Comparing Pruv® and Magnesium Stearate for External

and Internal Lubrication During Rotary Tableting

K. Hofmann[1], K.– J. Steffens[1] and R. F. Lammens[2]
[1] Department of Pharmaceutical Technology, Rheinische Friedrich–Wilhelms–University, 53121 Bonn, Germany
[2] Technical Services Consult Lammens, 51373 Leverkusen, Germany

Introduction lubrication were compared with the internal Pearlitol® 200 SD

One of the most important ingredients of tablet lubrication ejection force data. lubricant concentration [%], internal lubrication
0 0,25 0,5 0,75 1 1,25 1,5 1,75
formulations is the lubricant. Lubricants reduce Tablettose® 70 was lubricated with 1.0 % and 1000 1000
Pruv
friction between the particles and die wall during Neosorb® P60W with 0.5 % lubricant. For Pearlitol® 900 Magnesium stearate Pharma veg
Mallinckrodt stearate
900

compression and between the tablet and the 200 SD and Emcompress Premium®, a 800
Internal lubrication
1,5 % Pruv 800
1,5 % Magnesium stearate Pharma veg
compressing tools during ejection. concentration of 1.5 % lubricant was used.

ejection force [N]

ejection force [N]

700 700

In most cases, the lubricant is added in a final step The tablets were compressed on a Fette 102i rotary 600 600

to the tablet mass (internal lubrication). The tablet press (24 stations, 9 mm R 15 EU B–type 500 500

400 400
concentration of the lubricant for most tablet blends punches, Fette, Schwarzenbek, Germany). For all
300 300
varies from 0.25 to 1.5 %. Using external lubrication, experiments, the rotor speed (60 rpm = 86400 200 200
the concentration of the lubricant can be reduced tablets per hour), the fill–o–matic speed (60 rpm), 100 100
down to 0.05 %. the pre–compression force (5 kN = 78.6 MPa) and 0 100 200 300 400 500 600 700 800 900 1000 1100

The aim of the present study was to optimize the main compression force (20 kN = 314 MPa) Fig. 4: Influence of spray rate on ejection force level
spray rate [g/h], external lubrication

lubrication spray rate using press chamber coating were kept constant.
(PKB II) with dry air and to investigate sodium As reported by Jahn [1] the filling depth has an Emcompress Premium®
stearyl fumarate as an alternative to the most influence on the amount of external lubricant per lubricant concentration [%], internal lubrication

commonly used magnesium stearate for external tablet. Therefore, the experiments were conducted 1000
0 0,25 0,5 0,75 1 1,25 1,5 1,75
1000

lubrication. at a filling depth of 7 mm. 900

Pruv
Magnesium stearate Pharma veg 900
Mallinckrodt stearate
800 Internal lubrication 800
1,5 % Pruv
1,5 % Magnesium stearate Pharma veg
Materials

ejection force [N]

ejection force [N]

Results and Discussion 700

600
1,5 % Mallinckrodt stearate 700

600

Two different types of magnesium stearate and The Mallinckrodt and have a stearate® Pruv® 500 500

sodium stearyl fumarate were used for external and crystalline structure, whereas magnesium stearate 400 400

internal lubrication: Pharma veg® is amorphous. 300 300

ƒ Magnesium stearate Pharma veg® (Baerlocher, 200 200

Germany) External lubrication 100

0 100 200 300 400 500 600 700 800
100

ƒ Mallinckrodt stearate® (Mallinckrodt, USA) For Emcompress Premium®, the ejection forces spray rate [g/h], external lubrication

ƒ Pruv® (JRS Pharma, Germany)
The lubricants were characterized by x–ray powder
diffraction and scanning electron microscopy.
Pharmaceutical excipients with different compaction
behaviour were tested:
ƒ α–Lactose monohydrate (Tablettose® 70, Meggle,
Germany)
ƒ Sorbitol (Neosorb® P60W, Roquette, France)
ƒ Mannitol (Pearlitol® 200 SD, Roquette, France)
ƒ Dibasic calcium phosphate dihydrate
(Emcompress Premium®, JRS Pharma, Germany)
Materials
were practically constant [Fig. 5], whereas for all
other excipients the ejection force decreased when
increasing the spray rate [Fig. 2, 3, 4].
As obvious from Fig. 2 and 3, for Tablettose® 70 and
Neosorb® P60W, no significant differences between
the tested lubricants magnesium stearate Pharma
veg® and Pruv® could be found. When using
Mallinckrodt stearate®, the ejection forces turned out
to be slightly higher than for the other lubricants,
although these differences have no practical aspect.
Tablettose® 70
lubricant concentration [%], internal lubrication
0 0,25 0,5
1000
Fig. 5: Influence of spray rate on ejection force level
Using external lubrication, all excipients could be
compressed with the above listed lubricants, except
for Emcompress Premium® in combination with
magnesium stearate Pharma veg®.
Internal lubrication
As obvious from the encircled data points in Fig. 2,
for Tablettose® 70 the ejection forces obtained upon
external and internal lubrication were identical for
the three tested lubricants.
When tableting Neosorb® P60W, the stearate
0,75 1 1,25 1,5 1,75
ejection forces were a bit smaller as the Pruv® ones,

900
Pruv
Magnesium stearate Pharma veg
Mallinckrodt stearate
1000

900 but both types of lubricants seem to perform well

A mixture of powdered lubricant and air was 800 Internal lubrication
1 % Pruv
800 enough [Fig. 3].
sprayed directly onto the punch and die surfaces 1 % Magnesium stearate Pharma veg
Even at an internal lubricant concentration of 1.5 %,
ejection force [N]

ejection force [N]

700 1 % Mallinckrodt stearate 700

using the PKB II–system (K–Tron, Niederlenz, 600 600

Pearlitol® 200 SD could only be tableted with
Switzerland). To eliminate the effect of variation in 500 500
magnesium stearate Pharma veg® [Fig. 4]. Internal
air humidity, for all experiments dry air (Praxair, 400 400
lubrication with Pruv® and Mallinckrodt stearate®
300 300
Germany) was used. led to an adherence of the blend to the convex
200 200
The lubricant was deposited in a fill hopper. A twin 100 100
shaped surface of the upper punches.
screw feeder, located at the bottom of this hopper, 0 100 200 300 400 500 600 700 800 As obvious from Fig. 5, the ejection forces of the
conveyed the lubricant to the free fall tower. The spray rate [g/h], external lubrication
internal lubrication upon compressing Emcompress
Fig. 2: Influence of spray rate on ejection force level
lubricant was mixed with dry air and was Premium® were more or less the same. The ejection
transported to the spray nozzle. The position of the forces reached a level between Pruv® and
Neosorb® P60W
nozzle between the ejection and the filling area is Mallinckrodt stearate® using the PKB II–system.
schematically shown in Fig. 1.
lubricant concentration [%], internal lubrication
0 0,25 0,5 0,75 1 1,25 1,5 1,75
tablet scraper spray nozzle 1000 1000

900
Pruv
Magnesium stearate Pharma veg
Mallinckrodt stearate
900
Conclusion
800
Internal lubrication
0,5 % Pruv 800 From the results it can be concluded that both
0,5 % Magnesium stearate Pharma veg
sodium stearyl fumarate and magnesium stearate
ejection force [N]

ejection force [N]

700 0,5 % Mallinckrodt stearate 700

upper punch filling area 600 600 can be used as effective external lubricants, the
500 500
former one being the lubricant of choice for
400 400
Pearlitol® 200 SD and Emcompress Premium® .
300 300

200 200

lower punch 100

0 100 200 300 400 500 600 700 800
100 References
spray rate [g/h], external lubrication [1] Jahn, Till, Press chamber coating as external
Fig. 3: Influence of spray rate on ejection force level lubrication for high speed rotary presses:
lubricant

Fig. 1: Position of the spray nozzle

For optimizing the spray rate, the ejection force was
monitored. For Tablettose® 70 and Neosorb® P60W,
the spray rate was varied from 100 to 700 g/h and
for Emcompress Premium® from 200 to 500 g/h.
Upon compressing Pearlitol® 200 SD, the spray rate
ranged from 300 to 1000 g/h.
The ejection forces obtained with external
lubricant spray rate optimization. Drug Dev Ind
Pearlitol® 200 SD and Emcompress Premium® are Pharm. 2005 Dec, 31 (10), 951-7
powders, which in general require high lubricant
concentrations. With Pruv® as an external lubricant,
the ejection forces were significantly lower as for the Acknowledgements
magnesium stearate types [Fig. 4 and 5]. Even at a The authors would like to thank for placing the
spray rate of 500 g/h, with magnesium stearate 102i at the University of Bonn as well as Meggle,
Pharma veg® sticking problems were observed Baerlocher, Roquette, Mallinckrodt and JRS
upon tableting Emcompress Premium®. Pharma for the donation of excipients.

6th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmazeutical Technology; Barcelona; Spain; 7th – 10th April 2008 corresponding author: katrin.hofmann@uni-bonn.de