALDA was shown to be superior to placebo in inducing remission and treating the symptoms of mild-to-moderate UC. LIALDA was generally well tolerated.

About the Study

The release kinetics of 5-ASA from LIALDA were assessed using the TIM system that simulated the physiologic conditions in the adult human gastrointestinal tract under standardized fed and fasted conditions. In the analysis, the LIALDA 1.2g tablet was introduced to the TIM system, along with a mixture of artificial saliva and tap water (fasted state) or a mixture of artificial saliva and the standard FDA high-fat breakfast (fed state). The total intake was always 200g and all experiments were performed in duplicate.

After all samples were collected, a validated high-performance liquid chromatography method with ultra-violet detection was used to quantify levels of 5-ASA in the samples. Samples were analyzed using a Phenomenex Aqua 5 3m column (150mm by 3mm inner diameter) at 40 degrees Celsius (excitation/emission wavelength 315/430nm).

The analysis found that during passage through the gastric and small intestine compartments of TIM, on average less than one percent (0.25 percent in fasted state and 0.84 percent in fed state) of the 5-ASA was released from LIALDA. In contrast, during passage through the colon compartments o
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Contact: Sarah McGee
smcgee@golinharris.com
312-729-4125
Shire plc
Source:Eurekalert

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