CN109157520B - Tadalafil tablet and preparation method thereof - Google Patents
Tadalafil tablet and preparation method thereof Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
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Abstract
The invention discloses a tadalafil tablet which comprises the following raw materials in parts by weight: 10-20 parts of tadalafil, 40-60 parts of oligosaccharide, 5-10 parts of sodium alginate, 10-20 parts of superfine silica gel powder, 120-160 parts of microcrystalline cellulose, 20-40 parts of mannitol and 2-4 parts of magnesium stearate. Compared with the prior art, the tadalafil tablet prepared by the invention has high in-vitro dissolution rate, good oral absorbability and high bioavailability, correspondingly reduces the content of tadalafil in the tadalafil tablet, and reduces the adverse reaction of the medicine to a certain extent. And the preparation process of the tadalafil tablet is simple and is suitable for industrial production.
Description
Technical Field
The invention relates to the technical field of medicines, and particularly relates to a tadalafil tablet and a preparation method thereof.
Background
Tadalafil (tadalafil, molecular formula C22H19N3O4), chemical name 6- (1, 3-benzodioxol-5-yl) -2, 3, 6, 7, 12, 12 a-hexahydropyrazino [1 ', 2' -1, 6] -pyrido [3, 4-b ] indole-1, 4-dione, belongs to a selective reversible inhibitor of the second generation phosphodiesterase 5(PDE 5). In 2003, which was approved by the FDA, tadalafil was marketed in the united states as a drug for the treatment of penile Erectile Dysfunction (ED) under the trade name of loving. Compared with sildenafil and vardenafil which are similar marketed drugs, the drug has the advantages of high selectivity, long half-life period, greater autonomy of patients and the like, and is taken as the first choice drug for erectile dysfunction.
However, tadalafil is a poorly soluble drug and has low bioavailability, so that an ineffective dosage is large, various adverse reactions can be generated, and unreasonable administration can cause visual impairment or loss.
Aiming at the problem of poor solubility of tadalafil, the problem that the particle size of tadalafil is reduced, such as solid dispersion, raw material micronization and the like, is mainly solved at present, but the technical defects of complex process, low efficiency and the like exist. Therefore, the development of a tadalafil preparation process with simple process and stable dissolution is urgently needed.
Disclosure of Invention
The technical problem to be solved by the present invention is to provide a tadalafil tablet and a preparation method thereof, aiming at the above-mentioned deficiencies in the prior art.
In order to solve the technical problems, the invention adopts the technical scheme that: the tadalafil tablet comprises the following raw materials in parts by weight: 10-20 parts of tadalafil, 40-60 parts of oligosaccharide, 5-10 parts of sodium alginate, 10-20 parts of superfine silica gel powder, 120-160 parts of microcrystalline cellulose, 20-40 parts of mannitol and 2-4 parts of magnesium stearate.
Preferably, the tadalafil tablet comprises the following raw materials in parts by weight: 20 parts of tadalafil, 60 parts of oligosaccharide, 7 parts of sodium alginate, 20 parts of superfine silica gel powder, 140 parts of microcrystalline cellulose, 30 parts of mannitol and 3 parts of magnesium stearate.
Preferably, the oligosaccharide is one or more of fructo-oligosaccharide, galacto-oligosaccharide, inulin-oligosaccharide or xylo-oligosaccharide.
The invention also provides a preparation method of the tadalafil tablet, which comprises the following steps:
1) dissolving oligosaccharide and sodium alginate in water, adding tadalafil, and dissolving with ultrasound; adding the micro silica gel powder, uniformly stirring, drying and sieving to obtain the tadalafil solid dispersion;
2) uniformly mixing the tadalafil solid dispersion obtained in the step 1), microcrystalline cellulose, mannitol and magnesium stearate, and tabletting to obtain the tadalafil tablet.
Preferably, in the step 1), the ultrasonic dissolution conditions are as follows: the ultrasonic power is 80-120W, and the ultrasonic time is 10-20 min.
Preferably, in the step 1), the drying temperature is 60-80 ℃.
Preferably, in the step 1), the dried product is sieved by a sieve with 80-100 meshes.
Preferably, in the step 2), tabletting is carried out under the conditions that the ambient temperature is 20-30 ℃ and the humidity is 30-40%, the tabletting pressure is 35-40 kN, and the rotating speed of the tabletting machine is 10000-15000 tablets/hour
The tadalafil has low solubility in water, belongs to a medicament which is extremely difficult to dissolve, and the release of the medicament in a body is influenced by the difficulty in dissolving the medicament. For drugs that are poorly soluble in water, it is difficult to directly produce a suitable formulation.
In order to solve the problem, the invention designs and optimizes the raw material formula for preparing the tadalafil tablet, and effectively improves the in vitro dissolution rate, the oral absorbability and the bioavailability of the tadalafil tablet by combining the optimization of the preparation process.
In the raw material formula of the tadalafil tablet, the oligosaccharide is formed by connecting 2-10 monosaccharides by glycosidic bonds, the indissolvable tadalafil is dispersed in the polyhydroxy skeleton of the oligosaccharide, the hydrophobicity is reduced, the dissolution is facilitated, the dissolution is promoted, the oligosaccharide and sodium alginate are matched for use, and a cross-linked network structure can be formed by utilizing the sodium alginate, so that the solubility of the tadalafil in water is further improved; adsorbing the silica gel micropowder as a hydrophilic adsorbent; the microcrystalline cellulose has good fluidity and compression molding property; mannitol not only plays a filling role, but also has a positive influence on the stability of the tablet.
In the preparation process, the tadalafil is dissolved in the aqueous solution of oligosaccharide and sodium alginate, and then the hydrophilic adsorbent micropowder silica gel is used for adsorption, so that the specific surface area and the hydrophilicity of the insoluble tadalafil are increased, the solubility of the medicament is increased, the dissolution speed of the medicament is accelerated, and the dissolution rate of the prepared tadalafil tablet in a dissolution medium is greatly improved. The preparation method has the advantages that the environmental conditions can directly influence tabletting on the preparation conditions of the tablets, and the phenomenon of sticking of drug particles with stronger hygroscopicity is very obvious when the air humidity is too high. When the tabletting pressure is too high, the hardness of the tablet is too high, so that the disintegration of the tablet is slow, when the pressure is too low, the hardness of the tablet is too low, and the tablet is not easy to form.
Through the specific preparation formula and the optimization of the preparation process, the tadalafil tablet prepared by the invention has the overall effects of high dissolution speed, stable preparation quality and no obvious moisture absorption phenomenon after being placed in the air for a long time.
The invention has the beneficial effects that: the tadalafil tablet prepared by the invention has high in-vitro dissolution rate, good oral absorbability and high bioavailability, correspondingly reduces the content of tadalafil in the tadalafil tablet, and reduces the adverse reaction of the medicament to a certain extent. And the preparation process of the tadalafil tablet is simple and is suitable for industrial production.
Detailed Description
The present invention is further described in detail below with reference to examples so that those skilled in the art can practice the invention with reference to the description.
It will be understood that terms such as "having," "including," and "comprising," as used herein, do not preclude the presence or addition of one or more other elements or groups thereof.
The tadalafil tablet provided by the embodiment comprises the following raw materials in parts by weight: 10-20 parts of tadalafil, 40-60 parts of oligosaccharide, 5-10 parts of sodium alginate, 10-20 parts of superfine silica gel powder, 120-160 parts of microcrystalline cellulose, 20-40 parts of mannitol and 2-4 parts of magnesium stearate.
Wherein the oligosaccharide is one or more of fructo-oligosaccharide, galacto-oligosaccharide, inulin-oligosaccharide or xylo-oligosaccharide.
The invention also provides a preparation method of the tadalafil tablet, which comprises the following steps:
1) dissolving oligosaccharide and sodium alginate in water, adding tadalafil, and dissolving with ultrasound; adding the micro silica gel powder, uniformly stirring, drying and sieving to obtain the tadalafil solid dispersion;
2) uniformly mixing the tadalafil solid dispersion obtained in the step 1), microcrystalline cellulose, mannitol and magnesium stearate, and tabletting to obtain the tadalafil tablet.
The following specific examples are provided to further illustrate the invention.
The test materials used in the examples and comparative examples of the present invention are conventional in the art and are commercially available.
Example 1:
1. the raw material composition is as follows:
20 g of tadalafil, 60 g of fructo-oligosaccharide, 7 g of sodium alginate, 20 g of aerosil, 140 g of microcrystalline cellulose, 30 g of mannitol and 3 g of magnesium stearate.
2. The preparation process comprises the following steps:
(1) dissolving fructo-oligosaccharide and sodium alginate in water, adding tadalafil in a prescription amount, and dissolving by ultrasonic, wherein the ultrasonic dissolving conditions are as follows: the ultrasonic power is 100W, and the ultrasonic time is 15 min; and adding the micro silica gel powder, uniformly stirring, drying at 70 ℃, and sieving with a 100-mesh sieve to obtain the tadalafil solid dispersion.
(2) And (3) uniformly mixing the tadalafil solid dispersion, microcrystalline cellulose, mannitol and magnesium stearate, tabletting under the conditions that the ambient temperature is 20-30 ℃ and the humidity is 30-40%, wherein the tabletting pressure is controlled at 35-40 kN, and the rotating speed of the tabletting machine is controlled at 10000 tablets/hour, so that the tadalafil tablet is obtained.
Example 2:
1. the raw material composition is as follows:
10 g of tadalafil, 60 g of galacto-oligosaccharide, 5 g of sodium alginate, 20 g of aerosil, 120 g of microcrystalline cellulose, 40 g of mannitol and 2 g of magnesium stearate.
2. The preparation process comprises the following steps:
(1) dissolving the formula amount of galacto-oligosaccharide and sodium alginate in water, adding the formula amount of tadalafil, and ultrasonically dissolving under the conditions that: the ultrasonic power is 100W, and the ultrasonic time is 15 min; and adding the micro silica gel powder, uniformly stirring, drying at 70 ℃, and sieving with a 100-mesh sieve to obtain the tadalafil solid dispersion.
(2) And (3) uniformly mixing the tadalafil solid dispersion, microcrystalline cellulose, mannitol and magnesium stearate, tabletting under the conditions that the ambient temperature is 20-30 ℃ and the humidity is 30-40%, wherein the tabletting pressure is controlled at 35-40 kN, and the rotating speed of the tabletting machine is controlled at 10000 tablets/hour, so that the tadalafil tablet is obtained.
Example 3:
1. the raw material composition is as follows:
20 g of tadalafil, 40 g of oligoinulin, 10 g of sodium alginate, 10 g of aerosil, 160 g of microcrystalline cellulose, 20 g of mannitol and 2 g of magnesium stearate.
2. The preparation process comprises the following steps:
(1) dissolving the prescribed quantity of oligoinulin and sodium alginate in water, adding the prescribed quantity of tadalafil, and dissolving by ultrasonic, wherein the ultrasonic dissolving conditions are as follows: the ultrasonic power is 100W, and the ultrasonic time is 15 min; and adding the micro silica gel powder, uniformly stirring, drying at 70 ℃, and sieving with a 100-mesh sieve to obtain the tadalafil solid dispersion.
(2) And (3) uniformly mixing the tadalafil solid dispersion, microcrystalline cellulose, mannitol and magnesium stearate, tabletting under the conditions that the ambient temperature is 20-30 ℃ and the humidity is 30-40%, wherein the tabletting pressure is controlled at 35-40 kN, and the rotating speed of the tabletting machine is controlled at 10000 tablets/hour, so that the tadalafil tablet is obtained.
Comparative example 1:
1. the raw material composition is as follows:
20 g of tadalafil, 67 g of fructo-oligosaccharide, 20 g of superfine silica gel powder, 140 g of microcrystalline cellulose, 30 g of mannitol and 3 g of magnesium stearate.
2. The preparation process comprises the following steps:
(1) dissolving fructo-oligosaccharide with the prescription amount in water, adding tadalafil with the prescription amount, and ultrasonically dissolving under the following conditions: the ultrasonic power is 100W, and the ultrasonic time is 15 min; and adding the micro silica gel powder, uniformly stirring, drying at 70 ℃, and sieving with a 100-mesh sieve to obtain the tadalafil solid dispersion.
(2) And (3) uniformly mixing the tadalafil solid dispersion, microcrystalline cellulose, mannitol and magnesium stearate, tabletting under the conditions that the ambient temperature is 20-30 ℃ and the humidity is 30-40%, wherein the tabletting pressure is controlled at 35-40 kN, and the rotating speed of the tabletting machine is controlled at 10000 tablets/hour, so that the tadalafil tablet is obtained.
Comparative example 2:
1. the raw material composition is as follows:
20 g of tadalafil, 67 g of sodium alginate, 20 g of aerosil, 140 g of microcrystalline cellulose, 30 g of mannitol and 3 g of magnesium stearate.
2. The preparation process comprises the following steps:
(1) dissolving sodium alginate in a prescription amount in water, adding tadalafil in a prescription amount, and dissolving by ultrasonic, wherein the ultrasonic dissolving conditions are as follows: the ultrasonic power is 100W, and the ultrasonic time is 15 min; and adding the micro silica gel powder, uniformly stirring, drying at 70 ℃, and sieving with a 100-mesh sieve to obtain the tadalafil solid dispersion.
(2) And (3) uniformly mixing the tadalafil solid dispersion, microcrystalline cellulose, mannitol and magnesium stearate, tabletting under the conditions that the ambient temperature is 20-30 ℃ and the humidity is 30-40%, wherein the tabletting pressure is controlled at 35-40 kN, and the rotating speed of the tabletting machine is controlled at 10000 tablets/hour, so that the tadalafil tablet is obtained.
Test example 1: dissolution rate of tadalafil tablet and related substance determination
1. And (3) dissolution rate determination:
the tadalafil tablets prepared in example 1 and comparative examples 1 to 2 were subjected to dissolution rate measurement.
The determination method comprises the following steps: according to a dissolution determination method (second method of appendix X C of second part of 2010 edition of Chinese pharmacopoeia), taking 1000ml of 0.5% sodium dodecyl sulfate solution as a dissolution medium at a rotation speed of 50rpm for 5min, 10 min, 15min and 30min respectively (simultaneously adding 10ml of a homothermal solvent), filtering, and taking a subsequent filtrate as a test solution; taking another appropriate amount (about 10mg) of tadalafil reference substance, precisely weighing, placing in a 100ml measuring flask, adding mobile phase for dissolving and diluting to scale, shaking, precisely weighing 4ml, placing in a 20ml measuring flask, adding mobile phase for diluting to scale, and shaking to obtain reference substance solution. Precisely measuring 20ul of each of the reference solution and the sample solution, respectively injecting into a liquid chromatograph, and calculating the cumulative dissolution rate according to an external standard method.
Mobile phase: acetonitrile-0.1% trifluoroacetic acid solution (45:55, V: V).
Detection wavelength: 285 nm.
The results are shown in Table 1.
Table 1: dissolution rate measurement results
2. And (3) related substance determination:
and respectively weighing a proper amount of tadalafil tablets prepared in example 1 and comparative examples 1-2, adding 0.5% sodium dodecyl sulfate solution for dissolving and diluting, taking the subsequent filtrate as a test solution, and performing related substance determination. The results are shown in Table 2.
Table 2: measurement results of related substances
As can be seen from table 2, the tadalafil tablets prepared in comparative examples 1 and 2 had significantly greater increase in the related substances (single impurity, total impurity) than the tadalafil tablets provided by the present invention. Therefore, the tadalafil tablet provided by the invention has better stability.
While embodiments of the invention have been disclosed above, it is not limited to the applications listed in the description and the embodiments, which are fully applicable in all kinds of fields of application of the invention, and further modifications may readily be effected by those skilled in the art, so that the invention is not limited to the specific details without departing from the general concept defined by the claims and the scope of equivalents.
Claims (6)
1. The tadalafil tablet is characterized by comprising the following raw materials in parts by weight: 10-20 parts of tadalafil, 40-60 parts of oligosaccharide, 5-10 parts of sodium alginate, 10-20 parts of superfine silica gel powder, 120-160 parts of microcrystalline cellulose, 20-40 parts of mannitol and 2-4 parts of magnesium stearate;
the oligosaccharide is one or more of fructo-oligosaccharide, galacto-oligosaccharide, inulin-oligosaccharide or xylo-oligosaccharide;
the preparation method of the tadalafil tablet comprises the following steps:
1) dissolving oligosaccharide and sodium alginate in water, adding tadalafil, and dissolving with ultrasound; adding the micro silica gel powder, uniformly stirring, drying and sieving to obtain the tadalafil solid dispersion;
2) uniformly mixing the tadalafil solid dispersion obtained in the step 1), microcrystalline cellulose, mannitol and magnesium stearate, and tabletting to obtain the tadalafil tablet.
2. The tadalafil tablet according to claim 1, comprising the following raw materials in parts by weight: 20 parts of tadalafil, 60 parts of oligosaccharide, 7 parts of sodium alginate, 20 parts of superfine silica gel powder, 140 parts of microcrystalline cellulose, 30 parts of mannitol and 3 parts of magnesium stearate.
3. The tadalafil tablet according to claim 2, wherein the conditions for ultrasonic dissolution in step 1) are: the ultrasonic power is 80-120W, and the ultrasonic time is 10-20 min.
4. The tadalafil tablet according to claim 2, wherein the temperature for drying in step 1) is 60-80 ℃.
5. The tadalafil tablet according to claim 2, wherein in step 1), after drying, it is passed through a 80-100 mesh sieve.
6. The tadalafil tablet according to claim 2, wherein in the step 2), the tablet is compressed under the conditions of an ambient temperature of 20 to 30 ℃ and a humidity of 30 to 40%, the compression pressure is 35 to 40kN, and the rotation speed of the tablet press is 10000 to 15000 tablets/hour.
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| CN112773898A (en) * | 2019-11-11 | 2021-05-11 | 广州华真医药科技有限公司 | Application of phosphodiesterase 5 inhibitor in preparing anti-fibrosis disease medicine |
| CN111110633B (en) * | 2020-01-21 | 2022-12-02 | 合肥医工医药股份有限公司 | Tadalafil spray and preparation method thereof |
| CN113181185A (en) * | 2021-05-07 | 2021-07-30 | 苏州康恒研新药物技术有限公司 | Preparation method of tadalafil and dapoxetine hydrochloride mixed tablet |
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| US20110263606A1 (en) * | 2010-04-26 | 2011-10-27 | Horst Zerbe | Solid oral dosage forms comprising tadalafil |
| WO2012107090A1 (en) * | 2011-02-10 | 2012-08-16 | Synthon Bv | Granulated composition comprising tadalafil and a disintegrant |
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| CN103494792A (en) * | 2013-08-27 | 2014-01-08 | 寿光富康制药有限公司 | Compound phloroglucinol freeze-dried orally-disintegrating tablet and preparation method |
| CN104188912A (en) * | 2014-07-17 | 2014-12-10 | 山东大学 | Tadalafil solid dispersion and tablet thereof |
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| US20110263606A1 (en) * | 2010-04-26 | 2011-10-27 | Horst Zerbe | Solid oral dosage forms comprising tadalafil |
| WO2012107090A1 (en) * | 2011-02-10 | 2012-08-16 | Synthon Bv | Granulated composition comprising tadalafil and a disintegrant |
| CN102727455A (en) * | 2012-07-03 | 2012-10-17 | 北京科信必成医药科技发展有限公司 | Tadalafil oral disintegrating tablet and preparation method thereof |
| CN103494792A (en) * | 2013-08-27 | 2014-01-08 | 寿光富康制药有限公司 | Compound phloroglucinol freeze-dried orally-disintegrating tablet and preparation method |
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