TAP™ Tartaric Acid Spheres
TAP™ pellets are spherical cores made of tartaric acid. They are manufactured to be highly spherical, and high quality. These materials are a solubility enhancement solution for drugs that exhibit poor solubility in alkali environments.
PARTICLE ENGINEERING
SPI Pharma's tartaric acid pellets are manufactured for SPI using TAP® processes from Advanced Drug delivery Technology, ltd. This ensures robust mechanical stability and the highest consistency and quality.
TAP® Pellets ADVANTAGE
Spherical tartaric acid starter cores are emerging as a critical tool in the solubility enhancement toolkit for drug formulators Engineered for effective loading and coating, TAP pellets can be coated with an API that exhibits pH dependent solubility. TAP spheres can create an acidic micro-environment for the drug coating to improve solubility, release, absorption, and efficacy.
Product Properties
|
|
TAP 200 |
TAP 300 |
TAP 400 |
TAP 500 |
TAP 600 |
TAP 700 |
|
Particle size distribution (≥ 85 %) |
100-350 µm |
200-355 µm |
300-500 µm |
400-600 µm |
500-700 µm |
600-800 µm |
Additional Properties
|
Bulk density Ph.Eur. |
0.8-1.1 g/ml |
|
Identification A, solution strongly acidic Ph.Eur. |
strongly acidic |
|
Identification B, reaction of tartrate Ph.Eur., USP/NF |
positive |
|
Identification C, infra-red absorption USP/NF |
IR-spectrum equivalent reference standard |
|
Appearance in solution Ph.Eur. |
clear and not more intensely colored than the reference Y6 |
|
Water content Ph.Eur. |
≤ 0.5 % |
|
Loss on drying USP/NF |
≤ 0.5 % (for information only) |
|
Calcium Ph.Eur. |
≤ 200 ppm |
|
Chloride Ph.Eur. |
≤ 100 ppm |
|
Specific optical rotation Ph.Eur., USP/NF |
+12.0° to +12.8° |
|
Limit of oxalate USP/NF |
no turbidity |
|
Residue on ignition Ph.Eur., USP/NF, JP |
≤ 0.05 % |
|
Sulfate Ph.Eur., USP/NF, JP |
≤ 150 ppm |
|
Heavy metals Ph.Eur., USP/NF, JP |
≤ 10 ppm |
|
Arsenic JP |
≤ 1 ppm |
|
Assay USP/NF |
99.7 % to 100.5 % |
|
TAMC Ph.Eur., USP/NF, JP |
less than 1000 CFU/g |
|
TYMC Ph.Eur., USP/NF, JP |
less than 100 CFU/g |
| E.coli Ph.Eur., USP/NF, JP | absence in 1 g sample |