Dissolution of hydrophobic API, including avermectins with or without other API such as pyrantel, from a complicated matrix dosage form
AssigneeMerial Limited
InventorsAbu M. Rustum, Satish Kumar, Andrew L. McAdoo
Life of this patent
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Abstract
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.
Claims25
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;
- and
- ii. from about 5% to about 40% of an organic solvent;
- and
- b. determining the amount of active ingredient in the solution.
The method of any one of the proceeding claims, wherein the organic solvent is selected from dioxane, DMI, DMSO, THF, and combinations thereof.
A composition, useful in dissolving a multi-active ingredient-containing, matrix-style solid dosage form, said composition comprising:
- a. from about 60% to about 95% 1M NaOH (or an equivalent amount of base) in water;
- and
- b. from about 5% to about 40% of an organic solvent.
Dependencies are inferred from the claim text.