Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
  • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
  • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
  • A61K33/08—Oxides; Hydroxides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/2004—Excipients; Inactive ingredients
  • A61K9/2022—Organic macromolecular compounds
  • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
  • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
  • A61P1/10—Laxatives
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/02—Nutrients, e.g. vitamins, minerals

Definitions

• the present invention relates to a tablet containing magnesium oxide particles as a main ingredient.
• magnesium oxide particles as the main ingredient are known and widely used for various purposes such as antacid, laxative, magnesium supplementation, and antihypomagnesaemia.
• magnesium oxide tablets have poor moldability, they are highly friable, causing problems such as cracking and chipping during transportation and transportation. Cracking and chipping of tablets during manufacture, transportation, and dispensing becomes a problem due to wear and capping.
• it is common to compress a mixed powder having a low bulk density.
• capping is likely to occur due to entrapment of air inside the tablet during compression. Therefore, it is a challenge to achieve both a reduction in friability and a reduction in the rate of occurrence of capping.
• Patent Literature 1 shows an example in which a binder and a disintegrant are blended during dry granulation to suppress abrasion of the mortar and pestle during tableting, thereby coping with capping caused by shaving of the mortar and pestle.
• Patent Literature 2 the shape of the punch is designed so that the air can easily escape, thereby suppressing the capping that occurs when the air cannot completely escape during compression.
• An object of the present invention is to provide a magnesium oxide tablet that can achieve both a reduction in friability and a reduction in the incidence of capping.
• the present inventors have made intensive studies to simultaneously reduce the friability of tablets containing magnesium oxide particles as a main component and reduce the incidence of capping. By optimizing the compounding of the derivative, it is possible to obtain a tablet with both reduced friability and capping rate. .
• a tablet containing magnesium oxide as an active ingredient contains granules containing magnesium oxide particles and an internal additive, and an external additive, and contains at least cellulose and / or a cellulose derivative as an internal additive and an external additive,
• a tablet wherein the mass ratio of [cellulose and/or cellulose derivative contained as an internal additive]:[cellulose and/or cellulose derivative contained as an external additive] is in the range of 75:25 to 10:90.
• the cellulose and/or cellulose derivatives are crystalline cellulose, microcrystalline cellulose, powdered cellulose, methylcellulose, ethylcellulose, carboxymethylcellulose, carboxymethylcellulose calcium, carboxymethylcellulose sodium, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, and low-substituted hydroxy
• [4] [1]-[ 3] the tablet according to any one of the items.
• a method for producing a tablet containing magnesium oxide as an active ingredient mixing magnesium oxide particles with an internal additive comprising cellulose and/or cellulose derivatives; granulating the mixture into granules; adding an external additive containing cellulose and/or a cellulose derivative to the granules and tableting; [Cellulose and/or cellulose derivative contained as internal additive]:[Cellulose and/or cellulose derivative contained as external additive] mass ratio is in the range of 75:25 to 10:90. .
• the cellulose and/or cellulose derivative is crystalline cellulose, microcrystalline cellulose, powdered cellulose, methyl cellulose, ethyl cellulose, carboxymethyl cellulose, carboxymethyl cellulose calcium, carboxymethyl cellulose sodium, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose and low-substituted hydroxypropyl.
• the method according to [5], wherein the at least one selected from the group containing cellulose. A tablet produced by the method of [5] or [6].
• the friability and capping incidence of tablets containing magnesium oxide particles as a main ingredient are simultaneously reduced. becomes possible.
• both the friability and the capping occurrence rate are reduced, it becomes possible to suppress cracking and chipping during manufacturing, transportation, and dispensing.
• the present inventors have conducted intensive studies to achieve both reduction in friability and reduction in the rate of occurrence of capping.
• the present invention is based on such unexpected findings of the inventors.
• “friability” is an index of friability and brittleness against impact of tablets, and is measured by the method described in "17th Edition Japanese Pharmacopoeia, Reference Information, Tablet Friability Test Method". can. Specifically, using a tablet friability tester (manufactured by Toyama Sangyo Co., Ltd., tablet friability tester TFT-1200), 100 rotations (24 to 26 rotations / min.) ) is applied to the test tablet, the initial tablet mass before abrasion and the tablet mass after abrasion are measured, and the degree of abrasion is calculated according to the following formula 1.
• the upper limit may be less than 0.40%, preferably less than 0.35%, more preferably less than 0.30%. .
• the lower the friability the better, so there is no particular lower limit.
• capping refers to peeling of the top or bottom surface of a tablet as a cross-sectional piece, which occurs due to impact during tableting, transportation, packaging, and the like in the tablet manufacturing process.
• the capping incidence can be determined by the cassette rotor test. Specifically, the tablets are discharged from a cassette rotor (manufactured by TOSHO, for Magmit tablets 500 mg) set at a height of 2 m, and the number of capping tablets is counted from the fallen tablets, and a sufficient number, for example, 100 tablets. It can be obtained by testing test tablets, counting the number of tablets in which capping occurs, and calculating the ratio according to the following formula 2.
• concrete iron iron + epoxy-based floor coating material + paste construction method (thickness: 2 mm) (ABC Shokai) Chemicrete E or equivalent specifications can be adopted.
• the range of the capping occurrence rate of the tablet of the present invention is preferably less than 12%, more preferably less than 11%, and more preferably less than 10%, when the above measurement method is used.
• the lower the capping occurrence rate the better, so there is no particular lower limit.
• “hardness” is an index of tablet hardness, and can be measured with a commercially available tablet hardness tester. Specifically, it can be obtained by measuring the tablet hardness in the diameter direction using a tablet hardness tester DC-50 (Okada Seiko Co., Ltd.) or the like. From the viewpoint of achieving the effects of the present invention, if the hardness is too low, the friability increases, so the lower limit is preferably 30 N or more, especially 40 N or more, and more preferably 50 N or more. On the other hand, the higher the hardness, the better, so the upper limit is not particularly set.
• disintegration time is an index of how easily a tablet disintegrates in a solution.
• the disintegration time can be measured according to the 17th revision of the Japanese Pharmacopoeia, general test methods and disintegration test methods. Specifically, using a disintegration tester (manufactured by Toyama Sangyo Co., Ltd., disintegration tester NT-20HS), an appropriate number, for example, 6 test tablets of a test solution, for example, by measuring the disintegration time in water can ask. If the disintegration time is appropriate, it is possible to provide an easy-to-drink tablet that disintegrates in the oral cavity in a short period of time upon administration, which is preferable.
• the upper limit of the appropriate disintegration time is preferably 20 seconds or less, more preferably 15 seconds or less, and more preferably 11 seconds or less. Although the lower limit is not particularly limited, it is usually 5 seconds or longer, or 1 second or longer.
• cellulose refers to a linear polymer represented by (C 6 H 10 O 5 ) n in which ⁇ -glucose molecules are linearly polymerized through glycosidic bonds. Examples include crystalline cellulose and powdered cellulose.
• cellulose derivative refers to such a cellulose molecule in which different substituents are introduced into the hydroxy groups by ether bonds or ester bonds, and examples thereof include methyl cellulose, ethyl cellulose, carboxymethyl cellulose, carboxymethyl cellulose calcium, and carboxymethyl cellulose sodium.
• cellulose and/or cellulose derivative refers to at least one selected from the above-mentioned "cellulose” and "cellulose derivative".
• Low-substituted hydroxypropyl cellulose is cellulose in which a very small amount of hydroxypropoxy groups have been introduced into the glucose ring, that is, cellulose with a low level of O-(2-hydroxypropyl) conversion and a molar substitution of 0.2 to 0.4. point to Examples of the shape of such a cellulose derivative include powder, particulate, and fine particles.
• Cellulose and/or cellulose derivatives may be synthesized or commercially available.
• Commercially available products include various grades of Ceolus (registered trademark) from Asahi Kasei Corporation, such as Ceolus (registered trademark) PH-101, UF-711, PH-102, PH-200, PH-301, PH-302, PH Crystalline cellulose such as -20JP, UF-702, KG-802 and KG-1000 can be used.
• the magnesium oxide particles used in the present invention are magnesium oxide (MgO) particles.
• the magnesium oxide particles used in the present invention can be obtained by firing magnesium hydroxide particles. For example, it can be obtained by firing magnesium hydroxide having an average particle size of 1 to 10 ⁇ m by a laser diffraction scattering method at 600 to 1000°C.
• Magnesium oxide particles may be synthesized or commercially available. Heavy grade manufactured by Kyowa Chemical Industry Co., Ltd., powder grade manufactured by Kojima Chemical Industry Co., Ltd., or light grade and heavy grade magnesium oxide manufactured by Tomita Pharmaceutical Co., Ltd. can be used.
• the magnesium oxide particles used in the present invention may be in the form of either powder or granules, but granules are more effective in preventing abrasion of a tableting machine and have a high content of tablets with excellent shape retention stability. can be obtained.
• the magnesium oxide particles used in the present invention are not limited, they may preferably have a predetermined particle size.
• the upper limit of the average particle size of magnesium oxide particles measured by a laser diffraction scattering method can be usually 40 ⁇ m or less, 20 ⁇ m or less, or 10 ⁇ m or less.
• the suspended particle size at the time of tablet disintegration becomes small, and an effect of obtaining a tablet with less roughness in the oral cavity may be obtained.
• the lower limit of the average particle size is not limited, but can be, for example, usually 0.25 ⁇ m or more, 0.5 ⁇ m or more, or 1 ⁇ m or more in consideration of manufacturing limitations and cost effectiveness.
• the average particle size of the magnesium oxide particles of the present invention and the magnesium hydroxide particles as the raw material thereof and the average particle size of the magnesium hydroxide particles are measured by the laser diffraction scattering method, which is usually used. It can be achieved by using MT3300EX2) manufactured by Microtrack Bell Co., Ltd.
• the upper limit can be 0.8 g/mL or 0.7 g/mL or less.
• the lower limit can be 0.1 g/mL or more, or 0.2 g/mL or more.
• the bulk density can be measured, for example, using a 100 mL stainless cup (measured mass value (g)/100 (mL)).
• the angle of repose of the magnesium oxide particles used in the present invention is too large, it may lead to fluctuations in tablet mass during tableting due to deterioration of flowability, so the upper limit is 50 ° or less, or 48 ° or less. can. On the other hand, the lower the angle of repose, the better, so there is no particular lower limit.
• the angle of repose can be measured using, for example, Multitester MT-1 manufactured by Seishin Enterprise Co., Ltd.
• One aspect of the present invention is a tablet containing magnesium oxide as an active ingredient, comprising granules containing magnesium oxide particles and internal additives, and external additives, and at least cellulose and / or a tablet containing a cellulose derivative, wherein the mass ratio of [cellulose and/or cellulose derivative contained as an internal additive]:[cellulose and/or cellulose derivative contained as an external additive] is within a certain range. Regarding.
• the magnesium oxide particles are preferably contained in granules together with internal additives. If the content of magnesium oxide particles is too high, the moldability may be insufficient, so it can be, for example, 90% by mass or less, or 88% by mass or less with respect to the entire tablet. On the other hand, if it is too low, an additive with high compressibility and high plastic deformation can be blended accordingly, so that a tablet with high moldability can be obtained, but the cost per tablet increases. Therefore, it is preferable to make it 80 mass % or more, or 85 mass % or more with respect to the whole tablet.
• the mass ratio of [cellulose and/or cellulose derivative contained as an internal additive]:[cellulose and/or cellulose derivative contained as an external additive] is within a certain range.
• An increase in hardness and a reduction in friability can be expected by increasing the content of the external additive. Therefore, the mass ratio contained as an external additive has an upper limit of 90 or less, for example, 88 or less, 85 or less, 80 or less, 75 or less, when the mass of cellulose and / or cellulose derivative contained in the whole tablet is 100.
• the lower limit is more than 20, for example, 21 or more, 22 or more, 23 or more, 24 or more, or 25 or more.
• the mass ratio of the cellulose and/or cellulose derivative contained in the whole tablet is taken as 100
• the mass ratio of the content as an internal additive is preferably less than 80, for example, 79 or less, 78 or less, It is preferably 77 or less, 76 or less, 75 or less, and the lower limit is preferably 10 or more, for example, 12 or more, 15 or more, 20 or more, 25 or more.
• the amount may be 5% by mass or more, 7% by mass or more, or 9% by mass or more relative to the entire tablet.
• the cellulose and/or cellulose derivatives defined above are preferably used as excipients or binders in both internal and external additives. Moreover, the cellulose and/or cellulose derivative contained in the internal additive and the external additive may be the same or different.
• internal excipients refer to excipients containing one or more substances that are added to and mixed with the active ingredient prior to the granulation process in the manufacture of tablets.
• other additives than the cellulose and/or cellulose derivatives defined above may be added.
• croscarme in addition to the cellulose and/or cellulose derivatives contained in the internal and external additives in the specific ratios defined above, in order to adjust the preferred disintegration time as described above, croscarme It is preferred to add disintegrants such as sodium loin, maize starch, carmellose calcium, crospovidone and sodium carboxystarch.
• the disintegrant may be synthesized or commercially available.
• the upper limit may be, for example, 5% by mass or less, or 3.5% by mass or less with respect to the entire tablet.
• the lower limit can be, for example, 1% by mass or more, or 2% by mass or more relative to the entire tablet.
• an external additive refers to an additive containing one or more substances added to granules produced after the granulation process and tableted together with the granules in the production of tablets.
• other additives may be added besides the cellulose and/or cellulose derivatives contained in the internal and external additives in the specific proportions defined above.
• a lubricant from the viewpoint of the effectiveness of the present invention.
• Lubricants include stearic acid and salts thereof (Mg, Ca salts) and the like, preferably stearates, especially magnesium stearate and calcium stearate.
• a lubricant may be synthesized or a commercially available one may be used.
• the upper limit may be, for example, 2% by mass or less, or 1.5% by mass or less, or 1.0% by mass or less relative to the entire tablet. .
• the lower limit of the amount of lubricant added to the entire tablet is, for example, 0.2% by mass or more, or 0.5% by mass or more. , or 0.9% by mass or more.
• the shape of the tablet of the present invention is not particularly limited in consideration of the effect of the present invention, ease of drinking as an oral preparation, etc., but for example, the upper limit of the diameter can be 14 mm or less, or 10 mm or less.
• the lower limit can be 5 mm or more, or 6 mm or more.
• the upper limit of the thickness is not particularly limited, but it can be 8 mm or less, or 7 mm or less, and the lower limit can be 3 mm or more, or 4 mm or more.
• a shape such as that shown in Patent Document 2 may be used for the purpose of further suppressing capping.
• the mass of the tablet of the present invention is not particularly limited as long as it is within the range of an oral preparation normally used as a tablet containing magnesium oxide as an active ingredient. or 600 mg or less, and the lower limit can be 10 mg or more, or 50 mg or more, or 100 mg or more.
• the tablet of the present invention is orally administered as a pharmaceutical for humans or animals for antacid, laxative, prevention of calcium oxalate urolithiasis, and the like. It can also be used as a supplement for humans or animals for the purpose of supplementing magnesium, antihypomagnesemia, and the like.
• the dosage depends on the application, purpose or medical condition. For example, when used as an antacid, 0.5 to 1.0 g per adult in terms of magnesium oxide is orally administered in several divided doses per day. When used as a laxative, it is usually administered orally at 2 g per adult per day in terms of magnesium oxide in three divided doses before or after meals, or once before bedtime.
• magnesium oxide When used to prevent the occurrence of calcium oxalate calculi, 0.2 to 0.6 g of magnesium oxide is usually orally administered per adult with a large amount of water per day. For other uses, magnesium is usually taken within the tolerable upper limit.
• the dietary reference intake in the United States has been set at 350 mg per day for healthy adults and 5 mg per 1 kg of body weight per day for healthy children (Institute of Medicine ( IOM). Food and Nutrition Board. “Dietary Reference Intakes: Calcium, Phosphorus, Magnesium, Vitamin D and Fluoride”. Washington, DC: National Academy Press, 1997).
• the drug of the present invention has been approved in Japan for use as a desired antacid, laxative, and prevention of calcium oxalate calculi due to its active ingredient.
• one or more other optional additives may contain the components of Such other ingredients include, but are not limited to, various pharmaceutically acceptable excipients such as dyes, flavoring agents, and the like. Any one of these components may be used alone, or any two or more thereof may be used in any combination and ratio.
• Another aspect of the present invention is a method for producing a tablet containing magnesium oxide as an active ingredient, mixing magnesium oxide particles with an internal additive comprising cellulose and/or cellulose derivatives; granulating the mixture into granules; adding an external additive containing cellulose and/or a cellulose derivative to the granules and tableting; [Cellulose and/or cellulose derivative contained as internal additive]:[Cellulose and/or cellulose derivative contained as external additive] mass ratio is in the range of 75:25 to 10:90. Regarding.
• internal additives containing magnesium oxide particles, cellulose and/or cellulose derivatives, and optionally one or more other components are mixed according to known methods.
• Granulation by dry granulation is preferred in view of the ingredients of the tablet of the present invention.
• granules can be produced by granulating under normal granulation conditions using a commercially available dry granulator (Dry granulator RC-156 manufactured by Freund Corporation).
• the tableting pressure is punch pressure per tablet, for example, the upper limit can be 20 kN or less, or 18 kN or less, or 16 kN or less, and the lower limit can be 2 kN or more, or 3 kN or more, or 4 kN or more.
• the shape of the punch may be any of standard R, two-step R, sugar-coated R, corner R, flat corner, flat rounded corner, and the like.
• Calcium stearate Plant-based Physical properties of the magnesium oxide used in this example were measured and found to be as follows. ⁇ Average particle size: 7.691 ⁇ m (measured by laser diffraction scattering method using Microtrack Bell Co., Ltd. MT3300 EX2) ⁇ Bulk density: 0.249 g / mL (measured by 100 mL stainless cup (measured mass value (g) / 100 (mL))) ⁇ Angle of repose: 41.7° (measured by Multitester MT-1 manufactured by Seishin Enterprise Co., Ltd.)
• ⁇ Flake rate Calculated from the following formula 3 by measuring the mass of the product (A) processed for 1 minute after the granulation process and the product (B) obtained by sieving the product (A) for 1 minute at 1000 ⁇ m.
• ⁇ Bulk density Measured using a 100 mL stainless steel cup (actual mass value (g) / 100 (mL))
• Particle size distribution Particle size distribution analyzer (laser diffraction scattering particle size distribution analyzer LMS-2000e manufactured by Seishin Enterprise Co., Ltd.) measured using
• Disintegration tester Toyama Sangyo Co., Ltd., disintegration tester NT-20HS was used to measure the disintegration time of the test tablet in water. Tableting status: Visually confirm the presence or absence of tableting pressure / tableting failure / Suspension Particle diameter D50 ( ⁇ m): (Number of test tablets: 1 tablet) Suspended particles when test tablets are suspended in water using a laser diffraction scattering particle size distribution analyzer LMS-2000e manufactured by Seishin Enterprise Co., Ltd.
• Diameter measurement/Tube passability 5 Fr Remove the pusher from a syringe for catheter (Nipro Corporation Enteral Nutrition Infusion Set Syringe DS 20 mL Catheter Yellow), put one tablet in the outer cylinder, return the pusher, and return the plunger to 55 20 mL of hot water at °C is soaked up, the tip of the tube is covered and left to stand for 5 minutes. After 5 minutes, the catheter syringe was manually overturned at 90 degrees 15 times, and then a tube feeding tube (Atom Nutrition Catheter T manufactured by Atom Medical; thickness 5Fr, length 120 cm) was connected and used for internal suspension and washing.
• a tube feeding tube Atom Nutrition Catheter T manufactured by Atom Medical; thickness 5Fr, length 120 cm
• the more crystalline cellulose contained as an internal additive the better the processing capacity and flake rate, and the higher the bulk density of the granulated product. Therefore, it is preferable to include a certain amount of crystalline cellulose in the internal additive.
• the mass ratio of crystalline cellulose contained as an external additive for reducing friability is preferably about 25 or more when the mass of cellulose and/or cellulose derivatives contained in the whole tablet is 100. About 90 or less is considered appropriate.
• each tablet after compression was within the range of 5.3 to 5.5 mm, and no significant difference was observed.
• the disintegration time was within an appropriate range in both Examples and Comparative Examples.
• the range for example, within the range of 75:25 to 20:80, particularly within the range of 75:25 to 25:75, it is possible to efficiently produce magnesium oxide tablets that can both reduce the friability and the incidence of capping. I found out.
• physical properties required for tablet manufacturing such as moldability, granulation, tabletability, fluidity, tube passability, and physical properties required for magnesium oxide tablets such as disintegration are secured. , it is possible to achieve both a reduction in friability and a reduction in the incidence of capping.
• the present invention has extremely high applicability in industrial fields, particularly in the fields of pharmaceutical manufacturing and distribution, where both reduction in friability and reduction in the incidence of capping of tablets containing magnesium oxide particles as a main ingredient are required.

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• 2021
  • 2021-08-20 JP JP2021134883A patent/JP7340572B2/ja active Active
• 2022
  • 2022-08-09 WO PCT/JP2022/030484 patent/WO2023022078A1/ja not_active Ceased
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