Question: You have been assigned to develop a lyophilized formulation for a new product. Intravenous administration showed a target of 40 mg was acceptable. The target
You have been assigned to develop a lyophilized formulation for a new product. Intravenous administration showed a target of 40 mg was acceptable. The target dosage for subcutaneous administration with 80% bioavailability. Because it is subcutaneous, target 270-350 mOsm/kg for your dosage form. The pH should be 7.0. The maximum protein concentration is 60 mg/mL.
Use the table below for reference and show your work.
| Tg' (C) | mOsm/% | mM to = 1% | pKa | |
| Dextran | -11 | 0 | 1 | |
| HES | -12 | 0 | 1 | |
| Mannitol | -27 | 60 | 60 | |
| Sucrose | -32 | 30 | 30 | |
| Histidine | -33 | 65 | 64 | 6.0 |
| Trehalose | -34 | 30 | 30 | |
| Succinic Acid | (assume -35) | 85 | 85 | 5.6 |
| NaCitrate | -41 | 35 | 34 | 4.8, 6.4 |
| Sorbitol | -46 | 60 | 60 | |
| NaCl | -120 | 320 | 171 | |
| Phosphate | (assume -50) | (assume 100) | 100 | 7.2 |
| Glycine | -60 | 134 | 133 | |
| NaAcetate | -64 | 122 | 122 | 4.8 |
| Tris | -65 | 82 | 82 | 8.1 |
| Water | -133 | 0 |
What is your proposed formulation (including protein concentration and osmolality) - 6 points?
What is your Tg' - 3 points (note correctly setting up equation in text will receive full credit, don't need to calculate final value)?
View keyboard shortcuts
Step by Step Solution
There are 3 Steps involved in it
Get step-by-step solutions from verified subject matter experts
Study Help