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Orally Disintegrating Lansoprazole Tablets Approved by FDA

Cheryl A. Thompson

The Food and Drug Administration (FDA) has given the OK for TAP Pharmaceuticals Inc. to market lansoprazole in delayed-release orally disintegrating tablets. Prevacid SoluTabs, as the new dosage form is known, will be available toward the end of 2002, a company spokeswoman said.

Each tablet, containing 15 or 30 mg of lansoprazole in enteric-coated microgranules, is supposed to be placed on the tongue and allowed to disintegrate until the particles can be swallowed, a process that typically takes no more than one minute, according to the product's labeling.

The tablets contain a strawberry flavoring and the sweetener aspartame (adding 2.5 mg of phenylalanine per 15-mg tablet and 5.1 mg per 30-mg tablet). Patients must not swallow the tablets whole or chew or crush them. The product's labeling describes the new dosage form as well suited for patients who have difficulty swallowing capsules.

Approval of the new dosage form came three and a half weeks after the indications for use of lansoprazole were expanded to include the short-term treatment—up to 12 weeks—of symptomatic gastroesophageal reflux disease or erosive esophagitis in children 1–11 years old. Indications in the FDA-approved labeling exclude use of the drug in patients less than 1 year old or 12–17 years of age.

Both strengths of Prevacid SoluTabs will be available in unit dose packages of 30 tablets.