title: Challenges in Translational Development of Pharmaceutical Cocrystals.
abstract: The last 2 decades have witnessed increased research in the area of cocrystals resulting in deeper scientific understanding, increase in intellectual property landscape, and evolution in the regulatory environment. Pharmaceutical cocrystals have received significant attention as a new solid form on account of their ability to modulate poor physicochemical properties of drug molecules. However, pharmaceutical development of cocrystals could be challenging, thus limiting their translation into viable drug products. In the present commentary, the role of cocrystals in the modulation of material properties and challenges involved in the pharmaceutical development of cocrystals have been discussed. The major hurdles encountered in the development of cocrystals such as safety of coformers, unpredictable performance during dissolution and solubility in different media, difficulties in establishing in vitro-in vivo correlation, and polymorphism have been extensively discussed. The influence of selecting appropriate formulation and process design on these challenges has been discussed. Finally, a brief outline of cocrystals that are undergoing clinical development has also been presented.
authors.affiliation: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Punjab 160062, India.
authors.forename: Dnyaneshwar P
authors.initials: DP
authors.lastname: Kale
authors.affiliation: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Punjab 160062, India.
authors.forename: Sandeep S
authors.initials: SS
authors.lastname: Zode
authors.affiliation: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Punjab 160062, India. Electronic address: akbansal@niper.ac.in.
authors.forename: Arvind K
authors.initials: AK
authors.lastname: Bansal
mesh_terms: D002986:Clinical Trials as Topic; D003460:Crystallization / Q000379:methods*; D004339:Drug Compounding / Q000379:methods*; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D010330:Patents as Topic; D004364:Pharmaceutical Preparations / Q000737:chemistry*
chemical_list: D004364:Pharmaceutical Preparations
keywords: clinical trials; cocrystals; crystal engineering; formulation; physicochemical properties; preformulation