MEGGLE Tablettose® agglomerated lactose tableting excipients

MEGGLE’s world-leading portfolio of precisely tailored lactose-based functional pharmaceutical excipients includes the Tablettose® range of agglomerated lactoses that are particularly useful in direct compression (DC) tablet manufacturing.

Tablettose® excipients are available in three grades that are all produced using continuous spray agglomeration process and feature good flowability, compactibility and stability, together with low hygroscopicity, superior blending characteristics, and fast disintegration times.

Tablettose® Areas of Application include low dose DC formulations, capsule and sachet filling, effervescent and artificial sweetener tablets.

Agglomerated lactose

Lactose disaccharide, also called ‘milk sugar; occurs naturally as a simple carbohydrate in mammalian milk. Chemically, lactose is composed of molecules of D-galactose and D-glucose. It can exist in either alpha lactose and beta isomeric forms (a-lactose or b-lactose).

The chemical and physical stability of crystalline lactose monohydrate powdered lactose makes it highly suitable for oral pharmaceutical applications, with versatile properties for binding or filling, compressibility and global availability.

Agglomerated lactose is developed by combining the good flow of coarse lactose and good compactibility of fine powder grade. This grade is manufactured by wet granulation process by spraying water on fluidized fine particles of lactose monohydrate. This creates liquid bridges that bring the particles together. Upon drying, the excess water is evaporated and the bridges are maintained resulting in a very stable, non-hygroscopic alpha lactose monohydrate with no amorphous lactose.

Tablettose® grades

Meggle’s agglomerated lactose grades are marketed as Tablettose® 70, Tablettose® 80, and Tablettose® 100. The grades differ in the size of the lactose particles used, with compactibility improving as size decreases, and flowability increasing in relation to particle size. This range of grades allows manufacturers to achieve the ideal balance between the good flowability of coarse lactose and good compactibility of fine milled lactose.

All Tablettose® grades comply with the current harmonized Ph.Eur., USP-NF, and JP monographs, being manufactured in MEGGLE’s pharma-dedicated DIN ISO 9001:2008 and cGMP certified production facility in Wasserburg, Germany. They come packaged in 25 kg paper bags with PE-EVOH-PE Inliner and offer 24 months shelf life between retests.

Tablettose® 80:  This is the original agglomerated alpha-lactose monohydrate, manufactured by a continuous spray process, where water is used as the binder and is sprayed onto fluidized fine milled lactose particles, creating liquid bridges to aid agglomeration. Particularly tailored to DC applications, Tablettose® 80 combines the flowability of coarse lactose crystals and the good compressibility of fine milled lactose. It has a particle size distribution (PSD) as measured by mechanical sieve shaker of not more than (NMT) 20% under 63 μm, 40-70% under 180 μm  and not less than (NLT) 97% below 630 μm.

Typical Values for Tablettose® 80 are:

• Bulk Density [g/l]: 620
• Tapped Density [g/l] : 770
• Hausner factor: 1.24
• Carr’s index: 19 %

Tablettose® 70: This grade features reduced fines content smaller than 63 µm and contains no particles larger than 500 μm. These characteristics make Tablettose® 70 the excipient of choice for narrow particle size distribution (improved flowability) and dust free production.

PSD is NMT 6% under 63 μm, 30-70% under 250 μm and NLT 98% below 500 μm.

Typical Values for Tablettose® 70 are:

• Bulk Density [g/l]: 530
• Tapped Density [g/l] : 640
• Hausner factor: 1.21
• Carr’s index: 17 %

Tablettose® 100: This grade is produced from a smaller starting particle size than the material used for Tablettose® 80 and Tablettose® 70. As a result, Tablettose® 100 has a higher dilution potential compared to Tablettose® 70 and Tablettose® 80 due to increased compactibility.

PSD is NMT 25% under 63 μm, 60-90% under 250 μm and NLT 96% below 500 μm.

Typical Values for Tablettose® 100 are:

• Bulk Density [g/l]: 580
• Tapped Density [g/l] : 720
• Hausner factor: 1.24
• Carr’s index: 19 %

Resources

Click on Tablettose® 70 for detailed product information.
Click on Tablettose® 80 for detailed product information.
Click on Tablettose® 100 for detailed product information.
Click on MEGGLE lactose product configurator to access full excipient range.
Click on MEGGLE Lactose Sales to contact distribution partner.