FlowLac® 100 Low Nitrite
MEGGLEs Low Nitrite grades – simplifying nitrosamine compliance with specified limit of nitrite!
Due to the nitrosamine issue, the risk assessment and review of nitrite content in excipients have become essential. Pharmaceutical manufacturers must take appropriate measures, especially for critical products.
Spray-dried lactose, such as FlowLac®, is produced by spray-drying a fine milled alpha-lactose monohydrate suspension, resulting in a porous, spherical morphology with smooth surface properties. This enhances flowability, making it ideal for direct compression in high-speed tableting operations.
FlowLac® 100 Low Nitrite is a standard spray-dried alpha-lactose monohydrate grade offering superior flowability and compactibility compared to other lactose grades. Its spherical particle morphology and balanced amorphous content provide excellent tableting performance, making it suitable for direct compression processes and formulations with poorly flowing active pharmaceutical ingredients.
Nitrite testing is not a pharmacopoeia requirement, however MEGGLE has developed a method using ion chromatography to accurately quantify nitrite content, whereby the limit of quantification (LOQ) is 0.03 ppm. Values below this limit will be reported as < 0.03 ppm. Through additional validation, we have demonstrated that we can safely specify a limit of ≤ 0.10 ppm.
MEGGLE measures the nitrite parameter on each lot. The nitrite value is part of the Product Specification and the corresponding Certificate of Analysis (CoA) for all MEGGLE Low Nitrite grades. This does not only simplify the risk assessment, but also demonstrates compliance with the defined nitrite limits for critical products.
Benefits
- Superior flowability
- Best in class compactibility
- Very low strain rate sensitivity (high speed compression)
- Smooth surface (glossy tablets)
- Fast disintegration times
- Simplified Compliance: Streamlines nitrosamine compliance with a specified nitrite limit.
- Accurate Measurement: Uses ion chromatography for precise nitrite quantification, with a LOQ of 0.03 ppm.
- Validated Safety: Ensures a safe nitrite limit of ≤ 0.10 ppm, meeting industry targets.
- Consistent Quality: Includes nitrite values in every lot’s Product Specification and CoA.
Areas of Application
- Direct compression
- Continuous applications
- Formulations with poorly flowing API’s
- Capsule and sachet filling
- Manufacturers seeking to minimize risks associated with nitrosamine formation in their production processes.
- All applications of standard product
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- Direct compression
- Continuous processing
- Spray-dried Lactose
- Oral Solid Dose
- Placebo tablet
- Low to medium dose DC formulation
- Formulation with poorly flowing API
- Capsule
- Sachet
- Tablet
25kg – Paper bag with PE-EVOH-PE inliner
18 months
Wasserburg am Inn, Germany
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Typical particle size distribution
Typical Product Data
- x10: 43 µm, x50: 133 µm, x90: 239 µm
- Span [(x90-x10)/x50]: 1.47
- Density bulk: 0.613 g/ml
- Density tapped: 0.699 g/ml
- Hausner Ratio: 1.14
- Carr’s Index: 12 %
Specified Product Data
Particle size distribution
Sieve Method: Air-jet sieving
- <32 µm: NMT 10%
- <100 µm: 20-45%
- <200 µm: NLT 80%
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