CN105213333A - A kind of tadanafil pharmaceutical composition and preparation method thereof - Google Patents
A kind of tadanafil pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN105213333A CN105213333A CN201410306380.1A CN201410306380A CN105213333A CN 105213333 A CN105213333 A CN 105213333A CN 201410306380 A CN201410306380 A CN 201410306380A CN 105213333 A CN105213333 A CN 105213333A
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- tadanafil
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Abstract
The invention discloses a kind of tadanafil pharmaceutical composition, the percentage by weight of supplementary material is as follows: tadanafil 1-10%; Filler 80-95%; Lubricant 0.5-2%; Percentage by weight be no more than 7% binding agent and percentage by weight be no more than 5% disintegrating agent.Drug powder vertical compression Problems existing is solved by the order by merging of the type of preferred direct powder compression adjuvant, the ratio controlling supplementary material, optimization direct powder compression.Can beat all acquisition compressibility is good, the medicament contg uniformity is high, dissolution rate is fast tadalafil tablet.And this tablet significantly can reduce the amount of disintegrating agent compared with former triturate, obtain dissolution and the bioavailability of good disintegrate effect and Geng Gao simultaneously.This tablet is without the need to adding wetting agent as sodium lauryl sulphate in addition, can reduce it for gastrointestinal side effect.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of direct powder compression composition and method of making the same of slightly solubility micronized medicine, be specifically related to a kind of tadanafil direct powder compression composition and method of making the same.
Background technology
Tadanafil (Tadalafil), is reversible, selective PDE enzyme-5 (PDE5) inhibitor, can strengthens nitric oxide production release under sexual stimulus.Li Lai company develops two indications of this medicine: erection disturbance (erectiledysfunction, ED) and pulmonary hypertension, and its commodity are called Xi Aili (Cialis).A large amount of clinical research proves, tadanafil effectively can improve the erection function of the various cause of disease and various degree ED patient, even comprises intractable ED, as ED, diabetic ED and the postoperative ED of prostate excision etc. after severe spinal cord injury.
Xi Aili is the general thin garment piece of tadanafil, except containing except active component, also comprise following adjuvant: cross-linking sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, ferrum oxide, lactose monohydrate, magnesium stearate, microcrystalline Cellulose, sodium lauryl sulphate, Pulvis Talci, titanium dioxide and glyceryl triacetate.According to Chinese patent CN1365282A (application number 00811036.0); Yuan Yan producer protects a kind of pharmaceutical preparation containing tadanafil; its preparation method is wet granule compression tablet, needs to add a kind of wetting agent in preparation process, and the consumption of disintegrating agent reaches 3%-10%.
After direct compression of full-powder method refers to and is mixed homogeneously with suitable adjuvant by the powder of medicine, the method for direct compression without granule processed (wet granular or dry granule).Compared with common granulating tabletting process, direct compression of full-powder method has obvious technical advantage and cost advantage.First, direct compression of full-powder method avoids heating and moisture to the impact of tablet and technique.Direct compression of full-powder method, without the need to granulating, without the need to drying, thus can protect the quality stability of medicine effectively, avoids the various unstable factors that it causes because of wet granulation, thus ensures the quality of product.Meanwhile, the production technology of direct compression of full-powder method is simple, shortens the production cycle, enhances productivity, energy-and time-economizing, thus the production cost that can reduce product.
Typically, there is more difficult point in direct compression of full-powder for insoluble drug.In order to increase In Vitro Dissolution and the body absorption of insoluble drug, usually need medicine to carry out micronization processes.And the bulk density of micronized medicine is less, electrostatic phenomenon is serious, direct compression exists that mixing homogeneity difference, compressibility are poor, the mouldability of tablet also poor, stripping time medicine be easy to the problems such as gathering due to electrostatic interaction.Current tadanafil listing dosage form adopts wet granulation preparation, not yet finds that there is the report adopting direct compression process to prepare tadanafil.
Summary of the invention
The object of this invention is to provide a kind of tadanafil pharmaceutical composition and preparation method thereof, be troche medical composition of a kind of tadanafil direct powder compression and preparation method thereof, solve the uniformity of dosage units of this slightly solubility micronized medicine direct compression technique, compressibility and mouldability.
In order to above-mentioned goal of the invention, the present invention adopts following technical scheme:
A kind of tadanafil pharmaceutical composition, the percentage by weight of supplementary material is as follows:
Preferably, the percentage by weight of supplementary material is as follows:
In above-mentioned prescription, tadanafil adopts micronization technology such as Jet Mill to be crushed to D
90be less than 70 μm, preferably its D
90below 20 μm, most preferably its D
90below 10 μm.
Described filler comprises one or more in the adjuvant spray-dried lactose (Flowlac) of directly compressible, particulate lactose (Tablettose), mannitol, microcrystalline Cellulose, starch milk saccharide complex (Starlac), lactose-Microcrystalline cellulose composite (Cellactose), lactose-glyceryl monostearate complex (LubriToseAN).Premixed type adjuvant refers to by two kinds or two or more single adjuvants according to a certain percentage, with certain production technology (as common drying, hot-melt extruded, lyophilization, co-precipitation etc.) in advance Homogeneous phase mixing together, become a kind of and have apparent homogeneous new adjuvant that is multi-functional or specific function concurrently.Premixed type adjuvant keeps or improves the advantage of single adjuvant, and also compensate for weak point, the performance often in technique of direct powder compression is better than the physical mixture of single adjuvant or adjuvant simultaneously.Filler in the present invention most preferably a kind of premixed type adjuvant or a kind of premixed type adjuvant and other adjuvants share.
Described binding agent is selected from one or more in polyvinylpyrrolidone, hydroxypropyl emthylcellulose, hydroxypropyl cellulose.
Described disintegrating agent is selected from one or more of cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose etc.
Described lubricant is selected from magnesium stearate, stearic acid, sodium stearyl fumarate, Pulvis Talci etc.
A preparation method for tadanafil pharmaceutical composition, comprises the steps:
(1) adjuvant in described prescription is crossed 40 mesh sieves respectively;
(2) take the filler after mistake 40 mesh sieve of described percentage by weight, after 60 mesh sieves, the lower filler of sieve and the tadanafil mixing 5min of described percentage by weight, mix after 60 mesh sieves;
(3) the abundant mix homogeneously of other adjuvants of the filler of step (2) 60 mesh sieve upper part, step (1) mistake 40 mesh sieves is added successively;
(4) mix lubricant is finally added even, tabletting.
The invention has the beneficial effects as follows the order by merging solution drug powder vertical compression Problems existing by the type of preferred direct powder compression adjuvant, the ratio controlling supplementary material, optimization direct powder compression.Can beat all acquisition compressibility is good, the medicament contg uniformity is high, dissolution rate is fast tadalafil tablet.And this tablet significantly can reduce the amount of disintegrating agent compared with former triturate, obtain dissolution and the bioavailability of good disintegrate effect and Geng Gao simultaneously.This tablet is without the need to adding wetting agent as sodium lauryl sulphate in addition, can reduce it for gastrointestinal side effect.
Accompanying drawing explanation
Fig. 1 is that the tadalafil tablet of embodiment 1 is at H
2stripping curve in O (0.5%SDS)
Fig. 2 is that the tadalafil tablet of embodiment 2 is at H
2stripping curve in O (0.5%SDS)
Fig. 3 is that the tadalafil tablet of embodiment 3 is at H
2stripping curve in O (0.5%SDS)
Fig. 4 is that the tadalafil tablet of embodiment 4 is at H
2stripping curve in the water of O (0.5%SDS), pH1.2 (0.5%SDS), pH4.5 (0.5%SDS), pH6.8 (0.5%SDS)
Fig. 5 is that the tadalafil tablet of embodiment 5 is at H
2stripping curve in O (0.5%SDS)
Detailed description of the invention
The present invention is described in further detail in conjunction with the embodiments, but the non-scope being only limitted to these embodiments of protection scope of the present invention.
Embodiment 1 tadanafil direct powder compression prescription and preparation method thereof
[prescription]
| Composition | Every sheet weight (mg) |
| Tadanafil | 5.0 |
| Spraying dry mannitol | 274.0 |
| Microcrystalline Cellulose (PH102) | 90.5 |
| Hydroxypropyl cellulose (EXF) | 28.0 |
| Polyvinylpolypyrrolidone | 20.0 |
| Pulvis Talci | 2.5 |
| Amount to | 420.0 |
[preparation method]
(1) spraying dry mannitol, microcrystalline Cellulose (PH102), hydroxypropyl cellulose (EXF), polyvinylpolypyrrolidone, Pulvis Talci are crossed respectively 40 mesh sieves for subsequent use;
(2) cross the spraying dry mannitol of 40 mesh sieves in the step (1) taking recipe quantity, after 60 mesh sieves, by 60 mesh sieve lower part and tadanafil, (particle diameter is D
90=7.6 μm) mixing 5min, after 60 mesh sieve mixing;
(3) add successively the spraying dry mannitol of crossing 60 mesh sieve upper part in step (2) and step (1) cross 40 mesh sieves after hydroxypropyl cellulose (EXF), polyvinylpolypyrrolidone, abundant mix homogeneously;
(4) Pulvis Talci mix homogeneously is finally added, tabletting.
Adopt the coating solution of Opadry Western medicine film coating pre-mix dose preparation to carry out coating to tadalafil tablet, control coating weight gain at 2%-4%.
Embodiment 2 tadanafil direct powder compression prescription and preparation method thereof
[prescription]
| Composition | Every sheet weight (mg) |
| Tadanafil | 10.0 |
| Particulate lactose (Tablettose80) | 140.07 |
| Microcrystalline Cellulose (PH102) | 35.0 |
| Hydroxypropyl emthylcellulose | 1.5 |
| Sodium stearyl fumarate | 3.5 |
| Amount to | 190.0 |
[preparation method]
(1) particulate lactose (Tablettose80), microcrystalline Cellulose (PH102), hydroxypropyl emthylcellulose, cross-linking sodium carboxymethyl cellulose, sodium stearyl fumarate are crossed respectively 40 mesh sieves for subsequent use;
(2) cross the particulate lactose (Tablettose80) of 40 mesh sieves in the step (1) taking recipe quantity, after 60 mesh sieves, by 60 mesh sieve lower part and tadanafil, (particle diameter is D
90=53 μm) mixing 5min, after 60 mesh sieve mixing;
(3) particulate lactose (Tablettose80), the step (1) that add the middle 60 mesh sieve upper part excessively of step (2) successively cross microcrystalline Cellulose (PH102), hydroxypropyl emthylcellulose, cross-linking sodium carboxymethyl cellulose after 40 mesh sieves, abundant mix homogeneously;
(4) sodium stearyl fumarate mix homogeneously is finally added, tabletting.
With embodiment 1, coating is carried out to obtained tablet.
Embodiment 3 tadanafil direct powder compression prescription and preparation method thereof
[prescription]
| Composition | Every sheet weight (mg) |
| Tadanafil | 20.0 |
| Lactose-Microcrystalline cellulose composite (Cellactose) | 321.0 |
| Cross-linking sodium carboxymethyl cellulose | 7.2 |
| Magnesium stearate | 1.8 |
| Amount to | 350.0 |
[preparation method]
(1) lactose-Microcrystalline cellulose composite (Cellactose), cross-linking sodium carboxymethyl cellulose, magnesium stearate are crossed respectively 40 mesh sieves for subsequent use;
(2) cross the lactose-Microcrystalline cellulose composite (Cellactose) of 40 mesh sieves in the step (1) taking recipe quantity, after 60 mesh sieves, by 60 mesh sieve lower part and tadanafil, (particle diameter is D
90=7.6 μm) mixing 5min, after 60 mesh sieve mixing;
(3) the residue lactose-Microcrystalline cellulose composite (Cellactose), the step (1) that add the middle 60 mesh sieve upper part excessively of step (2) successively cross the abundant mix homogeneously of cross-linking sodium carboxymethyl cellulose after 40 mesh sieves;
(4) magnesium stearate mix homogeneously is finally added, tabletting.
With embodiment 1, coating is carried out to obtained tablet.
Embodiment 4 tadanafil direct powder compression prescription and preparation method thereof
[prescription]
| Composition | Every sheet weight (mg) |
| Tadanafil | 20.0 |
| Lactose-Microcrystalline cellulose composite (Cellactose) | 319.2 |
| Hydroxypropyl cellulose (EXF) | 7.2 |
| Cross-linking sodium carboxymethyl cellulose | 1.8 |
| Magnesium stearate | 1.8 |
| Amount to | 350.0 |
[preparation method]
(1) lactose-Microcrystalline cellulose composite (Cellactose), hydroxypropyl cellulose (EXF), cross-linking sodium carboxymethyl cellulose, magnesium stearate are crossed respectively 40 mesh sieves for subsequent use;
(2) cross the lactose-Microcrystalline cellulose composite (Cellactose) of 40 mesh sieves in the step (1) taking recipe quantity, after 60 mesh sieves, by 60 mesh sieve lower part and tadanafil, (particle diameter is D
90=7.6 μm) mixing 5min, after 60 mesh sieve mixing;
(3) lactose-Microcrystalline cellulose composite (Cellactose), the step (1) that add the middle 60 mesh sieve upper part excessively of step (2) successively cross hydroxypropyl cellulose (EXF), the abundant mix homogeneously of cross-linking sodium carboxymethyl cellulose after 40 mesh sieves;
(4) magnesium stearate mix homogeneously is finally added, tabletting.
With embodiment 1, coating is carried out to obtained tablet.
Embodiment 5 tadanafil direct powder compression prescription and preparation method thereof (investigation that particle diameter affects stripping)
[prescription]
| Composition | Every sheet weight (mg) |
| Tadanafil | 20.0 |
| Particulate lactose (Tablettose80) | 120.0 |
| Microcrystalline Cellulose (PH102) | 40.0 |
| Polyvinylpyrrolidone (K30) | 13.5 |
| Low-substituted hydroxypropyl cellulose | 10.5 |
| Magnesium stearate | 3.0 |
| Amount to | 207.0 |
[preparation method]
(1) particulate lactose (Tablettose80), microcrystalline Cellulose (PH102), polyvinylpyrrolidone (K30), low-substituted hydroxypropyl cellulose, magnesium stearate are crossed respectively 40 mesh sieves for subsequent use;
(2) particulate lactose (Tablettose80) crossing 40 mesh sieves in the step (1) of recipe quantity is taken, after 60 mesh sieves, by 60 orders with lower part and tadanafil (particle diameter D
90be respectively 63 μm, 18.7 μm, 7.6 μm) mixing 5min, after 60 mesh sieve mixing;
(3) particulate lactose (Tablettose80), the step (1) that add the middle 60 mesh sieve upper part excessively of step (2) successively cross microcrystalline Cellulose (PH102), polyvinylpyrrolidone (K30), low-substituted hydroxypropyl cellulose after 40 mesh sieves, abundant mix homogeneously;
(4) magnesium stearate mix homogeneously is finally added, tabletting.
With embodiment 1, coating is carried out to obtained tablet.
From the stripping curve of accompanying drawing 5, can find out: along with the reduction of tadanafil particle diameter, the dissolution of each time point increases to some extent.D
90be tablet prepared by the raw material of 7.6 μm, when 5min, dissolution is increased to more than 45%, and the dissolution when 10min reaches more than 80%, and the raw material being all 63 μm and 18.7 μm than D90 increases significantly.Illustrate for insoluble drug, reduce by micronization the dissolved corrosion that its particle diameter can improve preparation, be also conducive to improving the bioavailability in preparation body.
Claims (13)
1. a tadanafil pharmaceutical composition, the percentage by weight of supplementary material is as follows: tadanafil 1-10%; Filler 80-95%; Lubricant 0.5-2%.
2. tadanafil pharmaceutical composition as claimed in claim 1, is characterized in that: described filler percentage by weight is 85-95%.
3. tadanafil pharmaceutical composition as claimed in claim 1 or 2, is characterized in that: also comprise the disintegrating agent that percentage by weight is no more than 5%; Percentage by weight is no more than the binding agent of 7%.
4. tadanafil pharmaceutical composition as claimed in claim 3, is characterized in that: binder wt percentage ratio is no more than 5%.
5. tadanafil pharmaceutical composition as claimed in claim 1 or 2, is characterized in that: described filler is selected from one or more in spray-dried lactose, particulate lactose, mannitol, microcrystalline Cellulose, starch milk saccharide complex, lactose-Microcrystalline cellulose composite, lactose-glyceryl monostearate complex.
6. tadanafil pharmaceutical composition as claimed in claim 5, is characterized in that: described filler is lactose-Microcrystalline cellulose composite.
7. tadanafil pharmaceutical composition as claimed in claim 1 or 2, is characterized in that: described lubricant be selected from magnesium stearate, stearic acid, sodium stearyl fumarate, talcous one or more.
8. tadanafil pharmaceutical composition as claimed in claim 1 or 2, is characterized in that: the D of described tadanafil
90particle diameter is less than 70 μm.
9. tadanafil pharmaceutical composition as claimed in claim 8, is characterized in that: the D of described tadanafil
90particle diameter is less than 20 μm.
10. tadanafil pharmaceutical composition as claimed in claim 9, is characterized in that: or the D of described tadanafil
90particle diameter is less than 10 μm.
11. tadanafil pharmaceutical compositions as claimed in claim 3, is characterized in that: described binding agent is selected from one or more of hydroxypropyl emthylcellulose, hydroxypropyl cellulose and polyvinylpyrrolidone.
12. tadanafil pharmaceutical compositions as claimed in claim 3, is characterized in that: described disintegrating agent be selected from cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose one or more.
The preparation method of 13. tadanafil pharmaceutical compositions as described in claim 1 or 3, comprises the steps:
(1) adjuvant in described prescription is crossed 40 mesh sieves respectively;
(2) take the filler after the sieving of described percentage by weight, after 60 mesh sieves, the lower filler of sieve and the tadanafil mixing 5min of described percentage by weight, mix after 60 mesh sieves;
(3) the abundant mix homogeneously of other adjuvants of the filler of step (2) 60 mesh sieve upper part, step (1) mistake 40 mesh sieves is added successively;
(4) mix lubricant is finally added even, tabletting.
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|---|---|---|---|
| CN201410306380.1A CN105213333A (en) | 2014-06-30 | 2014-06-30 | A kind of tadanafil pharmaceutical composition and preparation method thereof |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104758941A (en) * | 2015-04-27 | 2015-07-08 | 浙江永宁药业股份有限公司 | Oral tablet capable of achieving rapid dissolution by using hydroxy propyl cellulose as adhesion agent |
| CN106821991A (en) * | 2017-03-21 | 2017-06-13 | 南京正科医药股份有限公司 | A kind of preparation method of particulate footpath Tadalafei |
| CN107303284A (en) * | 2016-04-25 | 2017-10-31 | 湖北生物医药产业技术研究院有限公司 | Prepare the method and Tadalafei tablet of Tadalafei tablet |
| CN110327305A (en) * | 2019-06-26 | 2019-10-15 | 慧生医学科技(徐州)有限公司 | A kind of ticagrelor piece and preparation method thereof |
| CN110638768A (en) * | 2019-10-25 | 2020-01-03 | 株洲千金药业股份有限公司 | Preparation method of medicine for treating male erectile dysfunction |
| CN110664766A (en) * | 2019-10-10 | 2020-01-10 | 甘肃普安制药股份有限公司 | Tadalafil tablet and preparation method thereof |
| CN111110640A (en) * | 2018-10-31 | 2020-05-08 | 长春海悦药业股份有限公司 | Tadalafil tablet composition and preparation method thereof |
| CN111329842A (en) * | 2020-03-30 | 2020-06-26 | 苏州弘森药业股份有限公司 | Tadalafil tablet and direct powder pressing production process thereof |
| CN111686083A (en) * | 2020-06-10 | 2020-09-22 | 石药集团中奇制药技术（石家庄）有限公司 | Ilaprazole enteric-coated tablet |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104758941A (en) * | 2015-04-27 | 2015-07-08 | 浙江永宁药业股份有限公司 | Oral tablet capable of achieving rapid dissolution by using hydroxy propyl cellulose as adhesion agent |
| CN107303284A (en) * | 2016-04-25 | 2017-10-31 | 湖北生物医药产业技术研究院有限公司 | Prepare the method and Tadalafei tablet of Tadalafei tablet |
| CN106821991A (en) * | 2017-03-21 | 2017-06-13 | 南京正科医药股份有限公司 | A kind of preparation method of particulate footpath Tadalafei |
| CN111110640A (en) * | 2018-10-31 | 2020-05-08 | 长春海悦药业股份有限公司 | Tadalafil tablet composition and preparation method thereof |
| CN110327305A (en) * | 2019-06-26 | 2019-10-15 | 慧生医学科技(徐州)有限公司 | A kind of ticagrelor piece and preparation method thereof |
| CN110664766A (en) * | 2019-10-10 | 2020-01-10 | 甘肃普安制药股份有限公司 | Tadalafil tablet and preparation method thereof |
| CN110638768A (en) * | 2019-10-25 | 2020-01-03 | 株洲千金药业股份有限公司 | Preparation method of medicine for treating male erectile dysfunction |
| CN110638768B (en) * | 2019-10-25 | 2024-04-16 | 株洲千金药业股份有限公司 | Preparation method of medicine for treating male erectile dysfunction |
| CN111329842A (en) * | 2020-03-30 | 2020-06-26 | 苏州弘森药业股份有限公司 | Tadalafil tablet and direct powder pressing production process thereof |
| CN111686083A (en) * | 2020-06-10 | 2020-09-22 | 石药集团中奇制药技术（石家庄）有限公司 | Ilaprazole enteric-coated tablet |
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Application publication date: 20160106 |