Dissolution of hydrophobic API, including avermectins with or without other API such as pyrantel, from a complicated matrix dosage form

摘要

This disclosure describes the results of the studies conducted to develop a dissolution method to monitor release profiles of hydrophobic active pharmaceutical ingredients such as ivermectin with or without pyrantel pamoate from a drug product made of complex matrix that includes, but is not limited to beef, tallow, corn cob and soy protein.

主权项

1. A method for determining the amount of at least one hydrophobic active pharmaceutical ingredient (API) released from a pharmaceutical solid dosage, said method comprising the steps of:
a. allowing said solid dosage form to release the active ingredient in a dissolution medium comprising
i. from about 60% to about 95% 1M NaOH (or an equivalent amount of base) in water; andii. from about 5% to about 40% of an organic solvent; and b. determining the amount of active ingredient in the solution.