Tablettose® 80 Agglomerated Lactose Monohydrate - MEGGLE
Tablettose® 80 is an agglomerated alpha-lactose monohydrate excipient developed for direct compression. It combines very good flowability and compactibility with low hygroscopicity, stable blending performance and controlled particle-size distribution.
Developed for low-dose direct-compression formulations.- Provides very good flowability and compactibility.
- Supports stable, homogeneous blending with APIs and other excipients.
- Suitable for capsule and sachet filling, effervescent tablets and artificial sweetener tablets.
- Shows low hygroscopicity and excellent storage stability.
- Supplied in 25 kg packaging with a 36-month shelf life.
AI Summary: Shows the controlled particle-size profile of Tablettose® 80.
| Particle Size Distribution | |
|---|---|
| Parameter | Specification |
| Particle size distribution <63 µm | Max. 20% |
| Particle size distribution <180 µm | 40-75% |
| Particle size distribution <400 µm | Min. 85% |
| Particle size distribution <630 µm | Min. 97% |
AI Summary: Shows the typical powder-flow properties relevant to handling and direct compression.
| Functional Characteristics | |
|---|---|
| Parameter | Specification |
| Grade | Tablettose® 80 |
| Angle of repose (°) | 34 |
| Density bulk (g/l) | 620 |
| Density tapped (g/l) | 770 |
| Hausner ratio | 1.24 |
| Carr’s index (%) | 19.48 |
AI Summary: Presents the principal composition, moisture, purity and elemental limits.
| Key Specifications | |
|---|---|
| Parameter | Specification |
| Assay: Lactose calculated on the anhydrous basis | 98.0-102.0% |
| Water | 4.5-5.5% |
| Loss on drying | Max. 0.5% |
| Sulfated ash | Max. 0.1% |
| Related substances | Max. 0.5% |
| Heavy metals | Max. 5 µg/g |
| Arsenic (As) | Max. 2 µg/g |
AI Summary: Presents the microbiological acceptance limits.
| Microbial Contamination | |
|---|---|
| Parameter | Specification |
| Total aerobic microbial count (TAMC) | Max. 100 cfu/g |
| Total combined yeasts/moulds count (TYMC) | Max. 10 cfu/g |
| Escherichia coli | Absence/10 g |
| Salmonella spp. | Absence/100 g |
AI Summary: Presents the material composition, production form, appearance and solubility.
TABLETTOSE® 80
Agglomerated alpha-lactose monohydrate produced by continuous spray agglomeration without forming amorphous lactose. It is a white or almost white, crystalline, odourless powder that is freely but slowly soluble in water and practically insoluble in ethanol 96%, chloroform and ether. It is suitable for a vegetarian diet.
AI Summary: Covers product identity, applications, performance and supply conditions.
What is Tablettose® 80?
An agglomerated alpha-lactose monohydrate excipient developed for direct compression.
Which applications are recommended?
Low-dose direct-compression formulations, capsules, sachets, effervescent tablets and artificial sweetener tablets.
What are its powder-flow characteristics?
Its typical angle of repose is 34°, Hausner ratio is 1.24 and Carr’s index is 19.48%.
Is it suitable for humid conditions?
It has low hygroscopicity and does not adsorb significant amounts of water below 80% relative humidity at 20°C.
How is it supplied?
In 25 kg paper bags with PE-EVOH-PE inliners.
What is the shelf life?
36 months under the recommended storage conditions.
AI Summary: Summarizes the supply format and conditions required to preserve product quality.
Storage, Packaging and Shelf Life
- Store unopened at room temperature.
- Keep under dry and odour-free conditions.
- Packaging: 25 kg paper bag with PE-EVOH-PE inliner.
- Shelf life: 36 months.
- Packaging material complies with Regulation (EC) No. 1935/2004 and applicable 21 CFR requirements.
AI Summary: Identifies the recommended formulation and processing uses.
Applications
- Low-dose direct-compression formulations
- Capsule filling
- Sachet filling
- Effervescent tablets
- Artificial sweetener tablets