CN110812336A - Tadalafil tablet composition - Google Patents
Tadalafil tablet composition Download PDFInfo
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- CN110812336A CN110812336A CN201810889840.6A CN201810889840A CN110812336A CN 110812336 A CN110812336 A CN 110812336A CN 201810889840 A CN201810889840 A CN 201810889840A CN 110812336 A CN110812336 A CN 110812336A
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- tadalafil
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- 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
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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 relates to a tadalafil tablet composition and a preparation method thereof, belonging to the technical field of pharmacy. The technical scheme of the invention is as follows: a tadalafil tablet composition comprises 200g of tadalafil, 2480g of lactose 2320-. The invention provides a tadalafil tablet with good quality for clinic.
Description
Technical Field
The invention relates to a tadalafil tablet composition and a preparation method thereof, belonging to the technical field of pharmacy.
Background
Tadalafil (Tadalafil) was developed by rituximab for the treatment of male erectile dysfunction. Tadalafil is a poorly soluble drug, and the commercially available dosage form is a tablet.
The original Chinese patent CN1213754C adopts a raw material micronizing process to obtain Tadalafil bulk drug with a particle size D90The particle size is controlled to be below 40 mu m so as to improve the solubility, but because the flowability of the tadalafil raw material drug is deteriorated after the tadalafil raw material drug is crushed, the wet granulation process is adopted to prepare the tablet, and the time of the disclosed tabletting process is longer. In the process of tablet preparation, we have found that the tablets prepared have a problem of large intra-batch dissolution difference.
Chinese patent CN104188912B dissolves tadalafil and carrier materials (polyvinylpyrrolidone K30 and poloxamer) in absolute ethyl alcohol, and then the solid dispersion is prepared by decompression and rotary evaporation at 50-90 ℃, but the method relates to the use of organic solvents and the detection of solvent residues, has certain safety problem and lower industrial production efficiency.
The Chinese patent CN107303284A mixes tadalafil and sodium dodecyl sulfate and then carries out crushing treatment, the using amount (4 times of the raw materials) in the patent is far higher than that (between 0.25 and 1.25 times of the raw materials) in the original patent CN1213754C, and the using amount is unreasonable.
Disclosure of Invention
Aiming at the problems in the existing preparation process of the tadalafil tablet composition, the tadalafil tablet which has higher dissolution rate and small dissolution difference in batches is provided.
The technical scheme is as follows:
the applicant has tried to find a simple and feasible formulation and process to produce tadalafil tablets with similar dissolution behavior to the original formulation, while expecting to reduce the intra-batch variation of the formulation, reducing the quality fluctuation. Through experimental research, the tadalafil blend with the particle size within 38 microns is prepared by crushing the tadalafil raw material medicine, lactose and polyethylene glycol 6000 together, the blend has good fluidity, and the problem of insolubility of the raw material medicine can be obviously improved. Based on the discovery, the tadalafil tablet is prepared by adopting a direct powder compression process, the dissolution curve of the prepared tadalafil tablet is similar to that of the original preparation (f 2 is more than 50), and the problem of batch difference is solved.
The technical scheme of the invention is as follows: a tadalafil tablet composition comprises 200g of tadalafil, 2480g of lactose 2320-.
The tadalafil tablet composition is a tadalafil blend which is obtained by co-crushing tadalafil, polyethylene glycol 6000 in a prescription amount and lactose in a mass ratio of 1: 2-1: 3 to D90 within 38 micrometers.
In the tadalafil blend with the D90 being within 38 micrometers, the mass ratio of tadalafil to lactose is in the range of 1: 2-1: 3, and the ratio range is favorable for controlling the dissolution rate and the mixture flowability.
Preferably, each thousand tablets of the tadalafil tablet composition comprise 200g of tadalafil, 2400g of lactose, 520g of microcrystalline cellulose, 225g of croscarmellose sodium, 60008g of polyethylene glycol, 35g of hydroxypropyl cellulose, 9.5g of sodium lauryl sulfate, 25g of magnesium stearate and 100g of opadry. The tadalafil was co-milled with polyethylene glycol 6000, a prescribed amount, and 500g lactose to a tadalafil blend with D90 within 38 microns.
The particle size distribution of the tadalafil blend was measured using a laser particle sizer.
The preparation method of the tadalafil tablet comprises the following steps:
firstly, the tadalafil raw material medicine is uniformly mixed with lactose and polyethylene glycol 6000 and then is crushed together to prepare D90A tadalafil blend of no greater than 38 μm;
the tadalafil blend obtained in the first step of the second step is uniformly mixed with the prescribed amount of microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate and the rest prescribed amount of lactose to obtain a mixture;
the third step: adding magnesium stearate with the prescription amount into the mixture obtained in the second step, uniformly mixing to obtain a final mixture, and tabletting to obtain tadalafil tablets;
the fourth step: and dissolving the coating powder with purified water according to the prescription amount, and coating the tadalafil tablets to obtain the tadalafil tablets.
Has the advantages that: according to the technical scheme, the tadalafil, the polyethylene glycol 6000 and the lactose are crushed together, the mixture after crushing is crushed together, the fluidity of the mixture after crushing is improved, and the dry tabletting technology can be adopted for directly tabletting. The technical scheme of the invention not only improves the dissolution rate of the tadalafil tablet, but also reduces the difference of dissolution in batches. The invention provides a tadalafil tablet with good quality for clinic.
Detailed Description
The following examples are given to aid in the understanding of the present invention, but the present invention is not limited to the examples.
The embodiments of the present invention are described in the following detailed description of the preferred embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can substitute or change the technical solution of the present invention and its inventive concept within the technical scope of the present invention.
Example 1
200g of tadalafil, 2320g of lactose, 500g of microcrystalline cellulose, 220g of croscarmellose sodium, 60007g of polyethylene glycol, 30g of hydroxypropyl cellulose, 9g of sodium dodecyl sulfate, 24g of magnesium stearate and 100g of Opadry. Preparing 1000 tablets according to the preparation method of the technical scheme, wherein the prescribed amount of tadalafil, the prescribed amount of polyethylene glycol and 400g of lactose are uniformly mixed and crushed together, and the obtained mixture D90 is 37.2 microns and the Carl index is 17.9. The Carr index is determined and calculated by a tap density meter.
Example 2
200g of tadalafil, 2480g of lactose, 540g of microcrystalline cellulose, 230g of croscarmellose sodium, 600010g of polyethylene glycol, 38g of hydroxypropyl cellulose, 10g of sodium dodecyl sulfate, 28g of magnesium stearate and 100g of Opadry. The 1000 tablets are prepared according to the preparation method of the technical scheme, wherein the tadalafil with the prescription amount, the polyethylene glycol with the prescription amount and 600g of lactose are uniformly mixed and crushed, and the obtained mixture D90 is 24.5 microns and the Carl index is 17.6.
Example 3
200g of tadalafil, 2400g of lactose, 520g of microcrystalline cellulose, 225g of croscarmellose sodium, 60008g of polyethylene glycol, 35g of hydroxypropyl cellulose, 9.5g of sodium dodecyl sulfate, 25g of magnesium stearate and 100g of opadry. Preparing 1000 tablets according to the preparation method of the technical scheme, wherein the prescribed amount of tadalafil, the prescribed amount of polyethylene glycol and 500g of lactose are uniformly mixed and crushed together, and the obtained mixture D90 is 26.7 microns and the Carl index is 17.7.
Comparative example 1
1000 tablets were prepared according to the recipe described in example 1, with reference to the preparation method described. Wherein the co-crushed tadalafil is as follows: the prescribed amount of tadalafil was uniformly mixed with the prescribed amount of polyethylene glycol 6000, and the resulting mixture was pulverized together, whereby the resulting mixture D90 was found to be 44.9 μm, and the Carl index was found to be 34.2.
Comparative example 2
1000 tablets were prepared according to the recipe described in example 1, with reference to the preparation method described. Wherein the co-crushed tadalafil is as follows: tadalafil in the prescribed amount, polyethylene glycol 6000 in the prescribed amount, and 200g lactose were mixed uniformly, and the resultant mixture was pulverized together, whereby the resultant mixture D90 was found to be 40.7 μm and the Carl index was found to be 27.4.
Comparative example 3. the formulation described in example 1, except polyethylene glycol 6000 and the operations related to polyethylene glycol 6000 in the preparation method, 1000 tablets were prepared according to the preparation method described in the technical scheme.
Wherein the prescribed amount of tadalafil was mixed with 200g of lactose homogeneously and co-pulverized, and the resulting mixture D90 was found to be 53.2 microns with a Carl index of 37.9.
Comparative example 4. the formulation described in example 2, except polyethylene glycol 6000 and the operations related to polyethylene glycol 6000 in the preparation method, 1000 tablets were prepared according to the preparation method described in the technical scheme.
Wherein the prescribed amount of tadalafil was mixed with 200g of lactose homogeneously and co-pulverized, and the resulting mixture D90 was found to be 46.2 microns with a Carl index of 32.7.
Dissolution test of the samples of examples and comparative examples: referring to an FDA dissolution database and physicochemical properties of tadalafil, the dissolution conditions of the dissolution medium with differentiated forces of tadalafil tablets were determined as follows: : 1. paddle method, 50rpm, 900ml of 0.3% SDS phosphate buffer (pH 6.8); 2. paddle method, 50rpm, 900ml of 0.5% SDS aqueous medium; the dissolution rate is measured by sampling at 5 min, 10 min, 15 min, 30 min and 60 min.
Test example 1
The dissolution rates of the products of examples 1 to 3 and comparative examples 1 to 4 in a 0.5% aqueous solution of Sodium Dodecyl Sulfate (SDS) were measured with reference to the dissolution rate measuring method described above, and the RSD values thereof were calculated and reported in Table 1.
TABLE 10.5% RSD values in SDS-aqueous medium
Test example 2
The dissolution rates of the products of examples 1 to 3 and comparative examples 1 to 4 in 0.3% SDS-pH6.8 phosphate buffer were measured, respectively, by the dissolution rate measuring method described above, and the RSD values thereof were calculated, and the data are shown in Table 2.
TABLE 20.3 RSD values in SDS-pH6.8 phosphate buffer
The data in tables 1 and 2 show that the product of the embodiment of the invention obviously reduces the dissolution difference in the preparation batches and provides high-quality medicines with stable quality for clinic.
Test example 3
The f2 factor method has been accepted and recommended by the FDA and EMA in the United states as a method for evaluating the similarity of in vitro dissolution profiles. The value of f2 ranges from 0 to 100, and the larger the f2 is, the higher the similarity of the two curves is. FDA and EMEA regulations: if the f2 value between the dissolution curves of the test sample and the reference preparation is not less than 50, the two are considered to be similar. Therefore, we evaluated the similarity of the dissolution profiles using the f2 factor method.
The dissolution rates of the reference formulation of the commercially available tadalafil tablets of the original research, the samples of examples 1 to 3, and the samples of comparative examples 1 to 4 were measured, respectively, and the calculated f2 values were calculated, and the calculation data are recorded in table 3, respectively.
TABLE 3 determination of f2 values
The data in table 3 show that the dissolution behavior of the tablets of examples 1-3 according to the invention is similar to that of the reference formulation. The comparative examples 1 to 4 showed a large difference in dissolution behavior compared with the reference.
Claims (3)
1. A tadalafil tablet composition is characterized in that each thousand tablets contain 200g of tadalafil, 2480g of lactose 2320-; the preparation method comprises the step of co-crushing tadalafil with a prescription amount of polyethylene glycol 6000 and lactose in a mass ratio of 1: 2-1: 3 to obtain a tadalafil blend with D90 within 38 microns.
2. The tadalafil tablet composition of claim 1 comprising 200g of tadalafil, 2400g of lactose, 520g of microcrystalline cellulose, 225g of croscarmellose sodium, 60008g of polyethylene glycol, 35g of hydroxypropyl cellulose, 9.5g of sodium lauryl sulfate, 25g of magnesium stearate, 100g of opadry, per thousand tablets, prepared by co-comminuting a prescribed amount of tadalafil with a prescribed amount of 6000 polyethylene glycol and 500g of lactose to a tadalafil blend having a D90 within 38 microns.
3. A process for preparing the tadalafil tablet composition of claim 1 comprising the steps of:
the first step is to mixMixing dalafei raw material with lactose and polyethylene glycol 6000, pulverizing together to obtain D90A tadalafil blend of no greater than 38 μm;
the tadalafil blend obtained in the first step of the second step is uniformly mixed with the prescribed amount of microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate and the rest prescribed amount of lactose to obtain a mixture;
the third step: adding magnesium stearate with the prescription amount into the mixture obtained in the second step, uniformly mixing to obtain a final mixture, and tabletting to obtain tadalafil tablets;
the fourth step: and dissolving the coating powder with purified water according to the prescription amount, and coating the tadalafil tablets to obtain the tadalafil tablets.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201810889840.6A CN110812336B (en) | 2018-08-07 | 2018-08-07 | Tadalafil tablet composition |
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| CN201810889840.6A CN110812336B (en) | 2018-08-07 | 2018-08-07 | Tadalafil tablet composition |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| WO2023232215A1 (en) * | 2022-06-02 | 2023-12-07 | Rontis Hellas S.A. | Improved pharmaceutical composition containing tadalafil and process for the preparation thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2023232215A1 (en) * | 2022-06-02 | 2023-12-07 | Rontis Hellas S.A. | Improved pharmaceutical composition containing tadalafil and process for the preparation thereof |
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Effective date of registration: 20210826 Address after: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Applicant after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Address before: 300457 room n1701-1, 17th floor, Tianjin International Biomedical Joint Research Institute, No. 220 Dongting Road, economic and Technological Development Zone, Binhai New Area, Tianjin Applicant before: DISHA PHARMACEUTICAL GROUP (TIANJIN) MEDICINE RESEARCH Co.,Ltd. Applicant before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. |
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Denomination of invention: Tadalafil tablet composition Effective date of registration: 20211025 Granted publication date: 20210910 Pledgee: Bank of China Limited Weihai Branch Pledgor: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Registration number: Y2021980010533 |