CN113143879A - Preparation method of dapoxetine hydrochloride sustained release tablet - Google Patents
Preparation method of dapoxetine hydrochloride sustained release tablet Download PDFInfo
- Publication number
- CN113143879A CN113143879A CN202110493111.0A CN202110493111A CN113143879A CN 113143879 A CN113143879 A CN 113143879A CN 202110493111 A CN202110493111 A CN 202110493111A CN 113143879 A CN113143879 A CN 113143879A
- Authority
- CN
- China
- Prior art keywords
- sustained release
- dapoxetine hydrochloride
- dapoxetine
- release
- release tablet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Classifications
-
- 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
-
- 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
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
Abstract
The invention discloses a preparation method of dapoxetine hydrochloride sustained release tablets, and belongs to the field of pharmaceutical preparations. The dapoxetine hydrochloride sustained release tablet is prepared from the following raw materials in percentage by weight: 30-34% of dapoxetine hydrochloride, 2-5% of disintegrant, 5-15% of framework type slow-release material, 1-3% of glidant and 43.4-58.4% of filler. The invention adopts insoluble framework material as a framework carrier to prepare the dapoxetine sustained-release particles, then the sustained-release particles are pressed into round tablets by proper pressure, and finally the coating is carried out, wherein the weight of the coating is increased by 2-5%. The dapoxetine hydrochloride sustained release tablet prepared by the invention has stable process, can well play a sustained release role, is stable in release within 24 hours, has no phenomena of burst release and difficult dissolution, has good results after being amplified to 2-4 ten thousand tablets, and meets the requirements.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of dapoxetine hydrochloride sustained-release tablets.
Background
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:
the drugs were widely used in the early days for the treatment of depression and related affective disorders, and in recent years mainly for the treatment of male sexual dysfunction. Namely, the reuptake of 5-HT is blocked, so that the 5-HT available for living beings in the gap of the nerve synapse is increased, thereby prolonging the ejaculation latency period and achieving the purpose of delaying the ejaculation time and treating premature ejaculation.
Dapoxetine was first developed by Elililyand company, USA, and later on, Qiangsheng, USA purchased its patent right and developed as a medicine for treating premature ejaculation. Dapoxetine from Janssen-Cilag, hansen, johnson, 2009, has gained a license in finland and sweden in europe, and countries that are currently approved for marketing also austria, spain, italy, and portugal, among others. The united states has not yet approved for marketing.
According to the survey results of '2013 Asia Pacific sexual behavior and sexual satisfaction survey report', men occupying about one third of the total number of adult men suffer from premature ejaculation with different degrees. At present, the number of adult male is about 4.6 hundred million, and analysis shows that the number of adult male premature ejaculation patients is about more than 1.5 hundred million in China. Of these adult male patients with premature ejaculation, 89% indicate that the cause of premature ejaculation affects the chaperone relationship. However, 76% of the population did not receive clinical knowledge guidance regarding premature ejaculation. However, more and more male siblings now recognize that premature ejaculation can be treated by drugs.
The product is not collected and carried by any national pharmacopoeia at present; the product on the market at present is a German Berlin-ChemieAG tablet, and the specification is 30 and 60 mg.
Dapoxetine hydrochloride is currently a common tablet, 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 up to 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 a dapoxetine hydrochloride sustained release tablet.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention provides a dapoxetine hydrochloride sustained release tablet, which is prepared from the following raw materials in percentage by weight:
30-34% of dapoxetine hydrochloride, 2-5% of disintegrant, 5-15% of framework type slow-release material, 1-3% of glidant and 43.4-58.4% of filler.
Preferably, the dapoxetine hydrochloride sustained release tablet is prepared from the following raw materials in percentage by weight:
33.6% of dapoxetine hydrochloride, 4% of disintegrant, 10% of framework type slow-release material, 2% of glidant and 50.4% of filler.
Preferably, the disintegrant is selected from one or more of croscarmellose sodium, starch or sodium carboxymethyl starch.
Preferably, the skeleton type slow release material is selected from a hydrophilic gel skeleton, a bioerodible skeleton or an insoluble skeleton; the hydrophilic gel skeleton is one or more of hydroxypropyl methylcellulose, carbomer, sodium alginate, methylcellulose and sodium carboxymethylcellulose, the bioerodible skeleton is a waxy material, a gastric-soluble or enteric-soluble material, and the insoluble skeleton is ethyl cellulose or permeable acrylic resin.
More preferably, the skeleton-type sustained-release material is ethyl cellulose. The invention is based on the characteristic that the ethyl cellulose has water insolubility, and the ethyl cellulose can play double slow release roles of skeleton (main effect) and membrane control (secondary effect) on drug release while forming an insoluble skeleton. Therefore, ethyl cellulose is preferred as the main key sustained release excipient.
Preferably, the glidant is selected from one or more of silicon dioxide, magnesium stearate, aerosil, talcum powder, hydrogenated vegetable oil and polyethylene glycol.
Preferably, the filler is selected from one or more of lactose, starch, powdered sugar, dextrin, milk essence, compressible starch, microcrystalline cellulose and inorganic salts.
The second aspect of the invention provides a preparation method of the dapoxetine hydrochloride sustained release tablet, which comprises the following steps:
(1) premixing dapoxetine hydrochloride, a disintegrating agent, a filling agent and a part of framework type slow-release material to obtain a premix;
(2) dissolving the rest of the skeleton type slow-release material with water to prepare a solution, spraying the solution into the premix, and granulating;
(3) granulating, and performing wet granulation and drying to obtain dry granules;
(4) dry finishing the dry granules, and adding a flow aid and a filling agent for total mixing;
(5) tabletting the totally mixed materials;
(6) and (3) coating the tabletted tablets to obtain the dapoxetine hydrochloride sustained release tablets.
Preferably, in the step (1), the stirring speed during premixing is 300-400rpm, and the shearing speed is 1800-2100 rpm.
Preferably, in the step (3), the drying conditions are as follows: the air inlet temperature of the fluidized bed is 60 ℃, the material temperature is 35-45 ℃, and the drying is carried out until the water content is 2.0-3.0%.
Preferably, in the step (5), the hardness is controlled to 4kgf to 10kgf during tabletting.
Preferably, in the step (6), the coating treatment conditions are as follows: the air inlet temperature is 55 ℃, the air outlet temperature is 35-40 ℃, the material temperature is 38-42 ℃, and the weight gain of the coating is controlled to be 2-5 percent.
The invention has the beneficial effects that:
the dapoxetine hydrochloride sustained release tablet prepared by the invention has stable process, can well play a sustained release role, is stable in release within 24 hours, has no phenomena of burst release and difficult dissolution, has good results after being amplified to 2-4 ten thousand tablets, and meets the requirements; the dapoxetine hydrochloride sustained release tablet prepared by the invention can provide stable and lasting effective blood concentration, avoid or reduce peak valley phenomenon, effectively improve the use safety of the medicine and reduce the adverse reaction of the medicine.
Drawings
FIG. 1: dissolution contrast profiles (ph1.0 medium) for the reference formulation and the home-made sustained release formulation of the invention.
FIG. 2: the process is enlarged to a dissolution contrast diagram of 2 ten thousand pieces and 4 ten thousand pieces of medium with pH1.0.
FIG. 3: the process is enlarged to a dissolution contrast diagram in 2 ten thousand pieces and 4 ten thousand pieces of medium with pH 4.5.
FIG. 4: the process is enlarged to a dissolution contrast diagram in 2 ten thousand pieces and 4 ten thousand pieces of medium with pH value of 6.8.
FIG. 5: the process is enlarged to a dissolution contrast diagram in 2 ten thousand pieces and 4 ten thousand pieces of 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 invention develops the sustained-release tablet which can slowly release the medicine and achieve the drug effect in a prolonged period of time.
The weight of the dapoxetine hydrochloride sustained release tablet is about 100-110 mg, wherein the dapoxetine hydrochloride sustained release tablet comprises 30-34% of dapoxetine hydrochloride, 2-5% of a disintegrating agent, 5-15% of a framework type sustained release material, 1-3% of a glidant and 43.4-58.4% of a filling agent.
Matrix-type sustained release materials include, but are not limited to, other materials such as: hydrophilic gel skeleton (such as hypromellose, carbomer, sodium alginate, methylcellulose, sodium carboxymethylcellulose, etc. of different specifications), bioerodible skeleton (waxy material, gastric soluble or enteric soluble material), and insoluble skeleton (ethyl cellulose, permeable acrylic resin, etc.). The wetting agent can be added in a dry powder form during premixing, or can be added in a partial dry powder form during premixing, wherein the partial wetting agent is dissolved in the wetting agent, and the adding proportion of the dry powder is 0-100%.
The dosage of the disintegrant is 2-5%, including but not limited to dry starch, sodium carboxymethyl starch and the like, the disintegrant can be added in whole or added in proportion (added in premixing) and added in addition (added in total mixing), and the range of the internal and external addition proportion is as follows: 5: 1-1: 5.
The amount of the glidant is 1-3%, and the glidant is added during total mixing, and the glidant comprises but is not limited to magnesium stearate, aerosil, talcum powder, hydrogenated vegetable oil, polyethylene glycol and the like.
The amount of the filler is 43.4-58.4%, and the filler comprises but is not limited to starch, powdered sugar, dextrin, milk essence, compressible starch, microcrystalline cellulose, inorganic salts and the like.
The coating adopts a conventional film coating premix, and the weight increase of the coating is 2 to 5 percent.
Adopts a wet granulation process, and comprises the following steps: premixing, wet granulation, drying, dry granulation, total mixing, tabletting, coating and the like.
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:
specification: 30mg in 1000 tablets. Prescription information is as follows:
the preparation process comprises the following steps:
1. premixing: 33.6g of dapoxetine hydrochloride raw material, 4g of croscarmellose sodium, 10g of ethyl cellulose and 44.4g of lactose, and premixing for 7min in a wet granulation machine at a stirring speed of 300rpm and a shearing speed of 1800 rpm;
2. and (3) granulating: dissolving 5g of ethyl cellulose in 18g of purified water to prepare a solution, spraying the solution into the premix, and granulating for 4min after spraying is finished within 1 min;
3. wet granulation: carrying out wet granulation by a 20-mesh screen of a wet granule swing granulator;
4. and (3) drying: the air inlet temperature of the fluidized bed is 60 ℃, the material temperature is 35-45 ℃, and the drying is carried out until the water content is 2.0-3.0%;
5. dry granulation: sieving the dried particles with a 20-mesh sieve for dry granulation;
6. total mixing: converting the yield of the dried granules into the amount of the added silicon dioxide and the croscarmellose sodium, and manually mixing for 10 min;
7. tabletting: 6.5mm round punch piece, hardness control: 4kgf to 10 kgf;
8. coating: the air inlet temperature is 55 ℃, the air outlet temperature is 35-40 ℃, the material temperature is 38-42 ℃, and the weight gain of the coating is controlled to be 2-5 percent.
Example 2:
prescription information is as follows:
the batch is 20000 tablets.
The preparation process comprises the following steps:
1. premixing: 672g of dapoxetine hydrochloride raw material, 20g of croscarmellose sodium, 200g of ethyl cellulose and 1008g of lactose, and premixing for 7min in a wet granulation machine at a stirring speed of 400rpm and a shearing speed of 2100 rpm;
2. and (3) granulating: dissolving 20g of ethyl cellulose in 360g of purified water to prepare a solution, adding the solution by spraying, and granulating for 3min after spraying is finished within 3 min;
3. wet granulation: carrying out wet granulation by a 20-mesh screen of a wet granule swing granulator;
4. and (3) drying: the air inlet temperature of the fluidized bed is 60 ℃, the material temperature is 35-45 ℃, and the drying is carried out until the water content is 2.0-3.0%;
5. dry granulation: sieving the dried particles with a 20-mesh sieve for dry granulation;
6. total mixing: converting the yield of the dried granules into the amount of the added silicon dioxide and the croscarmellose sodium, and mixing for 10min by a three-dimensional mixer;
7. tabletting: 6.5mm round punch piece, hardness control: 4kgf to 10 kgf;
8. coating: the air inlet temperature is 55 ℃, the air outlet temperature is 35-40 ℃, the material temperature is 38-42 ℃, and the weight gain of the coating is controlled to be 2-5 percent.
Example 3:
prescription information is as follows:
the batch was 40000 tablets.
The preparation process comprises the following steps:
1. premixing: 1344g of dapoxetine hydrochloride raw material, 160g of croscarmellose sodium, 200g of ethyl cellulose and 2056g of lactose, and premixing for 7min in a wet granulating machine at a stirring speed of 400rpm and a shearing speed of 2100 rpm;
2. and (3) granulating: dissolving 120g of ethyl cellulose in 720g of purified water to prepare a solution, adding the solution by spraying, and granulating for 3min after spraying is finished within 3 min;
3. wet granulation: carrying out wet granulation by a 20-mesh screen of a wet granule swing granulator;
4. and (3) drying: the air inlet temperature of the fluidized bed is 60 ℃, the material temperature is 35-45 ℃, and the drying is carried out until the water content is 2.0-3.0%;
5. dry granulation: sieving the dried particles with a 20-mesh sieve for dry granulation;
6. total mixing: converting the yield of the dried granules into the amount of the added silicon dioxide and the croscarmellose sodium, and mixing for 10min by a three-dimensional mixer;
7. tabletting: 6.5mm round punch piece, hardness control: 4kgf to 10 kgf;
8. coating: the air inlet temperature is 55 ℃, the air outlet temperature is 35-40 ℃, the material temperature is 38-42 ℃, and the weight gain of the coating is controlled to be 2-5 percent.
Test example: dissolution test
According to the national reference formulation catalogue, batch eight specifies: the Dapoxetine hydrochloride tablet reference preparation is Dapoxetine hydrochloride tables/Priligy (trade name: Bi Li), and the lasting quotient is as follows: Berlin-ChemieAG, an imported drug from the original research. The specification is 30, 60 mg. The dissolution properties of the sustained-release preparations prepared in examples 1 to 3 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 pH1.2 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 generally should 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 dissolution pair of the reference formulation and the home-made sustained release formulation of the present invention is shown in fig. 1; the process is enlarged to the dissolution ratio of 2 ten thousand pieces and 4 ten thousand pieces in dissolution media with different pH values 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 sustained release tablet is characterized by being prepared from the following raw materials in percentage by weight:
30-34% of dapoxetine hydrochloride, 2-5% of disintegrant, 5-15% of framework type slow-release material, 1-3% of glidant and 43.4-58.4% of filler.
2. The dapoxetine hydrochloride sustained release tablet of claim 1, wherein the dapoxetine hydrochloride sustained release tablet is prepared from the following raw materials in percentage by weight:
33.6% of dapoxetine hydrochloride, 4% of disintegrant, 10% of framework type slow-release material, 2% of glidant and 50.4% of filler.
3. The dapoxetine hydrochloride sustained release tablet of claim 1 or 2, wherein the disintegrant is selected from one or more of croscarmellose sodium, starch, or sodium carboxymethyl starch.
4. The dapoxetine hydrochloride sustained release tablet of claim 1 or 2, wherein the matrix-type sustained release material is selected from a hydrophilic gel matrix, a bioerodible matrix, or an insoluble matrix; the hydrophilic gel skeleton is one or more of hydroxypropyl methylcellulose, carbomer, sodium alginate, methylcellulose and sodium carboxymethylcellulose, the bioerodible skeleton is a waxy material, a gastric-soluble or enteric-soluble material, and the insoluble skeleton is ethyl cellulose or permeable acrylic resin.
5. The dapoxetine hydrochloride sustained release tablet of claim 1 or 2, wherein the matrix-type sustained release material is ethylcellulose.
6. The preparation method of the dapoxetine hydrochloride sustained release tablet of any one of claims 1 to 5, comprising the steps of:
(1) premixing dapoxetine hydrochloride, a disintegrating agent, a filling agent and a part of framework type slow-release material to obtain a premix;
(2) dissolving the rest of the skeleton type slow-release material with water to prepare a solution, spraying the solution into the premix, and granulating;
(3) granulating, and performing wet granulation and drying to obtain dry granules;
(4) dry finishing the dry granules, and adding a flow aid and a filling agent for total mixing;
(5) tabletting the totally mixed materials;
(6) and (3) coating the tabletted tablets to obtain the dapoxetine hydrochloride sustained release tablets.
7. The method according to claim 6, wherein in the step (1), the stirring speed during the premixing is 400rpm and the shearing speed is 2100rpm and 300 rpm.
8. The production method according to claim 6, wherein in the step (3), the drying conditions are: the air inlet temperature of the fluidized bed is 60 ℃, the material temperature is 35-45 ℃, and the drying is carried out until the water content is 2.0-3.0%.
9. The process according to claim 6, wherein in the step (5), the hardness is controlled to 4kgf to 10kgf during tabletting.
10. The method according to claim 6, wherein in the step (6), the coating treatment conditions are as follows: the air inlet temperature is 55 ℃, the air outlet temperature is 35-40 ℃, the material temperature is 38-42 ℃, and the weight gain of the coating is controlled to be 2-5 percent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110493111.0A CN113143879A (en) | 2021-05-07 | 2021-05-07 | Preparation method of dapoxetine hydrochloride sustained release tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110493111.0A CN113143879A (en) | 2021-05-07 | 2021-05-07 | Preparation method of dapoxetine hydrochloride sustained release tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113143879A true CN113143879A (en) | 2021-07-23 |
Family
ID=76873585
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110493111.0A Pending CN113143879A (en) | 2021-05-07 | 2021-05-07 | Preparation method of dapoxetine hydrochloride sustained release tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113143879A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115531405A (en) * | 2022-09-08 | 2022-12-30 | 江苏集萃新型药物制剂技术研究所有限公司 | Compound pharmaceutical composition for treating male diseases and preparation method and application thereof |
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 |
| US20120178810A1 (en) * | 2006-09-11 | 2012-07-12 | Tailor Prakash Boya | Extended release formulation of an antiepileptic agent |
| CN102958513A (en) * | 2010-07-06 | 2013-03-06 | 株式会社那笔制药 | Time-delayed sustained release pharmaceutical composition comprising dapoxetine for oral administration |
| CN106580905A (en) * | 2016-11-30 | 2017-04-26 | 江苏恒瑞医药股份有限公司 | Tapentadol slow-release pharmaceutical composition 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 |
-
2021
- 2021-05-07 CN CN202110493111.0A patent/CN113143879A/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 |
| US20120178810A1 (en) * | 2006-09-11 | 2012-07-12 | Tailor Prakash Boya | Extended release formulation of an antiepileptic agent |
| CN102958513A (en) * | 2010-07-06 | 2013-03-06 | 株式会社那笔制药 | Time-delayed sustained release pharmaceutical composition comprising dapoxetine for oral administration |
| 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 |
| CN106580905A (en) * | 2016-11-30 | 2017-04-26 | 江苏恒瑞医药股份有限公司 | Tapentadol slow-release pharmaceutical composition and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115531405A (en) * | 2022-09-08 | 2022-12-30 | 江苏集萃新型药物制剂技术研究所有限公司 | Compound pharmaceutical composition for treating male diseases and preparation method and application thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US20110071137A1 (en) | Process for preparing sustained release tablets | |
| CN111840239B (en) | Pregabalin sustained release preparation | |
| KR20060120596A (en) | Novel formulation of ropinirole | |
| AU2008262031A1 (en) | Extended release formulation of nevirapine | |
| CN112472679A (en) | Double-release tablet and preparation method thereof | |
| WO2006123213A1 (en) | Modified release formulations of gliclazide | |
| CN113143879A (en) | Preparation method of dapoxetine hydrochloride sustained release tablet | |
| WO2007080776A1 (en) | Sustained release preparation and method for production thereof | |
| CN102755310A (en) | Composition drug preparation containing levodopa | |
| CN101164532A (en) | Duloxetine hydrochloride sustained release medicine | |
| EP1589957A1 (en) | Pharmaceutical compositions and process of production thereof | |
| CA3107945A1 (en) | Immediate release formulation of a triple combination of active pharmaceutical ingredients useful in the treatment of polycystic ovary syndrome | |
| US20100272794A1 (en) | Pharmaceutical composition of memantine | |
| AU2018301924B2 (en) | Pharmaceutical compositions | |
| TW202143959A (en) | A febuxostat tablet | |
| EP2593081B1 (en) | Ferrimannitol-ovalbumin tablet composition | |
| CN111346066A (en) | Sustained release preparation containing piracetam | |
| CN113181127A (en) | Preparation method of dapoxetine hydrochloride pellet tablets | |
| KR102189200B1 (en) | Release controlled oral dosage form comprising itopride | |
| KR102189191B1 (en) | Once a day oral dosage sustained-release formulation comprising itopride | |
| KR102210422B1 (en) | Sustained-release formulation comprising itopride using parameters for release control | |
| CN116850153B (en) | Pregabalin pharmaceutical composition and preparation method thereof | |
| JP2017214352A (en) | High load and controlled release magnesium oral dosage form, and method for producing and using the same | |
| CN108066347B (en) | Orally disintegrating tablet pharmaceutical composition comprising tamsulosin and dutasteride | |
| CN114652693A (en) | Riluzole sustained-release tablet and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |