CN113181127A - Preparation method of dapoxetine hydrochloride pellet tablets - Google Patents
Preparation method of dapoxetine hydrochloride pellet tablets Download PDFInfo
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- CN113181127A CN113181127A CN202110493102.1A CN202110493102A CN113181127A CN 113181127 A CN113181127 A CN 113181127A CN 202110493102 A CN202110493102 A CN 202110493102A CN 113181127 A CN113181127 A CN 113181127A
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
Abstract
The invention discloses a preparation method of dapoxetine hydrochloride micro-pill tablets, and belongs to the field of medicinal preparations. The dapoxetine hydrochloride pellet tablet is prepared from the following raw materials in percentage by weight: 16-17% of dapoxetine hydrochloride, 2-8% of disintegrating agent, 15-35% of hydrophilic gel skeleton type slow release material, 1-3% of lubricant, 10-25% of silicified microcrystalline cellulose and the balance of lactose. The dapoxetine hydrochloride pellet tablet prepared by the preparation method has stable process, can well play a role of slow release, is stable in release within 24 hours, has no phenomena of burst release and difficult dissolution, has good results after being amplified to 1 ten thousand tablets, and meets the requirements.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to a preparation method of dapoxetine hydrochloride micro-pill tablets.
Background
Premature Ejaculation (PE) is the most common sexual dysfunction in men. According to the survey of the united states organization of health and longevity, about 71% of adult men have sexual disorders, about 39% of them have erectile dysfunction, and 61% of them have not had enough time to be satisfied with their sexual behavior.
Dapoxetine hydrochloride belongs to the selective 5-hydroxytryptamine reabsorption inhibitor (SSRI) and has the chemical name of (S) - (+) -N, N-dimethyl-3- (1-naphthyloxy) amphetamine hydrochloride, and the structural formula is as follows:
originally developed by american etiquette for the treatment of Major Depressive Disorder (MDD), but its pharmacokinetic properties (e.g. short half-life after oral administration, less accumulation at 24 hours) were not suitable for this indication, so its development was stopped. PPD genufro found that this compound has the potential to treat PE and was patented in 1998. In 2001, ALZA corporation obtained dapoxetine patent approval and continued its development as a PE therapeutic with Johnson & Johnson drug research & development.
The dapoxetine hydrochloride film coated tablet is produced by the Bilitham Yanseng pharmaceutical Co Ltd, the specification of the tablet is 30 mg/tablet and 60 mg/tablet, and the product is not collected and carried by any national pharmacopoeia at present.
Dapoxetine hydrochloride is currently a fast-release film coated tablet. The patient is required to take the medicine half an hour in advance when needed, the medicine can be quickly absorbed by the human body after taking the dapoxetine hydrochloride tablet, and the maximum plasma concentration (Cmax) is expected to be reached after 1 to 2 hours of administration. The absolute bioavailability was 42%. After 30mg and 60mg of dapoxetine are taken orally on an empty stomach, the maximum plasma concentrations will be reached after 1.01h and 1.27 h. The demethylated dapoxetine is an active metabolite of the medicine, and the protein binding rate of the demethylated dapoxetine is 98.5%. The binding rate of the medicine and the human serum protein is as high as 99%. Therefore, the research of sustained release preparations is necessary.
Disclosure of Invention
Aiming at the prior art, the invention aims to provide a preparation method of dapoxetine hydrochloride micro-pill tablets.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention provides a dapoxetine hydrochloride pellet tablet, which is prepared from the following raw materials in percentage by weight:
16-17% of dapoxetine hydrochloride, 2-8% of disintegrating agent, 15-35% of hydrophilic gel skeleton type slow release material, 1-3% of lubricant, 10-25% of silicified microcrystalline cellulose and the balance of lactose.
Preferably, the dapoxetine hydrochloride pellet tablet is prepared from the following raw materials in percentage by weight:
16.8 percent of dapoxetine hydrochloride, 6 percent of disintegrant, 25 percent of hydrophilic gel skeleton type slow-release material, 2 percent of lubricant, 18 percent of silicified microcrystalline cellulose and 32.2 percent of lactose.
Preferably, the disintegrant is croscarmellose sodium.
Preferably, the hydrophilic gel skeleton type slow-release material is hydroxypropyl methylcellulose.
Preferably, the lubricant is sodium stearyl fumarate.
In a second aspect of the present invention, a preparation method of the dapoxetine hydrochloride pellet tablet is provided, which comprises the following steps:
(1) premixing dapoxetine hydrochloride, a hydrophilic gel skeleton type slow-release material, silicified microcrystalline cellulose, lactose, part of a disintegrating agent and part of a lubricating agent to obtain a premix;
(2) granulating the premix, performing wet granulation, pelleting, and drying to obtain dry granules;
(3) dry granulating the dry granules, and then adding the rest disintegrating agent and lubricant for total mixing;
(4) tabletting the totally mixed materials;
(5) and (4) coating the tabletted tablets to obtain the dapoxetine hydrochloride micro-pill tablets.
Preferably, in the step (1), the stirring speed during premixing is 300-400rpm, the shearing speed is 1800-2100rpm, and the premixing time is 8-10 min.
Preferably, in the step (2), a spheronization device is adopted for pelleting.
Preferably, in the step (2), fluidized bed drying is adopted, and drying is carried out until the moisture content is 0.9-2.8%.
Preferably, the mass ratio of the disintegrant added in the step (1) to the disintegrant added in the step (3) is 9: 1-1: 3; the mass ratio of the lubricant added in the step (1) to the lubricant added in the step (3) is (0-3): (6-3).
Preferably, in the step (4), the hardness is controlled to 6kgf to 11kgf at the time of tableting.
Preferably, in the step (5), an ethanol solution of ethyl cellulose is used as a coating material, and the coating treatment conditions are as follows: the air inlet temperature is 40-65 ℃, the air outlet temperature is 30-40 ℃, the material temperature is 30-37 ℃, and the weight gain of the coating is controlled to be 2-5 percent by the coating.
The invention has the beneficial effects that:
the dapoxetine hydrochloride pellet tablet prepared by the method has stable process, can well play a role of slow release, is stable in release within 24 hours, has no phenomena of burst release and difficult dissolution, has good results after being amplified to 1 ten thousand tablets, and meets the requirements.
Drawings
FIG. 1: the process is enlarged to 2000 pieces, 4000 pieces and 10000 pieces of total mixed powder granularity distribution diagram
FIG. 2: the process is enlarged to 2000 tablets, 4000 tablets and 10000 tablets, and the dissolution contrast diagram in a medium with pH1.0
FIG. 3: the process is enlarged to 2000 tablets, 4000 tablets and 10000 tablets, and the dissolution contrast diagram in a medium with pH4.5
FIG. 4: the process is enlarged to 2000 tablets, 4000 tablets and 10000 tablets, and the dissolution contrast diagram in a medium with pH6.8
FIG. 5: the process is enlarged to 2000, 4000 and 10000 dissolution contrast graphs in an aqueous medium.
Detailed Description
It should be noted that the following detailed description is exemplary and is intended to provide further explanation of the disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.
As described in the background section, the dapoxetine preparation is a constant-release preparation which needs to be taken half an hour to one hour before sexual life, the dosage is 30mg, but side effects such as nervous system symptoms such as headache, dizziness and somnolence and digestive system symptoms such as nausea and diarrhea exist, other adverse effects are rare, and dosage dependence also exists. Clinically, if the effect is not satisfactory enough after 30mg is taken and the side effect is in an acceptable range, the dose can be adjusted to the maximum dose of 60mg, and the curative effect is obvious after 6 times of taking. The medicine needs to be gradually reduced, and needs to be gradually reduced according to the medical advice of a doctor, if the medicine is prepared into a sustained-release preparation, the blood concentration can be maintained in a longer time, the medicine taking frequency is reduced, and the toxic and side effects are reduced, so that the dapoxetine is considered to be prepared into the sustained-release preparation based on the problems.
The sustained release mode is divided into two types, one type is a framework type sustained release pellet, and the other type is a membrane-controlled sustained release pellet. The preparation method is characterized in that a soluble framework material is used as a carrier to prepare the dapoxetine drug-containing pellet, the drug-containing pellet is pressed into a round tablet under proper pressure, and finally, the weight of the coating is increased by 2-5%. The pellet tablet only contains one main component, and the invention is coated on the basis of skeleton slow release, which is a breakthrough in preparation.
The dapoxetine hydrochloride pellet tablet prepared by the invention has the weight of about 200mg, wherein 16.8% of the drug-containing pellet core is dapoxetine hydrochloride, 2-8% of the drug-containing pellet core is disintegrant, 15-35% of hydrophilic gel matrix type slow release material, 1-3% of lubricant, 10-25% of silicified microcrystalline cellulose, and the rest is lactose, and the tablet is coated by ethyl cellulose, and the concentration of the coating solution is as follows: 8% (w/w), the weight gain is 2-5%, the preparation process is wet granulation, and the wetting agent is purified water.
Wherein, the hydrophilic gel skeleton type slow release material is used as a main carrier, hydroxypropyl methylcellulose is mainly used, and the dosage is 15-35%.
The disintegrant can be added internally (added during premixing) or externally (added during total mixing), or externally according to different proportions, wherein the proportion range of the internal addition and the external addition is as follows: 9: 1-1: 3.
Sodium stearyl fumarate is used as lubricant, the dosage of the sodium stearyl fumarate is 1-3%, and the sodium stearyl fumarate can be added internally or externally according to different proportions.
Silicified microcrystalline cellulose and lactose are used as fillers in the sustained-release preparation, the proportion of the silicified microcrystalline cellulose and the lactose is increased or decreased according to the dosage of other materials, the dosage of the silicified microcrystalline cellulose is 10-25 percent, and the rest is the lactose.
The sustained-release preparation can be coated in a sustained-release manner after being tabletted, the coating adopts ethyl cellulose, and the weight increment of the coating is 2-5%.
The sustained-release preparation adopts a wet granulation process and comprises the following steps: premixing, wet granulating, pelletizing, drying, dry granulating, total mixing, tabletting, coating and the like.
The prescription and process are designed, optimized and improved, and are finally shown as follows:
the specific process comprises the following steps:
1. premixing: mixing dapoxetine hydrochloride, croscarmellose sodium, silicified microcrystalline cellulose, hydroxypropyl methylcellulose, lactose and sodium stearyl fumarate for 9 min;
2. and (3) granulating: granulating with pure water for 3 min;
3. wet granulation: carrying out wet granulation by a 16-mesh screen of a swing granulator, and putting the materials into a spheronization device in batches for pelleting;
4. and (3) drying: drying by a fluidized bed, and controlling the water content to be 0.9-2.8%;
5. dry granulation: sieving the dried particles with a 20-mesh sieve for dry granulation;
6. total mixing: adding croscarmellose sodium into the dried granules, mixing for 5min, adding sodium stearyl fumarate, and mixing for 2 min;
7. tabletting: controlling the hardness: 6kgf to 11 kgf;
8. coating: the coating pan is adopted, and the weight gain of the coating is controlled to be 2-5%.
The dapoxetine hydrochloride tablet obtained by the process can generate sustained release within 24 h.
In order to make the technical solutions of the present application more clearly understood by those skilled in the art, the technical solutions of the present application will be described in detail below with reference to specific embodiments.
The test materials used in the examples of the present invention, which were not specifically described, were all those conventional in the art and commercially available.
Example 1:
prescription information is as follows:
specification: 30mg in 1000 tablets.
The preparation process comprises the following steps:
1. premixing: 33.6g of dapoxetine hydrochloride, 6g of croscarmellose sodium, 36g of silicified microcrystalline cellulose, 50g of hydroxypropyl methylcellulose, 64.4g of lactose and 1g of sodium stearyl fumarate, and premixing for 9min in a wet granulating machine at a stirring speed of 300rpm and a shearing speed of 1800 rpm;
2. and (3) granulating: spraying pure water, wherein spraying is required to be completed within 2min, and then granulating for 1 min;
3. wet granulation: carrying out wet granulation by a 16-mesh screen of a wet granule swing granulator, and putting the materials into rounding equipment in batches for pelleting;
4. and (3) drying: the air inlet temperature of the fluidized bed is 50-70 ℃, the material temperature is 35-45 ℃, and the drying is carried out until the water content is 0.9-2.8%;
5. dry granulation: sieving the dried particles with a 20-mesh sieve for dry granulation;
6. total mixing: adding sodium stearyl fumarate and croscarmellose sodium according to the yield of dried granule, mixing for 5min, adding sodium stearyl fumarate, and mixing for 2 min;
7. tabletting: 8mm round punching sheet, hardness control: 6kgf to 11 kgf;
8. coating: about 68g of ethyl cellulose 1000mL of absolute ethanol is prepared into 8% (w/w) of coating solution, the air inlet temperature is 40-65 ℃, the air outlet temperature is 30-40 ℃, the material temperature is 30-37 ℃, and the coating weight is controlled to be increased by 2-5%.
Example 2:
prescription information is as follows:
the batch was 2000 tablets.
The preparation process comprises the following steps:
1. premixing: 67.2g of dapoxetine hydrochloride, 24g of croscarmellose sodium, 104g of silicified microcrystalline cellulose, 120g of hydroxypropyl methylcellulose, 76.8g of lactose and 6g of sodium stearyl fumarate, and premixing for 9min in a wet granulating machine at a stirring speed of 300rpm and a shearing speed of 1800 rpm;
2. and (3) granulating: spraying pure water, wherein spraying is required to be completed within 2min, and then granulating for 1 min;
3. wet granulation: carrying out wet granulation by a 16-mesh screen of a wet granule swing granulator, and putting the materials into rounding equipment in batches for pelleting;
4. and (3) drying: the air inlet temperature of the fluidized bed is 50-70 ℃, the material temperature is 35-45 ℃, and the drying is carried out until the water content is 0.9-2.8%;
5. dry granulation: sieving the dried particles with a 20-mesh sieve for dry granulation;
6. total mixing: adding sodium stearyl fumarate according to the amount of sodium stearyl fumarate converted from yield of dry granule, and mixing for 2 min;
7. tabletting: 8mm round punching sheet, hardness control: 6kgf to 11 kgf;
8. coating: about 68g of ethyl cellulose 1000mL of absolute ethanol is prepared into 8% (w/w) of coating solution, the air inlet temperature is 40-65 ℃, the air outlet temperature is 30-40 ℃, the material temperature is 30-37 ℃, and the coating weight is controlled to be increased by 2-5%.
Example 3:
prescription information is as follows:
the batch was 4000 pieces.
The preparation process comprises the following steps:
1. premixing: 134.4g of dapoxetine hydrochloride, 24g of croscarmellose sodium, 120g of silicified microcrystalline cellulose, 280g of hypromellose, 185.6g of lactose and 4g of sodium stearyl fumarate, and premixing for 9min in a wet granulating machine at a stirring speed of 300rpm and a shearing speed of 1800 rpm;
2. and (3) granulating: spraying pure water, wherein spraying is required to be completed within 2min, and then granulating for 1 min;
3. wet granulation: carrying out wet granulation by a 16-mesh screen of a wet granule swing granulator, and putting the materials into rounding equipment in batches for pelleting;
4. and (3) drying: the air inlet temperature of the fluidized bed is 50-70 ℃, the material temperature is 35-45 ℃, and the drying is carried out until the water content is 0.9-2.8%;
5. dry granulation: sieving the dried particles with a 20-mesh sieve for dry granulation;
6. total mixing: adding sodium stearyl fumarate and croscarmellose sodium according to the yield of dried granule, mixing for 5min, adding sodium stearyl fumarate, and mixing for 2 min;
7. tabletting: 8mm round punching sheet, hardness control: 6kgf to 11 kgf;
8. coating: about 68g of ethyl cellulose 1000mL of absolute ethanol is prepared into 8% (w/w) of coating solution, the air inlet temperature is 40-65 ℃, the air outlet temperature is 30-40 ℃, the material temperature is 30-37 ℃, and the coating weight is controlled to be increased by 2-5%.
Example 4:
prescription information is as follows:
the batch was 10000 tablets.
The preparation process comprises the following steps:
1. premixing: 336g of dapoxetine hydrochloride, 80g of croscarmellose sodium, 400g of silicified microcrystalline cellulose, 540g of hydroxypropyl methylcellulose and 504g of lactose, and premixing for 9min in a wet granulation machine at a stirring speed of 300rpm and a shearing speed of 1800 rpm;
2. and (3) granulating: spraying pure water, wherein spraying is required to be completed within 5min, and then granulating for 3 min;
3. wet granulation: carrying out wet granulation by a 16-mesh screen of a wet granule swing granulator, and putting the materials into rounding equipment in batches for pelleting;
4. and (3) drying: the air inlet temperature of the fluidized bed is 50-70 ℃, the material temperature is 35-45 ℃, and the drying is carried out until the water content is 0.9-2.8%;
5. dry granulation: sieving the dried particles with a 20-mesh sieve for dry granulation;
6. total mixing: adding sodium stearyl fumarate and croscarmellose sodium according to the yield of dried granule, mixing for 5min, adding sodium stearyl fumarate, and mixing for 2 min;
7. tabletting: 8mm round punching sheet, hardness control: 6kgf to 11 kgf;
8. coating: about 68g of ethyl cellulose 1000mL of absolute ethanol is prepared into 8% (w/w) of coating solution, the air inlet temperature is 40-65 ℃, the air outlet temperature is 30-40 ℃, the material temperature is 30-37 ℃, and the coating weight is controlled to be increased by 2-5%.
Test example: dissolution test
According to the national reference formulation catalogue, batch eight specifies: the Dapoxetine Hydrochloride tablet reference preparation is Dapoxetine Hydrochloride Tablets/Priligy (trade name: Bi Li), and the lasting quotient is as follows: Berlin-Chemie AG, an imported drug from the original research. The specification is 30, 60 mg. The dissolution properties of dapoxetine hydrochloride pellets prepared in examples 2 to 4 were examined.
Dissolution test method:
the dissolution medium is specified in detail in the technical guide principle of dissolution test of common oral solid preparations issued by the nation: the volume is generally 500, 900 or 1000mL, the volume of the dissolving medium can best meet the condition of a leak tank, and the aqueous medium with the pH value of 1.2-6.8 is generally adopted. The enzyme-free dissolution medium with pH 1.2 and 6.8 can be used as artificial gastric juice and artificial intestinal juice. In particular cases, dissolution media of high pH may be used, but should generally not exceed pH 8.0. With reference also to FDA regulations, the media selected in the present invention are: pH1.0, pH4.5, pH6.8, water, stirring: paddle method, the rotational speed is: 50rpm, medium volume: 900ml, sample points set to: 0.5h, 1h, 2h, 4h, 6h, 12h and 24 h.
The process scale-up is to the dissolution pair ratios of 2000 tablets, 4000 tablets and 1 ten thousand tablets in dissolution media at different pH as shown in figures 2-5.
The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Claims (10)
1. The dapoxetine hydrochloride pellet tablet is characterized by being prepared from the following raw materials in percentage by weight:
16-17% of dapoxetine hydrochloride, 2-8% of disintegrating agent, 15-35% of hydrophilic gel skeleton type slow release material, 1-3% of lubricant, 10-25% of silicified microcrystalline cellulose and the balance of lactose.
2. The dapoxetine hydrochloride pellet tablet as claimed in claim 1, wherein the pellet tablet is prepared from the following raw materials by weight:
16.8 percent of dapoxetine hydrochloride, 6 percent of disintegrant, 25 percent of hydrophilic gel skeleton type slow-release material, 2 percent of lubricant, 18 percent of silicified microcrystalline cellulose and 32.2 percent of lactose.
3. The dapoxetine hydrochloride pellet tablet of claim 1 or 2, wherein the hydrophilic gel-matrix slow release material is hypromellose.
4. Dapoxetine hydrochloride pellets according to claim 1 or 2, wherein the lubricant is sodium stearyl fumarate.
5. A process for preparing dapoxetine hydrochloride pellets according to any of claims 1 to 4, comprising the steps of:
(1) premixing dapoxetine hydrochloride, a hydrophilic gel skeleton type slow-release material, silicified microcrystalline cellulose, lactose, part of a disintegrating agent and part of a lubricating agent to obtain a premix;
(2) granulating the premix, performing wet granulation, pelleting, and drying to obtain dry granules;
(3) dry granulating the dry granules, and then adding the rest disintegrating agent and lubricant for total mixing;
(4) tabletting the totally mixed materials;
(5) and (4) coating the tabletted tablets to obtain the dapoxetine hydrochloride micro-pill tablets.
6. The method according to claim 5, wherein in the step (1), the stirring speed during the premixing is 400rpm, the shearing speed is 2100rpm and the premixing time is 8-10 min.
7. The method according to claim 5, wherein in the step (2), the pelletization is carried out using a spheronization apparatus.
8. The preparation method according to claim 5, wherein the mass ratio of the disintegrant added in step (1) to the disintegrant added in step (3) is 9:1 to 1: 3; the mass ratio of the lubricant added in the step (1) to the lubricant added in the step (3) is (0-3): (6-3).
9. The process according to claim 5, wherein in the step (4), the hardness is controlled to 6kgf to 11kgf in the tableting.
10. The preparation method according to claim 5, wherein in the step (5), the ethanol solution of ethyl cellulose is used as the coating material, and the coating treatment conditions are as follows: the air inlet temperature is 40-65 ℃, the air outlet temperature is 30-40 ℃, the material temperature is 30-37 ℃, and the weight gain of the coating is controlled to be 2-5 percent by the coating.
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| CN202110493102.1A CN113181127A (en) | 2021-05-07 | 2021-05-07 | Preparation method of dapoxetine hydrochloride pellet tablets |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1387432A (en) * | 1999-09-03 | 2002-12-25 | 伊莱利利公司 | Methods of sing rapid-onset selective serotonin reuptake inhibitors for treating sexual dysfnction |
| WO2010112203A1 (en) * | 2009-03-31 | 2010-10-07 | Ratiopharm Gmbh | Pills comprising dapoxetin and dry processing methods for the production thereof |
| CN104739773A (en) * | 2013-12-26 | 2015-07-01 | 鲁南贝特制药有限公司 | Dexibuprofen slow release pellet and preparation method thereof |
| CN107536821A (en) * | 2016-06-29 | 2018-01-05 | 康普药业股份有限公司 | A kind of dapoxetine hydrochloride sustained release preparation |
| CN111265489A (en) * | 2020-03-10 | 2020-06-12 | 乐普制药科技有限公司 | Divisible acarbose pellet sustained-release tablet |
-
2021
- 2021-05-07 CN CN202110493102.1A patent/CN113181127A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1387432A (en) * | 1999-09-03 | 2002-12-25 | 伊莱利利公司 | Methods of sing rapid-onset selective serotonin reuptake inhibitors for treating sexual dysfnction |
| WO2010112203A1 (en) * | 2009-03-31 | 2010-10-07 | Ratiopharm Gmbh | Pills comprising dapoxetin and dry processing methods for the production thereof |
| CN104739773A (en) * | 2013-12-26 | 2015-07-01 | 鲁南贝特制药有限公司 | Dexibuprofen slow release pellet and preparation method thereof |
| CN107536821A (en) * | 2016-06-29 | 2018-01-05 | 康普药业股份有限公司 | A kind of dapoxetine hydrochloride sustained release preparation |
| CN111265489A (en) * | 2020-03-10 | 2020-06-12 | 乐普制药科技有限公司 | Divisible acarbose pellet sustained-release tablet |
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