Case Study #1 – NanoPac® – Micronization Comparison
Purcision NanoPac was compared to a traditional micronization technique (milling) to show the unique particle characteristics produced during the Purcision process.
Particle Characteristics |
Raw Paclitaxel |
Milled Paclitaxel |
Purcision NanoPac® |
||
| Number Mean (µm) |
1.16 | 0.89 | – 23% | 0.82 |
– 29% |
| Surface Area (m2/g) |
10.5 | 15.0 | + 42% | 39.0 |
+ 271% |
| Dissolution (30 min) |
18% | 32% | + 77% | 42% |
+ 133% |
NanoPac® – Dissolution
Residual solvents in NanoPac are virtually eliminated when micronized with CritiTech’s Purcision technology
Solvent |
Raw Paclitaxel (ppm) |
Purcision NanoPac® (ppm) |
% Solvent Reduction |
| Methanol | Non-Detectable | Less than LLQ | NA |
| Acetone* | 1,156 | 84.1 |
– 93% |
| Ethyl Acetate | Non-Detectable | Non-Detectable | NA |
| Heptane | 1,799 | Non-Detectable |
– 100% |
*In addition to being present in the raw material, acetone is a process solvent and is still removed to a low level.
Particle Size Stability
Phase I Clinical Trial Material Stability Data
- 6 month accelerated conditions
- 24 month long-term conditions
- No increase in PSD observed
Variability is well within the method’s acceptable range.
Case Study #2 – CT-0401 – Particle Size Analysis
Where NanoPac was extremely hydrophobic, CT-0401 is extremely hydrophilic and was optimized to immediate release using Purcision technology.
Particle Characteristics |
Raw
|
Milled
|
Purcision CT-0401 |
||
| Number Mean (µm) |
1.16 | 0.85 |
-0.26% |
0.20 |
-82.5% |
| Surface Area (m2/g) |
5.21 | 14.7 |
+182% |
60.3 |
+1,057% |
| Dissolution (60 s) |
20.1% | 26.4% |
+31.3% |
98.7% |
+391% |
CT-0401 – Dissolution
CT-0401 – SEM Micrographs
Case Study #3 – Insulin – Initial Feasibility Study Results
Large molecules can be enabled with Purcision as well. Initial feasibility study results for insulin are shown below.
Raw Material Insulin |
Purcision Insulin |
% Change from raw |
|
| Number Mean | 4.37 |
0.72 |
-83% |
| D-10 | 0.57 |
0.52 |
-9% |
| D-90 | 12.15 |
0.98 |
-92% |
| Volume Mean | 10.36 |
4.02 |
-61% |
| D-10 | 1.96 |
1.52 |
-23% |
| D-90 | 25.12 |
9.91 |
-61% |
All numbers reported in micrometers
Results based on Initial Feasibility Study. Results do not indicate an attempt to optimize.
Case Study #4 – BSA – Initial Feasibility Study Results
Large molecules can be enabled with Purcision as well. Initial feasibility study results for bovine serum albumin are shown below.
Raw Material BSA |
Purcision BSA |
% Change from raw |
|
| Number Mean | 1.91 |
0.83 |
-57% |
| Volume Mean | 13.9 |
4.23 |
-70% |
All numbers reported in micrometers.
Results based on Initial Feasibility Study. Results do not indicate an attempt to optimize.
Case Study #5 – Acetaminophen
Raw |
SCP |
% Change |
|
| Volume mean (µm) | 22.427 | 6.059 | -73 % |
| D10 (µm) | 7.335 | 3.083 | -58 % |
| D90 (µm) | 55.995 | 10.766 | -81 % |