Comparative compaction

200

Tablet Strenght (N)

SuperTab® 14SD is designed to have better
175
compaction properties than for example
SuperTab® 11SD and Lactopress® Spray Dried 250. 150

This is a result of the optimisation of both the 125

particle size of the crystalline component and
100
the level of amorphous lactose. The improvement
75
in tablet strength may be useful for formulations
that require extra compactability or the lower 50 Application notes
8 10 12 14 16

Spray-dried lactose
compaction forces required to achieve a given SuperTab® 14SD Compaction Force (kN)
tablet strength can result in reduced tooling wear. SuperTab® 11SD
Lactopress® Spray Dried 250
(250 mg tablets / 9 mm flat bevel tooling: 0.5% mag stearate)

DFE Pharma direct compression products

Lactose
Product type Product name Product attributes and applications
Spray-dried lactose Lactopress® Spray Dried Direct Compression
Lactopress® Spray Dried 250 Direct Compression
Lactopress® Spray Dried 260 Direct Compression, for further improved flowability
SuperTab® 11SD Direct Compression
SuperTab® and Lactopress® are DFE Pharma’s brand names for direct compres­sion
SuperTab® 14SD Direct Compression, high compactability
Granulated lactose Lactopress® Granulated Direct Compression, good all round p
­ erformance
lactose. Both SuperTab® 11SD and 14SD are made in a dedicated pharmaceutical
SuperTab® 30GR Direct Compression, good all round p
­ erformance lactose plant in Nörten-Hardenberg, Germany, and SuperTab® 11SD is additionally
Anhydrous lactose Lactopress® Anhydrous Direct Compression made in Kapuni, New Zealand. Lactopress® Spray Dried products are all made in
Lactopress® Anhydrous 250 Direct Compression, dry granulation, encapsulation Borculo, the Netherlands. SuperTab® and Lactopress® Spray Dried products comply
SuperTab® 21AN Direct Compression, dry granulation, encapsulation with the requirements of the Ph. Eur., USP-NF and JP for lactose monohydrate.
SuperTab® 22AN Direct Compression, free flowing grade In the USP-NF they fall into the category of lactose monohydrate “modified”.

Morphology
The morphology of spray-dried lactose is shown
Head Office DMV-Fonterra Excipients GmbH & Co. KG - Warranty in the micrograph. The typical spherical granules
Klever Strasse 187 The details given here are merely intended for information ­purposes and
#001/October 2011

P.O. Box 20 21 20
47568 Goch, Germany
T. +49 2823 9288 770
F. +49 2823 9288 7799
pharma@dfepharma.com
are in no way legally binding. Consequently we ­accept no ­responsibility consist of finely milled α-lactose monohydrate in
in the broadest sense of the word for d­ amage that may result from
­applications based upon this ­information. Furthermore, this information a matrix of amorphous lactose. The spherical
does not constitute permission to infringe patent and licence rights.
shape and narrow particle size distribution
www.dfepharma.com confer the excellent flow properties of spray-
dried lactose. The amorphous lactose content
and the small individual crystals within the
granule are important in conferring the good
compaction properties of spray-dried lactose.
Direct compression Premix API with about 20% of the SD-lactose Selection of superdisintegrant Slight hardening of the tablets may be expected
Spray-dried lactose is an excellent choice for Both Primojel® (sodium starch glycolate) and on storage (attributed to crystallisation of the
De-agglomerate (500 µm screen or intensive mixing)
direct compression formulations. At its simplest Primellose® (croscarmellose sodium) are amorphous lactose) and disintegration time
the formulation need only contain the API, Blend with remaining excipients suitable disintegrants for Lactopress® Spray tends to decrease slightly with Primellose®.
spray-dried lactose, a superdisintegrant and a Dried or SuperTab® SD, used at starting levels The data below were generated after 6 months
Lubricate & compress
lubricant. Excellent content uniformity of low of 2% to 4% in a typical direct compression storage at 40˚C / 75% RH in open containers.
dose tablets is achieved by employing a mixing formulation. Physical stability of tablets Under these conditions the tablets did not
scheme that effectively de-agglomerates the The effectiveness of such a mixing scheme using these combinations is also good. increase in thickness or weight.
API. This can be achieved by the preparation can be seen in the example below using milled
of a premix which is subjected to a paracetamol (NAPA) as a model API at levels of
­de-agglo­merating step (such as sieving through 0.5 mg and 5 mg in 250 mg tablets. In the first
a 500 μm screen or use of an intensifier bar in example (left) the overall RSD through the
a V-blender) before completion of mixing. tableting run was 2.3% with a single tablet range
of 93% to 105%. The corresponding data for the
second example (right) were RSD of 1.6% and
range 98% to 105%.

0,575 5,75 250 10

Single tablet assay (mg)

Single tablet assay (mg)

Tablet strength (N)

Disintegration time (min)

0,550 5,50 200 8

0,525 5,25
150 6
0,500 5,00
100 4
0,475 4,75
50 2
0,450 4,50

0,425 4,25 0 0
0 5 10 15 20 25 30 0 5 10 15 20 25 30 35 0 1 2 3 4 5 6 0 1 2 3 4 5 6
SuperTab® 11SD / 0,5 mg NAPA Tableting duration (min) SuperTab® 11SD / 5 mg NAPA Tableting duration (min) 2% Primojel® Time (months) 2% Primojel® Time (months)
4% Primojel® 4% Primojel®
2% Primellose® 2% Primellose®
4% Primellose® 4% Primellose®