FlowLac® 90 and FlowLac® 100 Spray-Dried Lactose - MEGGLE
FlowLac® 90 and FlowLac® 100 are spray-dried lactose grades designed for direct compression. Their combination of brittle crystalline lactose and plastically deforming amorphous lactose provides strong powder flow and compactibility.
Both grades provide spray-dried lactose functionality for direct-compression formulations.- FlowLac® 90 has a tighter low-fines profile, while FlowLac® 100 provides a broader particle-size distribution.
- Both grades meet the same pharmacopoeial, purity, and microbiological requirements.
- Both are suitable for vegetarian formulations and Kosher certified; FlowLac® 100 is also Halal certified.
- Production is supported by EXCiPACT-certified GMP and GDP systems.
AI Summary: Compares the controlled air-jet sieving limits that distinguish the two grades.
| Particle Size Distribution | ||
|---|---|---|
| Particle size | FlowLac® 90 | FlowLac® 100 |
| <32 µm | Max. 5% | Max. 10% |
| <100 µm | 25–40% | 20–45% |
| <200 µm | Min. 85% | Min. 80% |
AI Summary: Compares the powder-flow and density characteristics of both grades.
| Functional Characteristics | ||
|---|---|---|
| Parameter | FlowLac® 90 | FlowLac® 100 |
| Angle of repose (°) | 27 | 28 |
| Density bulk (g/L) | 560 | 590 |
| Density tapped (g/L) | 670 | 710 |
| Hausner ratio | 1.20 | 1.20 |
| Carr’s index (%) | 16.42 | 16.90 |
AI Summary: Presents the principal chemical and quality limits shared by FlowLac® 90 and FlowLac® 100.
| Key Specifications | |
|---|---|
| Parameter | Shared specification |
| Water | 4.5–5.5% |
| Loss on drying | Max. 1.0% |
| Sulfated ash | Max. 0.1% |
| Heavy metals | Max. 5 µg/g |
| Arsenic | Max. 2 µg/g |
| Assay of lactose, anhydrous basis | 98.0–102.0% |
| Related substances | Max. 0.5% |
AI Summary: Presents the microbiological limits shared by both FlowLac® grades.
| Microbiological Requirements | |
|---|---|
| Parameter | Shared specification |
| Total aerobic microbial count | Max. 100 cfu/g |
| Total yeast and mould count | Max. 10 cfu/g |
| Escherichia coli | Absence in 10 g |
| Salmonella spp. | Absence in 100 g |
AI Summary: Compares the available packaging formats and corresponding shelf life for each grade.
| Packaging and Shelf Life | |||
|---|---|---|---|
| Grade | Net weight | Packaging | Shelf life |
| FlowLac® 90 | 25 kg | Carton box with aluminium-laminated inliner | 36 months |
| FlowLac® 100 | 25 kg | Carton box with aluminium-laminated inliner | 24 months |
| FlowLac® 100 | 25 kg | Paper bag with PE-EVOH-PE inliner | 18 months |
AI Summary: Introduces the composition, physical identity and distinguishing characteristics of each FlowLac® grade.
FlowLac® 90
Spray-dried, directly compressible lactose monohydrate supplied as a white or almost white, crystalline, odourless powder. It is freely but slowly soluble in water and practically insoluble in ethanol 96%, chloroform, and ether. FlowLac® 90 has an optimized amorphous lactose content for greater compactibility than FlowLac® 100. Its particle-size distribution also makes it virtually dust-free.
FlowLac® 100
Spray-dried, directly compressible lactose monohydrate supplied as a white or almost white, crystalline, odourless powder. It is freely but slowly soluble in water and practically insoluble in ethanol 96%, chloroform, and ether. FlowLac® 100 is the standard spray-dried lactose grade, providing excellent flowability and strong compactibility.
AI Summary: Provides quick answers to the main grade-selection, application, storage and packaging questions.
What is the main difference between FlowLac® 90 and FlowLac® 100?
FlowLac® 100 is the standard spray-dried lactose grade. FlowLac® 90 has an optimized amorphous lactose content for greater compactibility and a particle-size profile designed to make it virtually dust-free.
Which applications are supported?
Both grades are suitable for direct compression, poorly flowing active ingredients, capsule filling and sachet filling.
Do both grades meet the same pharmacopoeial standards?
Yes. Both conform to USP-NF, Ph. Eur., JP and ChP requirements for lactose monohydrate.
What is the shelf life?
FlowLac® 90 has a shelf life of 36 months. FlowLac® 100 has a shelf life of 24 months in the carton with aluminium-laminated inliner or 18 months in the paper bag with PE-EVOH-PE inliner.
Are both grades Halal and Kosher certified?
FlowLac® 100 is Halal and Kosher certified. FlowLac® 90 is Kosher certified.
AI Summary: Summarizes the conditions needed to preserve product quality and functionality.
Storage
- Store tightly closed in the unopened original MEGGLE container.
- Store at room temperature under dry and odour-free conditions.
- Avoid significant changes in relative humidity.
- Aluminium inliners are recommended under high-humidity conditions to retain functionality.
AI Summary: Shows the principal formulation and filling applications shared by both grades.
Applications
- Low- to medium-dose direct-compression formulations
- Formulations containing poorly flowing active ingredients
- Capsule filling
- Sachet filling