WO2013157841A1 - 레보드로프로피진 함유 서방정 및 이의 제조방법 - Google Patents
레보드로프로피진 함유 서방정 및 이의 제조방법 Download PDFInfo
- Publication number
- WO2013157841A1 WO2013157841A1 PCT/KR2013/003232 KR2013003232W WO2013157841A1 WO 2013157841 A1 WO2013157841 A1 WO 2013157841A1 KR 2013003232 W KR2013003232 W KR 2013003232W WO 2013157841 A1 WO2013157841 A1 WO 2013157841A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sustained
- release
- fitness
- tablet
- release layer
- Prior art date
Links
Images
Classifications
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
-
- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/10—Expectorants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/14—Antitussive agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
Definitions
- the present invention relates to a sustained-release tablet containing leprotropypizin used as an antitussive expectorant. More particularly, the present invention relates to a sustained release tablet containing leprotropyzin, which allows a drug absorption to be delayed by controlling the release of a drug by mixing the leprotropizin and a polymer compound.
- Leprotropropine inhibits c-fiber, a peripheral nerve that is involved in cough reflexes, and prevents inflammatory reactions, bronchial spasm, airway hypersensitivity, mucus hypersecretion, vascular permeability, and cough reflex caused by neuropeptides at the c-fiber end. It has an inhibitory effect.
- At least 75% is absorbed by oral administration, and the time to reach the highest blood concentration is about 0.25-1 hour, and then about 35% of the levodropropazine in the body is excreted (half-life). It is known to be about time.
- Levodropropizine is currently developed and marketed in tablet form, and 60 mg is given once a tablet and three times a day.
- Korean Patent Laid-Open Publication No. 10-2011-0113413 discloses a sustained-release pharmaceutical composition including the active ingredient including leprotropypizin and a method for preparing the same.
- the initial dissolution rate in bilayer tablets, double tablets and multi-layer tablets (formula consisting of immediate release and sustained release) at a point in time is achieved at the same time. It is important to keep the effective blood levels of the drug up to 12 hours and constant up to 12 hours.
- the inventors have accomplished this task by using a high-viscosity hydroxypropylmethylcellulose together to prepare a sustained-release portion of the matrix-type levodropropizin and a rapid release portion containing 1 tablet of leprotropyzine for initial rapid treatment. It turned out that it could.
- an object of the present invention is characterized by a multi-layered tablet consisting of an immediate release layer and a sustained release layer containing revodropropidine as an active ingredient, which was administered twice a day for which 60 mg of revotropropidine was conventionally administered three times a day.
- a sustained-release tablet containing leprotropypizin that can improve.
- the present invention provides a sustained release layer consisting of an immediate release layer comprising a leprotropropide, and a sustained release layer comprising a leprotropropine and a release control polymer.
- the two-layered leprotropypigin sustained-release tablet consisting of an immediate release layer and a sustained release layer is administered orally to give an immediate antitussive expectorant effect, and the drug is continuously maintained in the plasma for a considerable time, so that the number of administration It is very useful because it can reduce the drug and consequently increase the drug adaptability to the patients, thereby increasing the compliance with the medication.
- Figure 1 is a dissolution test results of the ready-release propidol immediate release layer preparation of the present invention.
- Figure 2 is a dissolution test results of the formulation of leprotropypigin sustained release layer of the present invention.
- Figure 3 is a dissolution test results of the levotropypigin sustained release of the present invention.
- 4 and 5 are the results of comparative dissolution test of the control formulation of leprotropypizin sustained release of the present invention.
- Figure 6 is a comparison of the control drug is "draw Pidgin, Jung, ⁇ Example 3> Blood Lebo draw after repeated oral administration of the formulation, UI04LDP090CT 'pro Pidgin concentration of the present invention in beagle dogs.
- the present invention provides a sustained release tablet comprising an immediate release layer containing a leprotropypizin, and a sustained release layer comprising a leprotropropine and a release controlling polymer.
- the content of the leprotropypizin of the immediate release layer is 10 to 70mg
- the content of the leprotropypizin of the sustained release layer is 20 to 80mg. More preferably, the content of the leprotropypizin of the immediate release layer is 30 to 60mg
- the content of the leprotropypizin of the sustained release layer is 30 to 60mg
- the sustained release layer of the leprotropypigin sustained-release tablet of the present invention comprises a polymer for emission control.
- the release controlling polymer may be used as long as it is a pharmaceutically acceptable polymer, hydroxypropyl methyl cellulose (Hydroxy propyl methyl cellulose), methyl cellulose (Methyl cellulose), ethyl cellulose (Ethyl cellulose), hydroxypropyl cellulose (Hydroxy propylcellulose, cellulose derivative composed of sodium carboxymethylcellulose, propylene oxide and its derivatives, polyvinylpyrrolidone (molecular weight 90, trade name Povidone K-90), polyethylene glycol glycol), polyvinyl alcohols, polyvinylacetate, polyvinylacetate phthalate, polymethacrylate, polymethacrylate polymers (commercially Eudragit), polyacrylic acid Polycrylic acid, polymethac Derivatives of the rate (typically a carbomer), glycerol monostearate and
- the content of the release controlling polymer included in the sustained release of the leprotropypigin is 10 to 80% by weight based on the total weight of the sustained release of the levopropipigin. More preferably, the content of the release controlling polymer is 10 to 60% by weight.
- the viscosity of the release controlling polymer is preferably 60,000 to 140,000cps.
- hydroxypropyl methyl cellulose products of various viscosities are known, and by adjusting the viscosity of the hydroxypropyl methyl cellulose, the dissolution rate of the sustained-release tablet of leprotropypizin can be controlled.
- Hydroxypropylmethylcellulose included in the sustained-release tablet of leprotropyzin according to the present invention can be used a high viscosity hydroxypropylmethylcellulose, the viscosity is 60,000cps to 140,000cps and the viscosity is less than 60,000cps a large amount of hydroxypropyl Methylcellulose is required, which increases the size of the tablet, and if the viscosity exceeds 140,000 cps, uniform mixing with the drug becomes difficult.
- the immediate release layer and the sustained release layer of the leprotropypigin sustained-release tablet of the present invention may further include excipients of various components used in the pharmaceutical composition in the art, in addition to the leprotropipi and the release-controlling polymer, respectively.
- it may further include one or more excipients selected from the group consisting of disintegrants, lubricants, water soluble additives, fast-acting excipients, fillers and binders commonly used in the manufacture of pharmaceutical compositions.
- the disintegrant is used to absorb the moisture to promote disintegration of the formulation to improve the dissolution of leprotropypizin, for example, crosscamellose sodium, sodium starch glycolate (Sodium starch glycolate), Pregelatinized Starch (Starch 1500 or Prejel), microcrystalline cellulose, crospovidone (cross-linked povidone), polyvinylpyrrolidone (PVP, Povidone), low substitution Hydroxypropylcellulose (low substituted), alginic acid, Carboxymethylcellulose calcium salt and sodium salt, colloidal silica dioxide, guar gum, magnesium aluminum silicate (Magnesium alumimum silicate), methylcellulose, powdered cellulose, starch and sodium eggs Carbonate can be given alone or in mixture of two kinds selected from the group consisting of (sodium alginate).
- crosscamellose sodium sodium starch glycolate
- Pregelatinized Starch Starch 1500 or Prejel
- microcrystalline cellulose crospovidone (cross-linked povidone), polyvinylpyr
- croscarmellose sodium sodium starch glycolate, pregelatinized starch, microcrystalline cellulose, crospovidone and polyvinylpyrrolidone are used. More preferably, as the disintegrant, crospovidone, sodium starch glycolate or microcrystalline cellulose may be used, and is most effective when a mixture of two or more disintegrants is used.
- the disintegrant may be added to the oral solid preparation in addition to the pharmaceutically acceptable method, and a second disintegrant may be further used for the faster release of the preparation.
- the disintegrant may be included in 10 to 60% by weight relative to the total weight of the immediate release layer or the sustained release layer.
- a lubricant is used to improve the moldability of the leprotropypigin sustained-release tablet of the present invention, for example magnesium stearate (magnesium stearate), silica (SiO 2 ), colloidal silica (collidal silica, Cabo) -SIL), talc, etc., but are not limited to these.
- the amount of the lubricant is preferably 0.25 to 2% by weight based on the total weight of the immediate release layer or the sustained release layer.
- the levodropropizine sustained-release tablet of the present invention may further include a water-soluble additive commonly used in pharmaceuticals, and such additives may include lactose, sugar, mannitol, lactose, sorbitol, and the like.
- the water-soluble additive may be included in 10 to 60% by weight relative to the total weight of the immediate release layer or the sustained release layer.
- the leprotropin sustained-release tablet of the present invention may further include a preservative, a stabilizer and the like as necessary.
- the leprotropypigin sustained-release tablet of the present invention is characterized in that it is a pellet-type tablet or a multi-tablet prepared by mixing the immediate release layer and the sustained release layer.
- the present invention comprises the steps of: a) preparing a sustained-release granules by mixing wet or dry by mixing a leprotropypigin, a polymer for controlling release and additives; And
- a solvent is added to the mixed powder of leprotropypigin, the release control polymer and the additive, wherein the solvent is water, ethanol, isopropyl alcohol, glycerin, propylene glycol and polyethylene glycol
- the solvent is water, ethanol, isopropyl alcohol, glycerin, propylene glycol and polyethylene glycol
- One or two or more mixed solvents selected from the group consisting of can be used, but water is preferred.
- a compound tablet machine for the tableting in step b), a compound tablet machine, a multilayer tablet machine, or a double tablet tablet machine may be used.
- the tablet when manufacturing a bimodal tablet consisting of an immediate release layer and a sustained release layer, the tablet is first compressed into a sustained release layer and then filled with the immediate release layer thereon to carry out a second tablet. It can manufacture. At this time, the tableting of the immediate release layer is not necessarily made after the tableting of the sustained release layer, and the tableting of the immediate release layer is performed first, and it is also possible to fill the tablets by filling the granules of the sustained release layer. In addition, the immediate release layer and the sustained release layer may be filled in a sequential order or in reverse order, respectively.
- the inventive levodropropizine sustained-release tablet may be prepared as a single-layer tablet having both immediate release and sustained release properties, including a bilayer tablet consisting of an immediate release layer and a sustained release layer, and a mixed composition of the immediate release layer composition and a sustained release layer composition.
- the sustained release layer after the sustained release layer is prepared as a nucleus, it may also be prepared as a multi-tablet containing a sustained release core (Core) in a form surrounded by an immediate release layer.
- Core sustained release core
- Dissolution rate graphs for Formulation 13a (F-13 (genus)), Formulation 14a (F-14 (genus)) and Formulation 19a (F-19 (genus)) are shown in FIG. 1.
- formulation 14a which is a rapid release formulation having a relatively low dissolution rate of 5 to 15 minutes.
- sodium starch glycolate was used in combination to increase the initial dissolution rate.
- the immediate release layer mixed as in Formulation 14a and the sustained release layer prepared by wet granulation of the formulations shown in Table 3 below were tableted with bilayer tablets, and subjected to fluidity test, hardness test, and dissolution test, respectively. Established.
- Formulation 17b (F-14 (genus) / F-17 (west)
- formulation 18b (F-14 (genus) / F-18 (west)
- formulation 19b (F-14 (genus) / F-19 ( X)
- dissolution rate graphs for Formulation 20b (F-14 (genus) / F-20 (west)) are shown in FIG. 2.
- the formulation 19b was suitable as the most suitable sustained release formulation for the fastest initial dissolution and a relatively constant concentration. .
- the immediate release layer was determined to be Formulation 14a, and the sustained release layer was Formulation 19b.
- the final formulation was prepared to have an excipient content as shown in Table 4 below the upper and lower limits of the dissolution criteria. Was carried out.
- Example 2 Example 3 Western layer Levodropropine 45.0 45.0 * MCC 101 7.0 6.8 6.8 * HPMC 2208 50.0 50.0 50.0 * PVP K-90 3.0 2.7 2.7 * s-Mg 1.7 1.7 1.7 Final weight (mg) 106.7 106.2 106.2 Immediate layer Levodropropine 45.0 45.0 45.0 Flowlac 67.0 67.0 67.0 MCC pH102 67.0 67.0 Sodium starch glycolate 10.0 10.0 7.5 s-Mg 1.9 1.9 1.9 Final weight (mg) 190.9 190.9 188.4 Total weight (mg) 297.6 297.1 294.6
- Droopidine of Kolon Pharmaceuticals was used as a control and ⁇ Example 3> formulation 'UI04LDP090CT' of Korea United Pharmaceutical Co., Ltd. was used as a test preparation, and three control tablets and two tablets of test preparation were repeated orally for 24 hours in beagle dogs. Administered. The concentration of levodropropizin in blood with time obtained after oral administration is shown in FIG. 6.
- Example 3 Tableted Specimen The dissolution profiles of the tablets of Example 3 from Table 4 and commercially available 60 mg of leprotropypizin were compared. As shown in FIGS. 4 and 5, 60 mg of levodropropidine was eluted within 30 minutes in the case of commercially-available 60 mg of levodropropidine, whereas 60 mg of the formulation of Example 3 was eluted within 1 hour. The dissolution rate was increased and the dissolution rate was gradually increased up to 12 hours to maintain a constant release rate of 90 mg of the drug.
- the initial effective therapeutic blood concentration was reached initially and the effective effective blood concentration was maintained so that the conventional administration of 60 mg of leprotropipizin three times a day was performed twice a day. It can be seen that by enabling the administration, it is possible to improve the patient's convenience and dose compliance.
- the leprotropropidine sustained-release tablet of the present invention is 60 mg of leprotropipi commercially available on the In-vitro due to the characteristics of the sustained-release tablet. Unlike the initial reaction time of about 60 minutes, in-vivo will show the same Cmax and Tmax as 60mg of commercially available Levodropropidine. You can expect
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
첨가제 | 초기 함량시험(%) | 가속시험 후 함량시험(%) | ||||
기준 | 결과 | 판정 | 기준 | 결과 | 판정 | |
미세결정셀룰로오스 | 95~105 | 100.5 | 적합 | 95~105 | 100.3 | 적합 |
Lactose monohydrate | 95~105 | 100.1 | 적합 | 95~105 | 99.8 | 적합 |
하이드록시프로필 셀룰로오스 | 95~105 | 99.3 | 적합 | 95~105 | 99.2 | 적합 |
하이드로멜로우즈 프탈레이트 | 95~105 | 99.9 | 적합 | 95~105 | 99.2 | 적합 |
카르복시메틸셀룰로오스 소듐 | 95~105 | 99.9 | 적합 | 95~105 | 100 | 적합 |
카르복시메틸셀룰로오스 칼슘 | 95~105 | 100.2 | 적합 | 95~105 | 99.8 | 적합 |
Copovidone | 95~105 | 99.3 | 적합 | 95~105 | 99.3 | 적합 |
Aerosil | 95~105 | 99.5 | 적합 | 95~105 | 99.4 | 적합 |
Poloxamer | 95~105 | 99.4 | 적합 | 95~105 | 99.4 | 적합 |
*PVP K-30 | 95~105 | 99.3 | 적합 | 95~105 | 100 | 적합 |
*PVP K-90 | 95~105 | 99.8 | 적합 | 95~105 | 99.8 | 적합 |
*HPMC2208(100,000cp) | 95~105 | 100.3 | 적합 | 95~105 | 99.4 | 적합 |
*HPMC2910(4000cp) | 95~105 | 99.7 | 적합 | 95~105 | 99.3 | 적합 |
크로스포비돈 | 95~105 | 99.7 | 적합 | 95~105 | 99.2 | 적합 |
스테아린산 마그네슘 | 95~105 | 99.9 | 적합 | 95~105 | 99.3 | 적합 |
크로스카멜로스 소듐 | 95~105 | 99.8 | 적합 | 95~105 | 99.7 | 적합 |
소듐 스타치(프리젤라틴화) | 95~105 | 99.4 | 적합 | 95~105 | 100 | 적합 |
저치환 하이드록시프로필 셀룰로오스 | 95~105 | 99.6 | 적합 | 95~105 | 99.5 | 적합 |
만니톨 | 95~105 | 99.5 | 적합 | 95~105 | 99.6 | 적합 |
소듐 스타치 글리콜레이트 | 95~105 | 100.4 | 적합 | 95~105 | 99.8 | 적합 |
수크로스 | 95~105 | 99.5 | 적합 | 95~105 | 99.5 | 적합 |
폴리비닐 알코올 | 95~105 | 99.5 | 적합 | 95~105 | 100 | 적합 |
하이드록시에틸 셀룰로오스 | 95~105 | 99.6 | 적합 | 95~105 | 100.3 | 적합 |
소듐 알기네이트 | 95~105 | 99.5 | 적합 | 95~105 | 99.8 | 적합 |
속방층 제제 | 마손도시험 | 경도시험 | 유동성시험 | 붕해시험 | 용출 시험 | |
제제 1a | 레보드로프로피진 (45mg) Flowlac (50mg) 스테아린산 마그네슘 (1.9mg) | 부적합 | 적합 | - | - | - |
제제 2a | 레보드로프로피진 (45mg) Flowlac (60mg) 스테아린산 마그네슘 (1.9mg) | 부적합 | 적합 | - | - | - |
제제 3a | 레보드로프로피진 (45mg) Flowlac (80mg) 스테아린산 마그네슘 (1.9mg) | 부적합 | 적합 | - | - | - |
제제 4a | 레보드로프로피진 (45mg) D-mannitol (50mg) 스테아린산 마그네슘 (1.9mg) | 부적합 | 적합 | - | - | - |
제제 5a | 레보드로프로피진 (45mg) D-mannitol (60mg) 스테아린산 마그네슘 (1.9mg) | 부적합 | 적합 | - | - | - |
제제 6a | 레보드로프로피진 (45mg) D-mannitol (80mg) 스테아린산 마그네슘 (1.9mg) | 부적합 | 적합 | - | - | - |
제제 7a | 레보드로프로피진 (45mg) Flowlac (67mg) Corn starch (20mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 부적합 | - | - |
제제 8a | 레보드로프로피진 (45mg) Flowlac (67mg) Corn starch (40mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 부적합 | - | - |
제제 9a | 레보드로프로피진 (45mg) Flowlac (67mg) Corn starch (60mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 부적합 | - | - |
제제 10a | 레보드로프로피진 (45mg) Flowlac (67mg) *MCC pH102 (20mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 부적합 | - | - |
제제 11a | 레보드로프로피진 (45mg) Flowlac (67mg) *MCC pH102 (40mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 부적합 | - | - |
제제 12a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (60mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 부적합 | - | - |
제제 13a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (5mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 적합 | 적합 |
제제 14a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 적합 | 적합 |
제제 15a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) Sodium starch glycolate (20mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 적합 | 부적합 |
제제 16a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) CL-PVP (5mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 적합 | 부적합 |
제제 17a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) CL-PVP (10mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 적합 | 부적합 |
제제 18a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) CL-PVP (20mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 적합 | 부적합 |
제제 19a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 크로스카멜로스 소듐 (5mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 적합 | 적합 |
제제 20a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) Croscarmellose sodium (10mg) 스테아린산 마그네슘(1.9mg) | 적합 | 적합 | 적합 | 적합 | 부적합 |
제제 21a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) Croscarmellose sodium (20mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 적합 | 부적합 |
제제 22a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) Starch 1500 (5mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 부적합 | 부적합 |
제제 23a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) Starch 1500 (10mg) 스테아린산 마그네슘(1.9mg) | 적합 | 적합 | 적합 | 적합 | 부적합 |
제제 24a | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) Starch 1500 (20mg) 스테아린산 마그네슘 (1.9mg) | 적합 | 적합 | 적합 | 적합 | 부적합 |
제제 | 경도 시험 | 유동성 시험 | 용출 시험 | ||
속방층 | 서방층 | ||||
제제 1b | 레보드로프로피진 (45mg) Flowlac (67mg) *MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) Kolidon SR (10mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 부적합 | - |
제제 2b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) Kolidon SR (30mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 부적합 | - |
제제 3b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) Kolidon SR (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 부적합 | - |
제제 4b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) HPMC2208(100,000cps) (10mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 부적합 | - |
제제 5b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) HPMC2208(100,000cps) (30mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 부적합 | - |
제제 6b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 부적합 | - |
제제 7b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) Lactose (5mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 8b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) Lactose (10mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 9b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) Lactose (15mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘(1.7mg) | 적합 | 적합 | 부적합 |
제제 10b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (5mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 11b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (10mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 12b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (15mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 13b | fp보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-30 (3mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 14b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-30 (6mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 15b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-30 (9mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 16b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-30 (9mg) HPMC2208(100,000cps) (60mg) 스테아린산 마그네슘(1.7mg) | 적합 | 적합 | 부적합 |
제제 17b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-30 (9mg) HPMC2208 (100,000cps) (80mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 적합 |
제제 18b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-30 (9mg) HPMC2208(100,000cps) (100mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 적합 |
제제 19b | 레보드로프로피진 (45mg) Flowlac (67mg) MCC pH102 (67mg) 소듐 스타치 글리콜레이트 (10mg) 스테아린산 마그네슘 (1.9mg) | 레보드로프로피진 (45mg) MCC pH 101 (7mg) PVP K-90 (3mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 적합 |
제제 20b | 레보드로프로피진 (45mg)Flowlac (67mg)MCC pH102 (67mg)소듐 스타치 글리콜레이트 (10mg)스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-90 (6mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 적합 |
제제 21b | 레보드로프로피진 (45mg)Flowlac (67mg)MCC pH102 (67mg)소듐 스타치 글리콜레이트 (10mg)스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-90 (9mg) HPMC2208(100,000cps) (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 22b | 레보드로프로피진 (45mg)Flowlac (67mg)MCC pH102 (67mg)소듐 스타치 글리콜레이트 (10mg)스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-90 (9mg) HPMC 2910 (50mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 23b | 레보드로프로피진 (45mg)Flowlac (67mg)MCC pH102 (67mg)소듐 스타치 글리콜레이트 (10mg)스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-90 (9mg) HPMC 2910 (80mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
제제 24b | 레보드로프로피진 (45mg)Flowlac (67mg)MCC pH102 (67mg)소듐 스타치 글리콜레이트 (10mg)스테아린산 마그네슘 (1.9mg) | 레보드로프로피진(45mg) MCC pH 101 (7mg) PVP K-90 (9mg) HPMC 2910 (100mg) 스테아린산 마그네슘 (1.7mg) | 적합 | 적합 | 부적합 |
최종 제제 | 실시예 1 | 실시예 2 | 실시예 3 | |
서방층 | 레보드로프로피진 | 45.0 | 45.0 | 45.0 |
*MCC 101 | 7.0 | 6.8 | 6.8 | |
*HPMC 2208 | 50.0 | 50.0 | 50.0 | |
*PVP K-90 | 3.0 | 2.7 | 2.7 | |
*s-Mg | 1.7 | 1.7 | 1.7 | |
최종중량(mg) | 106.7 | 106.2 | 106.2 | |
속방층 | 레보드로프로피진 | 45.0 | 45.0 | 45.0 |
Flowlac | 67.0 | 67.0 | 67.0 | |
MCC pH102 | 67.0 | 67.0 | 67.0 | |
Sodium starch glycolate | 10.0 | 10.0 | 7.5 | |
s-Mg | 1.9 | 1.9 | 1.9 | |
최종중량(mg) | 190.9 | 190.9 | 188.4 | |
전체 중량(mg) | 297.6 | 297.1 | 294.6 |
Claims (13)
- 레보드로프로피진을 포함하는 속방층과, 레보드로프로피진 및 방출제어용 고분자를 포함하는 서방층으로 이루어지는 레보드로프로피진 서방정.
- 청구항 1에 있어서, 상기 속방층의 레보드로프로피진의 함량은 10 내지 70mg, 상기 서방층의 레보드로프로피진의 함량은 20 내지 80mg인 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 1에 있어서, 상기 방출제어용 고분자는 하이드록시프로필메틸셀룰로오스, 카보머, 하이드록시프로필셀룰로오스, 메틸셀룰로오스, 폴리비닐피롤리돈 및 폴리비닐알코올로 구성된 그룹으로부터 선택된 1종 또는 2종 이상의 혼합물인 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 1에 있어서, 상기 방출제어용 고분자의 함량은 레보드로프로피진 서방정 전체 중량 대비 10 내지 80 중량%인 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 1에 있어서, 상기 방출제어용 고분자의 점도는 60,000 내지 140,000cps인 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 1에 있어서, 상기 레보드로프로피진 및 방출제어용 고분자 외에 붕해제, 활택제, 수용성 첨가제, 속효성 부형제, 충진제 및 결합제로 이루어진 군에서 선택되는 1종 이상의 부형제를 추가적으로 포함하는 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 6에 있어서, 상기 붕해제는 크로스카멜로오스 소듐, 소듐 스타치 글리콜레이트, 프리젤라틴화 스타치, 미세결정셀룰로오스, 크로스포비돈 및 폴리비닐피롤리돈으로 이루어진 군에서 선택되는 1종 또는 2종 이상의 혼합물인 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 6에 있어서, 상기 붕해제의 함량은 속방층 또는 서방층 전체 중량 대비 10 ~ 60 중량%인 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 6에 있어서, 상기 활택제의 함량은 속방층 또는 서방층 전체 중량에 대하여 0.25 ~ 2 중량%인 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 1에 있어서, 상기 서방층은 레보드로프로피진, 미세결정 셀룰로오스(MCC), 히드록시프로필메틸셀룰로오스(HPMC), 폴리비닐피롤리돈(PVP) 및 스테아린산 마그네슘을 포함하는 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 1에 있어서, 상기 속방층은 레보드로프로피진, 락토오스, 미세결정 셀룰로오스, 소듐 스타치 글리콜레이트(Sodium starch glycolate) 및 스테아린산 마그네슘을 포함하는 것을 특징으로 하는 레보드로프로피진 서방정.
- 청구항 1에 있어서, 상기 속방층과 서방층을 혼합하여 제조한 펠렛형 정제 또는 다중정인 것을 특징으로 하는 레보드로프로피진 서방정.
- a)레보드로프로피진, 방출제어용 고분자 및 첨가제를 혼합하여 습식 또는 건식으로 서방성 과립물을 제조하는 단계; 및b)상기 서방성 과립물과 레보드로프로피진을 함유한 혼합물에 각각 활택제를 후혼합하고, 타정하는 단계를 포함하는 레보드로프로피진 서방정의 제조방법.
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BR112014026040-0A BR112014026040B1 (pt) | 2012-04-17 | 2013-04-17 | Comprimido de liberação sustentada que contém levodropropizina |
EP13778634.9A EP2839829B1 (en) | 2012-04-17 | 2013-04-17 | Sustained release tablet containing levodropropizine and method for preparing same |
RU2014145845A RU2616263C2 (ru) | 2012-04-17 | 2013-04-17 | Таблетка с замедленным высвобождением, содержащая леводропропизин, и способ ее изготовления |
ES13778634.9T ES2693156T3 (es) | 2012-04-17 | 2013-04-17 | Comprimido de liberación sostenida que contiene levodropropizina y método para prepararlo |
PL13778634T PL2839829T3 (pl) | 2012-04-17 | 2013-04-17 | Tabletka o przedłużonym uwalnianiu zawierająca lewodropropizynę i sposób jej wytwarzania |
PH12014502325A PH12014502325B1 (en) | 2012-04-17 | 2014-10-17 | Sustained release tablet containing levodropropizine and method for preparing same |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR10-2012-0039907 | 2012-04-17 | ||
KR1020120039907A KR20130117128A (ko) | 2012-04-17 | 2012-04-17 | 레보드로프로피진 함유 서방정 및 이의 제조방법 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2013157841A1 true WO2013157841A1 (ko) | 2013-10-24 |
Family
ID=49383726
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/KR2013/003232 WO2013157841A1 (ko) | 2012-04-17 | 2013-04-17 | 레보드로프로피진 함유 서방정 및 이의 제조방법 |
Country Status (8)
Country | Link |
---|---|
EP (1) | EP2839829B1 (ko) |
KR (1) | KR20130117128A (ko) |
BR (1) | BR112014026040B1 (ko) |
ES (1) | ES2693156T3 (ko) |
PH (1) | PH12014502325B1 (ko) |
PL (1) | PL2839829T3 (ko) |
RU (1) | RU2616263C2 (ko) |
WO (1) | WO2013157841A1 (ko) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110934872A (zh) * | 2019-12-16 | 2020-03-31 | 湖南九典制药股份有限公司 | 左羟愈酚胶囊及其制备方法 |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102260235B1 (ko) * | 2018-09-10 | 2021-06-03 | 콜마파마 주식회사 | 레보드로프로피진 방출제어형 이층정제 및 이의 제조방법 |
KR102246066B1 (ko) * | 2019-02-12 | 2021-04-29 | 한국유나이티드제약 주식회사 | 레보드로프로피진 함유 서방정의 제조방법 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20100089532A (ko) * | 2009-02-04 | 2010-08-12 | 한국유나이티드제약 주식회사 | 제어 방출성 아세클로페낙을 함유하는 경구 제제의 조성물 및 그의 제조방법 |
KR20110113413A (ko) | 2010-04-09 | 2011-10-17 | 현대약품 주식회사 | 서방성 약제학적 조성물 및 이의 제조방법 |
KR20110132170A (ko) * | 2010-06-01 | 2011-12-07 | 한국유나이티드제약 주식회사 | 1일 1회 투여로 최적의 약리학적 임상 효과를 제공하는 아세클로페낙 서방성 제제 |
KR20120033557A (ko) * | 2010-09-30 | 2012-04-09 | 현대약품 주식회사 | 레보드로프로피진을 포함하는 속효성과 지속성을 동시에 갖는 약제학적 조성물 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2002350719A1 (en) * | 2002-11-29 | 2004-06-23 | Janssen Pharmaceutica N.V. | Pharmaceutical compositions comprising a basic respectively acidic drug compound, a surfactant and a physiologically tolerable water-soluble acid respectively base |
WO2011126327A2 (en) * | 2010-04-09 | 2011-10-13 | Hyundai Pharm Co., Ltd. | Pharmaceutical composition with controlled-release properties comprising mosapride or levodropropizine, and preparing method thereof |
-
2012
- 2012-04-17 KR KR1020120039907A patent/KR20130117128A/ko not_active Application Discontinuation
-
2013
- 2013-04-17 PL PL13778634T patent/PL2839829T3/pl unknown
- 2013-04-17 RU RU2014145845A patent/RU2616263C2/ru active
- 2013-04-17 EP EP13778634.9A patent/EP2839829B1/en active Active
- 2013-04-17 WO PCT/KR2013/003232 patent/WO2013157841A1/ko active Application Filing
- 2013-04-17 BR BR112014026040-0A patent/BR112014026040B1/pt active IP Right Grant
- 2013-04-17 ES ES13778634.9T patent/ES2693156T3/es active Active
-
2014
- 2014-10-17 PH PH12014502325A patent/PH12014502325B1/en unknown
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20100089532A (ko) * | 2009-02-04 | 2010-08-12 | 한국유나이티드제약 주식회사 | 제어 방출성 아세클로페낙을 함유하는 경구 제제의 조성물 및 그의 제조방법 |
KR20110113413A (ko) | 2010-04-09 | 2011-10-17 | 현대약품 주식회사 | 서방성 약제학적 조성물 및 이의 제조방법 |
KR20110132170A (ko) * | 2010-06-01 | 2011-12-07 | 한국유나이티드제약 주식회사 | 1일 1회 투여로 최적의 약리학적 임상 효과를 제공하는 아세클로페낙 서방성 제제 |
KR20120033557A (ko) * | 2010-09-30 | 2012-04-09 | 현대약품 주식회사 | 레보드로프로피진을 포함하는 속효성과 지속성을 동시에 갖는 약제학적 조성물 |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110934872A (zh) * | 2019-12-16 | 2020-03-31 | 湖南九典制药股份有限公司 | 左羟愈酚胶囊及其制备方法 |
CN110934872B (zh) * | 2019-12-16 | 2023-01-10 | 太阳升(亳州)生物医药科技有限公司 | 左羟愈酚胶囊及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
KR20130117128A (ko) | 2013-10-25 |
EP2839829A4 (en) | 2015-02-25 |
EP2839829A1 (en) | 2015-02-25 |
RU2014145845A (ru) | 2016-06-10 |
PL2839829T3 (pl) | 2019-03-29 |
EP2839829B1 (en) | 2018-09-26 |
BR112014026040A2 (pt) | 2017-06-27 |
BR112014026040B1 (pt) | 2022-02-22 |
PH12014502325A1 (en) | 2015-01-12 |
ES2693156T3 (es) | 2018-12-07 |
RU2616263C2 (ru) | 2017-04-13 |
PH12014502325B1 (en) | 2015-01-12 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
WO2013147462A1 (en) | Pharmaceutical composition comprising olmesartan medoxomil and rosuvastatin or its salt | |
EP2373319B1 (en) | Sustained release pharmaceutical composition of quetiapine and process for preparation thereof | |
ZA200602497B (en) | Pharmaceutical compositions of moxifloxacin and processes for their preparation | |
WO2011152652A2 (ko) | 1일 1회 투여로 최적의 약리학적 임상 효과를 제공하는 아세클로페낙 서방성 제제 | |
WO2013058450A1 (ko) | 안정화된 에페리손 의약 조성물 및 이를 함유하는 서방성 제제 | |
WO2013162114A1 (ko) | 위체류 약물전달 시스템을 이용한 서방성 제제 | |
CA2949154A1 (en) | Allisartan isoproxil solid dispersion and pharmaceutical composition | |
WO2013157841A1 (ko) | 레보드로프로피진 함유 서방정 및 이의 제조방법 | |
KR101853347B1 (ko) | 콜린 알포세레이트-함유 정제 및 이의 제조방법 | |
WO2012148181A2 (ko) | 약물 방출제어용 조성물 | |
US20050136107A1 (en) | Extended release antibiotic composition | |
KR20140041641A (ko) | 이토프라이드 염산염을 함유하는 제어 방출성 경구 제제의 조성물 및 그의 제조방법 | |
WO2019066555A1 (en) | PHARMACEUTICAL COMPOSITION COMPRISING MULTI-UNIT SPHEREOIDAL TABLET CONTAINING ESOMEPRAZOLE AND PHARMACEUTICAL QUALITY SALT THEREOF, AND PROCESS FOR PREPARING THE PHARMACEUTICAL COMPOSITION | |
KR101811700B1 (ko) | 레보드로프로피진 함유 서방정 및 이의 제조방법 | |
ES2963886T3 (es) | Comprimidos que contienen tamsulosina y solifenacina | |
WO2013032206A1 (ko) | 이토프라이드 염산염을 함유하는 제어 방출성 경구 제제의 조성물 및 그의 제조방법 | |
KR101093781B1 (ko) | pH조절제를 함유하는 목시플록사신 고형 조성물 | |
US20060182803A1 (en) | Oral sustained-release pharmaceutical composition of indapamide, production and use thereof | |
US10420764B2 (en) | Pharmaceutical formulation of N-[5-[2-(3,5-dimethoxyphenyl)ethyl]-2H-pyrazol-3-YL]-4-[(3R,5S)-3 ,5-dimethylpiperazin-1-YL] benzamide | |
KR100795419B1 (ko) | 암로디핀 및 아스피린을 함유하는 약학 제제 | |
KR102286497B1 (ko) | 다양한 용량의 레날리도마이드의 경구용 정제 조성물 | |
WO2020017808A1 (ko) | 날푸라핀 함유 구강붕해정 | |
WO2015056956A1 (ko) | 제어방출되는 프로피온산 계열의 약제학적 조성물 | |
WO2020166835A1 (ko) | 레보드로프로피진 함유 서방정의 제조방법 | |
US20080206329A1 (en) | Modified Release Ciprofloxacin Compositions |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 13778634 Country of ref document: EP Kind code of ref document: A1 |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2013778634 Country of ref document: EP |
|
ENP | Entry into the national phase |
Ref document number: 2014145845 Country of ref document: RU Kind code of ref document: A |
|
REG | Reference to national code |
Ref country code: BR Ref legal event code: B01A Ref document number: 112014026040 Country of ref document: BR |
|
ENP | Entry into the national phase |
Ref document number: 112014026040 Country of ref document: BR Kind code of ref document: A2 Effective date: 20141017 |