APPLICATION DATA
Converting oily actives into a free flowing powder which can be processed into capsules or tablets is a great challenge to formulators. The oil load may affect flowability, compactability and compressibility leading to poor quality tablets. Boiled linseed oil, a recommended oil for testing oil adsorption properties was adsorbed on to Fujicalin® and other available DCPA's. Fujicalin® showed excellent compressibility by achieving an optimum tablet hardness of 80 to 100 N at very low compression forces.
Vitamin E is a fat soluble vitamin like A, D and K. It is oily in physical appearance and exists either in the form of tochopherols or tocotreinols. 12.5 g of Vitamin E was diluted with same amount of ethanol and mixed well before loading on to 83.5 g of Fujicalin® or other grades of DCPA. The mixture was dried overnight in an oven at 50ºC. Fujicalin® produced high quality Vitamin E tablets with sufficient tablet hardness (80-100N) at low compression forces of 200-500 kgf. To achieve an optimum hardness of 80-100N, other DCPA's need to be compressed at higher forces.
| Fujicalin® | DCPA 1 | DCPA 3 | ||||
|---|---|---|---|---|---|---|
| Before | After | Before | After | Before | After | |
| Angle of repose (°) | 29.5 | 28.1 | 30.5 | 39.0 | 37.1 | 39.9 |
| Compressibility index | 15.1 | 11.6 | 11.8 | 18.3 | 14.9 | 19.7 |
| Angle of spatula (°) | 33.3 | 24.8 | 47.5 | 49.2 | 37.8 | 54.0 |
| Degree of uniformity | 1.8 | 6.5 | 1.6 | 16.9 | 2.2 | 11.2 |
| Carr value* | 86.5 | 92.0 | 82.0 | 67.0 | 80.5 | 69.0 |
| Flowability | Excellent | Excellent | Good | Poor | Good | Poor |
*Carr value calculated adding relevant index points. Higher value indicates better powder flow properties (Ref- Carr, R. L., Chem. Eng., 72(3), 163-168, 1965)
Fujicalin®'s powder properties in fact showed improved values after Vitamin E adsorption. Superior Carr value validates the efficiency of Fujicalin® in converting oily actives like vitamin E into a free flowing powder when compared to other DCPA's
For application data, refer to technical library.
Two different particle sizes of acetaminophen were blended using two different blending machines to study the content uniformity
| D50 (μm) | Twinshell blender | High shear mixer | |||
|---|---|---|---|---|---|
| SG150 | SG100 | SG150 | SG100 | ||
| Acetaminophen | 148.6 | 20 | - | 20 | - |
| 98.6 | - | 20 | - | 20 | |
| Fujicalin® | 115.1 | 64 | 64 | 64 | 64 |
| L-HPC* | 40.4 | 15 | 15 | 15 | 15 |
| Magnesium Stearate | - | 1 | 1 | 1 | 1 |
| Total (%) | 100 | 100 | 100 | 100 | |
Micronized drugs substances may exhibit increased cohesiveness and have a tendency to segregate in blend. Acetaminophen tablets were prepared by direct compression with Fujicalin® and three other DCPA's. Blending of micronized acetaminophen (14 µm) powder and DCPA's were carried out for 30 minutes in a 2 liter V shaped low shear blender.
