CN103784414A - Esomeprazole enteric-coated tablets and preparation method thereof - Google Patents
Esomeprazole enteric-coated tablets and preparation method thereof Download PDFInfo
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- CN103784414A CN103784414A CN201310698483.2A CN201310698483A CN103784414A CN 103784414 A CN103784414 A CN 103784414A CN 201310698483 A CN201310698483 A CN 201310698483A CN 103784414 A CN103784414 A CN 103784414A
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Abstract
The invention discloses esomeprazole enteric-coated tablets and a preparation method thereof. The formula of the tables comprises esomeprazole magnesium, and an inert pellet core, a binder, a dispersant and a disintegrant which are used for tablet preparation. The preparation method comprises spraying and coating esomeprazole magnesium on the blank pellet core, coating an isolating layer and an enteric coated layer, making into enteric-coated pellets, and making into the required enteric-coated preparation by using the specific tablet adjuvants and tabletting method. The esomeprazole enteric-coated tablets and the preparation method thereof disclosed by the invention have the characteristics that by adopting specific tablet preparation method, the shortcoming that the enteric coated layers of the enteric-coated pellets are easy to be broken during tabletting process to affect the acid resistance of esomeprazole enteric-coated tablets is effectively overcome.
Description
Technical field
The invention belongs to field of medicine preparations, be specifically related in a kind of esomeprazole enteric coatel tablets and preparation method thereof.These esomeprazole enteric coatel tablets are oral, and wherein esomeprazole is by multiple piller loads, outer wrapping sealing coat and enteric layer after piller load esomeprazole.In addition, the present invention also designs the preparation method of said preparation, and this preparation method can improve the resistance to pressure of piller in tabletting process, avoids enteric integument destroyed.
Background technology
The esophagitis patient of the treatment of gastro oesophageal reflux disease (GORD) (GERD)-erosive reflux esophagitis-cured prevents the symptom control of long term maintenance treatment-gastro oesophageal reflux disease (GORD) (GERD) of recurrence and suitable antimicrobial therapy drug combination eradicate helicobacter pylori, and-duodenal ulcer relevant to helicobacter pylori infections that heal-the prevent recurrent peptic ulcer relevant with helicobacter pylori.
Esomeprazole is the S-optical isomer of omeprazole, is global first isomer proton pump inhibitor (PPI), suppresses parietal cell proton pump reduce gastric acid secretion by specificity.Confirm through a large amount of clinical experiments and drug research: its time that maintains gastric pH>4 is longer, press down sour efficiency higher, curative effect is better than front two generation PPI, and individual variation is little.As PPI of new generation, be now widely used in the many acid related disorders of clinical treatment, existing multiple base salt forms now, as sodium salt, magnesium salt etc.
Proton pump inhibitor (PPI) is the choice drug of the acid related disorders such as treatment peptic ulcer, gastroesophageal reflux disease.At present conventional PPI has 5 kinds of omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazoles clinically.Omeprazole is as the first PPI medicine, and the curative effect of its therapic acid relevant disease has obtained consistent approval.Esomeprazole, the resistance to letter of trade name (Nexium), is the individual isomer of omeprazole, i.e. (S)-isomer.Owing to having metabolic advantage, esomeprazole has higher bioavailability and more consistent pharmacokinetics compared with omeprazole, and the medicine that arrives proton pump is increased, and presses down sour effect and is better than other PPI.
But esomeprazole can be degraded in acid and neutral medium; And in sour environment, degrade particularly rapid.The stability of this reactive compound also wet, be subject to the impact of light in heat, organic solvent and some degree.Therefore as oral drugs, the destruction of gastric juice is particularly evident, and the related preparations having gone on the market has mostly adopted salvo, and blocking-up esomeprazole contacts with the direct of gastric juice.Such enteric coating coated preparation has been described in CN1152671C.Described preparation mixes the unit of the independent enteric coating coating that contains active substance and optional alkaline matter with tablet excipient, and is pressed into multiple unit pharmaceutical preparation.But, as what describe in this piece of patent: " just occurred variety of issue in the time that the piller of the enteric coating coating that contains acid labile substances is pressed into sheet.If enteric coat layer is unable to undergo piller to be pressed into sheet, responsive active substance destroys the acidic gastric juice being permeated, and after tabletting, the acid resistance of the enteric coat layer of piller will be not enough." in this patent, applicant has narrated its way addressing this problem from material and two aspects of technique.Material aspect, this application people thinks: " at Drugs Made In Germany, 37No.2 (1994), has described the controlled release tablet of enteric coating granule in p.53.The document has been illustrated methacrylic acid copolymer (L30D-55) and the compositions of the copolymer (NE30D) of ethyl acrylate and methyl methacrylate and has been suitable for use as the coating polymer of the enteric coating granule that is pressed into tablet.Reference example III shows, in the time of the multiple unit pharmaceutical preparation of for example omeprazole of preparating acid sensitive materials, the method for this recommendation is inapplicable.The acid resistance of piller that is pressed into tablet is too low.The list of references Drugs Made In Germany quoting also addresses, and uses the copolymer L30D-55 that does not add copolymer NE30D will to cause coated pellets in tabletting process to be unable to undergo used pressure as enteric coating layer material.Have been surprisingly found that thus the piller (embodiment in vide infra) of the present invention L30D-55 coating can be pressed into the tablet of suit the requirements (acid resistance that comprises acceptable tablet).”。Process aspect, this application people thinks: " must affect indistinctively the acid resistance of the piller of enteric coating coating for the preparation of the method for densifying (compacting) of multiple unit pharmaceutical preparation.In other words, the mechanical property of enteric coat layer, for example flexible and hardness and thickness must guarantee to reach the requirement to enteric coating goods defined in American Pharmacopeia, and acid proof decline is no more than 10% in the process that piller is pressed into sheet." this patent inventor thinks that mechanical property by limiting enteric layer is as flexible and hardness and thickness, can solve copolymer L30D-55 that employing do not add copolymer NE30D as enteric coating layer material time, the destruction to enteric layer in tablet press process.In its claim 7-8, the restriction of enteric layer is comprised: " Vickers hardness of enteric coat layer is less than 8; The tablet of claim 1, is characterized in that the thickness of the enteric coat layer of described coated separate unit is at least 10 microns.”
Present inventor, in the favorite outer discovery of process of carrying out tabletting and preparing, adopts dry granulation technology, first tabletting is prepared into and is applicable to big or small granule with adjuvant, then carry out tabletting after mixing with the piller that has enteric layer coating, and after tabletting, optional material is carried out coating.Even if this technique is greater than in enteric layer piller Vickers hardness, also can protect enteric layer piller not to be damaged in tabletting process at 8 o'clock.The identical piller that has enteric layer coating is carried out to tabletting according to the method for describing in CN 1152671C, " piller of the enteric coating coating of with or without outer coatings layer is mixed with tablet excipient for example filler, binding agent, disintegrating agent, lubricant and other pharmaceutically useful additive, and be pressed into sheet.The sheet being pressed into is optionally used film former coating ".Relatively can find to adopt tablet acid-resistant strength prepared by dry granulation technology to be obviously better than the tablet that adopts the method for describing in CN 1152671C to prepare in two kinds of tablets that make, can solve the underproof defect of acid-resistant strength after piller tabletting.
Summary of the invention
The inventor finds, through the piller of enteric layer coating, adopts method of the present invention, can prepare tablet by tabletting, and the character of enteric layer is had no significant effect.In the process that the piller of enteric layer coating is suppressed, very easily destroy enteric layer coating, once enteric layer has destruction, the acid-resistant strength of the tablet of preparation will significantly reduce, the tablet of manufacturing is by the standard-required not meeting enteric coated preparation, for example defined in 2010 editions in Chinese Pharmacopoeia, measure 0.lmol/L hydrochloric acid solution 750ml, the each stripping rotor of note people, the deviation of the actual volume measuring and prescribed volume should be no more than ± and 1%, until dissolution medium temperature constant during at 37 ℃ ± 0.5 ℃, getting 12 throws respectively people and turns in basket or stripping rotor, notice that there is not bubble on test sample surface, start instrument by the rotating speed stipulating under each kind item, appropriate in regulation sample point draw solution after 2 hours, filter, should within 30 seconds, complete from being sampled to filtration.Measure by the method that stipulates under each kind item, calculate burst size in the acid of every.The burst size of every is not more than 10% of labelled amount.
First the inventive method, is wrapped in esomeprazole sprayed coating on ball core by coating such as in the equipment such as coating pan, fluid bed at suitable equipment.Ball core can be that various inert materials are obtained, as sucrose, cellulose etc.For by esomeprazole close adhesion on ball core, can add the binding agents such as the Polyethylene Glycol, polyvinylpyrrolidone, polyvinyl alcohol, cellulose derivative class of various saccharides, different molecular weight and suitable auxiliary agent as dispersant etc.Second step is by sealing coat sprayed coating on medicine carrying piller, and wherein sealing coat comprises that the binding agents such as the Polyethylene Glycol, polyvinylpyrrolidone, polyvinyl alcohol, cellulose derivative class of various saccharides, different molecular weight and suitable auxiliary agent are as plasticizer, dispersant etc.The 3rd step by enteric material sprayed coating on the piller with sealing coat.Enteric material can be that Lac, cellulose acetate-phthalate, crylic acid resin are if methacrylic acid copolymer (L30D-55), polyethylene kind are as one or more mixture in the materials such as PVAP.The adjuvant mix homogeneously that the 4th step is used tabletting, the dry granule of previously prepared one-tenth, by after particle screening, selects appropriate particle size and controls the ratio of different-grain diameter granule, mixes rear tabletting with piller and the fluidizer of enteric layer coating.Tabletting comprises that with adjuvant diluent is as pregelatinized Starch, mannitol, lactose, water soluble acrylic resin and cellulose derivative etc., and fluidizer is as micropowder silica gel, magnesium stearate etc.The tablet preparing detects acid-resistant strength according to Chinese Pharmacopoeia method, and burst size that should every is not more than 10% of labelled amount.
The specific embodiment
Following examples, for the present invention is illustrated, are not intended to limit scope of the present invention.
Embodiment 1
Drug-loaded layer coating:
500 grams of esomeprazole magnesiums
300 grams, sugar ball ball core
45 grams of hypromelloses
1000 grams of purified water
Sealing coat coating:
500 grams of drug-loaded layer pillers
100 grams of Opadries
1000 grams of purified water
Enteric layer coating:
500 grams of sealing coat pillers
400 grams of methacrylic acid copolymer
60 grams of triethyl citrates
1800 grams of purified water
Tabletting:
200 grams of enteric layer pillers
400 grams of microcrystalline Cellulose
200 grams of lactose
8 grams of micropowder silica gels
By dry granulation after microcrystalline Cellulose and lactose mix homogeneously, the granule making sieves, and the above granule of 30 order is defined as the following and above granule of 60 order of material 1,30 order and is defined as material 2,60 orders and is defined as below material 3.Material 1, material 2, material 3 and enteric layer piller, according to the ratio batching of 1:1:1:1, are mixed with micropowder silica gel, then tabletting.Sheet hardness 13.
Embodiment 2
Drug-loaded layer coating:
500 grams of esomeprazole magnesiums
500 grams, sugar ball ball core
50 grams of hypromellose E15
1000 grams of purified water
Sealing coat coating:
500 grams of drug-loaded layer pillers
40 grams of hypromellose E15
60 grams of Pulvis Talci
1000 grams of purified water
Enteric layer coating:
500 grams of sealing coat pillers
Refined gram suitable 400 grams
2000 grams of purified water
Tabletting:
200 grams of enteric layer pillers
300 grams, mannitol
300 grams of lactose
6 grams of micropowder silica gels
By dry granulation after mannitol and lactose mix homogeneously, the granule making sieves, and the above granule of 30 order is defined as the following and above granule of 60 order of material 1,30 order and is defined as material 2,60 orders and is defined as below material 3.Material 1, material 2, material 3 and enteric layer piller, according to the ratio batching of 1:1:1:1, are mixed with micropowder silica gel, then tabletting.Sheet hardness 13.
Embodiment 3
Drug-loaded layer coating:
500 grams of esomeprazole magnesiums
500 grams, sugar ball ball core
50 grams of hypromellose E15
1000 grams of purified water
Sealing coat coating:
500 grams of drug-loaded layer pillers
120 grams of Opadries
1000 grams of purified water
Enteric layer coating:
500 grams of sealing coat pillers
Refined gram suitable 500 grams
2500 grams of purified water
Tabletting:
200 grams of enteric layer pillers
300 grams of microcrystalline Cellulose
300 grams of lactose
8 grams of magnesium stearate
By dry granulation after microcrystalline Cellulose and lactose mix homogeneously, the granule making sieves, and the above granule of 30 order is defined as the following and above granule of 60 order of material 1,30 order and is defined as material 2,60 orders and is defined as below material 3.Material 1, material 2, material 3 and enteric layer piller, according to the ratio batching of 1:0.5:1.5:1, are mixed with magnesium stearate, then tabletting.Sheet hardness 11.
Embodiment 4
Drug-loaded layer coating:
500 grams of esomeprazole magnesiums
500 grams, sugar ball ball core
50 grams of hypromellose E15
1000 grams of purified water
Sealing coat coating:
500 grams of drug-loaded layer pillers
100 grams of Opadries
1000 grams of purified water
Enteric layer coating:
500 grams of sealing coat pillers
Refined gram suitable 400 grams
2000 grams of purified water
Tabletting:
200 grams of enteric layer pillers
300 grams of microcrystalline Cellulose
300 grams, mannitol
6 grams of magnesium stearate
By dry granulation after microcrystalline Cellulose and mannitol mix homogeneously, the granule making sieves, and the above granule of 30 order is defined as the following and above granule of 60 order of material 1,30 order and is defined as material 2,60 orders and is defined as below material 3.Material 1, material 2, material 3 and enteric layer piller, according to the ratio batching of 2:1:0:1, are mixed with magnesium stearate, then tabletting.Sheet hardness 12.
Embodiment 5
Drug-loaded layer coating:
500 grams of esomeprazole magnesiums
500 grams, sugar ball ball core
50 grams of hypromellose E15
1000 grams of purified water
Sealing coat coating:
500 grams of drug-loaded layer pillers
100 grams of Opadries
1000 grams of purified water
Enteric layer coating:
500 grams of sealing coat pillers
300 grams of methacrylic acid copolymer
90 grams of triethyl citrates
1000 grams of purified water
Tabletting:
200 grams of enteric layer pillers
450 grams of microcrystalline Cellulose
6 grams of magnesium stearate
Enteric layer piller is mixed homogeneously with microcrystalline Cellulose, magnesium stearate, then tabletting.Sheet hardness 13.Enteric layer coated pellets and tablet acid-resistant strength experimental result are as following table:
| ? | Enteric layer piller acid-resistant strength (%) | Tablet acid-resistant strength (%) |
| Embodiment 1 | 0.3 | 1.1 |
| Embodiment 2 | 0.5 | 1.7 |
| Embodiment 3 | 0.3 | 1.3 |
| Embodiment 4 | 0.6 | 2.1 |
| Embodiment 5 | 0.4 | 21.3 |
As can be seen from the above results, under enteric layer material category and proportioning and the close condition of weightening finish ratio, only have additive of tablet not adopt in advance dry granulation but enteric layer piller in the embodiment 5 of powder vertical compression is not withstand voltage, adopt the embodiment 1～4 of method described in the application to decline and all do not exceed requirement through tabletting process acid-resistant strength.
Claims (9)
1. esomeprazole enteric coatel tablets and preparation method thereof, is characterized in that: this tablet forms with diluent and fluidizer by being enclosed with drug-loaded layer, sealing coat and enteric layer piller; Wherein diluent is prepared into granule by dry granulation in advance, tabletting after mixing with piller and fluidizer according to a certain percentage.
2. the tablet acid-resistant strength in claim 1 meets the requirements, burst size <10% in acid.
3. in claim 1, the piller in tablet has wrapped up drug-loaded layer, sealing coat and enteric layer on inertia ball core.
4. the drug-loaded layer described in claim 3 also comprises except esomeprazole: binding agent is as various saccharides, polyvinylpyrrolidone, polyvinyl alcohol, cellulose derivative class; Dispersant is as Polyethylene Glycol, the Pulvis Talci etc. of various molecular weight.
5. binding agent described in claim 4 is preferably cellulose derivative class as hypromellose, low-substituted hydroxypropyl methylcellulose and hydroxypropyl cellulose etc.
6. the sealing coat described in claim 3 comprises film former, plasticizer and antitackiness agent: film former is as cellulose derivative class and crylic acid resin etc.; Plasticizer is as the Polyethylene Glycol of different molecular weight, triethyl citrate, propylene glycol and glycerol etc.; Antitackiness agent is as Pulvis Talci, magnesium stearate etc.
7. film former described in claim 6 is preferably cellulose derivative class as hypromellose, low-substituted hydroxypropyl methylcellulose and hydroxypropyl cellulose etc.
8. described in claim 6, plasticizer is preferably low molecular poly, triethyl citrate etc.
9. the piller Vickers hardness in claim 1 is more than or equal to 8.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027320A (en) * | 2014-06-26 | 2014-09-10 | 杭州新诺华医药有限公司 | Esomeprazole magnesium suspension tablet and preparation method thereof |
| CN104224728A (en) * | 2014-08-29 | 2014-12-24 | 济南康和医药科技有限公司 | Esomeprazole enteric-coated pellets and preparation method for same |
| CN104666268A (en) * | 2015-02-03 | 2015-06-03 | 山东省药学科学院 | Esomeprazole magnesium coated tablet and preparation method thereof |
| CN105596310A (en) * | 2015-12-23 | 2016-05-25 | 杭州新诺华医药有限公司 | Esomeprazole enteric-coated tablets and preparation method thereof |
| CN110237041A (en) * | 2019-06-20 | 2019-09-17 | 南京知和医药科技有限公司 | A kind of Omeprazole Enteric-coated Tablets and preparation method thereof |
| JP2021507926A (en) * | 2018-01-29 | 2021-02-25 | チョン クン ダン ファーマシューティカル コーポレイション | Pharmaceutical formulation containing esomeprazole and sodium bicarbonate |
| US11813285B2 (en) | 2018-01-29 | 2023-11-14 | Chong Kun Dang Pharmaceutical Corp. | Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate |
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| CN102525990A (en) * | 2010-12-23 | 2012-07-04 | 丽珠医药集团股份有限公司 | Ilaprazole enteric-coated tablets and preparation method thereof |
| CN102940611A (en) * | 2012-11-26 | 2013-02-27 | 康普药业股份有限公司 | Esomeprazole magnesium contained enteric-coated tablet and preparation method thereof |
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Patent Citations (5)
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| WO2001051050A1 (en) * | 2000-01-11 | 2001-07-19 | The Curators Of The University Of Missouri | Novel substituted benzimidazole dosage forms and method of using same |
| CN1555256A (en) * | 2001-07-16 | 2004-12-15 | Pharmaceutical formulation comprising a proton pump inhibitor and antacids | |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027320A (en) * | 2014-06-26 | 2014-09-10 | 杭州新诺华医药有限公司 | Esomeprazole magnesium suspension tablet and preparation method thereof |
| CN104224728A (en) * | 2014-08-29 | 2014-12-24 | 济南康和医药科技有限公司 | Esomeprazole enteric-coated pellets and preparation method for same |
| CN104224728B (en) * | 2014-08-29 | 2016-10-19 | 济南康和医药科技有限公司 | A kind of Esomeprazole enteric pellet and preparation method thereof |
| CN104666268A (en) * | 2015-02-03 | 2015-06-03 | 山东省药学科学院 | Esomeprazole magnesium coated tablet and preparation method thereof |
| CN104666268B (en) * | 2015-02-03 | 2018-10-02 | 山东省药学科学院 | A kind of esomeprazole magnesium clad sheet and preparation method thereof |
| CN105596310A (en) * | 2015-12-23 | 2016-05-25 | 杭州新诺华医药有限公司 | Esomeprazole enteric-coated tablets and preparation method thereof |
| JP2021507926A (en) * | 2018-01-29 | 2021-02-25 | チョン クン ダン ファーマシューティカル コーポレイション | Pharmaceutical formulation containing esomeprazole and sodium bicarbonate |
| JP7009634B2 (en) | 2018-01-29 | 2022-01-25 | チョン クン ダン ファーマシューティカル コーポレイション | Pharmaceutical formulation containing esomeprazole and sodium bicarbonate |
| US11759428B2 (en) | 2018-01-29 | 2023-09-19 | Chong Kun Dang Pharmaceutical Corp. | Pharmaceutical formulation comprising esomeprazole and sodium bicarbonate |
| US11813285B2 (en) | 2018-01-29 | 2023-11-14 | Chong Kun Dang Pharmaceutical Corp. | Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate |
| CN110237041A (en) * | 2019-06-20 | 2019-09-17 | 南京知和医药科技有限公司 | A kind of Omeprazole Enteric-coated Tablets and preparation method thereof |
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