Patent Issued for Continuous complexation of active pharmaceutical ingredients (USPTO 11759529).

In general, the formation and dissociation rate of the cyclodextrin/API complexes is similar, and their half-life is only a few thousands of second in solution, meaning that said complexes are continuously being formed and dissociated (Lima Guedes et al., 2008). The process according to claim 1, wherein solution B further comprises one or more solvents that can be the same or different from the at least one solvent in Solution A, and if different said solvents can be miscible or immiscible with each other. Preparing a first solution (solution A) comprising the at least one cyclodextrin selected from the group consisting of: a-cyclodextrin, b-cyclodextrin, g-cyclodextrin, sulfobutylether-beta-cyclodextrin, hydroxypropyl-beta -cyclodextrin, methyl-beta-cyclodextrin and maltosyl-beta-cyclodextrin, and at least one solvent; b. Preparing a second solution, partial solution or suspension (solution B), comprising the at least one API; c. Feeding said solution A and said solution B to a microfluidization system, wherein the feed flow ratio of solution A to the microfluidization system to solution B ranges from 0.1 to 10 kg/kg and the feed flow ratio of solution A to the microfluidization system and the amount of solid API added ranges from 0.01 to 10 kg/kg; d. Mixing said solution A and said solution B by a microfluidization system to produce a third solution (solution C) of at least one of said complex such that the at least one API is included in an internal cyclodextrin cavity; e. Isolating said solution C and/or optionally drying the solution C; and f. Optionally collecting a powdered form of the complex comprising the at least one cyclodextrin and the at least one active pharmaceutical ingredient (API). [Extracted from the article]

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