Sonic impinging jet crystallization apparatus and process
AssigneeBristol-Myers Squibb Company
InventorsMark D. Lindrud, Soojin Kim, Chenkou Wei
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Abstract
A novel apparatus and process for crystallizing submicron-sized crystals of a pharmaceutical composition. The submicron-sized crystals, which have an average size of less than 1 micron, provide high surface area end product crystals with greatly improved stability and purity, and which afford crystals having improved bioavailability, higher dissolution, decreased decomposition rate and longer shelf-life.
Claims17
A process for the crystallization of a pharmaceutical compound comprising positioning a tip of a sonication probe within a gap defined between two or more fluid jets positioned such that fluid jet streams which emerge from said fluid jets impinge in said gap creating a point of high turbulence at the point of impact of said fluid streams, each of said fluid streams having sufficient linear velocity to achieve high intensity micromixing of the solutions prior to nucleation, said sonication probe providing ultrasonic energy in the immediate vicinity of said impinging fluid streams so as to effect nucleation and the direct production of small crystals, at least 95% of said crystals having a diameter of less than 1 micron.
A crystallization apparatus for producing submicron-sized particles, which comprises:
- a crystallization flask;
- two or more fluid impinging jets,
- an agitator, and
- a sonication probe having a probe tip, wherein said impinging jets, said agitator and said sonication probe are positioned within said crystallization flask, said impinging jets positioned substantially diametrically opposed to each other, and said sonication probe positioned proximate said impinging jets such that said probe tip is positioned such that it is at the same level as the impinging jets.
Dependencies are inferred from the claim text.