CN110037994B - Ibuprofen quick-release and slow-release double-layer tablet and preparation method thereof - Google Patents
Ibuprofen quick-release and slow-release double-layer tablet and preparation method thereof Download PDFInfo
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Abstract
The invention provides an ibuprofen quick-release slow-release double-layer tablet and a preparation method thereof, the dosage form consists of an ibuprofen quick-release layer and an ibuprofen slow-release layer, ibuprofen is dispersed in the quick-release layer and the slow-release layer according to a certain proportion, and the rapid release and the subsequent slow release action within 12 hours can be provided, so that the effects of quick effect and continuous maintenance of effective blood concentration are achieved. The preparation method of the ibuprofen double-layer tablet adopts wet granulation, and the ibuprofen double-layer tablet is obtained by pre-compressing one layer of granules and then filling the second layer of granules for compression, so that the ibuprofen double-layer tablet is stable in preparation process and good in prescription reproducibility.
Description
Technical Field
The invention belongs to a modified release pharmaceutical preparation in the technical field of medicines, and particularly relates to an ibuprofen bilayer tablet which takes effect quickly and then takes effect slowly and continuously and a preparation method thereof.
Background
Ibuprofen is 2-methyl-4- (2-methylpropyl) phenylacetic acid in chemical name, white crystalline powder, insoluble in water, and easily soluble in ethanol, chloroform, ether, acetone, etc. Has no odor and taste. Melting point is 75-78 deg.C, solubility has pH dependence, and is easily soluble in sodium hydroxide or sodium carbonate solution.
Ibuprofen is a nonsteroidal anti-inflammatory drug, has antipyretic, analgesic and anti-inflammatory effects by inhibiting prostaglandin synthesis, has been used clinically for many years, and has been fully proven in safety and effectiveness.
Ibuprofen is fast to absorb orally, half-life period is short, most of the dosage forms on the market are quick-release dosage forms, and a small part of the dosage forms are slow-release dosage forms. The quick-release preparation takes effect quickly, but the concentration of the main drug is reduced quickly, and the quick-release preparation is generally taken once in 4 to 6 hours; sustained release dosage forms can maintain effective blood concentration for a longer time, generally taken once in 12 hours, but the effect of the medicine is usually slower. The double-layer tablet can realize the quick release of the quick release layer at the beginning so that the medicine takes effect quickly, and then the slow release layer continuously and slowly releases the medicine so that the medicine is maintained in the effective blood concentration range for a long time. In the patent publication CN101068532, an improved oral solid ibuprofen formulation is also proposed, in which at least 20% of the ibuprofen is released within 2 hours, and subsequently the ibuprofen is released at a relatively constant rate within at least 8 hours, but the preparation process mostly adopts powder direct compression and compression into single tablets, the flowability of the ibuprofen is poor, the requirements on the formulation composition and the process are high, and the requirements on the rapid release and slow sustained release of the single tablets are also high.
Currently, the specifications of ibuprofen sustained release preparations mainly used for treating pain relieving as main indications in the market are 300mg, 400mg and 600 mg. Among them, Advil 12hour, marketed in canada, is also a bilayer tablet consisting of a quick-release part and a sustained-release part, the dosage unit is 600mg, the total weight of the tablet is about 990mg, the mass of the tablet is large, and swallowing is difficult for asians. The ibuprofen sustained-release capsules on the market at home are more, wherein the fenbide produced by the Mesoke company is also sustained-release for 12 hours, and the dosage is 300mg and 400mg, so that the ibuprofen sustained-release capsules are used for relieving chronic pain. The sustained-release capsule is obtained by filling sustained-release pellets or granules into a hard capsule, and the pellet preparation process is relatively complex, has poor reproducibility and has higher requirements on equipment and process of the preparation.
Disclosure of Invention
The purpose of the invention is as follows: the invention aims to provide an ibuprofen quick-release slow-release double-layer tablet and a preparation method thereof.
The technical scheme is as follows: the invention discloses an ibuprofen quick-release slow-release double-layer tablet and a preparation method thereof, the double-layer tablet is divided into a quick-release layer and a slow-release layer, wherein the quick-release layer consists of ibuprofen, a diluent, a disintegrating agent, a lubricant and an adhesive, and the weight ratio of the components is as follows: 50-70% of ibuprofen, 20-50% of diluent, 0-10% of disintegrating agent, 0-2% of lubricant and a proper amount of adhesive. The sustained-release part consists of ibuprofen, a sustained-release framework material, a release regulator, a diluent and a lubricant, and the weight ratio of the components is as follows: 50-70% of ibuprofen, 3-25% of slow-release framework material, 5-20% of diluent, 15-30% of release regulator, 0-2% of lubricant, or a proper amount of wetting agent can be contained. The weight ratio of ibuprofen in the quick release layer to ibuprofen in the sustained release layer is 1:3 to 1:1, preferably 1: 2. The release amount of ibuprofen in 1 hour of the double-layer tablet is 20-40% of the total dose, and the rest part can be continuously released for 12 hours.
The ibuprofen quick-release and slow-release double-layer tablet disclosed by the invention has the advantages that the total dose of ibuprofen is 200-400 mg, preferably 300mg, the total tablet weight is smaller, and the ibuprofen quick-release and slow-release double-layer tablet is easy to swallow.
The ibuprofen quick-release and slow-release double-layer tablet adopts the following auxiliary materials:
the slow release skeleton material is selected from one or more of carbomer, hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, polyacrylic resin, sodium alginate and polyvinylpyrrolidone, preferably hydroxypropyl methylcellulose.
The release regulator is hydroxypropyl methylcellulose or polyethylene glycol, preferably hydroxypropyl methylcellulose.
The diluent comprises one or more of microcrystalline cellulose, sucrose, lactose, calcium hydrogen phosphate, mannitol, dextrin, starch and pregelatinized starch, the slow release layer is preferably the mixture of microcrystalline cellulose and pregelatinized starch, and the quick release layer is preferably the mixture of microcrystalline cellulose, starch and pregelatinized starch.
The wetting agent includes water or alcohol, a mixed solution of water and alcohol, and the like.
The adhesive is selected from one or more of hydroxypropyl methylcellulose, polyvinylpyrrolidone, hydroxypropyl cellulose or starch, preferably hydroxypropyl methylcellulose.
The disintegrant is one or more of croscarmellose sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, dry starch or crospovidone, preferably croscarmellose sodium.
The lubricant is stearic acid, pulvis Talci, and colloidal SiO2One or more of magnesium stearate or calcium, preferably stearic acid.
The preparation method of the invention adopts wet granulation for the slow release part and the quick release part, and the slow release layer granules are pre-compressed and then filled into the quick release layer granules for tabletting. The method comprises the following specific steps:
sustained release layer
1. Fully mixing the ibuprofen sieved by the 80-100 mesh sieve with a framework material, a diluent and a release regulator;
2. mixing a proper amount of wetting agent with the materials, granulating, and drying at 50-60 ℃;
3. and (4) drying the granules, sieving, finishing the granules, adding a lubricant, uniformly mixing, and marking as slow-release layer granules.
Quick release layer
1. Fully mixing the ibuprofen sieved by the 80-100 mesh sieve with a diluent, and selecting whether a disintegrating agent is added or not;
2. mixing a proper amount of adhesive with the materials, granulating, and drying at 50-60 ℃;
3. drying the granules, sieving, grading, adding disintegrating agent and lubricant, mixing, and making into quick-release layer granule.
The two part granules were compressed into a bilayer tablet.
Has the advantages that: compared with the prior art, the invention has the following remarkable advantages: 1. the ibuprofen can be rapidly released and can be continuously released for 12 hours, so that the effects of rapidly taking effect and continuously maintaining effective blood concentration are achieved; 2. the preparation process is stable, and the prescription reproducibility is good. The release characteristics of the drug release test in phosphate buffer solutions with pH6.0 and pH7.2 are that the cumulative release amount in 1 hour is 20-40%, the cumulative release amount in 4 hours is 50-65%, and the cumulative release amount in 12 hours is more than 85%.
Drawings
FIG. 1 is the release profile of example 1;
FIG. 2 is the release profile of example 2;
FIG. 3 is the release profile of example 3 in phosphate buffer at pH 6.0;
FIG. 4 is the release profile of example 3 in phosphate buffer at pH 7.2;
FIG. 5 is the release profile of example 4 in phosphate buffer at pH 6.0;
FIG. 6 is the release profile of example 5 in phosphate buffer at pH 6.0;
FIG. 7 is a graph of plasma concentration versus time for the immediate release and sustained release bi-layer ibuprofen tablet of example 1 and a commercially available formulation, immediate release and sustained release bi-layer ibuprofen tablet (Advil 12 hour).
Detailed Description
Example 1
Preparation of ibuprofen immediate-release sustained-release double-layer tablet (300 tablets, mg/tablet):
the preparation steps are as follows:
sustained release layer
1) Fully mixing the ibuprofen sieved by the 80-100 mesh sieve with hydroxypropyl methyl cellulose, microcrystalline cellulose and pregelatinized starch;
2) mixing a proper amount of 30% ethanol solution with the materials to prepare a soft material, sieving and granulating, and drying for 2-4 hours at the temperature of 50-60 ℃;
3) drying the granules, sieving, grading, adding stearic acid, mixing, and making into sustained release granule
Quick release layer
1) Fully mixing the ibuprofen sieved by a sieve of 80-100 meshes with microcrystalline cellulose, starch, pregelatinized starch and added croscarmellose sodium;
2) mixing hydroxypropyl methylcellulose E5 solution with the concentration of 3% with the above materials to prepare soft materials, sieving and granulating, and drying at 50-60 deg.C for 2-4 h;
3) drying the granules, sieving, grading, adding croscarmellose sodium and stearic acid, and mixing to obtain quick-release layer granules.
The two part granules were compressed into a bilayer tablet.
The dissolution rate and the dissolution rate were measured according to the first method of the measurement method of the dissolution rate and the dissolution rate of 0931 in accordance with the general rules of the four departments of the year 2015, China pharmacopoeia. 900mL of degassed pH6.0 phosphate buffer and pH7.2 phosphate buffer are used as release media, the temperature of the media is 37.0 ℃ +/-0.5 ℃, and the rotation speed is 100 r/min.
The release curve of the ibuprofen immediate-release sustained-release double-layer tablet in phosphate buffer with pH6.0 is shown in figure 1.
Example 2
Preparation of ibuprofen immediate-release and sustained-release double-layer tablet (mg/tablet):
the preparation steps are as follows:
sustained release layer
1) Fully mixing the ibuprofen sieved by the 80-100 mesh sieve with hydroxypropyl methylcellulose;
2) mixing a proper amount of 30% ethanol solution with the materials to prepare a soft material, sieving and granulating, and drying for 2-4 hours at the temperature of 50-60 ℃;
3) drying the granules, sieving, grading, adding stearic acid, mixing, and making into sustained release granule
Quick release layer
1) Fully mixing the ibuprofen sieved by a sieve of 80-100 meshes with microcrystalline cellulose, starch, pregelatinized starch and added croscarmellose sodium;
2) mixing hydroxypropyl methylcellulose E5 solution with the concentration of 3% with the above materials to prepare soft materials, sieving and granulating, and drying at 50-60 deg.C for 2-4 h;
3) drying the granules, sieving, grading, adding croscarmellose sodium and stearic acid, and mixing to obtain quick-release layer granules.
The two part granules were compressed into a bilayer tablet.
Release test As in example 1, the release profile of the immediate release and sustained release ibuprofen bilayer tablet in phosphate buffer at pH6.0 is shown in FIG. 2.
Example 3
Preparation of ibuprofen immediate-release and sustained-release double-layer tablet (mg/tablet):
the preparation steps are as follows:
sustained release layer
1) Fully mixing the ibuprofen sieved by the 80-100 mesh sieve with hydroxypropyl methyl cellulose, microcrystalline cellulose and pregelatinized starch;
2) mixing a proper amount of 30% ethanol solution with the materials to prepare a soft material, sieving and granulating, and drying for 2-4 hours at the temperature of 50-60 ℃;
3) drying the granules, sieving, grading, adding stearic acid and colloidal SiO2Uniformly mixed to form the sustained-release layer granules
Quick release layer
1) Fully mixing the ibuprofen sieved by a sieve of 80-100 meshes with microcrystalline cellulose, starch, pregelatinized starch and added croscarmellose sodium;
2) mixing hydroxypropyl methylcellulose E5 solution with the concentration of 3% with the above materials to prepare soft materials, sieving and granulating, and drying at 50-60 deg.C for 2-4 h;
3) drying the granules, sieving, grading, adding croscarmellose sodium and colloidal SiO2Uniformly mixed to form granules of a quick release layer
The two part granules were compressed into a bilayer tablet.
Release test As in example 1, the release profile of the immediate release/sustained release ibuprofen bilayer tablet in phosphate buffer at pH6.0 is shown in FIG. 3, and the release profile in phosphate buffer at pH7.2 is shown in FIG. 4.
Example 4
Preparation of ibuprofen immediate-release and sustained-release double-layer tablet (mg/tablet):
the preparation steps are as follows:
sustained release layer
1) Fully mixing the ibuprofen sieved by the 80-100 mesh sieve with hydroxypropyl methyl cellulose, microcrystalline cellulose and pregelatinized starch;
2) mixing a proper amount of 30% ethanol solution with the materials to prepare a soft material, sieving and granulating, and drying for 2-4 hours at the temperature of 50-60 ℃;
3) drying the granules, sieving, grading, adding stearic acid, mixing, and making into sustained release granule
Quick release layer
1) Fully mixing the ibuprofen sieved by a sieve of 80-100 meshes with microcrystalline cellulose, starch, pregelatinized starch and added croscarmellose sodium;
2) mixing hydroxypropyl methylcellulose E5 solution with the concentration of 3% with the above materials to prepare soft materials, sieving and granulating, and drying at 50-60 deg.C for 2-4 h;
3) drying the granules, sieving, grading, adding croscarmellose sodium and stearic acid, mixing, and making into quick release layer granule
The two part granules were compressed into a bilayer tablet.
Release test As in example 1, the release profile of the immediate release and sustained release ibuprofen bilayer tablet in phosphate buffer at pH6.0 is shown in FIG. 5.
Example 5
Preparation of ibuprofen sustained release tablets (mg/tablet):
the preparation steps are as follows:
sustained release portion
1) Fully mixing the ibuprofen sieved by the 80-100 mesh sieve with hydroxypropyl methyl cellulose, microcrystalline cellulose and pregelatinized starch;
2) mixing a proper amount of 30% ethanol solution with the materials to prepare a soft material, sieving and granulating, and drying for 2-4 hours at the temperature of 50-60 ℃;
3) drying the granules, sieving, grading, adding stearic acid, mixing, and making into sustained release granule
Quick release portion
1) Fully mixing the ibuprofen sieved by a sieve of 80-100 meshes with microcrystalline cellulose, starch, pregelatinized starch and added croscarmellose sodium;
2) mixing hydroxypropyl methylcellulose E5 solution with the concentration of 3% with the above materials to prepare soft materials, sieving and granulating, and drying at 50-60 deg.C for 2-4 h;
3) drying the granules, sieving, grading, adding croscarmellose sodium and stearic acid, mixing, and making into quick-release granule
The two parts of particles are uniformly mixed according to the weight ratio of 9:5, and a single-layer tablet is pressed.
Release test As in example 1, the release profile of ibuprofen sustained release tablets in phosphate buffer at pH6.0 is shown in FIG. 6.
The ibuprofen quick-release slow-release double-layer tablet disclosed by the invention has the advantages that the ibuprofen quick-release slow-release double-layer tablet can realize quick release and slow and sustained release of the drug, the drug takes effect quickly in vivo, and the effective drug concentration is kept for a longer time, so that the purposes of reducing the drug dose, improving the drug effect, prolonging the drug action time and reducing the adverse drug reaction are achieved. Meanwhile, a wet granulation double-layer tabletting process is adopted, the process is simpler, the reproducibility is good, the cost is saved, and the medication burden of a patient is reduced.
The in vivo pharmacokinetics research of the ibuprofen quick-release and slow-release double-layer tablet comprises the following steps:
the 300mg ibuprofen immediate release and sustained release bilayer tablet in example 1 and the commercially available 600mg ibuprofen immediate release and sustained release bilayer tablet Advil 12hour (Peyer company) were selected for the beagle dog in vivo double-cycle double-crossover test. A commercial preparation (R) and a self-made ibuprofen sustained-release tablet (a test preparation T) are tested, and the administration dose is 600mg (R is taken once, and the test preparation T is taken 2 tablets once). Appropriate amount of blood is collected in forelimb venous plexus 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h before and after administration, the blood is placed in a heparin anticoagulation tube, centrifuged at 4000rpm for 10min, and then the upper plasma is taken and stored at-20 ℃ for later use. After plasma treatment, the concentration of ibuprofen in plasma was determined by high performance liquid chromatography, and the in vivo plasma concentration-time curve is shown in fig. 7.
The result shows that the Cmax of the ibuprofen immediate-release and sustained-release double-layer tablet in the embodiment 1 of the invention is 66.05 +/-8.48 mu g/mL, the Tmax is 0.94 +/-0.43 h, and the AUC is 511.38 +/-94.38 mu g/mL.h; compared with the Advil 12hour double-layer tablet, the Brufen quick-release and sustained-release double-layer tablet has the Cmax of 71.15 +/-15.00 mu g/mL, the Tmax of 0.75 +/-0.50 h and the AUC of 502.78 +/-78.89 mu g/mL h, the Cmax ratio of 92.83% +/-27.24% and the relative bioavailability of the AUC of 101.71 +/-22.37%.
Claims (2)
1. A quick-release slow-release double-layer tablet containing ibuprofen as an active pharmaceutical ingredient comprises a quick-release layer and a slow-release layer, and is characterized in that the quick-release layer consists of ibuprofen, a diluent, a disintegrating agent, a lubricant and an adhesive; the sustained-release layer is composed of ibuprofen, a sustained-release framework material, a release regulator, a diluent and a lubricant; the total dose of ibuprofen is 300 mg; the weight ratio of ibuprofen in the quick release layer to ibuprofen in the slow release layer is 1: 2; the diluent in the quick release layer accounts for 20-50%, and the material is a mixture of microcrystalline cellulose, starch and pregelatinized starch; the proportion of the disintegrating agent is 0-10%, and the material is croscarmellose sodium; the lubricant is 0-2%, and the material is stearic acid or colloidal SiO2(ii) a The binder is selected from hydroxypropyl methylcellulose; the proportion of the skeleton material in the slow release layer is 3-25%, and hydroxypropyl methyl cellulose K4M is selected as the material; the proportion of the diluent is 5-20%, and the material is a mixture of microcrystalline cellulose and pregelatinized starch; the release regulator is 15-30% in proportion, and hydroxypropyl methyl cellulose K100LV is selected as a material; 0-2% of lubricant, stearic acid or colloidal SiO2(ii) a The wetting agent includes water or alcohol, and a mixed solution of water and alcohol.
2. A preparation method of the ibuprofen immediate-release slow-release double-layer tablet of claim 1, characterized in that the immediate-release layer and the slow-release layer are prepared into required granules by wet granulation respectively, and the granules of the slow-release layer are pre-compressed and then filled into the immediate-release layer granules for tabletting.
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| CN111481527B (en) * | 2020-04-30 | 2022-05-06 | 福建太平洋制药有限公司 | Method for improving yield of ibuprofen sustained-release capsule finished product |
| CN114177155B (en) * | 2020-09-08 | 2023-10-03 | 越洋医药开发(广州)有限公司 | Ibuprofen controlled release tablet and preparation method thereof |
| CN112891322A (en) * | 2021-03-26 | 2021-06-04 | 海南慧谷药业有限公司 | Dexibuprofen preparation and preparation method thereof |
| CN113750078B (en) * | 2021-09-10 | 2023-10-10 | 华中药业股份有限公司 | Ibuprofen quick-release slow-release nanoparticle and preparation method thereof |
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