WO2008062435A2 - Stabilised dosage forms of amlodipine besylate - Google Patents
Stabilised dosage forms of amlodipine besylate Download PDFInfo
- Publication number
- WO2008062435A2 WO2008062435A2 PCT/IN2007/000385 IN2007000385W WO2008062435A2 WO 2008062435 A2 WO2008062435 A2 WO 2008062435A2 IN 2007000385 W IN2007000385 W IN 2007000385W WO 2008062435 A2 WO2008062435 A2 WO 2008062435A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- solid dosage
- dosage form
- stable solid
- polyols
- combination
- 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.)
- Ceased
Links
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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
Definitions
- the technical field of present invention relates to a stable solid dosage form of amlodipine besylate comprising polyols and having reduced levels of total impurities on stability and especially impurity D (defined below).
- the invention has been developed primarily for use as a solid oral dosage fprm and will be described hereinafter with reference to this application.
- Amlodipine besylate is chemically described as3-Ethyl-5-methyl( ⁇ )-2-[(2- aminoethoxy ⁇ ethylJ ⁇ -chlorophenyO-l ⁇ -dihydro- ⁇ -methyl-SjS pyridinedicarboxylate,monobenzenesulphonate.
- This compound is used for the preparation of a medicament having calcium channel blocking activity that is useful, inter alia, in the nianagement of hypertension, congestive heart failure and angina pectoris.
- Polyols have been successfully used in food and confectionery applications for more than 30 years. Originally introduced in "sugar-free candies for diabetic diets, polyols have gained wide acpeptance for enhancing processing, stability, shelf-life, and texture in sugar applications as well Polyols are sugar-free sweeteners. Polyols are carbohydrates but they are not sugars. Unlike high potency sweeteners like aspartame, which is Used in very small amount, polyols are used in the same quantity as sucrose. Chemically, polyols are considered polyhydric alcohols or sugar alcohols because part of their structure resembles sugar and part is similar to alcohols. However, these sugar-free sweetenefs are neither sugars nor alcohols, as these words are commonly used.
- polyols are derived from carbohydrates whose carbonyl group (aldehyde or ketone, reducing sugar), has been reduced to a primary or secondary hydroxyl group.
- the most widely used polyols are sorbitol, mannitol, and maltitol. Sorbitol is derived from glucose, mannitol frqm fructose, and maltitol frotn high maltose corn syrup. There are a number of different polyols
- U.S. Pat. No. 4,879,303 and corresponding EP 244 944 Edward Davison describes the commercial product of amlodipine (NORV ASC® by Pfizer, Inc.), which contains amlodipine besylate.
- This patent discloses a singly form of amlodipine besylate, namely a crystalline anhydrous besylate salt of amlodipine.
- the inactive ingredients in the Norvasc tablets include microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
- Nagaprasad relates to stable solid dosage forms of amlodipine base and process of preparation, which it free of dicalcium phosphate.
- the stable amlodipine solid dosage form includes amlodipine base, microcrystalline cellulose, is substantially free of dicalcium phosphate, and has less than about 0.5% concentration (w/w) of Impurity D after three months at 40 Q C and 75% relative humidity.
- WO Patent No 03051364Al Fek ⁇ te relates to amlodipine bezylate tablets with improved ⁇ Stability of the active ingredient and reduced in weight containing microcrystalline cellulose, a lubricant and a disintegrating agent.
- the invention also relates to a process for the preparation of the said tablets.
- microcrystalline cellulose also absorbs the moisture and amlodipine degrades and generates impurity in presence of moisture.
- amlodipine salt form dis ⁇ losed in the above patents is suitable for a commercial product, but they suffer from some drawbacks in terms of stability, and impurity profiling. Further it has been disclosed in the prior art that free base compositions, which include microcrystalline cellulose as diluents lead to process related issues.
- the present invention relates to a stable solid dosage form comprising 2-20 % by weight of amlodipine besylate, 10-70 % by weight polyols, and at least a known pharmaceutical excipieni Particulalry, it relates to a stable solid dosage form of amlodipine besylate comprising polyols and having reduced levels of Impurity D and total impurities.
- Another aspect of the invention includes use of pregelatinised starch to improve the processing of the formulation.
- stable refers to chemical stability of amlodipine in solid dosage forms.
- the dosage form includes one or more pharmaceutical excipients selected from diluents, binders, de$iccants, disintegrants, coloring agents, flavoring agents, surfactants, lubricants/glidants, plasticizers and preservatives.
- disintegrants examples include sodium starch glycolate, croscarmellose sodium, crospovidone, low substituted hydroxypropyl cellulose, and the like.
- binders include dry ⁇ and wet binders like methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinylpyrrolidone, gelatin, gum arable, ethyl cellulose, polyvinyl alcohol, pullulan, pregelatinized starch, agar, tragarcanth, sodium alginate, and the like.
- diluents include- dextrates, dextrins, dextrose excipients, fructose, kaolin* lactitol, mannitol, sorbitol, xyletol, and other polyols, starch pregelatinized, sucrose, sugar compressible sugar confectioners, and the like.
- lubricants and glidants include colloidal silicon dioxide, magnesium stearate, and colloidal anhydrous silica, stearic acid, magnesium stearate, and calcium stearate, talc, hydrogenated castor oil, sucrose esters of fatty acid, microcrystalline wax, yellow beeswax, white beeswax, fumarates and the like.
- coloring agents include any FDA approved colors for oral use.
- stable solid dosage forms of amlodipine besylate along with other pharmaceutically accepted excipients more specifically the preferred embodiment is a composition of amlodipine besylate comprising polyols and having significantly reduced level of total impurities, especially impurity D.
- the stable amlodipine tablets were prepared as follows:
- step 5 was added to that of step 4 & lubricated for 5 minutes.
- step 6 The above blend obtained in step 6 was compressed with their respective punch.
- the tablets obtained above were subjected to stability evaluation on both enclosed and open exposure at 40°C and 75% relative humidity.
- the formulation was also subjected to stress studies like autoclaving.
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a stable solid dosage form comprising 2-20 % by weight of amlodipine besylate, 10-70 % by weight polyols, at least a known pharmaceutical excipient, and having levels of impurity D (3-ethyl-5-methyl-2[(2-aminoethoxy)-methyl]-4-(2- chlorophenyl)-6-methylpyridine-3,5 dicarboxylate) less than 0,5 %.
Description
TITLE
STABILISED DOSAGE FORMS OF AMLODEPINE BESYLATE
T1IELD OF INVENTION
The technical field of present invention relates to a stable solid dosage form of amlodipine besylate comprising polyols and having reduced levels of total impurities on stability and especially impurity D (defined below).
The invention has been developed primarily for use as a solid oral dosage fprm and will be described hereinafter with reference to this application.
BACKGROUND OF THE INVENTION
Amlodipine besylate is chemically described as3-Ethyl-5-methyl(±)-2-[(2- aminoethoxy^ethylJ^^-chlorophenyO-l^-dihydro-ό-methyl-SjS pyridinedicarboxylate,monobenzenesulphonate. This compound is used for the preparation of a medicament having calcium channel blocking activity that is useful, inter alia, in the nianagement of hypertension, congestive heart failure and angina pectoris.
DESCRIPTION OF THE PRIOR ART:
Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of the common general knowledge in the field.
Prior literature discloses that Amlodipine is highly hydroscopic and absorbs moisture, which leads to degradation via the catalytic oxidative process, which is pH dependent. The major related substances produced are {3-ethyl 5-methyl (4RS) 4-(2-chlorophenyl)- 6-methyI-2-[[2-&lsήb;[2(methylcarbamoyl) benzoyl&rsqb amino] ethoxy] methyl&rsqb ;-l,4-dihydropyridine-3,5 dicarboxylate}(Impurity B){3-ethyl-5-methyl-2-[ (2-aminoethόxy) methyl] 4- (2-chlorophenyl)-6-methylpyridine-3,5 dicarboxylate} ("Impurity D"); and {3- ethyl $-methyl (4RS) 4-(2-chlorophenyl)-2[[2-(l,3-dioxo- dihydro-2H-isoindol-2- yl) ethoxy]methyl]-6-methyI-l,4-4ihydropyridine-3, 5 dicarboxylate} ("Impurity A"), along with some unknown impurities.
Polyols have been successfully used in food and confectionery applications for more than 30 years. Originally introduced in "sugar-free candies for diabetic diets, polyols have gained wide acpeptance for enhancing processing, stability, shelf-life, and texture in sugar applications as well Polyols are sugar-free sweeteners. Polyols are carbohydrates but they are not sugars. Unlike high potency sweeteners like aspartame, which is Used in very small amount, polyols are used in the same quantity as sucrose.
Chemically, polyols are considered polyhydric alcohols or sugar alcohols because part of their structure resembles sugar and part is similar to alcohols. However, these sugar-free sweetenefs are neither sugars nor alcohols, as these words are commonly used. They are derived from carbohydrates whose carbonyl group (aldehyde or ketone, reducing sugar), has been reduced to a primary or secondary hydroxyl group. The most widely used polyols are sorbitol, mannitol, and maltitol. Sorbitol is derived from glucose, mannitol frqm fructose, and maltitol frotn high maltose corn syrup. There are a number of different polyols
The varipus compositions of amlodipine can be known from the prior patents as follows:
For example; U.S. Pat. No. 4,879,303 and corresponding EP 244 944 Edward Davison describes the commercial product of amlodipine (NORV ASC® by Pfizer, Inc.), which contains amlodipine besylate. This patent discloses a singly form of amlodipine besylate, namely a crystalline anhydrous besylate salt of amlodipine. The inactive ingredients in the Norvasc tablets include microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
WO Patent No 04075825A2, Nagaprasad relates to stable solid dosage forms of amlodipine base and process of preparation, which it free of dicalcium phosphate. The stable amlodipine solid dosage form includes amlodipine base, microcrystalline cellulose,
is substantially free of dicalcium phosphate, and has less than about 0.5% concentration (w/w) of Impurity D after three months at 40QC and 75% relative humidity.
WO Patent No 03051364Al Fekςte relates to amlodipine bezylate tablets with improved \ Stability of the active ingredient and reduced in weight containing microcrystalline cellulose, a lubricant and a disintegrating agent. The invention also relates to a process for the preparation of the said tablets.
A great deal of research has been done in this area to inporporate amlodipine with other pharmaceutically accepted excipients but it always results in stability problems.
To overcome the problems associated with the prior arts, an intensive and thorough research resulted in providing the most advantageous solid formulation in terms of both stability and processing characteristics. This inclμdes ariilodipine besylate along with polyols to overcome the shortcomings of microcrystalline cellulose. Besides this, results in reduced levels of Impurity D and total impurities.
It is well known that microcrystalline cellulose also absorbs the moisture and amlodipine degrades and generates impurity in presence of moisture.
While the amlodipine salt form disςlosed in the above patents is suitable for a commercial product, but they suffer from some drawbacks in terms of stability, and impurity profiling. Further it has been disclosed in the prior art that free base
compositions, which include microcrystalline cellulose as diluents lead to process related issues.
OBJECT1 OF THE INVENTION
It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.
It is an object of the invention in its preferred form to provide stable solid dosage forms of amlodipine besylate and pro, cess of preparation thereof comprising polyols and which have reduced levels of total impurities arid especially impurity D on stability.
SUMMARY OF THE INVENTION
The present invention relates to a stable solid dosage form comprising 2-20 % by weight of amlodipine besylate, 10-70 % by weight polyols, and at least a known pharmaceutical excipieni Particulalry, it relates to a stable solid dosage form of amlodipine besylate comprising polyols and having reduced levels of Impurity D and total impurities.
Another aspect of the invention includes use of pregelatinised starch to improve the processing of the formulation.
The term "stable" as used herein refers to chemical stability of amlodipine in solid dosage forms.
The dosage form includes one or more pharmaceutical excipients selected from diluents, binders, de$iccants, disintegrants, coloring agents, flavoring agents, surfactants, lubricants/glidants, plasticizers and preservatives.
Examples of disintegrants include sodium starch glycolate, croscarmellose sodium, crospovidone, low substituted hydroxypropyl cellulose, and the like.
Examples of binders include dry^ and wet binders like methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinylpyrrolidone, gelatin, gum arable, ethyl cellulose, polyvinyl alcohol, pullulan, pregelatinized starch, agar, tragarcanth, sodium alginate, and the like.
Examples of diluents include- dextrates, dextrins, dextrose excipients, fructose, kaolin* lactitol, mannitol, sorbitol, xyletol, and other polyols, starch pregelatinized, sucrose, sugar compressible sugar confectioners, and the like.
Examples of lubricants and glidants include colloidal silicon dioxide, magnesium stearate, and colloidal anhydrous silica, stearic acid, magnesium stearate, and calcium stearate, talc, hydrogenated castor oil, sucrose esters of fatty acid, microcrystalline wax, yellow beeswax, white beeswax, fumarates and the like.
Examples of coloring agents include any FDA approved colors for oral use.
PREFERRED EMBODIMENT OF THE INVENTION
In accordance with one preferred embodiment there is provided stable solid dosage forms of amlodipine besylate along with other pharmaceutically accepted excipients, more specifically the preferred embodiment is a composition of amlodipine besylate comprising polyols and having significantly reduced level of total impurities, especially impurity D.
Preferred embodiments are further illustrated in the following examples. Example: 1
The stable amlodipine tablets were prepared as follows:
1. Amlodipine Besylate was Weighed based on its potency.
2. Mannitol (Perlitol SD 200)» PG search, Ac-Di-SoI, Aerosil 200 and Magnesium Stearate were weighed.
3. Amlodipine Besylate, Mannitol (Eerlitoϊ SD 200), PG starch, Ac-Di-Soi, Aerosil 21OO were sieved separately through sieve size of mesh 40. 4. AU of the above ingredients were mixed in a blender for 30 minutes.
5. Equal quantities of above blend & Magnesium Stearate were miiced properly,
6. Finally, the blend of step 5 was added to that of step 4 & lubricated for 5 minutes.
7. The above blend obtained in step 6 was compressed with their respective punch.
The tablets obtained above were subjected to stability evaluation on both enclosed and open exposure at 40°C and 75% relative humidity.
40°c/75%RH Amlodipine Besylate tablets compilation data (stability chamber) of lixiample-5
Amlodipine besylate Tablets lOmg
Stability Batch VI
Amlodipine besylate Tablets lOmg
The formulation was also subjected to stress studies like autoclaving.
All the above studies indicated that amlodipine tablets without dicalcium phosphate and microcrystalline cellulose are more stable and had significantly lower levels of total impurities especially impurity D, which was less than 0.5%.
Although the invention has been described with reference to a specific example, it will be appreciated by those skilled in the art that trie invention may be embodied in many other forms.
Claims
1. A stable solid dosage form comprising 2-20 % by weight of amiodipine besylate, 10-70 % by weight polyols, and at least a known pharmaceutical excipient.
2. A stable solid dosage form as claimed in Claim I^ wherein said pharmaceutical excipient is selected from known diluents, binders, desiccants, disintegranfe, coloring agents, flavoring agents, surfactants, lubricants/glidants, plasticizers or preservatives.
3. A stable solid dosage form as claimed in Claim 1 or 2, wherein said polyols is mannitol, sorbitol, maltitol, xylitol, lactitol or erythritol.
4. A stable solid dosage form as claimed in Claim 2, wherein said disintegrants is sodium starch glycolate, croscarmellose sodium, crospovidone or low substituted hydroxypropyl cellulose or any combination thereof.
5. A- stable solid dosage form as claimed in Claim 2, wherein said binders include dry and wet binders like rήethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylceJIulose, polyvinylpyrrolidone, gelatin, gum arable, ethyl cellulose, polyvinyl alcohol, pullulan, pregelatinized starch, agar, tragarcanth or sodium alginate or any combination thereof.
6. A stable solid dosage form as claimed in Claim 2, wherein said diluents include dextrates, dextrins, dextrose excipients* fructose, kaolin, lactitol, mannitbl, sorbitol, xyletol, and other known polyols, starch pregelatinized, sucrose or sugar compressible sugar confectioners or any combination thereof.
7. A stable solid dosage forμi as- claimed in Claim 2, wherein said lubricants and glidants include colloidal silicon dioxide, magnesium stearate, and Colloidal anhydrQus silica, stearic acid, magnesium stearate, aad calcium stearate, talc, hydrogenated castor oil, sucrose esters of fatty acid, microcrystallϊne wax, yellow beeswax, white beeswax or fumarates or any combination thereof.
8. The stable solid dosage form as claimed in any of the aforesaid Claims having levels of impurity D less than 0.5%.
9. The stable solid dosage form according to Claim 8 wherein the levels of total impurities are less than 1.0%.
10. A stable solid dosage form substantially described herein with reference to the examples accompanying the specification.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN944MU2006 | 2006-08-15 | ||
| IN944/MUM/2006 | 2006-08-15 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2008062435A2 true WO2008062435A2 (en) | 2008-05-29 |
| WO2008062435A3 WO2008062435A3 (en) | 2008-07-31 |
Family
ID=39430164
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IN2007/000385 Ceased WO2008062435A2 (en) | 2006-08-15 | 2007-08-27 | Stabilised dosage forms of amlodipine besylate |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2008062435A2 (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011060944A2 (en) | 2009-11-20 | 2011-05-26 | Gp Pharm, S.A. | Active pharmaceutical ingredient capsules and polyunsaturated fatty acid esters |
| WO2014138603A1 (en) * | 2013-03-07 | 2014-09-12 | Amneal Pharmaceuticals, LLC | Stabilization of moisture-sensitive drugs |
| WO2016156550A1 (en) * | 2015-04-01 | 2016-10-06 | Ceva Sante Animale | Oral solid dosage form of amlodipine and veterinary uses thereof |
| US10350171B2 (en) | 2017-07-06 | 2019-07-16 | Dexcel Ltd. | Celecoxib and amlodipine formulation and method of making the same |
| CN112162047A (en) * | 2020-09-25 | 2021-01-01 | 宁波大红鹰药业股份有限公司 | Method for determining content of genotoxic impurities in amlodipine besylate |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2124445A1 (en) * | 1991-11-26 | 1993-06-10 | James W. Young | Methods and compositions for treating hypertension, angina and other disorders using optically pure (-) amlodipine |
| KR100604034B1 (en) * | 2003-10-08 | 2006-07-24 | 주식회사유한양행 | Oral fast disintegrating tablet containing amlodipine free base and compositions thereof |
| CN1546024A (en) * | 2003-12-09 | 2004-11-17 | 成都圣诺科技发展有限公司 | Orally disintegrating tablet of amlodipine besylate and its preparation process |
| CN1686121A (en) * | 2005-04-19 | 2005-10-26 | 昆明金殿制药有限公司 | Phenylsulfonic acid amido chloro diping dispersion tablet and its preparation method |
| WO2006118210A1 (en) * | 2005-04-28 | 2006-11-09 | Eisai R & D Management Co., Ltd. | Method of preventing dihydropyridine compound from degradation |
| JP2008013489A (en) * | 2006-07-06 | 2008-01-24 | Ohara Yakuhin Kogyo Kk | Tablet comprising amlodipine besylate |
-
2007
- 2007-08-27 WO PCT/IN2007/000385 patent/WO2008062435A2/en not_active Ceased
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011060944A2 (en) | 2009-11-20 | 2011-05-26 | Gp Pharm, S.A. | Active pharmaceutical ingredient capsules and polyunsaturated fatty acid esters |
| WO2014138603A1 (en) * | 2013-03-07 | 2014-09-12 | Amneal Pharmaceuticals, LLC | Stabilization of moisture-sensitive drugs |
| US9629805B2 (en) | 2013-03-07 | 2017-04-25 | Amneal Pharmaceuticals Llc | Stabilization of moisture-sensitive drugs |
| WO2016156550A1 (en) * | 2015-04-01 | 2016-10-06 | Ceva Sante Animale | Oral solid dosage form of amlodipine and veterinary uses thereof |
| WO2016155815A1 (en) * | 2015-04-01 | 2016-10-06 | Ceva Sante Animale | Oral solid dosage form of amlodipine and veterinary uses thereof |
| AU2016239689B2 (en) * | 2015-04-01 | 2021-06-24 | Ceva Sante Animale | Oral solid dosage form of amlodipine and veterinary uses thereof |
| US11147804B2 (en) | 2015-04-01 | 2021-10-19 | Ceva Sante Animale | Oral solid dosage form of amlodipine and veterinary uses thereof |
| US10350171B2 (en) | 2017-07-06 | 2019-07-16 | Dexcel Ltd. | Celecoxib and amlodipine formulation and method of making the same |
| US10945960B2 (en) | 2017-07-06 | 2021-03-16 | Dexcel Ltd. | Celecoxib and amlodipine formulation and method of making the same |
| CN112162047A (en) * | 2020-09-25 | 2021-01-01 | 宁波大红鹰药业股份有限公司 | Method for determining content of genotoxic impurities in amlodipine besylate |
| CN112162047B (en) * | 2020-09-25 | 2022-08-02 | 宁波大红鹰药业股份有限公司 | Method for determining content of genotoxic impurities in amlodipine besylate |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2008062435A3 (en) | 2008-07-31 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP5352474B2 (en) | Orally disintegrating tablet and method for producing the same | |
| US6645526B2 (en) | Storage stable thyroxine active drug formulations and methods for their production | |
| DK200300347U3 (en) | Pharmaceuticals containing amlodipine maleate | |
| WO2008062435A2 (en) | Stabilised dosage forms of amlodipine besylate | |
| US20050202083A1 (en) | Storage stable tablets of fosinopril sodium | |
| US20080305158A1 (en) | Methods For the Preparation of Stable Pharmaceutical Solid Dosage Forms of Atorvastatin and Amlodipine | |
| KR100209201B1 (en) | Solid dispersion tablet containing 1,4-dihydropyridine derivative and its manufacturing method | |
| RU2401109C2 (en) | Tablet-form slow-release preparation for vertigo | |
| JP5291324B2 (en) | Orally disintegrating tablets | |
| US20080268049A1 (en) | Stable Solid Dosage Forms of Amlodipine and Benazepril | |
| WO2006059217A1 (en) | Stable solid dosage forms of amlodipine besylate and processes for their preparation | |
| US20060270715A1 (en) | Dosage forms of amlodipine and processes for their preparation | |
| WO2003032954A1 (en) | Stabilized pharmaceutical formulations containing amlodipine maleate | |
| WO2005032553A1 (en) | Composition for rapidly disintegrable tablet comprising amlodipine free base | |
| US20200289523A1 (en) | Fixed dosed pharmaceutical composition comprising amiodipine, candesartan cilexetil and hydrochlorothiazide for the treatment of hypertension | |
| JP2001233766A (en) | Pravastatin sodium tablet | |
| HU200924B (en) | Process for producing pharmaceutical compositions comprising terfenadine | |
| JP5309977B2 (en) | Chewable tablets | |
| US20040001886A1 (en) | Stabilized pharmaceutical formulations containing amlodipine maleate | |
| JP2010280645A (en) | Oral composition containing γ-aminobutyric acid | |
| KR101244627B1 (en) | Composition for oral disitegrating tablets comprising olanzapine, and tablets manufactured therefrom | |
| US20050019395A1 (en) | Formulations of amlodipine maleate | |
| JP7101464B2 (en) | A method for improving the quality of azilsartan or a salt thereof and amlodipine or a salt-containing tablet thereof, and azilsartan or a salt thereof and amlodipine or a salt-containing tablet thereof and a method for producing the same. | |
| US20030180354A1 (en) | Amlodipine maleate formulations | |
| JP2024055785A (en) | Bilastine pharmaceutical composition and method for producing the same |
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: 07866692 Country of ref document: EP Kind code of ref document: A2 |
|
| NENP | Non-entry into the national phase |
Ref country code: DE |
|
| NENP | Non-entry into the national phase |
Ref country code: RU |
|
| 122 | Ep: pct application non-entry in european phase |
Ref document number: 07866692 Country of ref document: EP Kind code of ref document: A2 |