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BASF ExAct

page 6 No. 5, October 2000

KollidonY VA 64
An excellent dry binder.
D. Flick, K. Kolter Purpose Dry binders are intended to improve tablet formation by direct compression with the main emphasis on improving the mechanical properties [1], i. e. the hardness and friability of the tablets. Apart from microcrystalline cellulose and the cellulose ethers, polyvinylpyrrolidone is probably the best-known dry binder. An almost unknown dry binder is Kollidon VA 64 (copovidone), a vinylpyrrolidone vinyl acetatecopolymer (Figure 1)[2]. (Figure 1) Total 100.0 100.0 100.0 Table 1 Formulations (A) % (B) % (C) %

Di-Tab Ascorbic Acid Ludipress Dry Binder Kollidon CL Aerosil 200 Magnesium Stearate

90, 85, 80 5, 10, 15 4.5 0.5

40.0 51.3, 46.3, 41.3 5, 10, 15 3.0 0.24 0.5

99.5 0.5

HCHCH2CHCH2H N O O O C n m CH3
Ratio: 6 : 4

rpm, 12 mm, beveled edge) and (C) with a weight of 500 mg on a Korsch EK0 single punch press (30 tablets/min, 12 mm, beveled edge) with varied compression forces (10, 18, 25 kN). Tablet properties Hardness, weight and dimensions were determined using a Kraemer tablet tester(HT-TMB). Results and Discussion The dry binders tested exhibited considerable differences in their powder properties (Table 2) which are of interest with reference to tabletability. The particle size determinations clearly show that Kollidon VA 64 is the finest product and should, with its shell like structure (Figure 2), be able to coat drug and filler particles and bind them together under compression. The hardness of the tablets (A) made with Kollidon VA 64 places them in a class of their own (Figure 3). At a compression force of 18 kN and a dry binder content of 50 mg, the hardness of the tablets exceeds that of tablets without a dry binder by 120 %. If the same compression force is used in each case and the dry Mean Particle Size D [4,3]

binder content is increased from 25 to 50 to 75 mg, Kollidon VA 64 gives the steepest increase in hardness. Vitamin C powder (B) was selected as a substance that is very difficult to compress into tablets and in mix-tures with excipients, also greatly reduces compressibility. The compression force-hardness curves (Figure 4) are similar in appearance to those for the tablets of formulation A: without dry binder: with HPMC 2910, Kollidon 30 and MC PH 101: with Kollidon VA 64: low hardness

The objective of this study was to investigate the effectiveness of different dry binders and to correlate it with physicochemical properties. Experimental Methods Materials Dry Binder: Kollidon 30 (povidone), Kollidon VA 64 (copovidone) (BASF AG); Avicel PH 101 (microcrystalline cellulose (FMC); Pharmacoat 606 (hydroxypropylmethylcellulose 2910) (Shin Etsu); Maldex 18 (maltodextrin) (Amylum). Ingredients Di-Tab (Rhne-Poulenc); ascorbic acid powder, Ludipress, Kollidon CL (BASF AG); magnesium stearate (Brlocher); Aerosil 200 (Degussa). Methods The dry binders were tested in several formulations (Table 1). A dicalcium phosphate tablet (A), with excipients which are not soluble in water and a vitamin C tablet (B), with water-soluble constituents. To obtain detailed information on their compression properties, the pure dry binders were compressed (C). Powder properties s bulk and tap density (Erweka volumeter) s angle of repose (Pfrengle funnel) s particle size (Malvern Mastersizer) Tableting The ingredients (Table 1) were passed through an 800-m sieve and blended for 10 min in a Turbula mixer. The tablets (A) and (B) with a weight of 500 mg were produced on a Korsch PH 106 rotary press (30

slight improvements exceptional hardness

Because of the polymerized vinyl acetate component, Kollidon VA 64 is a softer and more plastic material than the other dry binders. This is confirmed by the low glass transition temperature (103C). The plasticity values of the products (Figure 5) were determined from the force-displacement curves (C). Kollidon VA 64 possesses a high plasticity of over 90 % that remains constant from 10 to 18 to 25 kN.

Table 2

Bulk Density

Hausner Ratio

Flowability Angle of Flow time Repose

[ m] Kollidon 30 Kollidon VA 64 MC PH 101 HPMC 2910 Maltodextrin DE 18 50 43 65 82 74

[g/ml] 0,389 0,241 0,326 0,367 0,522 1,24 1,37 1,40 1,37 1,34

[] 28 35 41 42 44

[s] 7,5 block block block block

page 7 No. 5, October 2000

BASF ExAct

Compression Force: 18 kN s without dry binder s 25 mg dry binder s 50 mg dry binder s 75 mg dry binder

100 80 60 40 20 0
without dry binder Kollidon 30 Kollidon VA 64 MC PH 101 HPMC 2910 Maldex 18

hardness [N]

Hardness of Dicalcium Phoshate tablets with increasing amounts of dry binders. (Figure 3)

Conclusions Kollidon VA 64 possesses unique properties as a dry binder, irrespective of the formulation, which far exceed those of all other materials tested. Important information can be derived on the effectiveness of dry binders from force displacement curves. The dry binding properties of a substance can be attributed to various physical properties like particle shape and plasticity.

v Kollidon VA 64 v Kollidon 30 s MC PH 101 q without dry binder


140 120 100
hardness [N]

x HPMC 2910 q Maldex 18 Compression force hardness profile of Vitamin C tablets. (Figure 4)

References [1] Lieberman, Lachman and Schwartz, Pharmaceutical Dosage Forms, Marcel Dekker (1998). [2] V. Bhler, Kollidon Polyvinylpyrrolidone for the pharmaceutical industry, BASF AG (1996).

80 60 40 20

50 mg dry binder
0 5 10 15 20 25 30

Scanning electron microscopy Kollidon VA 64. (Figure 2)

compression force [kN]

s 10 kN

s 18 kN

s 25 kN

Plasticity of dry binder. (Figure 5)

100 80 60 40 20 0
Kollidon 30 Kollidon VA 64 MC PH 101 HPMC 2910 Maldex 18

Plasticity in [%]

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