Case Studies


Crystal Control Technology (CCT) is well characterized after hundreds of successful experiments with multiple active pharmaceutical ingredients (API’s). GenSyn utilized response surface designs to model both nano and micro scale crystallization processes. This rigorous approach to developing statistically valid process models has contributed to new learnings and intellectual property. GenSyn’s CCT models enable efficient research projects having a high probability of success. In addition, CCT follows Bernoulli’s equation, which addresses the ever present industry concern regarding predictable, controllable and scalable technology.

The following case histories provide a representative sampling of CCT capabilities.

Itraconazole

Itraconazole was used to demonstrate the capability of CCT to produce nano-particles. An extensive DOE provided a model for reproducibly producing particles below 200 nano-meters. The following chart shows how particle size can be dialed-in to a specific size, in this case 35nm.

Nano Crystallization Process Example – Customized Particle Size & Distribution

Crystallization for inhalation therapies

Using models developed at GenSyn Technologies, three generic API’s were selected to demonstrate how quickly CCT could be used to meet a specific particle size target. The target was defined as a median particle size of 1-5 µm with a d90 < 10µm.

  1. Carbamazapine: Using the CCT models, it took 5 trials to hit the target – orange line. The graph below shows those 5 trials while the pictures compare API particles from standard industry processing and CCT.

    Carbamazapine
    Standard Processing
    Carbamazapine
    Crystal Control Technology Processing
    Note: Photo scale is 10 microns.
  2. Ketoprofen: Using the CCT models, it took 4 trials to hit the target – blue line. The graph below shows those 4 trials while the pictures compare API particles from standard industry processing and CCT.

    Ketoprofen
    Standard Processing
    Ketoprofen
    Crystal Control Technology Processing
    Note: Photo scale is 10 microns.
  3. Paracetamol: Using the CCT models, it took 2 trials to hit the target (green line) and a third trial was conducted to validate the results – overlapping red and green lines. The graph below shows those 3 trials while the pictures compare API particles from standard industry processing and CCT.

    Paracetamol
    Standard Processing
    Paracetamol
    Crystal Control Technology Processing
    Note: Photo scale is 10 microns.

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