Lubricants punch

Lubricants protect die and punch surfaces from wear and bum-out of the compact during sintering without objectionable effects or residues. They must have small particle size, and overcome the main share of friction generated between tool surfaces and powder particles during compaction and ejection. They must mix easily with the powder, and must not excessively impede powder flow (see Lubrication and lubricants). 

Ghdants are needed to faciUtate the flow of granulation from the hopper. Lubricants ensure the release of the compressed mass from the punch surfaces and the release/ejection of the tablet from the die. Combinations of siUcas, com starch, talc (qv), magnesium stearate, and high molecular weight poly(ethylene glycols) are used. Most lubricants are hydrophobic and may slow down disintegration and dmg dissolution. 

Pressing is carried out within a cemented carbide die between two steel or cemented carbide punches. In order to impart enough mechanical strength to the blank to permit further manipulation without risk, removable organic binders (camphor, natural or synthetic waxes, latex or synthetic rubber, methyl polymethacrylate, polyvinyl alcohol, carboxymethylcellulose, ammonium alginate) are mixed into the powder, dissolved in a convenient volatile solvent. Some of these also act as lubricants thus minimizing the wear on the die. 

Another example of the use of DOE during pilot studies is the study of factors affecting the ejection and take-off force. Measurement of ejection force and take-off force will determine if the formula is sufficiently lubricated. Ejection force is measured as an indication of the release of the tablet from the die wall forces, and the take-off force related to the adhesion forces to the punch face. Take-off force is an appropriate measurement to determine if a formula has a tendency to stick. Based on these designs, an optimal formula, including the lubricant level, and process can be predicted for scale-up (Figs. 12 and 13). 

Another force measurement to monitor is the ejection force during the compression event. Figure 15 shows the ejection force monitored during the compression run. The ejection force was approximately SOON throughout the compression run. This demonstrated that the blend was lubricated adequately. No picking/sticking was observed on the punch surfaces after 225 minutes. 

In sampling ten tablets, the following parameters were studied the lubrication index (R), the ejection force (F0), the residual force (Fr) and the cohesion index (CI=ratio of the pressure applied to the upper punch and the tensile strength) proposed by Guyot [17]. 

One very common beneficial interaction involving an excipient is the interaction between magnesium stearate and the metal of tablet punches and dies, or the equivalent parts on a powder encapsulation machine. Magnesium stearate is an example of a boundary lubricant. As such it has a polar head and a fatty acid tail. It is believed that the polar head of the magnesium stearate is oriented toward the die wall or tablet punch face. In these ways it is able to reduce the ejection force (the force required to eject the tablet from the die after compaction) and prevent sticking to the punch faces. The other boundary lubricants, e.g., calcium stearate and sodium stearyl fumarate, will also function in a similar manner. However, the so-called liquid film lubricants function in a very different manner (19). 

Lubricated (to prevents the powder/granulation and the tablet from sticking to punches and die, and to enable the formed tablet to be ejected from the die wall and released cleanly from the punch faces)... 

Third, after the tablet is compressed, the upper punch is withdrawn from the die and lower punch moves upwards to eject the tablet. Successful ejection of tablets without chipping or sticking requires sufficient lubrication of the powder blend so there is minimum adhesion between the tablet and the die wall. Lower ejection forces are preferred during tablet production to avoid unnecessary mechanical wear on the tablet press. 

Lubricants act by interposing an intermediate layer between the tablet constituents and the die wall, to prevent adherence of the granules to the punch faces and dies. Thus, they ensure smooth ejection of the tablet from the die. In addition, many lubricants also enhance the flow properties of the granules. Stearic acid and its magnesium and calcium salts are widely used. The most effective lubricants, such as magnesium stearate, are very hydrophobic and can also prevent wetting of powders and hence retard dissolution (Figure 6.9). 

There are three types of lubricants employed in solid dosage form manufacture. The first class of lubricant is the glidant. The flow properties of a powder can be enhanced by the inclusion of a glidant. These are added to overcome powder cohesiveness. The two other classes of lubricant are antiadherent excipients, which reduce the friction between the tablet punch faces and tablet punches, and die wall lubricant excipients, which reduce the friction between the tablet surface and the die wall during and after compaction to enable easy ejection of the tablet. The level of a lubricant required in a tablet is formulation dependent and can be optimized using an instrumented tableting machine. 

The third class of lubricant activity is the antiadherent. Some materials have adhesive properties and can adhere to the punch surfaces during compression. This will induce tablet disorders sticking, with a film forming on the surface of the tablets, or picking, where solid particles from the tablet stick to the punch surface. Most die wall lubricants also have antiadherent actions, and in many formulations, the addition of a specific antiadherent will not be required separately. The antiadherent includes talc, maize starch, and microcrystalline cellulose. 

When the lubricant should not be part of the tablet formulation, for example, when bonding properties of the drug are low, external lubrication is necessary [197], For single-tablet production the punches and dies can be manually lubricated with a fluid. In production several methods have been developed to place the fluid on the surface of punches and dies [198], Filaments applied at the punches to lubricate the die or special caps with fluid lubricant are possible solutions. However, external lubrication also has disadvantages [199],... 

Dies for aluminium may be of cast-iron with a hardened shell inset, and the punch may be of tool steel left soft. Drawing dies need to be carefully finished, and the surfaces must be kept brightly polished. Phe punch mu.st be quite smooth and a good lubricant used, otherwise difficulty... 

Extrinsic lubrication is provided via mechanisms that apply a lubricating substance, normally paraffin oil, to the tableting tool surface during processing. One method makes use of an oiled felt washer attached to the lower punch below the tip. This washer wipes the die cavity with each tablet ejection. To avoid having tablets stick to the punch faces, materials such as poly-tetrafiuorethylene or polyurethane have been applied to the faces. Another lubrication method sprays a thin layer of lubricant (either liquid or solid lubricant) onto the tool surfaces after one tablet is ejected and before the granulate of the next tablet enters the die cavity. 

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