CN114306264A - Tadalafil tablet and preparation method thereof - Google Patents
Tadalafil tablet and preparation method thereof Download PDFInfo
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- CN114306264A CN114306264A CN202210095069.1A CN202210095069A CN114306264A CN 114306264 A CN114306264 A CN 114306264A CN 202210095069 A CN202210095069 A CN 202210095069A CN 114306264 A CN114306264 A CN 114306264A
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- tadalafil
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Abstract
The invention relates to the technical field of medicines, and particularly relates to a tadalafil tablet and a preparation method thereof. The tadalafil tablet mainly comprises a tadalafil-containing suspension and an excipient; the suspension comprises tadalafil and a dispersing solvent; the dispersing solvent is one or more of chitosan, carbomer, sodium caprate, sodium alginate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and polyvidone. The preparation method comprises the following steps: adding tadalafil into a dispersion solvent, and homogenizing and dispersing to obtain a suspension; spraying the suspension onto hydrophilic filler and disintegrant, granulating, and drying; and mixing the dried granules with a non-hydrophilic filler, a disintegrating agent and a lubricating agent, tabletting and coating to obtain the tadalafil tablet. The invention prepares the tadalafil and the corresponding dispersing solvent into the suspension, thereby effectively improving the solubility and bioavailability of the tadalafil.
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) is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase 5(PDE 5). The tadalafil original preparation is developed by american gifts, marketed in the united states in 2003 and in china in 2004, and is clinically mainly used for treating male erectile dysfunction and pulmonary hypertension. The molecular structure is as follows:
tadalafil is a white, odorless, tasteless powder that is virtually insoluble in water and alcohol solvents.
Tadalafil is a poorly soluble drug with low bioavailability, and some techniques or methods are often adopted to increase the solubility of tadalafil in the preparation process, such as raw material micropowder and addition of surfactants to improve the bioavailability of the preparation. Tadalafil has a small-specification preparation, the raw materials are not easy to be uniformly mixed after being micronized, the compressibility and the tablet formability are poor, the medicine is easy to aggregate due to electrostatic action during dissolution, and the like, so that the product quality cannot be ensured; the addition of the surfactant can generate a large amount of foam in the preparation process, the process is difficult to control, and the product can also generate adverse effects such as stimulation to gastrointestinal tracts and the like.
Disclosure of Invention
Technical problem to be solved
In view of the above disadvantages and shortcomings of the prior art, the present invention provides a tadalafil tablet with high solubility and bioavailability without micronization of the drug substance or addition of surfactant;
correspondingly, the invention also provides a preparation method of the tadalafil tablet, which solves the problems of uneven mixing and incapability of ensuring the product quality caused by micronization of the bulk drugs and the technical problems of difficult process control, stimulation on gastrointestinal tracts and the like when the surfactant is added in the tadalafil dosage form.
(II) technical scheme
In order to achieve the purpose, the invention adopts the main technical scheme that:
in a first aspect, the present invention provides a tadalafil tablet consisting essentially of a tadalafil-containing suspension and an excipient; the suspension comprises tadalafil and a dispersing solvent;
the dispersing solvent is one or more of chitosan, carbomer, sodium caprate, sodium alginate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and polyvidone.
In an alternative embodiment of the tadalafil tablet of the present invention, the excipient comprises a filler, a disintegrant, or/and a lubricant.
In the optional scheme of the tadalafil tablet, the filler comprises the following components in parts by weight: 1 hydrophilic filler and non-hydrophilic filler;
the hydrophilic filler is one or more of dextrin, corn starch, pregelatinized starch, mannitol, and lactose;
the non-hydrophilic filler is one or the combination of more than two of microcrystalline cellulose, powdered cellulose or ethyl cellulose.
In the optional scheme of the tadalafil tablet, the disintegrant is one or the combination of more than two of carboxymethyl starch sodium, hydroxypropyl cellulose, crospovidone, croscarmellose sodium and croscarmellose calcium.
In the optional scheme of the tadalafil tablet, the lubricant is one or the combination of more than two of magnesium stearate, silicon dioxide, superfine silica powder, magnesium trisilicate and talcum powder.
In the optional scheme of the tadalafil tablet, the components are as follows in parts by weight: 2.5-20 parts of tadalafil, 100-180 parts of filler, 4-20 parts of disintegrant and 0.1-2 parts of lubricant.
In the optional scheme of the tadalafil tablet, the components are as follows according to parts by weight: the weight ratio of tadalafil to the dispersant is 5-10: 3.
In an alternative embodiment of the tadalafil tablet of the invention, the dosage of the tadalafil tablet is controlled by the amount of the active ingredient in parts by weight,
it includes: 2.5 parts of tadalafil, 1 part of hydroxypropyl cellulose, 100 parts of lactose, 10 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 2.5 parts of tadalafil, 1 part of hydroxypropyl methylcellulose, 100 parts of lactose, 10 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 2.5 parts of tadalafil, 1 part of povidone, 100 parts of lactose, 10 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1.5 parts of hydroxypropyl cellulose, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1g of chitosan, 0.5g of povidone, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1.5 parts of carbomer, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1.5 parts of sodium caprate, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1 part of carbomer, 0.5 part of sodium alginate, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 0.5 part of chitosan, 0.5 part of povidone, 0.5 part of sodium caprate, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate.
In a second aspect, the present invention further provides a method for preparing the tadalafil tablet according to any one of the above embodiments, which comprises the following steps:
s1 includes: adding tadalafil into a dispersion solvent, and homogenizing and dispersing to obtain a suspension;
s2 includes: spraying the suspension onto hydrophilic filler and disintegrant, granulating, and drying;
s3 includes: and (3) mixing the dried granules with a non-hydrophilic filler, a disintegrant and a lubricant, tabletting and coating to obtain the tadalafil tablet.
In a third aspect, the invention also provides the use of the tadalafil tablet in any of the above embodiments in a medicament for treating erectile dysfunction.
(III) advantageous effects
The invention has the beneficial effects that:
the invention prepares the tadalafil and corresponding dispersing solvent into suspension, and then prepares the suspension and excipient into tablets, thereby effectively improving the solubility of the tadalafil and obviously simplifying the preparation process of the preparation. The experimental results prove that: the tadalafil tablet provided by the invention has stable quality and high dissolution rate, the dissolution rate is over 85% in 15min, and the bioavailability of tadalafil is improved; the tadalafil tablet provided by the invention avoids the application of substances such as surfactants and the like which have potential adverse reactions to human bodies on the basis of higher dissolution rate.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
In order to better understand the above technical solutions, exemplary embodiments of the present invention will be described in more detail below. While the following shows exemplary embodiments of the invention, it should be understood that the invention may be embodied in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
Example 1
In 1000 tadalafil tablets, 2.5g of tadalafil, 1g of hydroxypropyl cellulose, 100g of lactose, 10g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet of the present example is:
s1, adding hydroxypropyl cellulose into purified water, stirring and dissolving, adding tadalafil, stirring and dispersing uniformly to obtain tadalafil suspension;
s2, adding lactose and croscarmellose sodium into a fluidized bed, spraying the tadalafil suspension onto the mixed material of the lactose and the croscarmellose sodium in a boiling state, granulating and drying;
s3 sieving and granulating the dried granules, mixing with microcrystalline cellulose, croscarmellose sodium and magnesium stearate uniformly, tabletting and coating to obtain Tadalafil tablets;
wherein the adding amount of the purified water in the step S1 is 35 g;
the amounts of croscarmellose sodium added in step S2 and step S3 were 3g each.
Example 2
In 1000 tadalafil tablets, 2.5g of tadalafil, 1g of hypromellose, 100g of lactose, 10g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet of the present example is:
s1, adding hydroxypropyl methylcellulose into purified water, stirring and dissolving, adding tadalafil, stirring and dispersing uniformly to obtain tadalafil suspension; the steps S2 and S3 are the same as in example 1.
Example 3
In 1000 tadalafil tablets, 2.5g of tadalafil, 1g of povidone, 100g of lactose, 10g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet of the present example is:
s1, adding the povidone into the purified water, stirring and dissolving, adding the tadalafil, stirring and dispersing uniformly to obtain a tadalafil suspension; the steps S2 and S3 are the same as in example 1.
Example 4
In 1000 tadalafil tablets, 5g of tadalafil, 1.5g of hydroxypropyl cellulose, 145g of lactose, 12.0g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet of the present example is:
s1, adding hydroxypropyl cellulose into purified water, stirring and dissolving, adding tadalafil, stirring and dispersing uniformly to obtain tadalafil suspension;
s2, adding lactose and croscarmellose sodium into a fluidized bed, spraying the tadalafil suspension onto the mixed material of the lactose and the croscarmellose sodium in a boiling state, granulating and drying;
s3 sieving and granulating the dried granules, mixing with microcrystalline cellulose, croscarmellose sodium and magnesium stearate uniformly, tabletting and coating to obtain Tadalafil tablets;
wherein the adding amount of the purified water in the step S1 is 60 g;
the amounts of croscarmellose sodium added in step S2 and step S3 were 3g each.
Example 5
In 1000 tadalafil tablets, 5g of tadalafil, 1g of chitosan, 0.5g of povidone, 145g of lactose, 12g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet of the present example is:
s1, adding chitosan and povidone into purified water, stirring and dissolving, adding tadalafil, stirring and dispersing uniformly to obtain tadalafil suspension; the steps S2 and S3 are the same as in example 4.
Example 6
In 1000 tadalafil tablets, 5g of tadalafil, 1.5g of carbomer, 145g of lactose, 12g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet of the present example is:
s1, adding carbomer into purified water, stirring and dissolving, adding tadalafil, stirring and dispersing uniformly to obtain a tadalafil suspension; the steps S2 and S3 are the same as in example 4.
Example 7
In 1000 tadalafil tablets, 5g of tadalafil, 1.5g of sodium caprate, 145g of lactose, 12g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet of the present example is:
s1, adding sodium caprate into purified water, stirring and dissolving, adding tadalafil, stirring and dispersing uniformly to obtain tadalafil suspension; the steps S2 and S3 are the same as in example 4.
Example 8
In 1000 tadalafil tablets, 5g of tadalafil, 1g of carbomer, 0.5g of sodium alginate, 145g of lactose, 12g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet of the present example is:
s1, adding carbomer and sodium alginate into purified water, stirring and dissolving, adding tadalafil, stirring and dispersing uniformly to obtain a tadalafil suspension; the steps S2 and S3 are the same as in example 4.
Example 9
In 1000 tadalafil tablets, 5g of tadalafil, 0.5g of chitosan, 0.5g of povidone, 0.5g of sodium caprate, 145g of lactose, 12g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet of the present example is:
s1, adding chitosan, povidone and sodium caprate into purified water, stirring and dissolving, adding tadalafil, stirring and dispersing uniformly to obtain tadalafil suspension; the steps S2 and S3 are the same as in example 4.
Comparative example 1
In 1000 tadalafil tablets, 2.5g of tadalafil, 100g of lactose, 1g of hydroxypropyl cellulose, 6g of croscarmellose sodium, 10g of microcrystalline cellulose and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet comprises the following steps: the tadalafil, the lactose and the croscarmellose sodium (3g) are sieved and mixed, the mixed materials are added with a hydroxypropyl cellulose-containing adhesive solution for wet granulation, the granules are sized and dried, the dried granules are mixed with the microcrystalline cellulose and the croscarmellose sodium (3g), then the mixture is mixed with the magnesium stearate, and the mixture is tabletted and coated.
Comparative example 2
In 1000 tadalafil tablets, 5g of tadalafil, 150g of lactose, 2.0g of hydroxypropyl cellulose, 10g of croscarmellose sodium, 1g of sodium lauryl sulfate, 25g of microcrystalline cellulose and 1g of magnesium stearate.
Wherein, tadalafil, lactose and croscarmellose sodium (5g) are sieved and mixed, mixed and added with a bonding agent solution containing hydroxypropyl cellulose and sodium dodecyl sulfate for wet granulation, the granules are sized and dried, the dried granules are mixed with microcrystalline cellulose and croscarmellose sodium (5g), and then mixed with magnesium stearate, and the mixture is tabletted and coated.
Comparative example 3
In 1000 tadalafil tablets, 2.5g of tadalafil, 100g of lactose, 10g of microcrystalline cellulose, 6g of croscarmellose sodium and 0.5g of magnesium stearate.
The preparation method of the tadalafil tablet comprises the following steps:
s1, adding tadalafil into purified water, stirring and dispersing uniformly to obtain tadalafil suspension.
S2 lactose and croscarmellose sodium are added into a fluidized bed, and the tadalafil suspension is sprayed onto the mixture of lactose and croscarmellose sodium (3g) under boiling conditions, granulated and dried.
S3 sieving and granulating the dried granules, mixing with microcrystalline cellulose, croscarmellose sodium (3g) and magnesium stearate, tabletting, and coating to obtain Tadalafil tablet.
Experiment one the tadalafil tablets prepared in examples 1 to 9 and comparative examples 1 to 3 above were used as samples for dissolution experiments and content uniformity comparisons. The dissolution results are shown in tables 1 and 2, and the content uniformity ratio is shown in table 3.
The dissolution method comprises the following steps: the dissolution medium is 0.5% SDS water solution, and the solution temperature is 37 + -0.5 deg.C by paddle method
TABLE 1 dissolution results for examples 1-3, comparative examples 1 and 3
| Sample (I) | 5min | 10min | 15min | 30min | 45min |
| Example 1 | 60 | 81 | 94 | 98 | 100 |
| Example 2 | 62 | 83 | 91 | 95 | 99 |
| Example 3 | 63 | 84 | 90 | 94 | 99 |
| Comparative example 1 | 45 | 62 | 78 | 86 | 95 |
| Comparative example 3 | 51 | 70 | 84 | 90 | 97 |
TABLE 2 dissolution results of examples 4-9, comparative example 2
| Sample (I) | 5min | 10min | 15min | 30min | 45min |
| Example 4 | 60 | 84 | 90 | 95 | 99 |
| Example 5 | 62 | 83 | 89 | 97 | 100 |
| Example 6 | 61 | 85 | 91 | 98 | 100 |
| Example 7 | 58 | 80 | 90 | 96 | 98 |
| Example 8 | 65 | 88 | 95 | 98 | 99 |
| Example 9 | 70 | 90 | 96 | 98 | 100 |
| Comparative example 2 | 55 | 69 | 83 | 92 | 98 |
From the data in tables 1 and 2, one can see: the suspension prepared by the dispersion solvent improves the dissolution effect of tadalafil. The dissolution effect is better by adding proper components and proportion into the dispersion solvent, which shows that the combination of the substances in the dispersion solvent realizes better dissolution effect of the auxiliary principal drug.
TABLE 3 content uniformity of the samples of the examples
| Sample (I) | Content uniformity |
| Example 1 | A+2.2S＝4.2 |
| Example 2 | A+2.2S＝4.4 |
| Example 3 | A+2.2S＝3.8 |
| Example 4 | A+2.2S＝3.5 |
| Example 5 | A+2.2S＝4.1 |
| Example 6 | A+2.2S＝3.7 |
| Example 7 | A+2.2S＝3.5 |
| Example 8 | A+2.2S＝4.0 |
| Example 9 | A+2.2S＝3.2 |
| Comparative example 1 | A+2.2S＝6.5 |
| Comparative example 2 | A+2.2S＝5.8 |
| Comparative example 3 | A+2.2S＝4.0 |
Experiment two, stability experiment, taking tadalafil tablets prepared in example 7, example 9 and comparative example 3 respectively to carry out accelerated test to test indexes such as content, related substances, dissolution rate and the like, and the results are shown in tables 4-6.
Table 4 stability results for example 7 samples
Table 5 stability results for example 9 sample
Table 6 stability results for comparative example 3 sample
From the stability test results, it can be seen that the experimental samples prepared by the combination and the preparation method of the invention maintain good stability under accelerated conditions.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
Claims (10)
1. A tadalafil tablet characterized by: it mainly consists of a suspension containing tadalafil and an excipient; the suspension comprises tadalafil and a dispersing solvent;
the dispersing solvent is water solution or ethanol solution of one or more of chitosan, carbomer, sodium caprate, sodium alginate, hydroxypropyl cellulose, hydroxypropyl methylcellulose and polyvidone.
2. The tadalafil tablet according to claim 1, wherein: the excipient comprises a filler, a disintegrant or/and a lubricant.
3. The tadalafil tablet according to claim 2, wherein: the filler comprises a hydrophilic filler and a non-hydrophilic filler according to the weight part ratio of 5-15: 1;
the hydrophilic filler is one or the combination of more than two of dextrin, corn starch, pregelatinized starch, mannitol and lactose;
the non-hydrophilic filler is one or the combination of more than two of microcrystalline cellulose, powdery cellulose or ethyl cellulose.
4. The tadalafil tablet according to claim 2, wherein: the disintegrating agent is one or the combination of more than two of carboxymethyl starch sodium, hydroxypropyl cellulose, crospovidone, croscarmellose sodium and croscarmellose calcium.
5. The tadalafil tablet according to claim 2, wherein: the lubricant is one or the combination of more than two of magnesium stearate, silicon dioxide, superfine silica gel powder, magnesium trisilicate and talcum powder.
6. The tadalafil tablet according to any of claims 2-5, wherein the components are, in parts by weight: 2.5-20 parts of tadalafil, 100-180 parts of filler, 4-20 parts of disintegrant and 0.1-2 parts of lubricant.
7. The tadalafil tablet according to any one of claims 1-5, wherein the ratio of tadalafil to dispersing solvent is 5-10: 3 by weight.
8. Tadalafil tablet according to any of claims 1 to 5, which comprises, in parts by weight,
it includes: 2.5 parts of tadalafil, 1 part of hydroxypropyl cellulose, 100 parts of lactose, 10 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 2.5 parts of tadalafil, 1 part of hydroxypropyl methylcellulose, 100 parts of lactose, 10 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 2.5 parts of tadalafil, 1 part of povidone, 100 parts of lactose, 10 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1.5 parts of hydroxypropyl cellulose, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1g of chitosan, 0.5g of povidone, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1.5 parts of carbomer, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1.5 parts of sodium caprate, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 1 part of carbomer, 0.5 part of sodium alginate, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate;
or
It includes: 5 parts of tadalafil, 0.5 part of chitosan, 0.5 part of povidone, 0.5 part of sodium caprate, 145 parts of lactose, 12 parts of microcrystalline cellulose, 6 parts of croscarmellose sodium and 0.5 part of magnesium stearate.
9. A process for the preparation of tadalafil tablets according to any of claims 1 to 5, comprising the steps of:
s1 includes: adding tadalafil into a dispersion solvent, and homogenizing and dispersing to obtain a suspension;
s2 includes: spraying the suspension onto hydrophilic filler and disintegrant, granulating, and drying;
s3 includes: and (3) mixing the dried granules with a non-hydrophilic filler, a disintegrant and a lubricant, tabletting and coating to obtain the tadalafil tablet.
10. Use of the tadalafil tablet according to any one of claims 1-5 in a medicament for the treatment of erectile dysfunction.
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| CN109793715A (en) * | 2019-03-15 | 2019-05-24 | 南京卡文迪许生物工程技术有限公司 | A kind of Eliquis oral solid formulation and preparation method thereof |
| CN113855639A (en) * | 2021-11-04 | 2021-12-31 | 昆明源瑞制药有限公司 | Tadalafil tablet and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109793715A (en) * | 2019-03-15 | 2019-05-24 | 南京卡文迪许生物工程技术有限公司 | A kind of Eliquis oral solid formulation and preparation method thereof |
| CN113855639A (en) * | 2021-11-04 | 2021-12-31 | 昆明源瑞制药有限公司 | Tadalafil tablet and preparation method thereof |
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| Title |
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| 鞠晓莉等: "新型速溶技术在速释制剂研究中的应用" * |
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