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
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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 |