CN105030720B - vonoprazan fumarate enteric-coated tablet and preparation method thereof - Google Patents
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Abstract
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a vonoprazan fumarate enteric-coated tablet and a preparation method thereof. The technical scheme of the invention is as follows: the tablet core is prepared from the vonoprazan fumarate and pharmaceutical excipients, and then enteric-coated layer coating is carried out, wherein each 1000 tablets of the tablet core comprise 13.36g of the vonoprazan fumarate, 40-50g of mannitol, 10-20g of microcrystalline cellulose, 3-8g of vonoprazan fumarate enteric-coated tablet cellulose, 1-5g of fumaric acid, 8-30g of croscarmellose sodium and 1-3g of magnesium stearate. Every 1000 tablets of the enteric film coating layer comprises: 7.0g of acrylic resin, 0.1g of triethyl citrate and 3.9g of talcum powder. The technical scheme of the invention solves the problem that the common tablet is unstable to release in the stomach.
Description
Technical Field
the invention belongs to the field of pharmaceutical preparations, and particularly relates to a vonoprazan fumarate enteric-coated tablet and a preparation method thereof.
Background
Vonoprazan fumarate (Vonoprazan), having the chemical name of (1- (5- (2-fluorophenyl) -1- (pyridin-3-ylsulfonyl) -1H-pyrrol-3-yl) -N-methylmethanemethanemethane fumarate, molecular formula C 21 H 20 FN 3 O 6 S, molecular weight: 461.46, melting point: 201 ~ 203 ℃, white or off-white crystalline powder, the chemical structural formula is as follows:
vonoprazan fumarate tablet is a new gastric acid secretion inhibitor developed by wutian pharmacy, is marketed in japan in 2014, and is used for the treatment of erosive esophagitis, gastric ulcer, duodenal ulcer, and helicobacter pylori eradication. The commercially available vonoprazan fumarate is a common tablet released in the stomach, and in-vitro dissolution experiments show that the vonoprazan fumarate can form crystal precipitation in a medium with the pH value of 1.0, and the obtained results of each in-vitro dissolution are different, which indicates that the release in the stomach is unstable. Since the pH value of the adult gastric juice is 0.9-1.5, it can be expected that the release of the vonoprazan fumarate ordinary tablet in the gastric juice is unstable, and the absorption of the drug and the treatment effect are influenced due to different pH values of the gastric juice. At present, no report is made on vonoprazan fumarate enteric-coated preparation.
Disclosure of Invention
the purpose of the invention is as follows: provides a vonoprazan fumarate enteric-coated tablet, and solves the problem of unstable release of the common tablet.
The invention realizes the purpose of the invention by researching the formula and the production process of the tablet core of the Vonoprazan fumarate enteric-coated tablet and the coating process of the isolation layer and the enteric-coated layer.
The technical scheme of the invention is as follows: the Vonoprazan fumarate enteric-coated tablet comprises a tablet core, an isolating layer and an enteric coating layer, and is characterized in that every 1000 tablets of the Vonoprazan fumarate enteric-coated tablet comprise 13.36g of Vonoprazan fumarate, 22-66g of mannitol, 14-59g of microcrystalline cellulose, 5.5g of hydroxypropyl cellulose, 3.3g of fumaric acid, 6.6g of croscarmellose sodium and 1.1g of magnesium stearate; the isolating layer is composed of hydroxypropyl methylcellulose and talcum powder, and the weight ratio of the hydroxypropyl methylcellulose to the talcum powder is 2.35: 3.15; the enteric film coating layer consists of polyacrylic resin II, triethyl citrate and talcum powder, and the weight ratio of the polyacrylic resin II to the triethyl citrate to the talcum powder is 10.5: 0.15: 5.85.
The preferable technical scheme of the invention is characterized in that the weight of the enteric film coating is increased to 5-15% of the sum of the weight of the tablet core and the weight of the isolating layer.
The preferable technical scheme is characterized in that the weight of the isolating layer coating is increased to 5% of the weight of the tablet core.
The preferable technical scheme of the invention is characterized in that the weight of the enteric film coating is increased to 8-10% of the total weight of the tablet core and the isolating layer.
The Vonoprazan fumarate enteric-coated tablet comprises a tablet core, an isolating layer and an enteric coating layer, wherein each 1000 tablets of the tablet core comprise 13.36g of Vonoprazan fumarate, 22-66g of mannitol, 14-59g of microcrystalline cellulose, 5.5g of hydroxypropyl cellulose, 3.3g of fumaric acid, 6.6g of croscarmellose sodium and 1.1g of magnesium stearate; each 1000 of said barrier layers comprises: 2.35g of hydroxypropyl methylcellulose and 3.15g of talcum powder, wherein the weight of the coating is increased to 5%; every 1000 tablets of the enteric film coating layer comprises: 10.5g of polyacrylic resin II, 0.15g of triethyl citrate and 5.85g of talcum powder, and the weight of the coating is increased to 5% -15% of the sum of the weight of the tablet core and the weight of the isolating layer, so that the vonoprazan fumarate enteric-coated tablet is obtained.
According to the invention, through the prescription research of the tablet core of the Vonoprazan fumarate enteric-coated tablet, the dosage of mannitol and microcrystalline cellulose has great influence on the flowability and compressibility of prescription granules, the compressibility of the granules is poor due to small dosage of microcrystalline cellulose, and the capping phenomenon occurs in the tabletting process due to large dosage of mannitol. According to prescription research, the dosage of mannitol is 22-66g, and the dosage of microcrystalline cellulose is 14-59 g.
According to the requirements of the dosage form performance of the enteric coated tablet, the surface of the tablet core is covered with the enteric coating layer with a certain thickness, and the enteric coated tablet can not be cracked and the like in 0.1mol/L hydrochloric acid solution for a long time, and researches show that when the weight gain of the coating is lower than 5%, the coating material can not completely cover the tablet core, and part of the tablet is cracked in 0.1mol/L hydrochloric acid solution, so that the enteric coating requirement can not be met; when the weight of the coating is increased too much, the disintegration time of the tablet in the buffer solution is prolonged, and the release degree is not satisfactory. The coating weight gain is determined to be 5% -15% in the invention.
The preferable technical scheme is characterized in that each 1000 tablet cores comprise 13.36g of vonoprazan fumarate, 22g of mannitol, 58.14g of microcrystalline cellulose, 5.5g of hydroxypropyl cellulose, 3.3g of fumaric acid, 6.6g of croscarmellose sodium and 1.1g of magnesium stearate.
The preferable technical scheme is characterized in that each 1000 tablet cores comprise 13.36g of vonoprazan fumarate, 44g of mannitol, 36.14g of microcrystalline cellulose, 5.5g of hydroxypropyl cellulose, 3.3g of fumaric acid, 6.6g of croscarmellose sodium and 1.1g of magnesium stearate.
The preferable technical scheme is characterized in that each 1000 tablet cores comprise 13.36g of vonoprazan fumarate, 66g of mannitol, 14.14g of microcrystalline cellulose, 5.5g of hydroxypropyl cellulose, 3.3g of fumaric acid, 6.6g of croscarmellose sodium and 1.1g of magnesium stearate.
the preparation process of the vonoprazan fumarate enteric-coated tablet comprises the following steps:
(1) weighing mannitol, Vonoprazan fumarate, microcrystalline cellulose, fumaric acid and croscarmellose sodium in a prescription amount, and uniformly mixing in a wet granulator;
(2) Adding a hydroxypropyl cellulose aqueous solution into a wet granulator, carrying out wet mixing, preparing a soft material, and granulating by using a 20-mesh screen;
(3) Drying the wet granules by a 40 ℃ oven, and finishing granules by a 20-mesh screen;
(4) Adding magnesium stearate with the prescription amount into the dry granules, and uniformly mixing in a mixer;
(5) Punching a shallow concave tablet with the diameter of 6.5mm to obtain a Vonoprazan fumarate tablet core;
(6) Preparing an isolating layer coating solution: slowly adding hydroxypropyl methylcellulose and talcum powder into 75% ethanol by calculating every 1000 Wobuelan fumarate tablets, and stirring to mix uniformly;
(7) Coating parameters of the isolation layer: the temperature of a tablet bed is 30-45 ℃, the rotating speed of a coating pan is 5-25rpm, the atomization pressure is 0.08-0.2MPa, the liquid spraying speed is 10-20ml/min, and the weight of the coating is increased to 5%;
(8) Preparing enteric-coated layer coating liquid: slowly adding the polyacrylic resin II, triethyl citrate and talcum powder into 75% ethanol by calculating every 1000 vonoprazan fumarate tablets, and stirring to be uniformly mixed;
(9) enteric coating parameters: the temperature of a tablet bed is 30-45 ℃, the rotating speed of a coating pan is 5-25rpm, the atomization pressure is 0.08-0.2MPa, the liquid spraying speed is 10-20ml/min, and the weight of the coating is increased to 5% -15%, so that the Vonoprazan fumarate enteric-coated tablet is obtained.
the invention has the following beneficial effects:
the optimum prescription and the optimum process are obtained by researching the prescription, the production process, the isolating layer and the enteric coating process of the Vonoprazan fumarate enteric-coated tablet core, the Vonoprazan fumarate enteric-coated tablet prepared on the basis has good release degree, and an accelerated test is carried out, the accelerated test result shows that related substances are not obviously changed and the release degree is good, and the problems of separation and unstable release of Vonoprazan fumarate in the stomach can be effectively solved by preparing the Vonoprazan fumarate enteric-coated tablet.
Detailed Description
The invention will now be further illustrated by the following examples, which are intended for the purpose of illustration only and do not limit the scope of the invention.
example 1, a vonoprazan fumarate tablet (core tablet) with the following composition per 1000 tablets:
tablet core:
| vonoprazan fumarate | 13.36g |
| mannitol | 22g |
| Microcrystalline cellulose | 58.14g |
| Hydroxypropyl cellulose | 5.5g |
| Fumaric acid | 3.3g |
| Croscarmellose sodium | 6.6g |
| Magnesium stearate | 1.1g |
| is made into | 1000 tablets |
The preparation process comprises the following steps:
(1) Weighing mannitol, Vonoprazan fumarate, microcrystalline cellulose, fumaric acid and croscarmellose sodium in a prescription amount, and uniformly mixing in a wet granulator;
(2) Adding a hydroxypropyl cellulose aqueous solution into a wet granulator, carrying out wet mixing, preparing a soft material, and granulating by using a 20-mesh screen;
(3) Drying the wet granules by a 40 ℃ oven, and finishing granules by a 20-mesh screen;
(4) Adding magnesium stearate with the prescription amount into the dry granules, and uniformly mixing in a mixer;
(5) And (5) punching a shallow concave tablet with the diameter of 6.5mm to obtain the Vonoprazan fumarate tablet core.
Example 2, a vonoprazan fumarate tablet (tablet core tablet) with the following composition per 1000 tablets:
tablet core:
| vonoprazan fumarate | 13.36g |
| Mannitol | 44g |
| microcrystalline cellulose | 36.14g |
| Hydroxypropyl cellulose | 5.5g |
| Fumaric acid | 3.3g |
| Croscarmellose sodium | 6.6g |
| Magnesium stearate | 1.1g |
| is made into | 1000 tablets |
The preparation process was the same as in example 1.
Example 3 a vonoprazan fumarate tablet (core tablet) with the following composition per 1000 tablets:
Tablet core:
| Vonoprazan fumarate | 13.36g |
| mannitol | 66g |
| microcrystalline cellulose | 14.14g |
| hydroxypropyl cellulose | 5.5g |
| fumaric acid | 3.3g |
| Croscarmellose sodium | 6.6g |
| Magnesium stearate | 1.1g |
| is made into | 1000 tablets |
The preparation process was the same as in example 1.
Example 4, the vonoprazan fumarate tablet prepared in example 1 is placed in a coating machine, and the vonoprazan fumarate enteric-coated tablet is prepared according to the following composition formula of an isolating layer and an enteric-coated layer and a coating process.
The coating of the isolating layer comprises the following components:
| Vonoprazan fumarate tablet | 1000 tablets |
| Hydroxypropyl methylcellulose | 2.35g |
| Talcum powder | 3.15g |
| 75% ethanol solution | 63.25g |
The enteric coating comprises the following components:
| Polyacrylic acid resin II | 10.5g |
| Citric acid triethyl ester | 0.15g |
| Talcum powder | 5.85g |
| 75% ethanol solution | 189.75g |
The preparation process comprises the following steps:
(1) preparing an isolating layer coating solution: slowly adding hydroxypropyl methylcellulose and talcum powder into 75% ethanol by calculating every 1000 Wobuelan fumarate tablets, and stirring to mix uniformly;
(2) coating parameters of the isolation layer: the temperature of a tablet bed is 30-45 ℃, the rotating speed of a coating pan is 5-25rpm, the atomization pressure is 0.08-0.2MPa, the liquid spraying speed is 10-20ml/min, and the weight of the coating is increased to 5%;
(3) Preparing an enteric coating solution: slowly adding the acrylic resin II, triethyl citrate and talcum powder into 75% ethanol by calculating every 1000 vonoprazan fumarate tablets, and stirring to be uniformly mixed;
(4) Coating parameters: the temperature of a tablet bed is 30-45 ℃, the rotating speed of a coating pan is 5-25rpm, the atomization pressure is 0.08-0.2MPa, the liquid spraying speed is 10-20ml/min, and the weight of the coating is increased to 5% -15%, so that the Vonoprazan fumarate enteric-coated tablet is obtained.
example 5, the vonoprazan fumarate tablet prepared in example 2 is placed in a coating machine, and the vonoprazan fumarate enteric-coated tablet is prepared according to the composition formula and the coating process of the isolating layer and the enteric-coated layer in example 4.
Example 6, the vonoprazan fumarate tablet prepared in example 3 is placed in a coating machine, and the vonoprazan fumarate enteric-coated tablet is prepared according to the composition formula and the coating process of the isolating layer and the enteric-coated layer in example 4.
test example 1 measurement of Release degree
Release degree measurement according to the second method of the second appendix XD of the 2010 edition of the Chinese pharmacopoeia, the Vonoprazan fumarate (enteric coated) tablets are put into 900ml of 0.1mol/L hydrochloric acid solution with the temperature of 37 +/-0.5 ℃, a first method device for dissolution degree measurement is adopted, the rotating speed is 100 revolutions per minute, the dissolution liquid is taken for 5ml after the operation according to the method and respectively carried out for 15 minutes, 30 minutes, 45 minutes, 60 minutes and 120 minutes, the filtration is carried out, the subsequent filtrate is taken, the release degree of each tablet is measured according to the high performance liquid chromatography (the second appendix D of the 2010 edition of the Chinese pharmacopoeia), and the result is shown in the table 1; 0.1mol/L hydrochloric acid solution in each of the dissolution cups was discarded, and immediately added to 900ml of a phosphate buffer solution (pH 6.8) at 37 ℃. + -. 0.5 ℃ by using a dissolution method first method apparatus at a rotation speed of 100 rpm. Operating according to the method, taking 5ml of dissolution liquid after 45 minutes, filtering, taking subsequent filtrate, measuring according to high performance liquid chromatography (XD in the second part of the 2010 edition of Chinese pharmacopoeia), calculating the release degree of each tablet, and the result is shown in Table 1:
Table 1: release of vonoprazan fumarate (enteric) tablets in each example
As can be seen from the results of the release rates in table 1, the vonoprazan fumarate tablets are precipitated in a 0.1mol/L hydrochloric acid medium, are released unstably, and are released in a decreasing trend with time, and the release rates are good after enteric coating.
test example 2, examination of the influence of the weight gain of the enteric layer coating on the release rate of Vonoprazan fumarate enteric-coated tablet
Using the formulation and process of example 2, after coating with the separating layer, the enteric coating weights were designed to be 3%, 5%, 10%, 15% and 20%, respectively, and the release of the coated tablets was examined, with the results shown in table 2:
Table 2: vonoprazan fumarate enteric-coated tablet release degree increased by coating with different enteric coating layers
When the weight gain of the enteric-coated layer coating is lower than 5%, the coating material can not completely cover the tablet core, and part of tablets are cracked in 0.1mol/L hydrochloric acid solution, so that the enteric-coated requirement can not be met; when the weight of the coating is increased too much, the disintegration time of the tablet in the buffer solution is prolonged, and the release degree is not satisfactory. The coating weight gain is determined to be 5% -15% in the invention.
test example 3 accelerated test
According to the requirements of the technical guidelines of the stability research of chemical drugs (bulk drugs and preparations), the vonoprazan fumarate enteric-coated tablet of the invention is subjected to accelerated tests. The product is packaged according to the product to be sold on the market, is placed for 6 months under the conditions of 40 ℃ plus or minus 2 ℃ and 75% plus or minus 5% of relative humidity, and is sampled and measured for 0, 1, 2, 3 and 6 months respectively to determine the release degree, related substances and content, and the results are shown in a table 3:
Table 3: stability data of accelerated test
The accelerated test result in table 26 months shows that the release rate, the related substances and the content of the vonoprazan fumarate enteric-coated tablet prepared by the method all meet the regulations, and the related substances and the content of the sample have no obvious change along with the increase of time, which indicates that the vonoprazan fumarate enteric-coated tablet has good stability.
Claims (6)
1. the Vonoprazan fumarate enteric-coated tablet comprises a tablet core, an isolating layer and an enteric coating layer, and is characterized in that every 1000 tablets of the Vonoprazan fumarate enteric-coated tablet comprise 13.36g of Vonoprazan fumarate, 22-66g of mannitol, 14-59g of microcrystalline cellulose, 5.5g of hydroxypropyl cellulose, 3.3g of fumaric acid, 6.6g of croscarmellose sodium and 1.1g of magnesium stearate; the isolating layer is composed of hydroxypropyl methylcellulose and talcum powder, and the weight ratio of the hydroxypropyl methylcellulose to the talcum powder is 2.35: 3.15; the enteric film coating layer consists of polyacrylic resin II, triethyl citrate and talcum powder, and the weight ratio of the polyacrylic resin II to the triethyl citrate to the talcum powder is 10.5: 0.15: 5.85, the weight of the enteric film coating is increased to 5% -15% of the sum of the weight of the tablet core and the weight of the isolating layer, and the Vonoprazan fumarate enteric-coated tablet is prepared by the following method:
(1) Weighing mannitol, Vonoprazan fumarate, microcrystalline cellulose, fumaric acid and croscarmellose sodium in a prescription amount, and uniformly mixing in a wet granulator;
(2) adding a hydroxypropyl cellulose aqueous solution into a wet granulator, carrying out wet mixing, preparing a soft material, and granulating by using a 20-mesh screen;
(3) Drying the wet granules by a 40 ℃ oven, and finishing granules by a 20-mesh screen;
(4) Adding magnesium stearate with the prescription amount into the dry granules, and uniformly mixing in a mixer;
(5) Punching a shallow concave tablet with the diameter of 6.5mm to obtain a Vonoprazan fumarate tablet core;
(6) Preparing an isolating layer coating solution: slowly adding hydroxypropyl methylcellulose and talcum powder into 75% ethanol by calculating every 1000 Wobuelan fumarate tablets, and stirring to mix uniformly;
(7) Coating parameters of the isolation layer: the temperature of a tablet bed is 30-45 ℃, the rotating speed of a coating pan is 5-25rpm, the atomization pressure is 0.08-0.2MPa, the liquid spraying speed is 10-20ml/min, and the weight of the coating is increased to 5%;
(8) preparing enteric-coated layer coating liquid: slowly adding the polyacrylic resin II, triethyl citrate and talcum powder into 75% ethanol by calculating every 1000 vonoprazan fumarate tablets, and stirring to be uniformly mixed;
(9) enteric coating parameters: the temperature of a tablet bed is 30-45 ℃, the rotating speed of a coating pan is 5-25rpm, the atomization pressure is 0.08-0.2MPa, the liquid spraying speed is 10-20ml/min, and the weight of the coating is increased to 5% -15%, so that the Vonoprazan fumarate enteric-coated tablet is obtained.
2. Vonoprazan fumarate enteric tablet according to claim 1, wherein the weight of the coating of the separating layer is increased to 5% of the weight of the tablet core.
3. The vonoprazan fumarate enteric tablet according to claim 1, wherein the weight of the enteric film coating is increased to 8% -10% of the sum of the weights of the tablet core and the isolating layer.
4. The vonoprazan fumarate enteric-coated tablet as claimed in claim 1, wherein per 1000 tablet cores, the tablet comprises 13.36g of vonoprazan fumarate, 22g of mannitol, 58.14g of microcrystalline cellulose, 5.5g of hydroxypropyl cellulose, 3.3g of fumaric acid, 6.6g of croscarmellose sodium and 1.1g of magnesium stearate.
5. The vonoprazan fumarate enteric-coated tablet as claimed in claim 1, wherein per 1000 tablet core tablets comprise 13.36g of vonoprazan fumarate, 44g of mannitol, 36.14g of microcrystalline cellulose, 5.5g of hydroxypropyl cellulose, 3.3g of fumaric acid, 6.6g of croscarmellose sodium and 1.1g of magnesium stearate.
6. The vonoprazan fumarate enteric-coated tablet as claimed in claim 1, wherein per 1000 tablet cores, the tablet comprises 13.36g of vonoprazan fumarate, 66g of mannitol, 14.14g of microcrystalline cellulose, 5.5g of hydroxypropyl cellulose, 3.3g of fumaric acid, 6.6g of croscarmellose sodium and 1.1g of magnesium stearate.
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| WO2019013310A1 (en) * | 2017-07-10 | 2019-01-17 | Takeda Pharmaceutical Company Limited | Preparation comprising vonoprazan |
| CN112237572A (en) * | 2020-10-28 | 2021-01-19 | 海南卫康制药(潜山)有限公司 | Vonoprazan fumarate tablet and preparation method thereof |
| CN114853728B (en) * | 2022-05-07 | 2023-11-07 | 四川制药制剂有限公司 | Vonopraz fumarate tablet and preparation method thereof |
| CN115364065B (en) * | 2022-08-23 | 2024-03-15 | 宁波高新区美诺华医药创新研究院有限公司 | Furanolas fumarate green sheet |
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| CN102164581A (en) * | 2008-07-28 | 2011-08-24 | 武田药品工业株式会社 | Pharmaceutical composition |
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| CN101300229A (en) * | 2005-08-30 | 2008-11-05 | 武田药品工业株式会社 | 1-heterocyclylsulfonyl, 2-aminomethyl, 5- (hetero-) aryl substituted 1-h-pyrrole derivatives as acid secretion inhibitors |
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Effective date of registration: 20210728 Address after: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Address before: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee before: Dijia Pharmaceutical Group Co.,Ltd. |
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Denomination of invention: Vorolazan fumarate enteric coated tablets and its preparation method Effective date of registration: 20220721 Granted publication date: 20191210 Pledgee: Bank of China Limited Weihai Branch Pledgor: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Registration number: Y2022980010828 |
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