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Direct pressing of powders in production

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Direct pressing of powders in production

Direct pressing is the process of pressing non-granulated powders. From the technological scheme of tablet production, it can be seen that direct pressing allows to eliminate 3-4 technological operations from the production process. The method of direct pressing has a number of advantages, they include: reducing the production cycle time by eliminating a number of operations and stages, using less equipment, reducing production space, reducing energy and labor costs, obtaining tablets from moisture, thermolabile materials and incompatible substances. The disadvantages of the method of direct pressing include: the possibility of delamination of the tablet mass; change of dosage when pressing with an insignificant amount of active substances; the need to use high pressure. Some of these disadvantages are minimized in tabletting by forcing the pressed substances into the matrix.
However, despite a number of advantages, direct pressing has been slow to be adopted in production. This is explained by the fact that for productive operation of tabletting machines the pressed material should have optimal technological characteristics, namely: isodiametric shape of crystals, good friability (at least 5-6 g/s), high compressibility (at least 0.4-0.5 g/mL) and low adhesion to the press tool of tabletting machine. Such characteristics are possessed by a small number of non-graulized powders: bromides, sodium chloride, potassium iodide, acetylsalicylic acid and some other drugs having isodiametric (equiaxial) shape of particles of approximately the same particle size distribution and, as a rule, not containing a large number of small fractions. Powders with a particle size of 0.5-1 mm and porosity of 37% are best suited for direct pressing. For example, for obtaining sodium chloride tablets, the oblong shape of particles is acceptable, while the round shape of this substance is almost impossible to press. The best fluidity is found in coarse powders with equiaxed particle shapes and low porosity, such as lactose, phenyl salicylate and other similar preparations. Such preparations can be compressed without prior granulation. What they have in common is that they can be uniformly discharged from the funnel by their own weight, i.e. they can be dosed spontaneously, and that they have a relatively good pressability.

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  • Information updated : 10 / 07 / 2024
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Due to the combination of spherical particles and microcrystals, lactose has good compressibility. Sometimes the addition of small amounts of substances such as aerosil, calcium silicate (aerogel) makes the mixture suitable for pressing. Thus, the optimum amount of aerosil added to improve the flowability of the mixture is 0.05-1 %. The technology of tablet production by direct pressing method is that the drug substances are thoroughly mixed with the required amount of excipients and pressed on tablet machines. At present it can be said that granulation remains the main technological operation in the preparation of substances for tabletting. But direct pressing is increasingly being introduced into pharmaceutical production due to its clear economic advantages and the emergence of modern high-speed tablet presses with high pressing forces. Sometimes the tabletting process is carried out using pellets containing the required drug and excipients. Tabletizing (pressing) on tablet machines is carried out by a press tool consisting of a matrix and two punches. The matrix is a steel disk in which a cylindrical hole with a diameter of 3 to 25 mm is drilled. The cross section of the hole is equal to the diameter of the tablet.
The matrices are inserted into the corresponding holes of the table top – the work surface. In order to increase productivity, the dies can be double and triple socketed. Punches (upper and lower) are cylindrical rods (pistons) made of chromium-plated steel, which are inserted into the holes of the matrix from above and below and provide pressing of the tablet under pressure. Pressing surfaces of punches can be flat or concave (of different radius or curvature), smooth or with transverse grooves (notches), as well as with engraved inscription. Punches can be one-piece or prefabricated. A one-piece punch is a single piece with a pusher. There are two types of tablet machines: with a resting die and a movable feed hopper; with a movable die and a resting feed hopper. The first type of tablet machines are called eccentric, or crank (by the type of mechanism that drives the punches), or percussion (by the nature of the pressing force). Machines of the second type are called rotary, turret or carousel (by the nature of the movement of the die with a system of punches). Eccentric tablet machines (as simpler in their design) appeared earlier.

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Technical specifications

However, the vast majority of drugs are not able to spontaneously fill the matrix of the tablet machine due to a significant (more than 70%) content of fine fractions and irregularities in the surface of the particles, causing strong inter-particle friction. In these cases, auxiliary agents that improve the flow properties and belong to the class of sliding agents are added. Tablets of vitamins, alkaloids, acetylsalicylic acid, phenobarbital, ascorbic acid, sodium hydrocarbonate, streptocide, and phenacetin are prepared in this way. The mentioned characteristics are very important for the control of substances used in the technology of direct pressing, especially g large quantities, because the quality of tablets in this case will directly depend on the technological parameters of the tablet mass, its friability, pressability and compactability. It is experimentally established that the lower the concentration in the tablet mass of a component, the finer its particles should be. tHe can get a homogeneous tablet mass consisting of components with sharply different particle sizes. It is known that a system consisting of two fine powders forms more homogeneous and stable mixtures than a system in which the particles of one component are larger than the other. To obtain the optimal composition of the mixture of multicomponent drugs, it is desirable to observe the following conditions: the particle sizes of individual components should correspond to their concentration, the density of substances of individual components is desirable to select close to each other, the shape of the particles should be close to spherical. If the medicinal substance is suitable for the direct pressing process, it is tabletized using the usual excipients. If the drug substance is not suitable for direct pressing when using conventional excipients, excipients with sufficient binding effect on the particles are used, or granules of the drug substance with a binder suitable for direct pressing are used. Currently, tabletting without granulation (direct pressing) is carried out by the following methods: with the addition of excipients that improve the technological properties of the material; by forced feeding of the tabletting material from the feed hopper of the tabletting machine into the matrix; pre-directed crystallization of the pressed substance.

Additional information

Pre-directed crystallization is one of the most complex methods of obtaining drug substances suitable for pressing, which consists in achieving the tabletable substance in crystals of a given bulkiness, pressability and humidity by selecting certain crystallization conditions. The result is a crystalline drug substance with crystals of isodiametric shape, freely pouring out of the funnel and therefore easily subjected to volumetric dosing, which is a prerequisite for direct pressing. This method is used to obtain tablets of acetylsalicylic and ascorbic acid. To increase the compressibility of drug at direct pressing in the composition of the powder mixture add dry binders – most often microcrystalline cellulose (MCC) or polyethylene oxide (PEO). Due to its ability to absorb water and hydrate individual layers of tablets, MCC has a favorable effect on the process of drug release. With MCC, strong but not always well disintegrating tablets can be manufactured. It is recommended to add ulypra-amylopectin together with MCC to improve tablet disintegration. Copovidone (vinylpyrrolidone copolymer) has a small particle size, which results in improved plasticity and excellent dry binding capacity. The analysis of the presented binders shows that Collidon VA 64 fine has one of the best binding effects when tablets are obtained by direct pressing. In direct pressing it is recommended to use modified starches as binders, which enter into chemical interaction with drug substances, significantly affecting their release and biological activity. Often used milk sugar as a means of improving the bulkiness of powders, as well as granulated calcium sulfate, which has good bulkiness and provides the receipt of tablets with sufficient mechanical strength. Cyclodextrin is also used, which increases the mechanical strength of tablets and their disintegration.
In direct pressing, maltose is recommended as a substance that provides a uniform filling rate and has negligible hygroscopicity. A mixture of lactose and cross-linked polyvinylpyrrolidone is also used. Anhydrous lactose is capable of direct pressing and has good friability. It does not lose its tabletability properties even when ground to a fine powder, although its flowability is reduced. Spray-dried lactose consists of microcrystals – particles of amorphous and vitreous structure.

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