StarLac^®

Lactose and starch are very well established excipients. Both are naturally derived and used frequently in oral dosage formulations (ODT). Lactose is mainly used as diluent. Starch can be used as disintegrant and diluent as well.

In an effort to obtain synergistic effects, such as improved tablet hardness and faster disintegration, by co-processing both excipients, spray-dyring was used in order to bring lactose and starch together. As a result, StarLac^®, a co-processed excipient was achieved. It provides capability for direct compression and fast disintegration, that is basically independent from compaction pressure and level of lubricant.

In addition the flowability of StarLac^® has been significantly improved over the corresponding physical blend. StarLac^® is made up of 85 % alpha-lactose-monohydrate and 15 % white maize starch.

Shelf life / Retest:
36 months

Standard Packaging:
25 kg - Paper bag with PE-EVOH-PE Inliner

Particle size distribution
[Air jet sieve]

<32 µm: NMT 15%
<160 µm: 35-65%
<250 µm: NLT 80%

Typical Values

Bulk Density [g/l]: 540
Tapped Density [g/l] : 670
Hausner factor: 1.24
Carrs index: 19.4 %

Starch Lactose_Fast disintegration_ODT_taste masking

Benefits

Excellent flowability,
Fast disintegration of final tablets
Disintegration of final tablets independent from tablet hardness
Disintegration of final tablets independent from lubricant level

Areas of Application

StarLac^® is primarily designed for direct compression. In comparison with its corresponding physical blend, StarLac^® provides improved tablet hardness, faster disintegration, and superior flowability.
Improved robustness during tablet production is provided by StarLac^® in the sense, that level of lubrication and utilized compaction force show less impact on tablet’s disintegration behavior. StarLac^® is a valuable excipient for roller compaction as well. Its balanced elastic and brittle tribologic properties guarantee excellent results in dry granulation, especially the good maintance of hardness yield after the second compression.

Typical particle size distribution (PSD) ofsomething new

Batch to batch consistency (B2B) ofsomething new

StarLac®

StarLac^®