ST-246 liquid formulations and methods
The present invention provides for a novel liquid formulation for solubilizing poorly soluble ST-246 in cyclodextrins and a novel process of making the formulation.
1. A unit dosage liquid formulation comprising:
a) ST-246 content ranging from about 2 mg/ml to about 20 mg/ml; and
b) hydroxypropyl-β-cyclodextrin content ranging from about 125 mg/ml to about 400 mg/ml.
2. The unit dosage liquid formulation of claim 1 further comprising one or more pharmaceutically acceptable ingredients selected from the group consisting of: mannitol, trehalose dehydrate, lactose monohydrate, and purified water.
3. The unit dosage liquid formulation of claim 1 having a pH range from about 3.0 to about 10.0.
4. The unit dosage liquid formulation of claim 1 having a total volume of about 100 ml.
5. A unit dosage liquid formulation comprising:
a) ST-246 ranging from about 2 mg/ml to about 20 mg/ml; and
hydroxypropyl-β-cyclodextrin content ranging from about 12.5 mg/ml to about 40 mg/ml.
6. The unit dosage liquid formulation of claim 5 further comprising one or more pharmaceutically acceptable ingredients selected from the group consisting of:
polyethylene glycol 400, polysorbate 80, polyethylene glycol 300, and purified water.
7. The unit dosage liquid formulation of claim 5 having a total volume of about 100 ml.
8. The unit dosage liquid formulation of claim 5 having a pH range from about 3.0 to about 10.0.