CN108125922A - A kind of carbamazepine oral slow-releasing preparation and preparation method thereof - Google Patents
A kind of carbamazepine oral slow-releasing preparation and preparation method thereof Download PDFInfo
- Publication number
- CN108125922A CN108125922A CN201810033180.1A CN201810033180A CN108125922A CN 108125922 A CN108125922 A CN 108125922A CN 201810033180 A CN201810033180 A CN 201810033180A CN 108125922 A CN108125922 A CN 108125922A
- Authority
- CN
- China
- Prior art keywords
- carbamazepine
- sustained release
- preparation
- oral slow
- cellulose
- 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
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
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
Abstract
The present invention relates to a kind of carbamazepine oral slow-releasing preparations and preparation method thereof, the sustained release preparation is the elementary osmotic pump sustained release preparation of punching, the sustained release preparation includes the anhydrous carbamazepine of 30 60wt%, the sustained release preparation further includes film control coated systems, the filmogen that the film control coated systems include water-insoluble forms, the dosage of the filmogen is 1 10 wt% parts by weight, and the coating solvent is without the use of the solvent of the ICHII classes such as dichloromethane or toxicity bigger.The sustained release preparation of the present invention has under conditions of without using toxic, efficient solvent and grinds medicine statistically equivalent pharmacokinetic parameter with original.
Description
Technical field
The present invention relates to a kind of carbamazepine oral slow-releasing preparations.The invention further relates to a kind of carbamazepine oral sustained release systems
The preparation method of agent.
Background technology
Carbamazepine or 5H- dibenzo [b, f] azatropylidene -5- formamides are usually used in epilepsy, triangle neuralgia and two-phase card
Clinical treatment.The drug is the synthesis of Schneider in 1961, and in nineteen sixty-eight by Ciba-Geigy with the formal of tablet
City, trade name Tegretol.So far, international top-brand mainly has：Tegretol® ( Novartis), Carbatrol®
( Shire), equetrotm ( Validus ), Epitol® (TEVA) and Teril®(Taro).The dosage form of listing
Also chewable tablets, oral administration mixed suspension, delayed release preparation are developed to from conventional tablet.FDA has approved delayed-release tablet within 1996
400mg, 200mg, and 100mg(TEGRETOL-XR, Novartis).1997, the spansule of Shire companies
（CARBATROL）FDA approvals are obtained, the multicomponent capsule technique of use is made of three kinds of different types of balls.2004,
The spansule EQUETRO of Validus also obtains FDA approvals, for the only effective molecusol-carbamazepine of two-phase disease patient.
Carbamazepine is typical BCS II class drugs, with oral solid formulation application.The drug is practically insoluble in water
(120 μ g/ml, 25 °C), and have that there are four types of crystal forms.Different crystal forms, internal transformation of crystal, dissolution in digestive juice and
Dissolving is slow, causes drug and absorbs in the gastrointestinal tract slow and irregular, bioavilability is low, the individual difference of blood concentration
Greatly, and therapeutic window is narrow (4 ~ 12 μ g/ml), easily generates toxic side effect.
Carbamazepine sustained-release tablet take mode for 1 day twice, the maintenance dose of the crowd of 12 years old or more is 800-
1200mg/ days, maximum daily dose was 2400mg.Maintenance dose was 20-30mg/kg/ days in the children of 6-12 Sui, less than 6 years old
Children in maintenance dose be 10-20mg/kg/ days.For trigeminal neuralgia maintenance dose at 400-800mg/ days.
Carbamazepine can be used in combination with other anticonvulsive drugs.Other than the effect of clinic proves, carbamazepine is than it
The side effect of its anticonvulsive drug and severity are more preferable.Such as there is less calmness with phenytoinum naticum, phenobarbital, Mai Sulin
Property, less intellectual function is caused to damage.So that carbamazepine becomes the first choice of women and children.
Carbamazepine is taken along with incomplete, slow and variable absorption, widened protein binding and itself is new old
The induction of metabolism.Oral absolute bioavailability is estimated as 75%-85%.Sustained-release preparation is released with a relative constant speed
Drug is put, with the blood concentration of held stationary, this is even more important for the drug of narrow therapeutic window.There is local irritation to gastrointestinal tract
Or the drug of elimination half-life short is also especially important.Drug that one good sustained release preparation should provide a kind of sustained release, reappearing
Release, without toxicity.Usual sustained release preparation is realized by the control of corrosion, diffusion, osmotically active.
Since original grinds medicine Tegretol XR listings, listed so far without the imitation medicine of osmotic pump preparation, and original grinds medicine
United States Patent (USP) US 5284662 discloses a kind of coated systems using methylene chloride-methanol as solvent, but dichloromethane and methanol
It is ICH II class toxic solvents, industrial production causes environment greatly to destroy.On the one hand due to osmotic pump preparation technical barrier
Height on the other hand due to using dichloromethane as the special coated systems of coating solvent, leads to the imitated original of nobody's breakthrough so far
This problem of medicine Tegretol XR is ground, in addition today for the more rigors of narrow therapeutic window drug, imitated original grinds medicine
Tegretol XR are extremely difficult.
Invention content
For original is overcome to grind the defects of 5284662 patents of medicine Tegretol XR US are using this kind of toxic solvents of dichloromethane,
The present invention provides a kind of carbamazepine without the use of the solvent of the ICHII classes such as dichloromethane or toxicity bigger as coating solvent
Oral slow-releasing preparation, and the present invention meets requirements of the FDA for NTI drug bioequivalence limits.In addition, the present invention also provides
A kind of preparation method of carbamazepine oral slow-releasing preparation.
The present invention provides a kind of carbamazepine oral slow-releasing preparation, the sustained release preparation is that the elementary osmotic pump of punching is delayed
Release formulation, the sustained release preparation include the anhydrous carbamazepine of 30-60wt%, and the sustained release preparation further includes film control coated systems,
The filmogen that the film control coated systems include water-insoluble forms, and the dosage of the filmogen is 1-10 wt % weight
Part, the coating solvent is without the use of the solvent of the ICHII classes such as dichloromethane or toxicity bigger.
As a kind of perferred technical scheme, the coating solvent of the film control coated systems is selected from ethyl alcohol, acetone, isopropyl
One or more of alcohol, water.
As a kind of perferred technical scheme, a diameter of 600 ~ 1200 μm of the drug release duct of the sustained release preparation.
As a kind of perferred technical scheme, the filmogen be selected from cellulose acetate and derivative, ethyl cellulose,
One or more of methacrylic acid of water-insoluble.
As a kind of perferred technical scheme, the carbamazepine oral slow-releasing preparation further includes the crystallization of 2-20 wt %
Inhibitor, the crystallization inhibitor in cellulose ether, polyvinylpyrrolidone, hypromellose succinate one
Kind is several.
As a kind of perferred technical scheme, the carbamazepine oral slow-releasing preparation further includes the controlled release material of 0-30wt%
Material, the controlled-release material are selected from hypromellose, hydroxyethyl cellulose, methylcellulose and derivative, phthalic acid
Hydroxypropyl methyl cellulose, cellulose acetate-phthalate, hydroxypropyl cellulose, carboxymethyl cellulose and its esters, seaweed
One or more of acid and its esters, polyoxyethylene, hydroxymethyl cellulose.
As a kind of perferred technical scheme, the carbamazepine oral slow-releasing preparation further includes the infiltration work of 5-40wt%
Property agent, the osmotically active agent be selected from the agent of carbohydrate osmotically active and/or salt osmotically active agent, the carbohydrate osmotically active agent
Selected from one or more of mannitol, xylitol, glucose, sorbierite, fructose, sucrose, starch oligomerization pool, the salt
One or two kinds of mixed above object of the class osmotically active agent in sodium chloride, potassium chloride, sulfate, phosphate.
As a kind of perferred technical scheme, the carbamazepine oral slow-releasing preparation further includes wetting agent, lubricant,
Toner.
The present invention also provides a kind of preparation process of carbamazepine oral slow-releasing preparation, the preparation process includes following step
Suddenly：
（1）Carbamazepine is mixed with core material and is pelletized with appropriate solvent；
（2）After granulation, tray dried or fluidized bed drying；
（3）Dry particle adds in additional auxiliary material and lubricant is tabletted；
（4）The tablet being pressed into is coated；
（5）Drug release duct is formed by mechanical punching or laser boring in coating.
Carbamazepine sustained-release drug delivery system of the present invention has grinds medicine statistically equivalent drug metabolism with original
Kinetic parameter.For example, the carbamazepine sustained-release drug delivery system carried out for 2 periods with Tegretol XR or 4 periods repeated to hand over
The human trial of administration is pitched, maximum plasma concentration Cmax, area under serum drug concentration AUC are the 80% of Tegretol XR
~125%.More optimizedly 90% CI of the carbamazepine sustained-release drug delivery system and Cmax, AUC ratio of Tegretol XR exists
((YA-YB) of (Unscaled average bioequivalence approach) between 80-125%, the 95% CI upper limits
2–θ•s²WR ≤0 (Scaled Average Bioequivalence (SABE) method).Relevant concept is in FDA works
There is further explanation in industry guide " statistical approaches to establish bioequivalence ".
The above-mentioned of the application and other features, aspect and advantage is more readily understood with reference to following detailed description.
Description of the drawings
Fig. 1 comparative examples 10, example 11 and Tegretol XR dissolve out comparison diagram.
Fig. 2 carbamazepine sustained-release preparations of the present invention dissolve out comparison diagram with Tegretol XR under the conditions of USP.
The pharmacokinetic profiles comparison diagram of Fig. 3 carbamazepine sustained-release preparations of the present invention and Tegretol XR.
Specific embodiment
Purpose, technical scheme and advantage to make the embodiment of the present invention are clearer, below in conjunction with the embodiment of the present invention
Attached drawing, the technical solution of the embodiment of the present invention is clearly and completely described.Obviously, described embodiment is this hair
Bright part of the embodiment, instead of all the embodiments.Based on described the embodiment of the present invention, ordinary skill
All other embodiment that personnel are obtained under the premise of without creative work, shall fall within the protection scope of the present invention.
Unless otherwise defined, technical term or scientific terminology used herein should be in fields of the present invention and have
The ordinary meaning that the personage of general technical ability is understood.Used in present patent application specification and claims " the
One ", " second " and similar word are not offered as any sequence, quantity or importance, and are used only to distinguish different
Component part.Equally, the similar word such as "one" or " one " does not indicate that quantity limits yet, but represents that there are at least one.
Carbamazepine oral sustained release drug delivery system of the present invention is the elementary osmotic pump drug delivery system of punching, is had such as
Lower feature：
（1）Preferred preparation composition includes carbamazepine, crystallization inhibitor, osmotically active agent, controlled-release material, wetting agent, lubrication
Agent, colorant, film control coated systems；
（2）Preferred film control coated systems include filmogen, pore-foaming agent or the plasticizer of water-insoluble；
（3）The coated systems, it is characterised in that without the use of the solvent of the ICHII such as dichloromethane classes or toxicity bigger as molten
Agent；
（4）Film control coated systems preferably release the drug a diameter of 600 ~ 1200 μm of duct.
The wherein described carbamazepine oral sustained release drug delivery system, it is characterised in that the carbamazepine is carbamazepine
Anhydride.Anhydrous carbamazepine contacts the dihydrate crystal form that can form acicular crystal with water, by adding in crystallization inhibitor, energy
Carbamazepine is effectively avoided in formulation system and the conversion of internal crystal form and is increased.
The wherein described crystallization inhibitor, it is characterised in that cellulose ether, such as hydroxypropyl cellulose, ethoxy can be selected
Cellulose and methylcellulose ether polymer；Polyvinylpyrrolidone class, such as povidone, copolyvidone；And hydroxypropyl is fine
The plain succinate of dimension.Wherein methyl cellulose ether is such as hydroxypropyl methyl cellulose, carboxymethyl cellulose, carboxymethyl cellulose
Salt.
The wherein described osmotically active agent, it is characterised in that optional carbohydrate and/or salt, the carbohydrate are selected from sweet dew
One or more of alcohol, xylitol, glucose, sorbierite, fructose, sucrose, starch oligomerization pool, salt are selected from chlorination
One or two kinds of object mixed above in sodium, potassium chloride, sulfate, phosphate.
The wherein described controlled-release material, it is characterised in that it is fine that hypromellose, hydroxyethyl cellulose, methyl can be selected
Dimension element and derivative, Hydroxypropyl Methylcellulose Phathalate, cellulose acetate-phthalate, hydroxypropyl cellulose, carboxylic
One or more in methylcellulose and its esters, alginic acid and its esters, polyoxyethylene, hydroxymethyl cellulose.
The wherein described wetting agent, it is characterised in that sldium lauryl sulfate, polyoxyethylene macrogol ester, pool Lip river can be selected
It is one or more of in Sha Mu, Crodaret derivative, polysorbate.
The wherein described lubricant, it is characterised in that optional stearic acid, magnesium stearate, calcium stearate, micro mist can be selected
One kind in silica gel, talcum powder, hydrogenated vegetable oil, polyethylene glycols, magnesium laurylsulfate, sldium lauryl sulfate or it is a kind of with
On.
The wherein described colorant, it is characterised in that iron oxide red, iron oxide yellow, iron oxide black, titanium dioxide can be selected
Deng.
The wherein described filmogen, it is characterised in that it is not digested absorption in alimentary canal, it is final to exclude in vitro.It is optional
With cellulose acetate and derivative, ethyl cellulose, water-insoluble methacrylate polymer.
The wherein described pore-foaming agent or plasticizer, it is characterised in that it is fine that hypromellose HPMC, hydroxypropyl can be selected
Tie up element HPC, povidone PVP, copolyvidone, sorbierite, mannitol, glucose, lactose, water-soluble inorganic salt, polyethylene glycols,
Lead diethyl phthalate, triethyl citrate, dibutyl sebacate, tributyl citrate, polyphenyl hexene, glyceride, poly- second
One or more of enol.
The wherein described coating solvent, it is characterised in that one or more of ethyl alcohol, acetone, isopropanol, water can be selected.
Coating material is without using the solvent of dichloromethane, chloroform, methanol etc. ICH II classes or toxicity bigger, industrial production pair
Environment does not damage.Film control coated systems are made into the coating solution that solid content is 3-10% with mixed solvent, using above-mentioned composition
Film control coated systems and solvent, the sustained release preparation being prepared can ensure anhydrous carbamazepine punching elementary osmotic pump to
Pharmacokinetic parameter and Tegretol XR in medicine system is closer.It is achieved thereby that substitute what is be harmful in Tegretol XR
Solvent.
The preparation process of carbamazepine oral sustained release drug delivery system provided by the invention, it includes following steps：
（1）Carbamazepine is mixed with core material and is pelletized with appropriate solvent；
（2）After granulation, tray dried or fluidized bed drying；
（3）Dry particle adds in additional auxiliary material and lubricant is tabletted；
（4）Coating；
（5）Drug release duct is formed by mechanical punching or laser boring in coating.
Carbamazepine sustained-release drug delivery system of the present invention be by effective therapeutic dose carbamazepine and can physiologically connect
The auxiliary material composition received, preferred composition are as follows：
Ingredients Weight %
Carbamazepine 30-60%
Crystallization inhibitor 2-20%
Osmotically active agent 0-40%
Controlled-release material 0-40%
Wetting agent 0-5%
Lubricant 0.1-2%
Colorant 0-3%
Filmogen 1-10%
Pore-foaming agent 0-10%
Plasticizer 0-10%.
Carbamazepine sustained-release preparation of the present invention is prepared using the common method of industry, for example, mixing carbamazepine
It pelletizes with core material and with appropriate solvent, preferred granulation solvent is water or lower alcohols such as methanol, ethyl alcohol or isopropyl
Alcohol.After granulation, tray dried or fluidized bed drying.Dry particle adds in additional auxiliary material and appropriate lubricant is tabletted
Agent.Spray coating, pressed coated, dry powder coating, dipping coating etc. may be used in coating.Preferably, machine can be passed through in coating
Tool punches or laser boring forms drug release duct.
1 ~ 3 core of embodiment
Preparation process
It is prepared by core：Core material composition 1-10 is added in into trough type mixing machine or bulk drug of pretreatment adds with interior granulator mixing 15min, is added in
Purified water carries out mixing granulation.Wet softwood is sieved whole grain, then with 80 DEG C of baking ovens or fluidized bed drying.Stearic acid is added in dry particl
Magnesium mixes 5min, then using high speed rotary tablet press tabletting.Above-mentioned carbamazepine is anhydrous carbamazepine.
4 ~ 11 film control coated systems of embodiment
It prepares：Embodiment 4-6 coating materials are scattered in 85:Then the in the mixed solvent of 15 acetone-waters is sprayed to implementation respectively
Example 1-3 piece wicking surfaces.After coating is dry, punched in coating by machinery or laser.
It prepares：The material of embodiment 7-9 is dissolved in 90:The in the mixed solvent of 10 alcohol-water, it is 7% to be made into solid content
Coating solution, be then sprayed to embodiment 1-3 piece wicking surfaces respectively.After coating is dry, beaten in coating by machinery or laser
Hole.Fig. 2 is the carbamazepine sustained-release preparation that is prepared of embodiment 4/6/7 and Tegretol XR are dissolved out pair under the conditions of USP
Than figure.As can be seen that embodiment 7 has especially prominent performance.
Example 10 carries out sample preparation according to patent US5284662A embodiments, and embodiment, as follows as a comparison.It is wrapped
Clothing ingredient is using the methylene chloride-methanol described in patent（80:20）Mixed solvent.As a comparison, embodiment 11 are coated into it
Divide and the coated systems are prepared using acetone-water mixed solvent.Dissolution the result shows that, such as Fig. 1, coated systems described in patent use two
It is consistent with commercialized product dissolution during chloromethanes-methanol solvate, and when similary coating constituents use acetone-water as solvent, it dissolves out
Rate is significantly low.
As shown in figure 3,2 intersecting of being carried out in healthy human body with TegretolXR of the carbamazepine sustained-release preparation of the present invention
Bioequivalence Test, the two has pharmacokinetic profiles equal on statistical significance, after figure below provides single-dose
The time front of blood concentration of the two.
Carbamazepine sustained-release drug delivery system of the present invention has grinds medicine statistically equivalent drug metabolism with original
Kinetic parameter.For example, the carbamazepine sustained-release drug delivery system carried out for 2 periods with Tegretol XR or 4 periods repeated to hand over
The human trial of administration is pitched, maximum plasma concentration Cmax, area under serum drug concentration AUC are the 80% of Tegretol XR
~125%.More optimizedly 90% CI of the carbamazepine sustained-release drug delivery system and Cmax, AUC ratio of Tegretol XR exists
((YA-the YB of (Unscaled average bioequivalence approach) between 80-125%, the 95% CI upper limits
)2–θ•s²WR ≤0 (Scaled Average Bioequivalence (SABE) method).Relevant concept is in FDA works
There is further explanation in industry guide " statistical approaches to establish bioequivalence ".
The foregoing is only a preferred embodiment of the present invention, is not intended to limit the scope of the present invention.It is every
The equivalent changes and modifications done according to the content of present invention are encompassed by the scope of the claims of the present invention.
Claims (9)
1. a kind of carbamazepine oral slow-releasing preparation, which is characterized in that the sustained release preparation is the elementary osmotic pump sustained release of punching
Preparation, the sustained release preparation include the anhydrous carbamazepine of 30-60wt%, and the sustained release preparation further includes film control coated systems, institute
The filmogen composition that film control coated systems include water-insoluble is stated, the dosage of the filmogen is 1-10 wt % parts by weight,
The coating solvent is without the use of the solvent of the ICHII classes such as dichloromethane or toxicity bigger.
A kind of 2. carbamazepine oral slow-releasing preparation according to claim 1, which is characterized in that the film control coated systems
Coating solvent be selected from ethyl alcohol, acetone, isopropanol, one or more of water.
3. a kind of carbamazepine oral slow-releasing preparation according to claim 1, which is characterized in that the sustained release preparation is released
Medicine channel diameter is 600 ~ 1200 μm.
4. a kind of carbamazepine oral slow-releasing preparation according to claim 1, which is characterized in that the filmogen is selected from
Cellulose acetate and derivative, ethyl cellulose, water-insoluble one or more of methacrylic acid.
5. a kind of carbamazepine oral slow-releasing preparation according to claim 1, which is characterized in that the carbamazepine takes orally
Sustained release preparation further includes the crystallization inhibitor of 2-20 wt %, and the crystallization inhibitor is selected from cellulose ether, polyvinylpyrrolidine
One or more of ketone, hypromellose succinate.
6. a kind of carbamazepine oral slow-releasing preparation according to claim 1, which is characterized in that the carbamazepine takes orally
Sustained release preparation further includes the controlled-release material of 0-30wt%, the controlled-release material be selected from hypromellose, hydroxyethyl cellulose,
Methylcellulose and derivative, Hydroxypropyl Methylcellulose Phathalate, cellulose acetate-phthalate, hydroxy propyl cellulose
Element, carboxymethyl cellulose and one or more of its esters, alginic acid and its esters, polyoxyethylene, hydroxymethyl cellulose.
7. a kind of carbamazepine oral slow-releasing preparation according to claim 1, which is characterized in that the carbamazepine takes orally
Sustained release preparation further includes the osmotically active agent of 5-40wt%, and the osmotically active agent is selected from the agent of carbohydrate osmotically active and/or salt
Osmotically active agent, it is few that the carbohydrate osmotically active agent is selected from mannitol, xylitol, glucose, sorbierite, fructose, sucrose, starch
One or more of polywater pool, the salt osmotically active agent is in sodium chloride, potassium chloride, sulfate, phosphate
One or two kinds of object mixed above.
8. a kind of carbamazepine oral slow-releasing preparation according to claim 1, which is characterized in that the carbamazepine takes orally
Sustained release preparation further includes wetting agent, lubricant, colorant.
9. a kind of preparation work of the carbamazepine oral slow-releasing preparation in 1-8 such as claim as described in any one claim
Skill, which is characterized in that the preparation process comprises the steps of：
（1）Carbamazepine is mixed with core material and is pelletized with appropriate solvent；
（2）After granulation, tray dried or fluidized bed drying；
（3）Dry particle adds in additional auxiliary material and lubricant is tabletted；
（4）The tablet being pressed into is coated；
（5）Drug release duct is formed by mechanical punching or laser boring in coating.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810033180.1A CN108125922A (en) | 2018-01-14 | 2018-01-14 | A kind of carbamazepine oral slow-releasing preparation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810033180.1A CN108125922A (en) | 2018-01-14 | 2018-01-14 | A kind of carbamazepine oral slow-releasing preparation and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108125922A true CN108125922A (en) | 2018-06-08 |
Family
ID=62399709
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810033180.1A Pending CN108125922A (en) | 2018-01-14 | 2018-01-14 | A kind of carbamazepine oral slow-releasing preparation and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108125922A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1153475A (en) * | 1994-07-01 | 1997-07-02 | 德雷斯顿药品工厂有限公司 | Carbamazepine medicament with retarded active substance release |
| US20030008006A1 (en) * | 2001-02-02 | 2003-01-09 | Puthli Shivanand P. | Oral osmotic controlled drug delivery system for a sparingly soluble drug |
| US20090004229A1 (en) * | 2007-06-28 | 2009-01-01 | Osmotica Costa Rica Sociedad Anonima | rupturing controlled release device comprising a subcoat |
| US20100285119A1 (en) * | 2008-01-11 | 2010-11-11 | Jubilant Organosys Ltd. | Multiparticulate Extended Release Pharmaceutical Composition Of Carbamazepine And Process For Manufacturing The Same |
-
2018
- 2018-01-14 CN CN201810033180.1A patent/CN108125922A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1153475A (en) * | 1994-07-01 | 1997-07-02 | 德雷斯顿药品工厂有限公司 | Carbamazepine medicament with retarded active substance release |
| US20030008006A1 (en) * | 2001-02-02 | 2003-01-09 | Puthli Shivanand P. | Oral osmotic controlled drug delivery system for a sparingly soluble drug |
| US20090004229A1 (en) * | 2007-06-28 | 2009-01-01 | Osmotica Costa Rica Sociedad Anonima | rupturing controlled release device comprising a subcoat |
| US20100285119A1 (en) * | 2008-01-11 | 2010-11-11 | Jubilant Organosys Ltd. | Multiparticulate Extended Release Pharmaceutical Composition Of Carbamazepine And Process For Manufacturing The Same |
Non-Patent Citations (2)
| Title |
|---|
| 凌沛学: "《药物制剂技术》", 31 May 2007, 北京：中国轻工业出版社 * |
| 潘卫三: "《药剂学》", 31 July 2017, 北京：化学工业出版社 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US5316772A (en) | Bilayered oral pharmaceutical composition with pH dependent release | |
| EP1830855B1 (en) | Solid, orally applicable pharmaceutical administration forms containing rivaroxaban having modified release | |
| US7022345B2 (en) | Oral solid pharmaceutical formulations with pH-dependent multiphasic release | |
| EP1453487B1 (en) | Pharmaceutical dosage form with multiple coatings | |
| US20110008426A1 (en) | Modified release pharmaceutical compositions comprising mycophenolate and processes thereof | |
| EP1113787B1 (en) | Multiple unit controlled food effect-independent release pharmaceutical preparations and method for preparing the same | |
| US7074417B2 (en) | Multiple-delayed release anti-viral product, use and formulation thereof | |
| DE19732903A1 (en) | Pellet formulation for the treatment of the intestinal tract | |
| US9642808B2 (en) | Extended release compositions comprising mycophenolate sodium and processes thereof | |
| US6613361B1 (en) | Ketoprofen microgranules, method for preparing same and pharmaceutical compositions | |
| CA2121038C (en) | Oral preparation for release in lower digestive tracts | |
| EP1315481B1 (en) | Medicament for treating intestinal diseases | |
| DE69816624T2 (en) | ADMINISTRATION FORM FOR SERTRALIN WITH DELAYED ACTIVE SUBSTANCE RELEASE | |
| US20040115264A1 (en) | Fenofibrate tablets | |
| DE19850445A1 (en) | Medicines for the topical treatment of inflammatory bowel disease | |
| WO2011064797A2 (en) | Controlled release pharmaceutical compositions of galantamine | |
| US20100285119A1 (en) | Multiparticulate Extended Release Pharmaceutical Composition Of Carbamazepine And Process For Manufacturing The Same | |
| CN108125922A (en) | A kind of carbamazepine oral slow-releasing preparation and preparation method thereof | |
| WO2017125856A1 (en) | Formulations in modified-release tablets containing high-dosage mesalazine, process for their preparation and their use | |
| WO2021001860A1 (en) | Pharmaceutical compositions of boswellia serrata | |
| JP3592723B2 (en) | Non-disintegrating and sustained capsule formulation | |
| JP2678556B2 (en) | Antiarrhythmic drug and method for producing the same | |
| Abinaya | Development and Evaluation of Felodipine Extended Release Tablet Formulation | |
| KR19980038359A (en) | Preparation of Biphenyl Dimethyl Dicarboxylate (DDB) Formulation with Improved Dissolution Rate | |
| CZ2001984A3 (en) | Retarded pharmaceutical multicomponent preparations independent on agitation and process of their preparation |
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 | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20180608 |