[en] Flexible solid dosage manufacturing platforms that enable customizing doses for personalized medicine, are recognized as the future standard in pharmaceutical therapy. This study uses a solution-based additive manufacturing approach for the solid dosage formulation of individualized doses, precisely controlled in increments as little as 0.2 mg. The drug substance warfarin sodium isopropanol (WS-IPA) has relevant personalized formulation needs and was used as the highly potent model compound. A solution (drug substance, solvent, antisolvent, polymer) is dispensed into a capsule carrier (pullulan) based on a model-informed precision dosing algorithm to manufacture crystalline solid dispersion (CrySoD). Upon a controlled evaporative antisolvent-solvent crystallization (heptane/IPA), WS-IPA crystallizes inside the polymer matrix (polyethylene glycol, PEG). By controlling the critical process parameters (temperature, drug substance - PEG concentration, antisolvent composition) of the coupled crystallization and formulation process, the commercial crystalline solid form of WS-IPA can be obtained. The CrySoD capsules (commercial and individualized doses) met key performance metrics (e.g., dissolution profile) of commercially formulated WS-IPA tablets (Coumadin®) following United States Pharmacopeia (USP) protocols. The workflow and insights provide a generalizable proof-of-concept for a model-informed solid dosage formulation platform enabled by process intensification. This study might be used as a rationale for further investigations, including other personalized medicine relevant drug substances, regulatory science, and technoeconomic analysis.
Disciplines :
Chemical engineering
Author, co-author :
Mbodji, Aliou ; Crystallization Design Institute, Molecular Sciences Research Center, University of Puerto Rico, San Juan, PR 00926, United States, Department of Pharmaceutical Sciences, University of Puerto Rico, Medical Sciences Campus, San Juan, PR 00936, United States
Gomez, Andrea Arroyo; Crystallization Design Institute, Molecular Sciences Research Center, University of Puerto Rico, San Juan, PR 00926, United States, Department of Chemistry, University of Puerto Rico, Rio Piedras Campus, San Juan, PR 00926, United States
Silva, Gianelle Bigio ; Crystallization Design Institute, Molecular Sciences Research Center, University of Puerto Rico, San Juan, PR 00926, United States, Department of Chemistry, University of Puerto Rico, Rio Piedras Campus, San Juan, PR 00926, United States
Vlaar, Cornelis P ; Department of Pharmaceutical Sciences, University of Puerto Rico, Medical Sciences Campus, San Juan, PR 00936, United States
Duconge, Jorge ; Department of Pharmaceutical Sciences, University of Puerto Rico, Medical Sciences Campus, San Juan, PR 00936, United States
Cersonsky, Rose K; Department of Chemical and Biological Engineering, University of Wisconsin-Madison, Madison, WI 53705, United States
Yu, Lian; School of Pharmacy, University of Wisconsin-Madison, Madison, WI 53705, United States, Department of Chemistry, University of Wisconsin-Madison, Madison, WI 53705, United States
Zhang, Geoff Gz ; Department of Industrial and Molecular Pharmaceutics, Purdue University, West Lafayette, IN 47907, United States, ProPhysPharm, Lincolnshire, IL 60069, United States
Coquerel, Gérard ; SMS Laboratory EA3233, University of Rouen Normandy, Mont Saint Aignan CEDEX, F-76821, France
Romañach, Rodolfo J ; Department of Chemistry, University of Puerto Rico, Mayaguez Campus, Mayaguez, PR 00681, United States
Stelzer, Torsten ; Crystallization Design Institute, Molecular Sciences Research Center, University of Puerto Rico, San Juan, PR 00926, United States, Department of Pharmaceutical Sciences, University of Puerto Rico, Medical Sciences Campus, San Juan, PR 00936, United States. Electronic address: torsten.stelzer@upr.edu
Language :
English
Title :
Evaporative coupled with antisolvent crystallization for additive manufacturing of personalized solid dosage forms.
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