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

Autor:	Nimmy Kumari, Parag Roy, Sukanta Roy, Prashantkumar K. Parmar, Soumalya Chakraborty, Sourav Das, Noopur Pandey, Anirbandeep Bose, Arvind Kumar Bansal, Animesh Ghosh
Rok vydání:	2022
Předmět:	Cross-Over Studies Pyridones Administration Oral Biological Availability Pharmaceutical Science Healthy Volunteers Fumarates Solubility Therapeutic Equivalency Area Under Curve Delayed-Action Preparations Drug Discovery Humans Molecular Medicine Tablets
Zdroj:	Molecular Pharmaceutics. 19:1557-1572
ISSN:	1543-8392 1543-8384
DOI:	10.1021/acs.molpharmaceut.2c00052
Popis:	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
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a8f41a8d87c9810e15b08c982a1cd123 https://doi.org/10.1021/acs.molpharmaceut.2c00052 Zobrazit plný text záznamu