Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
  • B30B15/0088—Lubricating means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
  • B30B11/18—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using profiled rollers
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
  • B30B15/30—Feeding material to presses
  • B30B15/302—Feeding material in particulate or plastic state to moulding presses
  • B30B15/308—Feeding material in particulate or plastic state to moulding presses in a continuous manner, e.g. for roller presses, screw extrusion presses
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
  • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
  • B01J2/22—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by pressing in moulds or between rollers
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B3/00—Presses characterised by the use of rotary pressing members, e.g. rollers, rings, discs

Definitions

• the invention relates to a method and a device for external lubrication of the press rolls of a roll compacting system by a continuous coating of the press rolls with a suitable lubricant and the use of the method.
• Roller presses of the type are known from EP-A-0525 135. Roller presses are used for pressing powders into slugs or slug fragments, which are then comminuted into granules. This process is also called dry granulation. The dry granulate further serves to produce e.g. Tablets, capsules, sachets, batteries and instant dishes.
• the lubricant consists of a solid rod made by melt extrusion.
• the rod contains zinc stearate and lubricating oils.
• stearates agnesstearate is also called.
• In order to uniformly distribute the lubricant on the rotating surface first a little lubricant is scraped off a solid rod and then firmly pressed and smeared into a thin film with the aid of a scraper, which must be pressed onto the roller surface with a well-defined force.
• Essential for the application described is the fact that an extremely thin film adhering well to the surface of lubricant is applied as uniformly as possible and completely on the rotating roller. There must be no lubricant aggregates in this film.
• the amount of lubricant applied is 0.11 to 1.2 mg / m 2 roll surface. An amount greater than 1.2 mg / m 2 roll surface is absolutely unsuitable.
• toner cartridges are not the subject of the invention, the non-stick properties of particular agnesiumstearat be adversely affected by an extrusion process.
• Another disadvantage is the requirement of an additional scraper, with which the lubricant is pressed onto the roller surface. Another disadvantage is "that all particles are applied to the process to the role with a
• a method for preventing the adhesion of material to be briquet on a roll surface of a briquetting press is known.
• the final product is a briquette.
• An emulsion is sprayed onto the surface of press rolls.
• the emulsion consists of a mixture of graphite, water and gas.
• a lubricant In the manufacture of tablets by means of suitable presses, a lubricant must generally be added to the powder to be compressed in order to reduce the forces required to eject the tablet (from the die after the powder / granule compaction process). This lubricant added to the powder / granulate is also called internal lubricant. The addition of such a lubricant prevents mechanical damage to the tablet press. By reducing the ejection forces is often also prevents the currently pressed, still in the die tablet is damaged during the ejection process, which is noticeable for example by capping or laminating (capping or laminating) of the tablet. Also, such a lubricant is added to the formulation to prevent or reduce attachment to the tabletting tool (top and / or bottom punch and / or die). The most commonly used lubricant, especially in the pharmaceutical field, is magnesium stearate.
• magnesium stearate usually leads to a reduction in tablet strength.
• the hydrophobic properties of this lubricant can also lead to problems with the release of the active substance, which can lead to a deterioration of the biopharmaceutical availability.
• Both the problems of release and of the compressibility of the powder, e.g. The reduction in tablet strength can also be significantly enhanced by more or less intensive mixing.
• the magnesium stearate is distributed in such a way that it is no longer possible to produce sufficiently strong tablets or the release is reduced in such a way that the intended effect in the body is no longer achieved or is not achieved to a sufficient extent.
• lubricants are used, inter alia. to reduce the friction during the powder transport through the screws. Propagation in this transport area can be prevented as far as possible or at least reduced so much that sufficient powder is transported in order to carry out the process under the selected manufacturing conditions can.
• a lubricant is added to the mixture to be roll-compacted to prevent the formation of powder / slug remnants on the press rolls.
• this can lead to analogous problems, as in the tableting: on the one hand, a reduction in the slug strength, resulting in the same process conditions granules with more fines. This in turn leads to poorer flow properties of the granules, which can result in larger weight fluctuations when tableting.
• magnesium stearate concentration in the composition to be roll compacted is e.g. Reduced to less than 0.3% (m / m), or even omitted entirely from the addition of magnesium stearate, problems such as reducing the compressibility and reducing the release of magnesium stearate can be remedied or reduced to an acceptable level.
• the addition of scraps remains usually increases to the surface of the roll presses. Even though these residues may be mechanically removed from the press rolls by so-called scraper wipers, which by the way do not touch the roll surface, before this press roll section is used again to press slugs, it is generally not possible to prevent the press roll surfaces with caking , which can be different thickness, are provided.
• Another problem associated with caking is the determination of the apparent density of the slug during the manufacture of these slugs.
• This "at gap” density is a direct measure of the apparent density of the slugs, which in turn essentially determines the properties of the slug and the resulting granules, so that monitoring or even control of this "at gap” density for the quality of the slug Granules is extremely relevant. Too low a density leads to too low strength and therefore to an increased fines content in the granules, which has flowability problems in tableting.
• the object of the invention is on the one hand to prevent caking and the problems associated with it completely or almost completely, and on the other hand to reduce the internal amount of lubricants and / or non-stick agents, especially magnesium stearate, so much that neither problems caused by lubricants and / or non-stick agents, in particular magnesium stearate, during pressing into tablets, nor is the release of the active ingredient in the dissolution of the tablets adversely affected.
• This task should now be realized because of the associated with solvent use economic and process engineering disadvantages without the use of solvents.
• This object is achieved according to the invention by coating the press rolls solvent-free and continuously with a thin layer of lubricant and / or non-sticking agent.
• the coating without solvent has the advantage that the product does not have to be aftertreated.
• the solvent would have to be removed with great effort from the product, if that's even possible.
• Another advantage This solvent-free coating is that caking on the press roll surfaces avoided or largely avoided. This can produce Schölpen with smaller variations in the apparent density. This results in a better granule quality.
• the coating with a lubricious and / or non-sticking agent, in particular magnesium stearate, has the advantage that magnesium stearate is used most frequently as a lubricant and / or antiblocking agent in the pharmaceutical sector and is approved by the authorities.
• magnesium stearate-containing powder mixture has proven itself.
• a mixture of magnesium stearate with an adjuvant or Hiffsstoffgemisch, consisting of substances that are already included in the formulation has also proved to be suitable.
• the coating with one or more compacts containing a suitable lubricating and / or non-sticking agent, preferably magnesium stearate has proved to be suitable.
• a suitable lubricating and / or non-sticking agent preferably magnesium stearate
• These compacts are e.g. produced by compressing magnesium stearate-containing powders by means of (tablet) presses.
• a suitable lubricating and / or non-sticking agent preferably magnesium stearate
• compacts can be easily refilled in a containment area.
• compacts take up less volume than a powder with the same magnesium stearate concentration.
• a further advantage of these coatings is that the concentration of lubricating and / or non-sticking agent, in particular magnesium stearate, in the product produced by the roll compacting system is reduced by less than 0.01% to 0.2% (m / m). , usually by less than 0.04 to 0, 1% (m / m) increases. Nevertheless, caking on the press roll surfaces were completely prevented or reduced to a non-relevant level.
• concentrations are generally required, namely from 0.5% to 1.5%.
• the external lubrication caused by contrast in the product just an increase in lubricating and / or anti-blocking agent especially the magnesium concentration of usually 0.04% to 0.1%.
• a reduction of the lubricating and / or anti-adhesive, in particular the magnesium stearate concentration in turn has an extremely beneficial effect on the solution of lubricating and / or non-sticking agents, in particular magnesium stearate-induced problems in the tableting of the granules to sufficiently solid tablets.
• the reduction in the solution of lubricating and / or non-sticking agents, in particular magnesium stearate-induced problems in the release of the active ingredient from tablets or capsules, is likewise advantageous.
• Another advantage of the invention is that caking on the press roll surfaces is prevented so that the volume of the slugs produced per unit of time between the pressurized press rolls is better than 3%, preferably better than 2% and more particularly better than 1, 5% can be determined.
• a further advantage is that, in particular when applying a powder layer according to the invention, the aggregates containing antiadhesive agent are not pressed onto the press roll surface and distributed as uniformly as possible on the press roll surface. This avoids that the lowest possible coefficient of friction between the product to be compacted roll and the press roll surface is formed, so that the collection of powder between the press roll rollers is not unnecessarily difficult.
• Such a feeder is essential for the roll compacting process.
• FIG 1 shows the method in which the invention is applied
• Figure 3 shows a variant of the inventive device
• the reference numeral 1 shows a process housing.
• the press rolls 2 and 2.1 are arranged.
• the associated measuring device 2.2 is used to measure the rotational speed of the press rollers 2 and 2.1.
• a granulating roller 3 is arranged with a screen basket 3.1.
• a collecting container 6 for the dry granules which is on a weighing device 7.
• This weighing device 7 is connected via a collecting line 9 to a computer 8. More than one signal line may be needed, depending on how many load cells are needed.
• Fig. 2 and Fig. 3 like parts of Fig. 1 are given the same reference numerals.
• Fig. 2 are located within the process housing 1, the two press rollers 2 and 2.1.
• the product is supplied by means of a screw conveyor 12 and forms after the pressing operation between the counter-rotating, pressurized press rollers 2 and 2.1 a scarf or Schülpenbruch publishede 10th
• a storage container 15 and 15.1 in the lateral region of the press rolls 2 and 2. Under each container 15 and 15.1 are depending on a transfer roller 13 and 13.1 and a conveyor roller 14 and 14.1 arranged.
• the lubricating and / or anti-adhesive agent feed 15 and 15.1 are placed on the process housing 1 of the roll compacting system in such a way that the transfer rolls 13 and 13.1 touch the press rolls in the region 16 and 16.1 respectively after the scraper scraps 11 and 11.1 and before the product feed 12.
• this area it is to be expected that there will no longer be any scabs or rag particles on the press roll surfaces during roll compaction. It should be emphasized that these scraper wipers do not touch the press roll surface, so that abrasion between the surface of the press rolls and the scraper wiper is basically avoided.
• the application of a thin lubricant and / or non-stick layer with a delivery and transfer roll can also be accomplished with a device consisting of more than two rolls, e.g. two conveyor rollers and a transfer roller done.
• each press roll may be provided with a plurality of such application devices to apply a thin layer of powder to the press roll surface.
• the diameter of the conveying and transfer rollers can be the same but also different. It is irrelevant whether the diameter of the conveying roller is larger or smaller than that of the transfer roller.
• the storage container 15 or 15.1 (FIG. 2) contains a suitable lubricant and / or antiblocking agent, preferably magnesium stearate or a magnesium stearate-containing powder mixture, which is transferred to the transfer roller 13 or 13.1 by the conveyor roller 14 or 14.1.
• the transfer roller 13 or 13.1 then applies the lubricating and / or anti-adhesive agent to the surface of the press roller 2 or 2.1.
• the object according to the invention can likewise be achieved with the aid of compacts which contain suitable lubricants and / or antiblocking agents, preferably magnesium stearate.
• suitable lubricants and / or antiblocking agents preferably magnesium stearate.
• These compacts are prepared, for example, by compressing magnesium stearate-containing powders by means of suitable (tablet) presses.
• suitable (tablet) presses it must be ensured that the lubricating and / or non-sticking effect of the substances used is retained to a sufficient extent. For this reason extrusion or fusion processes are used Production of such magnesium stearate containing moldings, because thereby the lubricating and / or non-stick properties of the magnesium stearate are significantly reduced.
• the lubricants and / or antiadhesive containing compacts are shown schematically by the reference numeral 19 or 19.1 ( Figure 3). These sufficiently solid compacts are pressed with an adjustable, preferably constant force, shown schematically by the spring assembly 18 and 18.1 in Fig. 3, directly on the surface of the press rollers 2 and 2.1.
• the device with which these compacts are pressed onto the press roll surfaces, and the compacts themselves are located in a housing 17 and 17.1.
• lubricating and / or anti-sticking agent preferably magnesium stearate or a magnesium stearate-containing mixture applied with these coating devices and ultimately received by the roll compacting powder from the press roll surface
• amount of lubricating and / or anti-sticking agent, preferably magnesium stearate or a magnesium stearate-containing mixture applied with these coating devices and ultimately received by the roll compacting powder from the press roll surface will depend on the process conditions chosen, such as Texture of the surface of the conveying and transfer rollers (Nos. 13 and 13.1 in Fig. 2), the contact pressure and the mechanical strength of the compacts (Nos. 19 and 19.1 in FIG. 3), the nature of the surface of the press rolls (Nos. 2 and 2.1 in Fig. 3, respectively) (eg, smooth, roughened, rimmed, corded or trough-shaped press roll surfaces) and the properties of the powder to be compacted.
• the amount of magnesium stearate introduced into the product by this solvent-free coating is thus significantly lower than the amount necessary for internal lubrication to completely or almost completely prevent caking on the press roll surfaces.
• internal concentrations of between 0.5% and 1.5% (m / m) are generally required, depending on the product properties and condition of the press roll surface.
• the caking substance citric acid could be processed without the addition of the (internal) lubricant magnesium stearate over the same preparation parameter range as magnesium stearate coated press rolls.
• the caking substance citric acid could be processed without the addition of the (internal) lubricant magnesium stearate over the same preparation parameter range as magnesium stearate coated press rolls.
• caking was completely avoided or reduced to an insignificant extent.
• This manufacturing area amounts to a gap of 24 mm per meter of press roll diameter over the complete roller press force range of 80 kN per cm press roller width and per meter
• the same smooth press roll surface was also used in the compaction of citric acid without internal magnesium stearate but with magnesium stearate coated press rolls.
• the slugs contained significantly less than 1% magnesium stearate, namely between 0.01% and at most 0.1% (m / m) magnesium stearate, depending on the press rolls of the powder coating apparatus used or the pressing force of the compacts (the in the latter case were prepared from a magnesium stearate-containing powder mixture) and their mechanical strength.
• the external coating of the press roll surfaces also reduced the concentration of magnesium stearate in the roll-compacted product by at least a factor of 10 to 0.1% (m / m).
• concentrations of 0.02% to 0.05% (m / m) have been realized, which is up to a factor of 50 less than with internal lubrication.
• the press roll surfaces remain free of caking or the extent of caking is so low that this has no or an insignificant effect on the granule quality. Furthermore, this also ensures that the "at gap" density can be determined with an accuracy of 1.5% or better, but in any case better than 3%.

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• Mechanical Engineering (AREA)
• Engineering & Computer Science (AREA)
• Health & Medical Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Medicinal Chemistry (AREA)
• Chemical & Material Sciences (AREA)
• Glanulating (AREA)
• Battery Electrode And Active Subsutance (AREA)
• Medicinal Preparation (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

Applications Claiming Priority (2)

Publications (1)

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ID=52465137

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Country Status (8)

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• 2014
  • 2014-02-05 CH CH00147/14A patent/CH709229A1/de not_active Application Discontinuation
• 2015
  • 2015-01-23 CN CN201580007614.5A patent/CN106029355A/zh active Pending
  • 2015-01-23 JP JP2016568091A patent/JP2017506160A/ja active Pending
  • 2015-01-23 CA CA2938916A patent/CA2938916A1/en not_active Abandoned
  • 2015-01-23 EP EP15703727.6A patent/EP3102403A1/de not_active Withdrawn
  • 2015-01-23 KR KR1020167022276A patent/KR20160117486A/ko not_active Application Discontinuation
  • 2015-01-23 WO PCT/CH2015/000006 patent/WO2015117252A1/de active Application Filing
  • 2015-01-23 US US15/117,144 patent/US20170173911A1/en not_active Abandoned

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