fumaric-acid has been researched along with pirfenidone* in 1 studies
1 other study(ies) available for fumaric-acid and pirfenidone
Article | Year |
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Investigating the Role of the Reduced Solubility of the Pirfenidone-Fumaric Acid Cocrystal in Sustaining the Release Rate from Its Tablet Dosage Form by Conducting Comparative Bioavailability Study in Healthy Human Volunteers.
Pirfenidone (PFD) is the first pharmacological agent approved by the US Food and Drug Administration (FDA) in 2014 for the treatment of idiopathic pulmonary fibrosis (IPF). The recommended daily dosage of PFD in patients with IPF is very high (2403 mg/day) and must be mitigated through additives. In the present work, sustained-release (SR) formulations of the PFD-FA cocrystal of two different strengths such as 200 and 600 mg were prepared and its comparative bioavailability in healthy human volunteers was studied against the reference formulation PIRFENEX (200 mg). A single-dose pharmacokinetic study (200 mg IR Topics: Administration, Oral; Area Under Curve; Biological Availability; Cross-Over Studies; Delayed-Action Preparations; Fumarates; Healthy Volunteers; Humans; Pyridones; Solubility; Tablets; Therapeutic Equivalency | 2022 |