CN103054820B - A kind of Dronedarone hydrochloride pharmaceutical composition and preparation method thereof - Google Patents
A kind of Dronedarone hydrochloride pharmaceutical composition and preparation method thereof Download PDFInfo
- Publication number
- CN103054820B CN103054820B CN201210302793.3A CN201210302793A CN103054820B CN 103054820 B CN103054820 B CN 103054820B CN 201210302793 A CN201210302793 A CN 201210302793A CN 103054820 B CN103054820 B CN 103054820B
- Authority
- CN
- China
- Prior art keywords
- dronedarone hydrochloride
- pharmaceutical composition
- mannitol
- dronedarone
- parts
- 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.)
- Active
Links
Abstract
The invention provides a kind of be suitable for sublingual administration, can rapid-onset and the Dronedarone hydrochloride pharmaceutical composition of bioavailability and curative effect is greatly improved.This pharmaceutical composition is made up of dronedarone hydrochloride 5 65 parts, disintegrating agent 1 10 parts, filler 10 80 parts, antacid 0.5 3 parts, correctives 05 parts, binding agent 1 10 parts and lubricant 0.3 2 parts.Invention also provides the preparation method of applicable industrialized production.Dronedarone hydrochloride pharmaceutical composition of the present invention is directly absorbed by hypoglossis mucous membrane, it is to avoid the first pass effect of oral drugs, it is to avoid gastrointestinal tract enzymolysis, acidolysis etc., makes bioavailability be greatly improved.And the non-keratinization of sublingual mucosal epithelium, surface area is big, and penetrating power is strong.After administration, medicine absorbs rapidly, and onset is rapid, easy to use；Than other drug-delivery preparation convenient drug administration, patient compliance is good.
Description
Technical field
The invention belongs to field of medicaments, particularly to a kind of Dronedarone hydrochloride pharmaceutical composition and preparation method.
Background technology
The chemical entitled N-of dronedarone (Dronedarone) [2-butyl-3-[4-[3-(dibutylamino) propoxyl group] benzoyl]-5-benzofuranyl] Methanesulfomide benzofuran, molecular formula C31H44N2O5S, molecular weight 593.22. chemical formula is as follows:
Dronedarone hydrochloride is the treatment antiarrhythmic medicament developed by Sanofi-Aventis.This product is the benzofuran derivative without iodine, and structure with feature with iodine amine ketone seemingly, but does not contains iodine, and lipotropy is low, takes rear phospholipid and will not be deposited on pulmonary, so the outer untoward reaction of cardiovascular system is fewer than iodine amine ketone, clinical tolerability is good.This product half-life is 1-2 days, is more conducive to adjust drug dose.
Dronedarone hydrochloride dissolubility in water-bearing media is the lowest, and particularly its dissolubility at room temperature becomes pH value dependency.Having the dissolubility of maximum, about 1-2mg/ml in the range of pH value 3-5, dissolve hardly when the dissolution medium of pH1.0, pH2.0, the most about 10-30 μ g/ml, the dissolubility under pH7.0 only has 10 μ g/ml.Due to this characteristic, the bioavailability causing its gastrointestinal administration is low, although because medicine dissolubility under one's belt is preferable, but will be unable to dissolution from solid preparation after entering intestinal.For improving the bioavailability of dronedarone hydrochloride, it is necessary to find the approach that can improve its dissolution.
WO9858643 discloses a kind of solid composite medicament containing benzofuran derivatives, it finds poloxamer class nonionic surfactant and dronedarone or its hydrochlorate, this active component can be made to keep in pH neutral 6-7 without separating out precipitation, improve the bioavailability of dronedarone hydrochloride.
CN101152154A discloses a kind of solid composite medicament, wherein contains micronized dronedarone hydrochloride, surfactant (sodium lauryl sulfate) and the hydrophilic polymer as cosolvent.
CN101039657A discloses a kind of pharmaceutical composition containing solid dispersion, this dispersion contains at least one active principle and contains (i) and mixture (ii) at pharmaceutically acceptable polymeric matrix: (i) in the polydextrose of continuous polydextrose phase form, the (ii) polymer of at least one continuous phase form in this polymer in addition to polydextrose.
CN102188417A invention relates to dronedarone medicinal composition, it is characterized in that it contains for treating ARR dronedarone or its pharmaceutically acceptable salt as active component, a kind of pharmaceutically acceptable amphipathic lipids surfactant and phospholipid, optional be combined with one or more medicated premixs.
CN102078307A discloses a kind of Dronedarone hydrochloride pharmaceutical composition, this product is dispersible tablet, said preparation is the tablet will made with adjuvant again after dronedarone hydrochloride solid dispersion technology micronization processes, this product improves the dissolubility of principal agent, promote the fater disintegration of medicine, with entering to add absorbability in blood, improve the bioavailability of principal agent.
Medicine exists in gastrointestinal tract in solid form, and dissolubility is low, and just can not well be absorbed by the body entrance blood, so that bioavailability is low, does not reaches curative effect.
Above technology is for increasing the dissolubility of dronedarone, and studies and show, dronedarone is oral can well be absorbed.No matter the main cause affecting bioavailability is between 1-4 hour after oral drugs of what its blood plasma peak time of species at all, once being absorbed, dronedarone can experience a first pass effect, thus causes its absolute bioavailability low.Therefore gastrointestinal administration mode all can not solve the problem that oral bioavailability rate is low at all, and develop into parenteral routes and can solve this problem.
First pass effect, refers to that some drugs, through gastrointestinal administration, before being not yet absorbed into blood circulation, is metabolized at intestinal mucosa and liver, and makes the phenomenon that the original shape dose of entrance blood circulation reduces, the also referred to as first pass effect.After some drugs is oral after being stood by intestinal mucosa and liver to inactivate metabolism, the dose of entrance body circulation reduces, drug effect reduces effect.Make the phenomenon that drug influence creates a difference the most significant because route of administration is different.
Parenteral administration can avoid first-pass effect such as injection, subcutaneous or sublingual administration.
US20040044070 discloses the injection of dronedarone hydrochloride.This invention adds beta-cyclodextrin derivative in buffer system (PH3-5), improves the dissolubility of effective ingredient from face.But the method for this raising dronedarone hydrochloride dissolubility, manufacture process is complicated, and cost is high and less stable.
Summary of the invention
The deficiency existed for prior art, it is an object of the invention to provide a kind of sublingual administration that is suitable for, it is possible to rapid-onset, the Dronedarone hydrochloride pharmaceutical composition of bioavailability and curative effect is greatly improved.
The Dronedarone hydrochloride pharmaceutical composition of the present invention, is prepared from by dronedarone hydrochloride 5-65 part, disintegrating agent 1-10 part, filler 10-80 part, correctives 0.5-5 part, binding agent 1-10 part and lubricant 0.3-2 part.
Preferred version is: described pharmaceutical composition is prepared from by dronedarone hydrochloride 5-65 part, disintegrating agent 1-10 part, filler 10-80 part, antacid 0.5-3 part, correctives 0.5-5 part, binding agent 1-10 part, lubricant 0.3-2 part.
More preferably scheme is: described pharmaceutical composition is prepared from by dronedarone hydrochloride 20-50 part, disintegrating agent 1-5 part, filler 30-55 part, antacid 1.5-2.5 part, correctives 1-3 part, binding agent 1-6 part and lubricant 0.3-1 part.
Most preferably scheme is: described pharmaceutical composition is prepared from by dronedarone hydrochloride 38-40 part, disintegrating agent 2-5 part, filler 40-45 part, antacid 2 parts, correctives 1.5-2 part, binding agent 4-5 part and lubricant 0.5-0.8 part.
The mixture of any one or more in the present invention, in described disintegrating agent preferably microcrystalline cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl methylcellulose, starch, tween, sodium lauryl sulphate.
The mixture of any one or more in described filler preferably microcrystalline cellulose, microcrystalline Cellulose-mannitol, microcrystalline Cellulose-micropowder silica gel, lactose, starch, modified starch-1500, mannitol, sorbitol, xylitol, erythrose, pregelatinized Starch, Icing Sugar, glucose, dextrin, calcium sulfate.
Described antacid includes any inorganic or organic acid, presented in free acid, anhydride or hydrochlorate.Preferably citric acid, ascorbic acid, lactic acid, tartaric acid, malic acid, fumaric acid, adipic acid, succinic acid, glycolic acid, aminoacid, and derivant etc..Present inventors discovered unexpectedly that, prescription adds antacid, can effectively improve the absorption of dronedarone hydrochloride sublingual administration, thus improve bioavailability.
The preferred stevioside of described correctives, Icing Sugar, Liquoride sugar element, Aspartane, sucralose, cyclamate, Talin, the mixture of any one or more of saccharin.
The mixture of any one or more in the preferred purified water of described binding agent, ethanol, starch slurry, hydroxypropyl first methylcellulose, polyvinylpyrrolidone, carbomer, dextrin, gelatine size, mucialga of arabic gummy, sodium alginate and syrup.
The mixture of any one or more in the preferred stearic acid of described lubricant, magnesium stearate, calcium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycol 6000, Macrogol 4000, sodium lauryl sulphate, fumaric acid sodium stearate；
A kind of Dronedarone hydrochloride pharmaceutical composition that the present invention provides, is preferably administered by sublingual administration mode.The Dronedarone hydrochloride pharmaceutical composition that the present invention provides, by sublingual administration mode, without first pass effect, improves bioavailability and the curative effect of medicine；The effect of having immediate effect, it is possible to discharge rapidly active component and absorbed immediately.
The Dronedarone hydrochloride pharmaceutical composition (sublingual administration) that the present invention provides, compare through carrying out vivo biodistribution availability with Yuan Yan producer commercialized product dronedarone hydrochloride sheet (Oral Gastrointestinal Tract absorption), pharmaceutical composition dosage of the present invention is significantly less than listing tablet, and bioavailability and commercialized product quite or are better than commercialized product.
Invention also provides the preparation method of a kind of Dronedarone hydrochloride pharmaceutical composition so that the smooth industrialized production of Dronedarone hydrochloride pharmaceutical composition sheet of the present invention.
It is characterized in that comprising the steps:
(1) binding agent and antacid are dissolved in suitable quantity of water prepare binder solution；
(2) principal agent dronedarone hydrochloride, filler, disintegrating agent, correctives, lubricant are dried, pretreatment of sieving；
(3) by pretreated principal agent, filler, disintegrating agent, correctives mix homogeneously；
(4) being added by binder solution in the above-mentioned material of mixing, make soft material, pelletize, 40-60 DEG C is dried；
(5) dry granule adds lubricant mixing, then tabletting obtains finished product.
Preferred version is: sieve as by 60 mesh sieves in described step (2)；In step (4), baking temperature is 50 DEG C.
The Dronedarone hydrochloride pharmaceutical composition that the present invention provides is not limited to use method made above to prepare; such as; after one or both in binding agent and antacid are sieved; can directly mix with other supplementary material; use water as wetting agent to pelletize, be not required to prepare binder solution, in addition; in above-mentioned preparation method, method of granulating can be in the way of using dry granulation or fluidized bed granulation.Dronedarone hydrochloride pharmaceutical composition of the present invention can also be realized by direct powder compression or compressing dry granulation, also first dronedarone hydrochloride can be prepared as solid dispersion or clathrate, then be prepared as the Dronedarone hydrochloride pharmaceutical composition of sublingual absorption.
Dronedarone hydrochloride pharmaceutical composition of the present invention is directly absorbed by hypoglossis mucous membrane, it is to avoid the first pass effect of oral drugs, it is to avoid gastrointestinal tract enzymolysis, acidolysis etc., makes bioavailability be greatly improved.And the non-keratinization of sublingual mucosal epithelium, surface area is big, and penetrating power is strong.Hypoglossis mucous membrane has a large amount of blood capillary to collect to internal jugular vein, is directly entered blood circulation through superior vena cava, and after administration, medicine absorbs rapidly, and onset is rapid, easy to use.And than other non-oral administration preparation convenient drug administration, patient compliance is good.
Accompanying drawing explanation
Fig. 1 present invention prepares product and listing ordinary tabletBlood concentration-time curve chart
Wherein, 1 is ordinary tablet, and 2 is to be the product that obtains of the present invention.
Detailed description of the invention
Below embodiment is all with the gauge of 1000.
Embodiment 1:
Preparation prescription: dronedarone hydrochloride 5g, lactose 40g, mannitol 40g, crospolyvinylpyrrolidone 5g, lactic acid 0.5g, stevioside 5g, Macrogol 4000 lg, polyvinylpyrrolidone 2g.
Concrete preparation method is as follows: carries out principal agent, filler lactose, mannitol, disintegrating agent crospolyvinylpyrrolidone, correctives steviol glycosides and lubricant Macrogol 4000 drying, pulverize, pretreatment of sieving；Polyvinyl pyrrolidone and antacid lactic acid dissolution are made binder solution in suitable quantity of water；By pretreated principal agent and filler, correctives and disintegrating agent mixing, the binder solution soft material prepared, 20 mesh sieves is used to pelletize；It is dried to meeting moisture≤2% at a temperature of 40 DEG C；Being added by lubricant in the dry granule of gained, always mix, last tabletting obtains dronedarone hydrochloride Sublingual tablet.
Embodiment 2:
Preparation prescription: dronedarone hydrochloride 40g, microcrystalline Cellulose-mannitol 40g, crospolyvinylpyrrolidone 5g, citric acid 2g, stevioside 2g, Macrogol 4000 0.5g, polyvinylpyrrolidone 5g.
Concrete preparation method is as follows: by principal agent, fills microcrystalline Cellulose-mannitol, disintegrating agent crospolyvinylpyrrolidone, and correctives steviol glycosides and lubricant Macrogol 4000 carry out drying, pulverize, pretreatment of sieving；Polyvinyl pyrrolidone and antacid citric acid are dissolved in suitable quantity of water and make binder solution；By pretreated principal agent and filler, correctives and disintegrating agent mixing, the binder solution soft material prepared, 20 mesh sieves is used to pelletize；It is dried to meeting moisture≤2% at a temperature of 50 DEG C；Being added by lubricant in the dry granule of gained, always mix, last tabletting obtains dronedarone hydrochloride Sublingual tablet.Prepare product and listing ordinary tabletBlood concentration-time curve is shown in Fig. 1.
Embodiment: 3:
Preparation prescription: dronedarone hydrochloride 65g, Icing Sugar 10g, mannitol 30g, carboxymethyl starch sodium 10g, citric acid 3g, stevioside 3g, magnesium stearate 2g, polyvinylpyrrolidone 3g.
Concrete preparation method is as follows: carries out principal agent, filler Icing Sugar, mannitol, carboxymethyl starch sodium, correctives steviol glycosides and magnesium stearate lubricant drying, pulverize, pretreatment of sieving；Polyvinyl pyrrolidone and antacid citric acid are dissolved in suitable quantity of water and prepare binder solution；By pretreated principal agent and filler, correctives and disintegrating agent mixing, the binder solution soft material prepared, 20 mesh sieves is used to pelletize；It is dried to meeting moisture≤2% at a temperature of 60 DEG C；Being added by lubricant in the dry granule of gained, always mix, last tabletting obtains dronedarone hydrochloride Sublingual tablet.
Embodiment 4:
Preparation prescription: dronedarone hydrochloride 20g, microcrystalline Cellulose-mannitol 30g, crospolyvinylpyrrolidone lg, citric acid 1.5g, stevioside 1g, Macrogol 4000 0.3g, polyvinylpyrrolidone 1g.
Concrete preparation method is as follows: carries out principal agent, filler Icing Sugar, mannitol, carboxymethyl starch sodium, correctives steviol glycosides and magnesium stearate lubricant drying, pulverize, pretreatment of sieving；Polyvinyl pyrrolidone and antacid citric acid are dissolved in suitable quantity of water and prepare binder solution；By pretreated principal agent and filler, correctives and disintegrating agent mixing, the binder solution soft material prepared, 20 mesh sieves is used to pelletize；It is dried to meeting moisture≤2% at a temperature of 60 DEG C；Being added by lubricant in the dry granule of gained, always mix, last tabletting obtains dronedarone hydrochloride Sublingual tablet.
Embodiment 5:
Preparation prescription: dronedarone hydrochloride 50g, microcrystalline Cellulose-mannitol 55g, crospolyvinylpyrrolidone 5g, citric acid 2.5g, stevioside 3g, Macrogol 4000 1g, polyvinylpyrrolidone 6g.
Concrete preparation method is as follows: carries out principal agent, filler Icing Sugar, mannitol, carboxymethyl starch sodium, correctives steviol glycosides and magnesium stearate lubricant drying, pulverize, pretreatment of sieving；Polyvinyl pyrrolidone and antacid citric acid are dissolved in suitable quantity of water and prepare binder solution；By pretreated principal agent and filler, correctives and disintegrating agent mixing, the binder solution soft material prepared, 20 mesh sieves is used to pelletize；It is dried to meeting moisture≤2% at a temperature of 60 DEG C；Being added by lubricant in the dry granule of gained, always mix, last tabletting obtains dronedarone hydrochloride Sublingual tablet.
Embodiment 6:
Preparation prescription: dronedarone hydrochloride 38g, microcrystalline Cellulose-mannitol 45g, crospolyvinylpyrrolidone 2g, citric acid 2g, stevioside 1.5g, Macrogol 4000 0.8g, polyvinylpyrrolidone 4g.
Concrete preparation method is as follows: carries out principal agent, filler Icing Sugar, mannitol, carboxymethyl starch sodium, correctives steviol glycosides and magnesium stearate lubricant drying, pulverize, pretreatment of sieving；Polyvinyl pyrrolidone and antacid citric acid are dissolved in suitable quantity of water and prepare binder solution；By pretreated principal agent and filler, correctives and disintegrating agent mixing, the binder solution soft material prepared, 20 mesh sieves is used to pelletize；It is dried to meeting moisture≤2% at a temperature of 60 DEG C；Being added by lubricant in the dry granule of gained, always mix, last tabletting obtains dronedarone hydrochloride Sublingual tablet.
Embodiment 7:
Vivo biodistribution availability is tested: carry out crossover single dose relative bioavailability comparative study according to embodiment 2 gained Sublingual tablet (40mg) and ordinary tablet (400mg), and after fasting, the Beagle dog of empty stomach is as laboratory animal.
This experimentation purpose is the relative bioavailability that the single dose of the Beagle dog of empty stomach after fasting is administered by the oral formulations evaluating two kinds of different way of administration, illustrate that medicine is after sublingual administration, effectively prevent the first pass effect of dronedarone, significantly improve the bioavailability of medicine.
Tablet according to embodiment 2 preparation and be administered 6 Beagle with reference to product respectively, the measurement pharmacokinetic parameter such as Cmax, Tmax, AUC.
The dronedarone sheet produced with reference to Pin Shi Sanofi-Aventis company, trade markListing in world wide.
The present invention and reference product all contain dronedarone (hydrochloride form), but drug containing of the present invention is the dronedarone of 40mg, and are the dronedarone of 400mg with reference to product drug containing.
The blood sampling time: be sampled with reference to the following time before being administered and after being administered.
The Sublingual tablet blood sampling time: be administered before and be administered after 0.17,0.33,0.5,0.75,1,1.5,2,3,4,6,8,12,24,36,48h.
With reference to the product blood sampling time: before being administered and after being administered 0.5,1,2,3,4,5,6,7,8,12,24,36,48h.
The main pharmacokinetic parameters such as AUC0-t, AUC0-∞, Tmax, Cmax calculate according to dronedarone in blood plasma.
Result is as shown in table 1:
Table 1 blood concentration-time curve
Product of the present invention and reference productAverage ratio as shown in table 2:
Table 2 relative bioavailability
Result is given the most simultaneously.
Research display: product of the present invention is similar to bioavailability and the Cmax with reference to product, and relative bioavailability is more than 90%, bioequivalence.
Illustrate that Dronedarone hydrochloride pharmaceutical composition of the present invention can reach the drug effect suitable with commercialized product through sublingual administration with smaller dose.
Above example, the most for the purpose of description, not in order to limit the present invention, all within the spirit and principles in the present invention, any modification, equivalent substitution and improvement etc. made, should be included within the scope of the present invention.
Claims (3)
1. a Dronedarone hydrochloride pharmaceutical composition, it is characterised in that the most described pharmaceutical composition is determined by hydrochloric acid
Dalong, disintegrating agent, filler, correctives, binding agent and lubricant are prepared from；
Described composite preparation prescription is calculated as with the amount of 1000:
Dronedarone hydrochloride 5g, lactose 40g, mannitol 40g, crospolyvinylpyrrolidone 5g, lactic acid 0.5g,
Stevioside 5g, Macrogol 4000 1g, polyvinylpyrrolidone 2g；Or
Dronedarone hydrochloride 40g, microcrystalline Cellulose-mannitol 40g, crospolyvinylpyrrolidone 5g, citron
Acid 2g, stevioside 2g, Macrogol 4000 0.5g, polyvinylpyrrolidone 5g；Or
Dronedarone hydrochloride 65g, Icing Sugar 10g, mannitol 30g, carboxymethyl starch sodium 10g, citric acid 3g,
Stevioside 3g, magnesium stearate 2g, polyvinylpyrrolidone 3g；Or
Dronedarone hydrochloride 20g, microcrystalline Cellulose-mannitol 30g, crospolyvinylpyrrolidone 1g, citron
Acid 1.5g, stevioside 1g, Macrogol 4000 0.3g, polyvinylpyrrolidone 1g；Or
Dronedarone hydrochloride 50g, microcrystalline Cellulose-mannitol 55g, crospolyvinylpyrrolidone 5g, citron
Acid 2.5g, stevioside 3g, Macrogol 4000 1g, polyvinylpyrrolidone 6g；Or
Dronedarone hydrochloride 38g, microcrystalline Cellulose-mannitol 45g, crospolyvinylpyrrolidone 2g, citron
Acid 2g, stevioside 1.5g, Macrogol 4000 0.8g, polyvinylpyrrolidone 4g；
Described Dronedarone hydrochloride pharmaceutical composition is to be administered by sublingual administration mode.
The preparation method of a kind of Dronedarone hydrochloride pharmaceutical composition the most according to claim 1, it is special
Levy and be to comprise the steps:
(1) binding agent and antacid are dissolved in suitable quantity of water prepare binder solution；
(2) principal agent dronedarone hydrochloride, filler, disintegrating agent, correctives, lubricant are dried,
Sieve pretreatment；
(3) by pretreated principal agent, filler, disintegrating agent, correctives mix homogeneously；
(4) binder solution is added in the above-mentioned material of mixing, make soft material, pelletize, 40-60 DEG C
It is dried；
(5) dry granule adds lubricant mixing, then tabletting obtains finished product.
Preparation method the most according to claim 2, it is characterised in that: described step (2) is sieved into
By 60 mesh sieves；In step (4), baking temperature is 50 DEG C.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210302793.3A CN103054820B (en) | 2012-08-22 | 2012-08-22 | A kind of Dronedarone hydrochloride pharmaceutical composition and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210302793.3A CN103054820B (en) | 2012-08-22 | 2012-08-22 | A kind of Dronedarone hydrochloride pharmaceutical composition and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103054820A CN103054820A (en) | 2013-04-24 |
| CN103054820B true CN103054820B (en) | 2016-07-13 |
Family
ID=48097920
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210302793.3A Active CN103054820B (en) | 2012-08-22 | 2012-08-22 | A kind of Dronedarone hydrochloride pharmaceutical composition and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103054820B (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104721178A (en) * | 2015-03-25 | 2015-06-24 | 河北仁合益康药业有限公司 | Composition for dronedarone hydrochloride tablet and preparation method thereof |
| CN108042500A (en) * | 2017-12-19 | 2018-05-18 | 佛山市弘泰药物研发有限公司 | A kind of dronedarone hydrochloride oral disintegrating tablet and preparation method thereof |
| CN108042501A (en) * | 2017-12-28 | 2018-05-18 | 广东伊茗药业有限公司 | A kind of Dronedarone hydrochloride tablet without surfactant |
| CN114377148B (en) * | 2020-10-20 | 2023-09-29 | 上海博志研新药物研究有限公司 | Dronedarone hydrochloride pharmaceutical composition, preparation method and application thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1267217A (en) * | 1997-06-23 | 2000-09-20 | 萨诺菲-合成实验室公司 | Solid pharmaceutical composition contg. benzofurane derivs. |
| CN101039657A (en) * | 2004-09-17 | 2007-09-19 | 赛诺菲-安万特 | Pharmaceutical composition comprising a solid dispersion with a polymer matrix containing a continuous polydextrose phase and a continuous phase of a polymer other than polydextrose |
| CN101152154A (en) * | 2006-09-29 | 2008-04-02 | 北京德众万全药物技术开发有限公司 | Hydrochloric acid dronedarone medicinal compositions for oral use and method for preparing the same |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102078307B (en) * | 2009-12-01 | 2012-11-07 | 天津市汉康医药生物技术有限公司 | Medicine composition of dronedarone hydrochloride solid dispersion and preparation method thereof |
| CN102188417A (en) * | 2010-03-19 | 2011-09-21 | 江苏恒瑞医药股份有限公司 | Dronedarone medicinal composition |
| CN102342907A (en) * | 2010-07-30 | 2012-02-08 | 江苏恒瑞医药股份有限公司 | Dronedarone solid dispersoid and preparation method thereof |
| CN102349889B (en) * | 2011-11-01 | 2013-08-28 | 江苏先声药物研究有限公司 | Composition containing dronedarone |
-
2012
- 2012-08-22 CN CN201210302793.3A patent/CN103054820B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1267217A (en) * | 1997-06-23 | 2000-09-20 | 萨诺菲-合成实验室公司 | Solid pharmaceutical composition contg. benzofurane derivs. |
| CN101039657A (en) * | 2004-09-17 | 2007-09-19 | 赛诺菲-安万特 | Pharmaceutical composition comprising a solid dispersion with a polymer matrix containing a continuous polydextrose phase and a continuous phase of a polymer other than polydextrose |
| CN101152154A (en) * | 2006-09-29 | 2008-04-02 | 北京德众万全药物技术开发有限公司 | Hydrochloric acid dronedarone medicinal compositions for oral use and method for preparing the same |
Also Published As
| Publication number | Publication date |
|---|---|
| CN103054820A (en) | 2013-04-24 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US8747901B2 (en) | Delayed release, oral dosage compositions that contain amorphous CDDO-Me | |
| US20040234593A1 (en) | Diphenhydramine tannate compositions and methods of use | |
| US20100215740A1 (en) | Taste-masked orally disintegrating tablets of memantine hydrochloride | |
| US20030083354A1 (en) | Phenylephrine tannate and pyrilamine tannate salts in pharmaceutical compositions | |
| TWI522100B (en) | Formulations containing nalbuphine and uses thereof | |
| WO2011110939A2 (en) | Pharmaceutical compositions of substituted benzhydrylpiperazines | |
| CN103054820B (en) | A kind of Dronedarone hydrochloride pharmaceutical composition and preparation method thereof | |
| CN1911211A (en) | Solid oral prepn. of leishajilan | |
| US20080125453A1 (en) | Phenylephrine tannate, pyrilamine tannate and dextromethorphan tannate salts in pharmaceutical compositions | |
| WO2021254409A1 (en) | Pharmaceutical composition of complex and preparation method therefor | |
| US7943585B2 (en) | Extended release antibiotic composition | |
| WO2011093828A2 (en) | Solid dosage forms comprising cefprozil | |
| US20060182803A1 (en) | Oral sustained-release pharmaceutical composition of indapamide, production and use thereof | |
| AU2003217704A1 (en) | Diphenhydramine tannate compositions and methods of use | |
| KR20080002313A (en) | Pharmaceutical compositions of an oral medication for improved dissolution rate of poorly water soluble sibutramine | |
| CN104523717A (en) | Simethicone otilonium bromide chewable tablets and preparing method thereof | |
| EP1560568B1 (en) | Controlled release pharmaceutical compositions containing sodium alginate and sodium calcium alginate | |
| JP3935539B2 (en) | Pharmaceutical composition containing ketotifen fumarate | |
| CN101375843B (en) | Compound tranilast orally disintegrating tablet formulation and preparation method thereof | |
| KR100754239B1 (en) | Controlled releasable oral administrative composition comprising cetirizine HCl and pseudoephedrine HCl and manufacturing method thereof | |
| WO2010005257A2 (en) | Controlled-release pharmaceutical preparation containing nicorandil | |
| CN101152142A (en) | Solid pharmaceutical composition containing 2-(3-cyano-4- isobutoxy phenyl)-4-methyl-5-thiazole methanoic acid | |
| US20110160213A1 (en) | Pharmaceutical compositions for the treatment of inflammatory and allergic disorders | |
| CN101683330A (en) | Oral compound pharmaceutic preparation containing tranilast and salbutamol | |
| CN115887392A (en) | Urolithin A dispersible tablet medicinal composition and 3D printing preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C41 | Transfer of patent application or patent right or utility model | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20160523 Address after: 050035 No. 226, the Yellow River Avenue, hi tech Industrial Development Zone, Hebei, Shijiazhuang Applicant after: Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. of CSPC Group Applicant after: Shijiazhuang Pharmaceutical Group Ouyi Pharma Co., Ltd. Address before: 050035 No. 226, the Yellow River Avenue, hi tech Industrial Development Zone, Hebei, Shijiazhuang Applicant before: Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. of CSPC Group |
|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |