Compositions for improved delivery of cgrp inhibitors
AssigneePfizer Ireland Pharmaceuticals
InventorsCharles M. CONWAY, Gene M. DUBOWCHIK, Rajesh KUMAR
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Abstract
Provided is a pharmaceutical formulation in the form of a softgel dosage form including a calcitonin gene-related peptide (CGRP) inhibitor, a lipophilic phase, and at least one lipophilic surfactant. Also provided is a method for increasing bioavailability of a calcitonin gene-related peptide (CGRP) inhibitor in a subject, including orally administering the pharmaceutical formulation to increase the bioavailability of the CGRP inhibitor in the subject.
Claims24
A pharmaceutical formulation in the form of a soft gel dosage form, comprising:
- a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist or salt or solvate thereof in an amount 0.01-20 weight % of the total weight of the formulation;
- a lipophilic phase comprising triglycerides of fatty acids in an amount of 50-80 weight % of the total weight of the formulation;
- and
- at least one lipophilic surfactant comprising partial esters of polyol and fatty acids in an amount of 10-50 weight % of the total weight of the formulation,
- wherein the small molecule CGRP receptor antagonist is zavegepant, ubrogepant, atogepant, telcagepant, or olcegepant, a solvate thereof, or a pharmaceutically acceptable salt thereof.
(canceled)
A method for treatment or prevention of a condition associated with aberrant levels of CGRP in a subject in need thereof, wherein the method comprises administering to the subject a pharmaceutical formulation in a form of a soft gel dosage form, comprising:
- a small molecule CGRP receptor antagonist or salt or solvate thereof in an amount 0.01-20 weight % of the total weight of the formulation;
- a lipophilic phase comprising triglycerides of fatty acids in an amount of 50-80 weight % of the total weight of the formulation;
- and
- at least one lipophilic surfactant comprising partial esters of polyol and fatty acids in an amount of 10-50 weight % of the total weight of the formulation, wherein the delayed release dosage form is a coated dosage form whose release is pH dependent,
- wherein the small molecule CGRP receptor antagonist is zavegepant, ubrogepant, atogepant, telcagepant, or olcegepant, a solvate thereof, or a pharmaceutically acceptable salt thereof.
(canceled)
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Dependencies are inferred from the claim text.