WO1993015724A1 - Fast soluble tablet - Google Patents
Fast soluble tablet Download PDFInfo
- Publication number
- WO1993015724A1 WO1993015724A1 PCT/JP1993/000192 JP9300192W WO9315724A1 WO 1993015724 A1 WO1993015724 A1 WO 1993015724A1 JP 9300192 W JP9300192 W JP 9300192W WO 9315724 A1 WO9315724 A1 WO 9315724A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tablet
- tensile strength
- present
- fast
- hydrochloride
- Prior art date
Links
Classifications
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
Definitions
- a tablet which dissolves rapidly in the oral cavity and can be prepared in a simple manner without resort to any special preparation technique includes a sugar alcohol or the like as the principal ingredient and is prepared by the wet granulation method, a kneaded mixture. of the sugar alcohol or the like with a drug is compression molded before drying.
- This tablet can be prepared merely by modifying partly the conventional tableting method ana has a sufficient physicochemical stability.
- the present invention provides: 1) a sugar alcohol or the like as a main component of the tablet; and 2) in the process of tableting by wet granulation, during compression molding, before drying a kneaded product of a sugar alcohol or the like and a drug. ⁇ Gaafugi
- the fast-dissolving tablet of the present invention can be manufactured by only partially changing the conventional method of manufacturing a two-stroke cafuncita agent.
- the present invention relates to a tablet containing a medicament, which rapidly dissolves in the oral cavity.
- Fast dissolving tablets are tablets that usually dissolve in the oral cavity within 15 seconds to 3 minutes, and are suitable for use in infants, elderly people, severely ill patients, etc. who have difficulty taking tablets.
- a drug When a drug is administered in a pill, it may be in the form of a tablet, a granule, a powder, a liquid, or the like.
- Liquids such as Shilo V-pulp are suitable for administration to elderly people and infants with weak physical strength because they are easy to swallow. However, it must be accurately weighed each time it is taken, and it lacks convenience. In addition, they have the disadvantage that they are fluctuating due to outside air and the like, and their chemical and physical stability is poor.
- Granules and thorns do not have the above-mentioned drawbacks, but they have drawbacks such as lack of ease of swallowing, and the inability to take the entire amount accurately unless ice or the like is consumed at the same time. I have.
- Tablets are suitable for administering a precisely fixed volume and have excellent chemical and physical stability of the contained drugs, but have the drawback that they are difficult to swallow, especially for infants, the elderly, and severely ill patients. ing. If the disadvantages that are difficult to swallow can be overcome, it is possible to provide an excellent formulation that eliminates the disadvantages of other dosage forms.
- tablets have been produced by pressing the components contained in the tablet in a dry state with strong force. This is because tablets originally disintegrate in the gastrointestinal tract to absorb the drug, and are required to be physicochemically stable after tableting until they reach the digestive tract. This is because it is necessary to strongly bind the components to each other by the pressure.
- there was a wet tablet and there was a method in which the tablet was inserted into a mold while it was damp, formed into a tablet shape, and then dried to make a tablet.
- this tablet was also not intended to dissolve rapidly in the oral cavity because it was intended to disintegrate in the digestive tract.
- the tablets are not mechanically strongly compressed and have a weak force to maintain their form, making them impractical today.
- An object of the present invention is, without following the special formulation technique of the freezing ⁇ is to provide a fast soluble tablet that can be produced by a simple method 0
- the above-mentioned object is achieved by manufacturing a tablet mainly composed of a pharmaceutical excipient having a high melting rate in ice, with a part of the conventional tablet manufacturing method by wet granulation being modified. Heading, the present invention has been completed.
- the gist of the present invention is as follows: (1) the main component of the tablet (2) is a pharmaceutical additive having a high dissolution rate in water; It must be molded as it is.
- compositions having a high dissolution rate in water may be any water-soluble crystalline or powdery planar substance, and include, for example, those usually used as excipients.
- the fast dissolving agent of the present invention dissolves rapidly in the oral cavity, it is usually preferable that the fast dissolving agent is a sweet substance.
- examples of such substances include sugars such as sucrose, lactose, glucose, and fructose.
- xylite is more preferable in that it has a good taste and the highest dissolution rate in the oral cavity.
- Mannit and lactose are inferior to xylitol in taste and dissolution rate, but are excellent in compressibility described later.
- the fast-dissolving tablet according to the present invention is obtained by a conventional manufacturing method in which a tablet is tableted by a wet granulation method. It is manufactured by compression molding before. Tablet raw materials are mixed, a binder is added, they are combined, then dried, and then compressed and molded.
- the conventional pharmaceuticals, which are manufactured by compression molding, are linked in that the order of the molding operation and the drying operation is reversed. I do.
- a relatively low pressure for example, 50 to 1000 kg is sufficient.
- the lower the pressure the shorter the dissolution time in the oral cavity tends to be.
- the pressure is lower than 50 kg, the tensile strength is usually reduced, making it difficult to be practically used.
- the higher the pressure the higher the tensile strength and the stronger the strength tends to be.
- the dissolution time in the oral cavity is generally longer.
- the weight is less than 50 kg, depending on the combination of two or more of the above-mentioned pharmaceutical additives, a substance having practically usable strength may be obtained.
- a combination of two or more of the above-mentioned excipients can provide a product having a short oral dissolution time. Therefore, even a fast-dissolving tablet manufactured outside the compression pressure of 50 to 1000 kg is included in the present invention.
- tablets generally having a tensile strength of 5 / era 2 or more can be sufficiently put to practical use.
- the strength of the quick-dissolving tablet according to the present invention is mainly maintained by the ability of a pharmaceutical additive having a high melting rate to be dissolved in ice.
- general tablets are manufactured at a compression pressure of about 50 kg to 3000 kg.
- the pressing pressure is preferable to set the pressing pressure to about 50 to 300 kg. If it is less than this, it is difficult to mold, and if it is more than this, the tensile strength will be low and it will be difficult to put it to practical use (see Fig. 1).
- the fast-dissolving tablet according to the present invention is characterized in that it dissolves rapidly in the oral cavity.For example, when a drug having a possibility of causing harm is taken as it is, for example, in the case of severe bitterness, the tablet may be appropriately dissolved. After performing a masking treatment typified by microcapsulation, crystal surface coating, and the like, such a harmful effect can be eliminated by taking measures S such as including the tablet in the quick dissolving tablet of the present invention.
- a compound of a pharmaceutical excipient having a fast dissolution rate in water and a drug is usually prepared by mixing the excipient having a fast dissolution rate in water with an appropriately treated drug, and then mixing the mixture with ice, a binder solution or sugar. Add a saturated solution of, uniformly disperse, and combine to produce.
- the amount of water to be added is preferably about 1 to 10% by weight, and most preferably about 3% by weight in the components of the tablet before compression. If the added amount is too large, the sugar alcohol or sugar dissolves or the ability to maintain the form is weakened, so that favorable results cannot be obtained in the subsequent pressing and drying of the molded product. It will be difficult.
- the amount of water added is too small, tableting troubles such as blemishes occur during press-fitting molding, and it is not possible to carry out the molding preferably. Even if it is molded, its strength is weak and it tends to collapse.
- the water to be added for example, purified water and the like are preferable.
- the compression molding may be performed in a wet state of a kneaded product of a pharmaceutical additive and a pharmaceutical having a high dissolution rate in water, and may be performed in any state of granular, condylar, soft lump, and the like.
- Examples of the compression molding machine include a general tableting machine, a Japanese confectionery automatic compression molding machine, and a sugar sugar manufacturing device. 7
- the quick dissolving tablet according to the present invention can be produced by only partially changing the method for producing a tablet by the conventional wet granulation pressure box method, and thus the freeze-drying technology is used. It is simpler to manufacture and can be manufactured for children.
- a known binder can be contained in the course of the kneading operation for the purpose of further improving the physical properties of the preparation.
- the binder applied to the present invention is not particularly limited, but a substance having a relatively high dissolution rate is preferred.
- examples of such a binder include polyvinylpyrrolidone (PVP), hydroxypropylcellulose 13-acetate (HPC), and hydropi ⁇ xib mouth, virumethylcellose (HPMC), and the like. it can.
- Rabbia rubber etc. can be appropriately contained.
- the binder applied to the present invention can contain 0.1 to several percent by weight of the components of the tablet before compression molding, and more preferably contains about 0.5 to 1 percent by weight. Can be.
- the quick dissolving tablet according to the present invention after compression molding and drying, is subjected to steam for one to several seconds to perform glazing, whereby the tablet surface can be smoothed to improve the appearance, and the tablet surface can be prevented from being worn.
- compositions applicable to the fast-dissolving tablet according to the present invention are not particularly limited as long as they are intended for oral administration.
- examples of such a drug include the following.
- Ebubufen Mefenamic acid
- Dexamethasone Desamethazone Sodium sulfate, Hydrocotisone, Blednisolone, Azulene, Fuenacetin, Isoprovirintivirin, Case Tominofen, benzodiamine hydrochloride, fenilbutazone, flufenamic acid, mef X namic acid, sodium salicylate, choline salicylate, sutheravirin, crofaison, Etodok.
- Propanthelin bromide Lithium acetate bottle, Oxopiium bromide, Timebizium bromide, Butylscopolamine bromide, Trospiuum chloride, Ptium bromide bromide, N-methylscopolamine methylsulfate, Bromide Methyloctrobin, butpium iodide.
- Procaine hydrochloride mesoviramid, azimarin, quinidine sulphate, abrindine hydrochloride, propafinone hydrochloride, mexiletine hydrochloride.
- Polymaleic acid Polymaleic acid; t-dilamin, clemastine fumarate, mequitazine, alimemazine tartrate, butadine to cyclohexylate.
- Dipnitdol hydrochloride meth- ⁇ -bramid, domperidone, betahistine mesylate, trimebutine maleate.
- the quick dissolving tablet according to the present invention has the following effects.
- the pressure box was molded to a tablet diameter of 130 with a molding pressure of 100-700 kg and a pressure speed of 20 ⁇ . Thereafter, the tablet was left at 50 at 2 hours in a hot water circulation oven (GT-100: manufactured by Ryrub Co., Ltd.) and dried to obtain the quick dissolving tablet of the present invention.
- GT-100 manufactured by Ryrub Co., Ltd.
- the tablet was allowed to stand at 50 t for 2 hours in a Yun oven (GT-100: manufactured by Albu) and dried to obtain the fast-dissolving tablet of the present invention.
- the granules are sized using a feather mill (Model PM-1: manufactured by Takakawa Micron) equipped with a 12mn0 screen, and the granules are compressed into a tableting machine equipped with a forced stirring device (Clean Press Collect 12HUK). : Kikusui Seisakusho Co., Ltd.) and pressed at a molding pressure of 150 kg to a tablet diameter of 9 and a tablet of 500 mg. Next, the molded resin is put into a hot-air circulation oven (GT-100: manufactured by Albu) and dried at 55 t for 3 hours. 16
- GT-100 hot-air circulation oven
- the product of the present invention was added to obtain the quick dissolving tablet of the present invention.
- This is sized with a fuser mill (PM-1 type: manufactured by Hosokawa Micron) equipped with a 120-screen, and the granules are ⁇ -ta U hitch (RT-P-9 type: Using a press made at 220kg with a molding pressure of 220kg, a pressurized box was molded into tablets of 15ram 0, 1 lOOmg. Next, the molded tablet was put into a hot-circulation oven (GT-100 type: manufactured by Ryrub Co., Ltd.), and dried at 55 t for 3 hours to obtain the fast-dissolving tablet of the present invention.
- PM-1 type manufactured by Hosokawa Micron
- R-P-9 type Using a press made at 220kg with a molding pressure of 220kg, a pressurized box was molded into tablets of 15ram 0, 1 lOOmg. Next, the molded tablet was put into a hot-circulation oven (GT-100 type: manufactured by Ryrub Co., Ltd.), and dried at 55 t for
- Suitable for sieving 300 g of xylite using a 32 mesh sieve Take this powder (lg) and use an autograph material testing machine (AG-5000: manufactured by Shimadzu Corporation) to mold at a molding pressure of 50 to: I000 kg, compress Speed 20 « ⁇ minutes, tablet diameter Then, tablets for comparison were prepared.
- AG-5000 manufactured by Shimadzu Corporation
- Example 1 For each of the fast-dissolving tablet of the present invention of Example 1, the tablet of Comparative Example 1, and the undried preparation of Example 1, the tensile strength and the dissolution time in the oral cavity were measured.
- Tensile strength is an autograph material testing machine equipped with a 100 KGP mouth cell.
- the oral dissolution time was measured by including each tablet in the mouth, and first measuring the time until the lumps dissolved and disappeared by leaving the tablet in the mouth, and taking the average of five patients. The results are shown in ⁇ ⁇ .
- the fast-dissolving tablet of the present invention has a molding pressure of 50 to 300 kg, a tensile strength of 3 kg / cm 3 or more, and an oral dissolution time of 30 seconds or less.
- the tablet had excellent properties as a quick dissolving tablet.
- the tensile strength of the undried tablet and the tablet obtained by the dry tableting method was 3 kg / cm 2 or less at a molding pressure of 501000 kg, which was not practical.
- the present invention rapid dissolving tablets have a tensile strength within the limits of the measured molding pressure is at 8 kg / ctn s or more, oral dissolution time was excellent as fast ⁇ so on within one minute Had properties.
- the present invention rapid dissolving tablets have a tensile at within range the intensity of the measured molding pressure is at 7 kg / cin a higher, oral dissolution time was excellent as fast dissolving tablet such as within 40 seconds Had properties.
- the fast-dissolving tablet of the present invention has a much higher tensile strength than the undried tablet and the tablet obtained by the dry tableting method, and can be put to practical use. 19
- Tensile strength, oral dissolution time, disintegration time, and friability of the fast-dissolving tablets of the present invention of Examples 5 to 8 were determined. Tensile strength and oral dissolution time were determined in the same manner as in Test Example 1, and the time of disintegration was determined by the method (water) specified in the Japanese Pharmacopoeia. The friability was measured for only one tablet using a friability meter. The results are shown in Table 1.
- the fast-dissolving tablet of the present invention has a tensile strength of! ⁇ ⁇ £ 1 above, and had excellent properties as a fast-dissolving tablet with an oral dissolution time of 30 seconds or less.
- Fig. 1 shows the relationship between the tensile strength and the dissolution time in the oral cavity and the molding pressure measured for each of the fast-dissolving tablet of the present invention of Example 1, the tablet of Comparative Example 1, and the corn leaf of Example 1. Is shown.
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Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1019940702813A KR100286505B1 (ko) | 1992-02-18 | 1993-02-17 | 속용정 |
US08/290,890 US5837285A (en) | 1992-02-18 | 1993-02-17 | Fast soluble tablet |
DE69331378T DE69331378D1 (de) | 1992-02-18 | 1993-02-17 | Verfahren zur Herstellung von schnelllöslicher Tabletten und schnelllöslichen Tablette beinhaltend Xylitol |
DE0627218T DE627218T1 (de) | 1992-02-18 | 1993-02-17 | Schnelllösliche tablette. |
EP93904312A EP0627218B1 (en) | 1992-02-18 | 1993-02-17 | Process for producing fast soluble tablets and fast soluble tablets comprising xylitol |
AT93904312T ATE210968T1 (de) | 1992-02-18 | 1993-02-17 | Verfahren zur herstellung von schnelllöslicher tabletten und schnelllöslichen tablette beinhaltend xylitol |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP4/69565 | 1992-02-18 | ||
JP6956592 | 1992-02-18 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1993015724A1 true WO1993015724A1 (en) | 1993-08-19 |
Family
ID=13406427
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP1993/000192 WO1993015724A1 (en) | 1992-02-18 | 1993-02-17 | Fast soluble tablet |
Country Status (7)
Country | Link |
---|---|
US (1) | US5837285A (ja) |
EP (1) | EP0627218B1 (ja) |
KR (1) | KR100286505B1 (ja) |
AT (1) | ATE210968T1 (ja) |
CA (1) | CA2130487A1 (ja) |
DE (2) | DE69331378D1 (ja) |
WO (1) | WO1993015724A1 (ja) |
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US6699845B2 (en) | 1998-07-15 | 2004-03-02 | Asahi Kasei Kabushiki Kaisha | Excipient |
EP1598061A1 (en) | 1996-06-14 | 2005-11-23 | Kyowa Hakko Kogyo Co., Ltd. | Intraorally rapidly disintegrable tablet |
JP2006508052A (ja) * | 2002-08-29 | 2006-03-09 | ノヴァデル ファーマ インコーポレイテッド | 筋肉及び骨障害治療用薬を含有する口腔内極性及び非極性噴霧剤又はカプセル剤 |
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- 1993-02-17 EP EP93904312A patent/EP0627218B1/en not_active Revoked
- 1993-02-17 AT AT93904312T patent/ATE210968T1/de not_active IP Right Cessation
- 1993-02-17 KR KR1019940702813A patent/KR100286505B1/ko not_active IP Right Cessation
- 1993-02-17 WO PCT/JP1993/000192 patent/WO1993015724A1/ja not_active Application Discontinuation
- 1993-02-17 DE DE69331378T patent/DE69331378D1/de not_active Expired - Lifetime
- 1993-02-17 US US08/290,890 patent/US5837285A/en not_active Expired - Fee Related
- 1993-02-17 CA CA002130487A patent/CA2130487A1/en not_active Abandoned
- 1993-02-17 DE DE0627218T patent/DE627218T1/de active Pending
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JP2006077018A (ja) * | 1996-06-14 | 2006-03-23 | Kyowa Hakko Kogyo Co Ltd | 口腔内速崩壊錠 |
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US8956650B2 (en) | 1996-06-14 | 2015-02-17 | Kyowa Hakko Kirin Co., Ltd. | Intrabuccally rapidly disintegrating tablet and a production method of the tablets |
JP2006306891A (ja) * | 1998-03-18 | 2006-11-09 | Yamanouchi Pharma Technologies Inc | ポリマーベースの迅速に溶解する錠剤およびその生成プロセス |
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US9040086B2 (en) | 2001-10-04 | 2015-05-26 | Aptalis Pharmatech, Inc. | Timed, sustained release systems for propranolol |
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Also Published As
Publication number | Publication date |
---|---|
ATE210968T1 (de) | 2002-01-15 |
EP0627218B1 (en) | 2001-12-19 |
EP0627218A1 (en) | 1994-12-07 |
CA2130487A1 (en) | 1993-08-19 |
KR950700052A (ko) | 1995-01-16 |
KR100286505B1 (ko) | 2001-04-16 |
EP0627218A4 (en) | 1995-06-14 |
DE627218T1 (de) | 1995-08-24 |
US5837285A (en) | 1998-11-17 |
DE69331378D1 (de) | 2002-01-31 |
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