KR101944085B1 - Solid oral dosage form containing valsartan, and preparation method therefor - Google Patents
Solid oral dosage form containing valsartan, and preparation method therefor Download PDFInfo
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- KR101944085B1 KR101944085B1 KR1020157005710A KR20157005710A KR101944085B1 KR 101944085 B1 KR101944085 B1 KR 101944085B1 KR 1020157005710 A KR1020157005710 A KR 1020157005710A KR 20157005710 A KR20157005710 A KR 20157005710A KR 101944085 B1 KR101944085 B1 KR 101944085B1
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- valsartan
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- 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
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- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- 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
Abstract
The present invention relates to a method for producing a solid oral dosage form containing valsartan and a solid oral dosage form, and more particularly to a method for producing a solid oral dosage form containing valsartan or a salt thereof produced by a wet granulation method, ≪ / RTI > solid oral formulations. The process for preparing valsartan-containing solid oral dosage forms of the present invention makes it possible to prepare solid oral dosage forms containing valsartan by wet granulation. The valsartan-containing solid oral formulations prepared by the above process provide excellent dispersibility, bioavailability and dissolution rate of valsartan.
Description
The present invention relates to a solid oral dosage form containing valsartan and a preparation method thereof, and more particularly to a process for producing a solid oral dosage form containing valsartan or a salt thereof produced by a wet granulation method and a solid oral dosage form ≪ / RTI >
Valsartan is administered in an amount of 80-320 mg to adult patients once or twice a day, which is generally produced in the form of capsules due to the low density of valsartan, and has a pharmacologically effective dose of 80 mg to 320 mg In order to make capsules containing valsartan, the size of the capsules is increased, thereby decreasing the compliance of the patients with the drug.
Methods for preparing conventional pharmaceutical solid oral formulations include direct compression and granular compression. The direct compression method is to prepare a solid oral formulation by directly kneading a homogeneous dry mixture prepared by mixing additives or additives such as excipients, binders and disintegrants into crystals or powders of active ingredients, It is a method of preparing granules by mixing of additives and then tableting.
The granular compression method is usually used when the fluidity of the pharmaceutical composition is poor or when the binding force is weak. Since valsartan has very sticky physical properties, granulation is preferred over direct compression.
The granular compression method can be divided into a dry method and a wet method. The wet method is a method in which an excipient, a disintegrant, or the like is added to an active ingredient, and then a binding liquid is added to the active ingredient, followed by drying And then granulating the granules by using a granulating machine.
Methods for tabletting using the dry granulation method are described in International Patent Publication No. WO 97/49394. However, in the dry granulation method, expensive new equipment such as a roller compactor is required, which is economically disadvantageous, and if not densified by a uniform compressive force, the reproducibility of drug elution from granules may be deteriorated.
In addition, valsartan is physically bophile and has a low density, so the flowability in the hopper of the tablet machine is not good. Therefore, when a tablet is prepared by a dry granulation method, it is difficult to fill the die with an accurate amount of composition, and sticking or capping is likely to occur when a large amount of tablets are tableted due to the nature of the drug. As a result, the dry granulation method has a significantly lower dispersibility than the wet granulation method.
To overcome this problem, there have been many studies on the preparation of valsartan by the wet granulation method. Korean Patent Publication Nos. 2010-0052253 and 2009-0096070 describe a process for producing valsartan tablets by the wet granulation method.
However, when a solid oral formulation containing valsartan or a salt thereof is prepared by the method described in the above publication, it is not easy to prepare a solid oral dosage form due to the sticky physical properties of valsartan when mixed with a solvent, and the dissolution rate of valsartan And bioavailability are not sufficient.
It is an object of the present invention to provide a method for producing a solid oral dosage form containing valsartan or a salt thereof having excellent dissolution rate and bioavailability, and a solid oral dosage form prepared thereby.
According to the present invention,
(a) pulverizing and micronizing valsartan or a pharmaceutically acceptable salt thereof so that the diameter of the particles is not more than 5 占 퐉;
(b) the undifferentiated valsartan or a pharmaceutically acceptable salt thereof; Excipients comprising low substituted hydroxypropylcellulose (L-HPC) and crospovidone CL; And a mixing ratio of isopropanol to water is 3 to 10: 90 to 97;
(c) drying the resulting product;
(d) granulating the dried product obtained above; And
(e) adding the excipient to the granules obtained above, mixing and tableting
≪ / RTI > to a method of making a valsartan-containing solid oral dosage form.
In addition,
For 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof; 41 to 95 parts by weight of an excipient comprising 40 to 75 parts by weight of low substituted hydroxypropylcellulose (L-HPC) and 1 to 20 parts by weight of crospovidone CL; And 85 to 100 parts by weight of a binding solution mixed so that the volume ratio of isopropanol and water is 3 to 10: 90 to 97, and the granulate produced by drying the association product, and the undifferentiated valsartan or a pharmaceutically acceptable salt thereof And 16 to 25 parts by weight of an excipient based on 100 parts by weight of the solid oral dosage form.
The process for preparing valsartan-containing solid oral dosage forms of the present invention makes it possible to prepare solid oral dosage forms containing valsartan by wet granulation. In addition, the valsartan-containing solid oral dosage forms prepared by the above process provide excellent dispersibility, bioavailability and dissolution rate of valsartan.
Fig. 1 is a view showing the size of valsartan pulverized by a jet mill.
Fig. 2 is a view showing the size of unground crushed valsartan.
FIG. 3 is a graph comparing the dissolution rates of the solid oral formulations of Example 1 prepared by the wet granulation method, including the undifferentiated valsartan, and the solid oral formulations of Comparative Example 1 prepared by the wet granulation method, including non-undifferentiated valsartan to be.
4 is a diagram showing the results of bioequivalence test of tablets (Example 1) prepared by the wet granulation method using undifferentiated valsartan of the present invention.
Best Mode for Carrying Out the Invention
According to the present invention,
(a) pulverizing and micronizing valsartan or a pharmaceutically acceptable salt thereof so that the diameter of the particles is not more than 5 占 퐉;
(b) the undifferentiated valsartan or a pharmaceutically acceptable salt thereof; Excipients comprising low substituted hydroxypropylcellulose (L-HPC) and crospovidone CL; And a mixing ratio of isopropanol to water is 3 to 10: 90 to 97;
(c) drying the resulting product;
(d) granulating the dried product obtained above; And
(e) adding the excipient to the granules obtained above, mixing and tableting
≪ / RTI > to a method of making a valsartan-containing solid oral dosage form.
In the (b) association step, for 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof; 41 to 95 parts by weight of an excipient comprising 40 to 75 parts by weight of low substituted hydroxypropylcellulose (L-HPC) and 1 to 20 parts by weight of crospovidone CL; And 85 to 100 parts by weight of a binding solution in which the volume ratio of isopropanol and water is 3 to 10: 90 to 97.
In addition, in the step (b), in association with 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof; 80 to 95 parts by weight of an excipient comprising 50 to 60 parts by weight of low substituted hydroxypropylcellulose (L-HPC), 2 to 4 parts by weight of crospovidone CL and 28 to 31 parts by weight of microcrystalline cellulose; And 90 to 96 parts by weight of a binding liquid mixed so that the volume ratio of isopropanol and water is 3 to 10: 90 to 97.
The method of manufacturing a valsartan-containing solid oral dosage form of the present invention is characterized by the use of undifferentiated valsartan. When undifferentiated valsartan is used, an excellent dissolution rate can be obtained as compared with a solid oral dosage form obtained by wet granulation using non-undifferentiated valsartan.
Figure 1 shows the size of the undifferentiated valsartan which is the material of the solid oral dosage form according to the invention milled with a jet mill and Figure 2 measures the size of the unprocessed (i.e. undifferentialiated) valsartan . FIG. 1 and FIG. 2 (A) show the distribution density according to the particle size, and the distribution density of valsartan corresponding to the particle size is shown by the log value (right y-axis). Figures 1 and 2 (B) show the cumulative distribution of particles as the particle size increases. The cumulative distribution according to the particle size of valsartan is expressed as% value (left y-axis). Referring to FIG. 1 and FIG. 2, X 50 is 1.37 μm and 7.59 μm, respectively. It can be seen that the valsartan used in the present invention has a significantly smaller diameter than unprocessed valsartan. The use of the undifferentiated valsartan results in appropriate granularity and precision in the preparation of solid oral formulations through the wet granulation method, and only the solid oral formulations thus prepared can exhibit optimal dissolution rates and bioavailability.
However, it is necessary to use certain excipients and binders since valsartan is sticky in mixing with a solvent in the wet granulation process and it is difficult to maintain the undifferentiated state.
The undifferentiation can be performed through a jet mill.
The valsartan (molecular formula: C 24 H 29 N 5 O 3 , molecular weight: 435.519) is an angiotensin II receptor antagonist and is known to be effective in lowering blood pressure regardless of age, sex, or race.
In the present invention, the low-substituted hydroxypropylcellulose (L-HPC) is used as a wetting agent to prevent the morphology of valsartan from being deformed by the binding liquid at the time of kneading and serves to disperse valsartan . In order to perform this role, low substituted hydroxypropylcellulose (L-HPC) should be included within the above-mentioned range.
The crospovidone CL may have a surface area of 0.5 to 1.1 m 2 / g, and particularly preferably a surface area of 1.0 m 2 / g. When the surface area of the above-mentioned crospovidone CL satisfies the above-mentioned range, a preferable dissolution rate of tablets can be expected. Particularly, when crospovidone CL has a surface area exceeding the above range, it is difficult to obtain a desired dissolution rate.
The binding liquid may be mixed such that the volume ratio of isopropanol and water is 3 to 10: 90 to 97, and the volume ratio of isopropanol to water is less than 3 to 5: more preferably 95 to 97. If the amount of isopropanol is too small, it is difficult to effectively carry out the association process. If too much isopropanol is present, the undifferentiated valsartan is dissolved in isopropanol and the form thereof is deformed to make it difficult to prepare a solid oral dosage form. The bioavailability is also insufficient. For this reason, it is particularly preferable that the volume ratio of isopropanol and water is less than 3: less than 95: 97. In addition, the same problem may occur even when the content of the bonding liquid is out of the range of 90 to 96 parts by weight.
As the excipient in the (e) tableting step, ingredients commonly used in this field can be used. Examples thereof include disintegrants, lubricants and fillers, and more specifically, microcrystalline cellulose, polyvinylpyrrolidone, silicon dioxide, crospovidone, croscarmellose, low-substituted hydroxypropylcellulose, carboxymethylcellulose or Sodium stearate, sodium lauryl sulfate, sodium lauryl sulfate, sodium lauryl sulfate, sodium lauryl sulfate, sodium lauryl sulfate, sodium lauryl sulfate, sodium lauryl sulfate, sodium lauryl sulfate, sodium lauryl sulfate, Dextrose, dextrose, mannitol, sorbitol, gelatin, sugar (sucrose, glucose, dextrose, lactose, lactose or anhydrous), calcium phosphate (dihydrate or anhydrous), calcium carbonate, Oz), starch, sodium starch glycolate, acacia, sodium alginate, polyvinylpyrrolidone, cellulose (carboxymethylcellulose, De hydroxypropyl cellulose, and methyl cellulose, hydroxypropyl methylcellulose, or polyethylene glycol.
Particularly, in the present invention, 10 to 15 parts by weight of crospovidone XL, 4 to 6 parts by weight of colloidal silicon dioxide, and 2 to 4 parts by weight of stearic acid based on 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof contained in the previous step It is preferable that a weight portion is included.
The crospovidone XL-10 has a surface area of preferably 1.2 to 2.0 m 2 / g, more preferably 1.2 to 1.4 m 2 / g.
The present invention provides a pharmaceutical composition comprising amlodipine or a pharmaceutically acceptable salt thereof in an amount of 7 to 10 wt% based on 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof contained in the above (b) associating step or (e) May be further added to prepare a complex agent.
Amlodipine is a persistent functional calcium channel blocker, used to treat hypertension and angina. Like other calcium channel blockers, it relaxes the smooth muscle of the arterial wall and lowers total peripheral resistance to lower blood pressure. When amlodipine is added to the valsartan preparation, the drug efficacy is superior to that when valsartan alone is used. It is also possible to increase the duration of long-term use when taking one tablets type of medication daily rather than taking several medications. As the amlodipine or a pharmaceutically acceptable salt thereof, amlodipine besylate may be preferably used.
In the method for producing valsartan-containing solid oral dosage forms of the present invention, the association may be carried out by a conventional tablet preparation method by a wet granulation method.
The dried material is granulated for easy tableting and can be sieved through a mesh.
The method for producing a valsartan-containing solid oral dosage form of the present invention may further comprise the step of (e) coating the tablets prepared after the tableting step. The coating agent used for the coating of the tablets is not particularly limited, but Opadry Yellow (03B62519) can be preferably used.
Further, according to the present invention,
For 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof; 41 to 95 parts by weight of an excipient comprising 40 to 75 parts by weight of low substituted hydroxypropylcellulose (L-HPC) and 1 to 20 parts by weight of crospovidone CL; And 85 to 100 parts by weight of a binding solution mixed so that the volume ratio of isopropanol and water is 3 to 10: 90 to 97, and the granulate produced by drying the association product, and the undifferentiated valsartan or a pharmaceutically acceptable salt thereof And 16 to 25 parts by weight of an excipient based on 100 parts by weight of the solid oral dosage form.
Wherein the valsartan-containing solid oral dosage form comprises 7 to 10 parts by weight of amlodipine or a pharmaceutically acceptable salt thereof, based on 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof, with the granulation process or the granulation (tableting process) And the like.
In the valsartane-containing solid oral dosage form, the contents of the respective ingredients are the same as those described in the above-described preparation method of the valsartan-containing solid oral dosage form.
The valsartan-containing solid oral dosage form provides an excellent dissolution rate by using undifferentiated valsartan than when undigested valsartan is used.
The solid oral dosage forms of the present invention are useful for the treatment and / or prophylaxis of hypertension (either malignant, essential, neovascular, diabetic, isolated systolic or other secondary type), congestive heart failure, angina pectoris (stability or instability), myocardial infarction, atherosclerosis, Nephropathy, diabetic cardiomyopathy, renal failure, peripheral vascular disease, left ventricular hypertrophy, cognitive dysfunction (e. G., Alzheimer's disease) and stroke.
Since the solid oral formulation prepared according to the preparation method of the present invention is prepared by the wet granulation method, the drug dispersion is superior to the solid oral formulation prepared by the dry granulation method. In addition, the drug dissolution rate and bioavailability have the advantage of being significantly increased compared to the solid oral formulations prepared by the methods disclosed in the prior art.
The tablet core may be shaped, for example, circular, elliptical, rectangular, cylindrical or other suitable shape, and may also vary in size depending on the concentration of the therapeutic.
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the present invention will be described in more detail by way of examples. However, the following examples are intended to further illustrate the present invention, and the scope of the present invention is not limited by the following examples. The following examples can be appropriately modified and changed by those skilled in the art within the scope of the present invention.
Examples 1 to 3: Valsartan-containing solid oral dosage forms Produce
Example 1
Valsartan was pulverized by a jet mill to prepare undifferentiated valsartan (see Fig. 1) having a particle diameter of 5 탆 or less. 160 mg of the undifferentiated valsartan, 47.2 mg of microcrystalline cellulose, 90 mg of low-substituted hydroxypropyl cellulose and 5 mg of the excipient crospovidone CL were mixed and 150 mg of the binding solution [IPA: Water 18: 350 (V / V) "He said.
The allied material obtained above was dried using a plate dryer or fluidized bed dryer until the drying loss was 2% or less. The dried material was sieved using an 18 mesh sheave to obtain granules.
13.87 mg of the granules and amlodipine besylate prepared above, 20 mg of crospovidone XL-10, 8 mg of colloidal silicon dioxide and 5 mg of magnesium stearate were uniformly mixed and tableted to prepare valsartan-containing solid oral formulations.
The prepared solid oral formulation was prepared by dissolving 10.47 mg of Opadry Yellow (03B62519) in a mixed solution of 24 mg of purified water and 84 mg of ethanol (KP).
The composition of Example 1 is shown in Table 1 below.
Example 2
Valsartan-containing solid oral dosage form of Example 2 was prepared in the same manner as in Example 1, except that amlodipine besylate was added during the granulation process.
Example 3
The oral oral dosage form containing valsartan of Example 3 was prepared according to the composition of Table 2 below in the same manner as in Example 1 above.
Comparative Example 1
Solid oral formulations containing crystalline valsartan were prepared in the same manner as in Example 1, according to the composition of Table 4 below.
Test Example 1: dissolution rate comparison test
The tablets prepared in Example 1 and Comparative Example 1 were tested by the pharmacopoeial dissolution test No. 2 (paddle method). The eluate was adjusted to pH 6.8, 900 mL, the paddle speed was set to 50 rpm, the agitation temperature was set to 37 ± 0.5 ° C, and the content of valsartan was determined by HPLC. The results are shown in FIG.
As shown in Fig. 3, the tablets prepared by the wet granulation method using the undifferentiated valsartan of the present invention (Example 1) were superior to the tablets prepared by the wet granulation method using the crystalline valsartan (Comparative Example 1) And provides an improved dissolution rate.
Test Example 2: Biological equivalence test
The tablets prepared in Example 1 were subjected to the daughter bioequivalence test as shown in Table 5 below.
As shown in the graph of the bioequivalence test result of FIG. 4, the tablets prepared by the wet granulation method using the undifferentiated valsartan of the present invention (Example 1) showed equivalence with the reference drug in the bioequivalence test, .
The process for preparing valsartan-containing solid oral dosage forms of the present invention makes it possible to prepare solid oral dosage forms by wet granulation using undifferentiated valsartan. In addition, the valsartan-containing solid oral dosage forms prepared by the above-described method have industrial applicability because they provide excellent dispersibility, bioavailability and dissolution rate.
Claims (15)
(b) the undifferentiated valsartan or a pharmaceutically acceptable salt thereof; Excipients comprising low substituted hydroxypropylcellulose (L-HPC) and crospovidone CL; And a mixing ratio of isopropanol to water is 3 to 10: 90 to 97;
(c) drying the resulting product;
(d) granulating the dried product obtained above; And
(e) adding the excipient to the granules obtained above, mixing and tableting
≪ RTI ID = 0.0 > a < / RTI > valsalin-
To 100 parts by weight of the undifferentiated valsartan or a pharmaceutically acceptable salt thereof in the (b) association step;
80 to 95 parts by weight of an excipient comprising 50 to 60 parts by weight of low substituted hydroxypropylcellulose (L-HPC), 2 to 4 parts by weight of crospovidone CL and 28 to 31 parts by weight of microcrystalline cellulose; And 90 to 96 parts by weight of a binding solution mixed so that the volume ratio of isopropanol and water is 3 to 10: 90 to 97,
In step (e), the excipient comprises 10 to 15 parts by weight of crospovidone XL-10, 4 to 6 parts by weight of colloidal silicon dioxide based on 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof contained in the previous step And 2 to 4 parts by weight of magnesium stearate.
7 to 10 parts by weight of amlodipine or a pharmaceutically acceptable salt thereof is further added, based on 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof contained in the step (b) or the step (e) Lt; RTI ID = 0.0 > valsartan < / RTI >
Wherein the crospovidone CL has a surface area of 0.5 to 1.1 m 2 / g.
Wherein the crospovidone XL-10 has a surface area of 1.2 to 2.0 m 2 / g.
Characterized in that the grinding of valsartan or a pharmaceutically acceptable salt thereof is carried out via a jet mill (Jetmill).
The method of manufacturing a valsartan-containing solid oral dosage form, further comprising the step of (e) coating the tablets prepared after the tableting step.
Characterized in that the coating of the tablet is carried out using the coating Opadry (03B62519).
Wherein the valsartan-containing solid oral dosage form comprises 7 to 10 parts by weight of amlodipine or a pharmaceutically acceptable salt thereof, based on 100 parts by weight of undifferentiated valsartan or a pharmaceutically acceptable salt thereof, Lt; RTI ID = 0.0 > valsartan < / RTI >
Wherein the crospovidone CL has a surface area of 0.5 to 1.1 m 2 / g.
Wherein the crospovidone XL-10 has a surface area of 1.2 to 2.0 m < 2 > / g.
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| KR20120098950 | 2012-09-06 | ||
| KR1020120098950 | 2012-09-06 | ||
| PCT/KR2013/008090 WO2014038895A1 (en) | 2012-09-06 | 2013-09-06 | Solid oral dosage form containing valsartan, and preparation method therefor |
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| KR101920628B1 (en) * | 2017-04-12 | 2018-11-22 | 대원제약주식회사 | A pharmaceutical composition comprising angiotensin receptor blocker |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20100272801A1 (en) * | 2007-12-31 | 2010-10-28 | Lupin Limited | Pharmaceutical compositions of amlodipine and valsartan |
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| GB9613470D0 (en) * | 1996-06-27 | 1996-08-28 | Ciba Geigy Ag | Small solid oral dosage form |
| WO2007070843A2 (en) * | 2005-12-15 | 2007-06-21 | Acusphere, Inc. | Processes for making particle-based pharmaceutical formulations for oral administration |
| WO2008035364A2 (en) * | 2006-06-23 | 2008-03-27 | Usv Limited | Process for the preparation of micronized valsartan |
| EP2468258A1 (en) * | 2010-12-22 | 2012-06-27 | LEK Pharmaceuticals d.d. | Process for the preparation of a pharmaceutical composition comprising a low soluble pharmaceutically active ingredient |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20100272801A1 (en) * | 2007-12-31 | 2010-10-28 | Lupin Limited | Pharmaceutical compositions of amlodipine and valsartan |
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