odt; odt composition; method for preparing a multiparticulate odt tablet, method for treating or preventing postoperative nausea and vomiting or post-discharge nausea and vomiting for up to 24 hours after dosing, method for treating pu preventing nausea for up to 24 hours after dosing and Method for treating or preventing nausea and vomiting associated with radiotherapy in patients receiving either full body irradiation, single high dose to the abdomen, or daily fractions to the abdomen for up to 24 hours after dosing.

摘要

This invention is related to a pharmaceutical composition in the patient-friendly orally disintegrating tablet form comprising a weakly basic, selective serotonin 5-HT3 blocking agent for the prevention of nausea and/or vomiting for up to 24 hrs postdosing in cancer patients prior to undergoing moderately emetogenic chemotherapy or partial or whole body radiotherapy or in subjects at moderate to high risk of postoperative or postdischarge nausea and/or vomiting prior to inpatient or outpatient ambulatory surgery. The unit dosage form comprising a multitude of immediate-release drug particles providing dissolution profiles similar to that of reference drug product, and one or more timed, pulsatile-release bead populations, comprising at least one organic acid, which solubilizes said weakly basic selective serotonin 5-HT3 blocking agent prior to releasing it into the hostile intestinal environment, wherein the blocking agent is practically insoluble, is capable of delivering said antiemetic agent in patients in need thereof in a sustained-released fashion to be suitable for a once-daily dosing regimen.