CN114848603B - Vardenafil freeze-dried flash-release tablet and preparation process thereof - Google Patents
Vardenafil freeze-dried flash-release tablet and preparation process thereof Download PDFInfo
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- CN114848603B CN114848603B CN202210441748.XA CN202210441748A CN114848603B CN 114848603 B CN114848603 B CN 114848603B CN 202210441748 A CN202210441748 A CN 202210441748A CN 114848603 B CN114848603 B CN 114848603B
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- SECKRCOLJRRGGV-UHFFFAOYSA-N Vardenafil Chemical compound CCCC1=NC(C)=C(C(N=2)=O)N1NC=2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(CC)CC1 SECKRCOLJRRGGV-UHFFFAOYSA-N 0.000 title claims abstract description 41
- 229960002381 vardenafil Drugs 0.000 title claims abstract description 41
- 238000002360 preparation method Methods 0.000 title abstract description 16
- 239000004373 Pullulan Substances 0.000 claims abstract description 22
- 229920001218 Pullulan Polymers 0.000 claims abstract description 22
- 235000019423 pullulan Nutrition 0.000 claims abstract description 22
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 15
- 229930195725 Mannitol Natural products 0.000 claims abstract description 15
- 239000000594 mannitol Substances 0.000 claims abstract description 15
- 235000010355 mannitol Nutrition 0.000 claims abstract description 15
- 239000004376 Sucralose Substances 0.000 claims abstract description 13
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims abstract description 13
- 235000019408 sucralose Nutrition 0.000 claims abstract description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 11
- 239000007788 liquid Substances 0.000 claims description 18
- 238000003756 stirring Methods 0.000 claims description 12
- 230000001804 emulsifying effect Effects 0.000 claims description 9
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 6
- 238000007872 degassing Methods 0.000 claims description 6
- 238000007710 freezing Methods 0.000 claims description 6
- 230000008014 freezing Effects 0.000 claims description 6
- 238000004806 packaging method and process Methods 0.000 claims description 6
- 238000007789 sealing Methods 0.000 claims description 6
- 238000005303 weighing Methods 0.000 claims description 6
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 3
- 229910052782 aluminium Inorganic materials 0.000 claims description 3
- 239000011248 coating agent Substances 0.000 claims description 3
- 238000000576 coating method Methods 0.000 claims description 3
- 238000001816 cooling Methods 0.000 claims description 3
- 238000005520 cutting process Methods 0.000 claims description 3
- 238000004945 emulsification Methods 0.000 claims description 3
- 239000000839 emulsion Substances 0.000 claims description 3
- 238000011049 filling Methods 0.000 claims description 3
- 239000006260 foam Substances 0.000 claims description 3
- 238000010438 heat treatment Methods 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 3
- 229910052757 nitrogen Inorganic materials 0.000 claims description 3
- 239000002984 plastic foam Substances 0.000 claims description 3
- 239000008213 purified water Substances 0.000 claims description 3
- 230000009286 beneficial effect Effects 0.000 abstract description 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 239000007916 tablet composition Substances 0.000 description 8
- 238000004108 freeze drying Methods 0.000 description 4
- BNRNXUUZRGQAQC-UHFFFAOYSA-N sildenafil Chemical compound CCCC1=NN(C)C(C(N2)=O)=C1N=C2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(C)CC1 BNRNXUUZRGQAQC-UHFFFAOYSA-N 0.000 description 4
- 208000010228 Erectile Dysfunction Diseases 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 201000001881 impotence Diseases 0.000 description 3
- 102000011016 Type 5 Cyclic Nucleotide Phosphodiesterases Human genes 0.000 description 2
- 108010037581 Type 5 Cyclic Nucleotide Phosphodiesterases Proteins 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 229960003310 sildenafil Drugs 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
Classifications
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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
- A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/2004—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
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- 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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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Gynecology & Obstetrics (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
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Abstract
The invention discloses a vardenafil freeze-dried flash-released tablet and a preparation method thereof, wherein the freeze-dried flash-released tablet comprises the following components in parts by weight: 5-15 parts of vardenafil, 14-17.5 parts of mannitol, 16.5-18.5 parts of pullulan, 0.3-1.4 parts of sucralose and a proper amount of water. The vardenafil freeze-dried flash-release tablet provided by the invention does not need water when being taken, and is beneficial to protecting the privacy of men. The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a vardenafil freeze-dried flash-release tablet and a preparation process thereof.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a vardenafil freeze-dried flash-release tablet and a preparation process thereof.
Background
Vardenafil (Vardenafil) is a drug in the field of treatment of Erectile Dysfunction (ED), developed over the years by Bayer (Bayer) and ghatti (Glaxo Smith Kline) in germany, and acts by inhibiting phosphodiesterase type 5 (PDE-5), which has the following advantages compared to sildenafil (pego): the dosage is small, only 20mg (120 mg-150mg of sildenafil is needed). The medicine takes effect within 15 to 30 minutes, reaches the peak value within 30 to 60 minutes, has the duration of more than 6 hours and has small side effect.
The dosage forms of vardenafil on the market at present are common tablets prepared by a tabletting method, and the vardenafil is taken by drinking water, so that the vardenafil is not very convenient to use for some men to want to protect personal privacy under certain conditions.
Disclosure of Invention
The invention aims to provide vardenafil freeze-dried flash-release tablets and a preparation process thereof, so as to solve the problems in the background technology.
In order to solve the technical problems, the vardenafil freeze-dried flash release tablet provided by the invention comprises the following components in parts by weight: 5-15 parts of vardenafil, 14-17.5 parts of mannitol, 16.5-18.5 parts of pullulan, 0.3-1.4 parts of sucralose and a proper amount of water.
In addition, the invention also discloses a preparation process of the vardenafil freeze-dried flash release tablet, which comprises the following steps:
(1) Dissolving pullulan, adding a proper amount of purified water into a stirring kettle, heating to 55 ℃, weighing the pullulan with the prescription amount, adding the pullulan into the stirring kettle, stirring to completely dissolve the pullulan, and then cooling to room temperature;
(2) Preparing an emulsion, namely respectively weighing the prescription amount of sucralose, mannitol and vardenafil, adding the sucralose, mannitol and vardenafil into the feed liquid prepared in the step (1), stirring until the components are completely dissolved, and adding a proper amount of water to fix the volume so that the concentrations of the vardenafil, mannitol, pullulan and sucralose are 17-25g/L, 25-40g/L, 30-40g/L and 1-2g/L;
(3) Emulsifying and degassing, namely pouring the feed liquid obtained in the step (2) into an emulsifying machine for emulsification, wherein the rotating speed of the emulsifying machine is 5000-12000r/min, and then degassing the emulsified feed liquid under vacuum for 15min;
(4) Filling, namely sub-packaging the feed liquid obtained in the step (3) into foam holes of an aluminum plastic foam plate at a ratio of 0.5 ml/piece;
(5) Quick freezing, namely placing the bubble cap plate filled with the feed liquid into a liquid nitrogen tunnel at the temperature of minus 100 ℃ for pre-freezing for 15 minutes;
(6) Freeze-drying, namely transferring the pre-frozen bubble cap plate into a plate layer of a freeze dryer for freeze-drying, and running the following curves: -35 ℃ for 60 minutes; -25 ℃ for 330 minutes; -20 ℃ for 100 minutes; -15 ℃ for 120 minutes; raising the temperature from-15 ℃ to-5 ℃ and keeping the temperature at-5 ℃ for 60 minutes; -5-25 ℃ for 30 minutes, 25 ℃ for 210 minutes;
(7) Sealing, taking out the bubble plate from the freeze dryer, and coating film on the sealing machine for packaging and cutting.
The invention adopts the structure to obtain the beneficial effects as follows: the vardenafil freeze-dried flash-released tablet provided by the invention is taken without water, is dissolved in an inlet, is completely disintegrated within 3 seconds, has good taste, has no gritty feel and has no peculiar smell. Can completely meet the needs of some male ED patients in certain situations for protecting personal privacy.
Detailed Description
The technical scheme of the invention is further described in detail in the following with specific implementation, and all parts of the technical features of the invention, which are not described in detail, are adopted in the prior art.
The present invention will be described in further detail with reference to examples.
1. Examples of formulations
Example 1
Vardenafil lyophilized flash tablet formulation:
the preparation process of the vardenafil freeze-dried flash release tablet comprises the following steps:
(1) Dissolving pullulan, adding a proper amount of purified water into a stirring kettle, heating to 55 ℃, weighing the pullulan with the prescription amount, adding the pullulan into the stirring kettle, stirring to completely dissolve the pullulan, and then cooling to room temperature;
(2) Preparing an emulsion, namely respectively weighing the prescription amount of sucralose, mannitol and vardenafil, adding the sucralose, mannitol and vardenafil into the feed liquid prepared in the step (1), stirring until the components are completely dissolved, and adding a proper amount of water to fix the volume so that the concentrations of the vardenafil, mannitol, pullulan and sucralose are 17-25g/L, 25-40g/L, 30-40g/L and 1-2g/L;
(3) Emulsifying and degassing, namely pouring the feed liquid obtained in the step (2) into an emulsifying machine for emulsification, wherein the rotating speed of the emulsifying machine is 5000-12000r/min, and then degassing the emulsified feed liquid under vacuum for 15min;
(4) Filling, namely sub-packaging the feed liquid obtained in the step (3) into foam holes of an aluminum plastic foam plate at a ratio of 0.5 ml/piece;
(5) Quick freezing, namely placing the bubble cap plate filled with the feed liquid into a liquid nitrogen tunnel at the temperature of minus 100 ℃ for pre-freezing for 15 minutes;
(6) Freeze-drying, namely transferring the pre-frozen bubble cap plate into a plate layer of a freeze dryer for freeze-drying, and running the following curves: -35 ℃ for 60 minutes; -25 ℃ for 330 minutes; -20 ℃ for 100 minutes; -15 ℃ for 120 minutes; raising the temperature from-15 ℃ to-5 ℃ and keeping the temperature at-5 ℃ for 60 minutes; -5-25 ℃ for 30 minutes, 25 ℃ for 210 minutes;
(7) Sealing, taking out the bubble plate from the freeze dryer, coating film on the sealing machine for packaging, cutting, and preparing 1000 tablets from the ingredients of the prescription.
Example 2
Vardenafil lyophilized flash tablet formulation:
the preparation process is as in example 1.
Example 3
Vardenafil lyophilized flash tablet formulation:
the preparation process is as in example 1.
Example 4
Vardenafil lyophilized flash tablet formulation:
the preparation process is as in example 1.
Example 5
Vardenafil lyophilized flash tablet formulation:
the preparation process is as in example 1.
Example 6
Vardenafil lyophilized flash tablet formulation:
the preparation process is as in example 1.
Example 7
Vardenafil lyophilized flash tablet formulation:
the preparation process is as in example 1.
Example 8
Vardenafil lyophilized flash tablet formulation:
the preparation process is as in example 1.
2. Evaluation result
The preparation process conditions of examples 1 to 5 are the same, the ratios of vardenafil and sucralose in the formulation are the same, the only changes are the amounts of mannitol and pullulan, and examples 1 to 5 can be used to evaluate the effect of mannitol and pullulan on the formation of vardenafil lyophilized flash tablets.
The experimental results are as follows:
| sample of | Whether or not to split | Whether or not to collapse | Degree of shrinkage of the sheet | Disintegration time |
| Example 1 | Whether or not | Whether or not | 0 | 2.3s |
| Example 2 | Whether or not | Whether or not | 0 | 2.6s |
| Example 3 | Whether or not | Whether or not | 0 | 2.2s |
| Example 4 | Is that | Whether or not | 10.7％ | / |
| Example 5 | Is that | Is that | / | / |
Conclusion: the pullulan accounts for 3.3 to 3.7 percent of the total weight of the pullulan; when the mannitol accounts for 2.8-3.5%, the obtained freeze-dried flash tablet is well formed, has no phenomena of cracking and collapse, and disintegrates rapidly and completely within 3 seconds.
The invention and its embodiments have been described above with no limitation, and the examples shown are only one of the embodiments of the invention and are not limited thereto in practice. In summary, those skilled in the art, having benefit of this disclosure, will appreciate that many changes can be made without departing from the spirit and scope of the invention as disclosed herein.
Claims (3)
1. The vardenafil freeze-dried flash release tablet is characterized by comprising the following components in parts by weight: 5-15 parts of vardenafil, 14-17.5 parts of mannitol, 16.5-18.5 parts of pullulan, 0.3-1.4 parts of sucralose and a proper amount of water.
2. A method for preparing the vardenafil freeze-dried flash-release tablet according to claim 1, comprising the following steps:
(1) Dissolving pullulan, adding a proper amount of purified water into a stirring kettle, heating to 55 ℃, weighing the pullulan with the prescription amount, adding the pullulan into the stirring kettle, stirring to completely dissolve the pullulan, and then cooling to room temperature;
(2) Preparing an emulsion, namely respectively weighing the prescription amount of sucralose, mannitol and vardenafil, adding the sucralose, mannitol and vardenafil into the feed liquid prepared in the step (1), stirring until the components are completely dissolved, and adding a proper amount of water to fix the volume so that the concentrations of the vardenafil, mannitol, pullulan and sucralose are 17-25g/L, 25-40g/L, 30-40g/L and 1-2g/L;
(3) Emulsifying and degassing, namely pouring the feed liquid obtained in the step (2) into an emulsifying machine for emulsification, wherein the rotating speed of the emulsifying machine is 5000-12000r/min, and then degassing the emulsified feed liquid under vacuum for 15min;
(4) Filling, namely sub-packaging the feed liquid obtained in the step (3) into foam holes of an aluminum plastic foam plate at a ratio of 0.5 ml/piece;
(5) Quick freezing, namely placing the bubble cap plate filled with the feed liquid into a liquid nitrogen tunnel at the temperature of minus 100 ℃ for pre-freezing for 15 minutes;
(6) Lyophilizing, namely transferring the pre-frozen bubble cap plate into a plate layer of a lyophilizing machine for lyophilizing;
(7) Sealing, taking out the bubble plate from the freeze dryer, and coating film on the sealing machine for packaging and cutting.
3. The method for preparing vardenafil freeze-dried flash-release tablets according to claim 2, wherein the freeze dryer in step (5) operates the following curve: -35 ℃ for 60 minutes; -25 ℃ for 330 minutes; -20 ℃ for 100 minutes; -15 ℃ for 120 minutes; raising the temperature from-15 ℃ to-5 ℃ and keeping the temperature at-5 ℃ for 60 minutes; -5-25 ℃ for 30 minutes, 25 ℃ for 210 minutes.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210441748.XA CN114848603B (en) | 2022-04-25 | 2022-04-25 | Vardenafil freeze-dried flash-release tablet and preparation process thereof |
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| CN202210441748.XA CN114848603B (en) | 2022-04-25 | 2022-04-25 | Vardenafil freeze-dried flash-release tablet and preparation process thereof |
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| CN114848603A CN114848603A (en) | 2022-08-05 |
| CN114848603B true CN114848603B (en) | 2023-12-12 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20070102065A (en) * | 2006-04-13 | 2007-10-18 | 한미약품 주식회사 | Fast acting formulation of vardenafil |
| CN112972405A (en) * | 2019-12-02 | 2021-06-18 | 北京兴源联合医药科技有限公司 | Tadalafil freeze-dried orally disintegrating tablet and preparation method thereof |
| CN112972404A (en) * | 2019-12-02 | 2021-06-18 | 北京兴源联合医药科技有限公司 | Sildenafil freeze-dried orally disintegrating tablet and preparation method thereof |
| CN113081981A (en) * | 2021-04-06 | 2021-07-09 | 北京菲瑞阳林医药技术研发有限公司 | Lactase freeze-drying flash-release tablet and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102005009240A1 (en) * | 2005-03-01 | 2006-09-07 | Bayer Healthcare Ag | Dosage forms with improved pharmacokinetic properties |
-
2022
- 2022-04-25 CN CN202210441748.XA patent/CN114848603B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20070102065A (en) * | 2006-04-13 | 2007-10-18 | 한미약품 주식회사 | Fast acting formulation of vardenafil |
| CN112972405A (en) * | 2019-12-02 | 2021-06-18 | 北京兴源联合医药科技有限公司 | Tadalafil freeze-dried orally disintegrating tablet and preparation method thereof |
| CN112972404A (en) * | 2019-12-02 | 2021-06-18 | 北京兴源联合医药科技有限公司 | Sildenafil freeze-dried orally disintegrating tablet and preparation method thereof |
| CN113081981A (en) * | 2021-04-06 | 2021-07-09 | 北京菲瑞阳林医药技术研发有限公司 | Lactase freeze-drying flash-release tablet and preparation method thereof |
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