WO2008133537A1 - Pharmaceutical composition exhibiting improved stability comprising ace inhibitor or pharmaceutically acceptable salt thereof and method for manufacturing thereof - Google Patents
Pharmaceutical composition exhibiting improved stability comprising ace inhibitor or pharmaceutically acceptable salt thereof and method for manufacturing thereof Download PDFInfo
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- WO2008133537A1 WO2008133537A1 PCT/PL2008/000031 PL2008000031W WO2008133537A1 WO 2008133537 A1 WO2008133537 A1 WO 2008133537A1 PL 2008000031 W PL2008000031 W PL 2008000031W WO 2008133537 A1 WO2008133537 A1 WO 2008133537A1
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- pharmaceutical composition
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- pharmaceutically acceptable
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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
- A61K9/2004—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
-
- 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
Definitions
- composition exhibiting improved stability comprising ACE inhibitor or pharmaceutically acceptable salt thereof and method for manufacturing thereof.
- the subject of the invention includes a pharmaceutical composition exhibiting improved stability comprising ACE inhibitor or pharmaceutically acceptable salt thereof and method for manufacturing thereof.
- Inhibitors of angiotensin convertase belong to a group of compounds used in the treatment of cardiovascular system and, particularly, arterial hypertension.
- the group of these compounds consists of, for example, perindopril, quinapril, ramipril.
- These compounds were first disclosed in patents EP 049658B, EP 049605B and EP 079022B.
- the problem associated with ACE inhibitors is that they are prone to degradation process due to cyclization, hydrolysis or oxidation. Being a degradation product of ACE inhibitors, the form of diketopiperazine produced in the cyclization process may be of particular disadvantage due to its toxicity.
- the prior art disclosed various solutions to this problem.
- the patent EP 280999B describes a pharmaceutical composition comprising ACE inhibitor as the active ingredient whereby the instability problem was overcome by using alkaline earth metal carbonate in combination with saccharide.
- the method for manufacturing of the composition includes wet granulation and tableting of the obtained granulate.
- the patent EP 108393 IB describes a pharmaceutical composition comprising ACE inhibitor as the active ingredient whereby the instability problem was overcome by using magnesium oxide in combination with a suitable amount of saccharide.
- the method for manufacturing of the composition includes wet granulation and tableting of the obtained granulate.
- the patent EP 468929B describes a pharmaceutical composition comprising a compound prone to degradation process as the active ingredient, in particular ACE inhibitor stabilized by a hydrochloric acid donor selected from among e.g. glycine hydrochloride or glutamic acid hydrochloride.
- the international patent application WO 2005/094793 described the method for manufacturing of the pharmaceutical composition comprising perindopril, or the salt thereof, consisting in the dry mixing of excipients mixture with at least one inorganic carbonate, and dry processing of the mixture obtained.
- the objective of the present invention is to develop a new, pharmaceutical composition exhibiting improved stability comprising inhibitor of angiotensin convertase (ACE) or pharmaceutically acceptable salt thereof as the active ingredient.
- ACE angiotensin convertase
- the pharmaceutical composition according to the present invention preferably comprises alkali copolymer of butyl methacrylate in the form of a powder, known under the trade name as Eudragit E PO. Additionally, the weight ratio of the content of alkali copolymer of butyl methacrylate to the content of the active ingredient should preferably be within 1 :2.5 to 2: 1.
- the pharmaceutical composition according to the present invention preferably comprises ACE inhibitor selected from a group consisting of perindopril, quinapril, ramipril or combination thereof.
- the pharmaceutical composition according to the present invention preferably comprises the pharmaceutically acceptable excipients selected from a group consisting of fillers, disintegrants, glidants and/or lubricants.
- the pharmaceutical composition according to the present invention preferably takes the form of a tablet, capsule or powder for oral use.
- the pharmaceutical composition according to the present invention preferably comprises fillers selected from a group consisting of lactose, microcrystalline cellulose, powdered cellulose, microcrystalline cellulose co- processed with silica colloidal, sucrose, dextrose, fructose, dibasic calcium phosphate, tribasic calcium phosphate, starch and modified starch.
- the pharmaceutical composition according to the present invention preferably comprises disintegrants selected from a group consisting of croscarmellose sodium, carboxymethylcellulose calcium, carboxymethylcellulose sodium, sodium starch glycolate, sodium alginate, starch, modified starch, microcrystalline cellulose and powdered cellulose.
- the pharmaceutical composition according to the present invention preferably comprises glidants selected from a group consisting of colloidal anhydrous silica, talk, magnesium stearate, starch.
- the pharmaceutical composition according to the present invention preferably comprises lubricants selected from a group consisting of magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, glycerol behenate, glycerol monostearate, glycerol palmitostearate, polyethylene glycol, stearic acid.
- lubricants selected from a group consisting of magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, glycerol behenate, glycerol monostearate, glycerol palmitostearate, polyethylene glycol, stearic acid.
- the pharmaceutical composition according to the present invention may be comprised of the pharmaceutically acceptable excipients which simultaneously act as fillers, disintegrants, glidants and/or lubricants.
- the invention includes a method for manufacturing of a pharmaceutical composition exhibiting improved stability comprising inhibitor of angiotensin convertase (ACE) or pharmaceutically acceptable salt thereof as the active ingredient.
- ACE angiotensin convertase
- the method for manufacturing of the pharmaceutical composition according to the present invention consists in the mixing of the active ingredient, alkali copolymer of butyl methacrylate and pharmaceutically acceptable excipients in appropriate weight ratio, and, subsequently, tableting of the mixture using direct tableting method.
- the method for manufacturing of the pharmaceutical composition according to the present invention is preferably carried out using alkali copolymer of butyl methacrylate in the form of a powder. Additionally, the weight ratio of the content of alkali copolymer of butyl methacrylate to the content of the active ingredient in the pharmaceutical composition should preferably be within 1 :2.5 to 2:1.
- the method for manufacturing of the pharmaceutical composition according to the present invention is carried out using ACE inhibitor selected from a group consisting of perindopril, quinapril, ramipril or combination thereof.
- the method for manufacturing of the pharmaceutical composition according to the present invention is carried out using the substances selected from a group consisting of fillers, disintegrants, glidants and lubricants as pharmaceutically acceptable excipients.
- the method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the fillers selected from a group consisting of lactose, microcrystalline cellulose, powdered cellulose, microcrystalline cellulose co-processed with silica colloidal, sucrose, dextrose, fructose, dibasic calcium phosphate, tribasic calcium phosphate, starch and modified starch.
- the fillers selected from a group consisting of lactose, microcrystalline cellulose, powdered cellulose, microcrystalline cellulose co-processed with silica colloidal, sucrose, dextrose, fructose, dibasic calcium phosphate, tribasic calcium phosphate, starch and modified starch.
- the method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the disintegrants selected from a group consisting of croscarmellose sodium, carboxymethylcellulose calcium, carboxymethylcellulose sodium, sodium starch glycolate, sodium alginate, starch, modified starch, microcrystalline cellulose and powdered cellulose.
- the disintegrants selected from a group consisting of croscarmellose sodium, carboxymethylcellulose calcium, carboxymethylcellulose sodium, sodium starch glycolate, sodium alginate, starch, modified starch, microcrystalline cellulose and powdered cellulose.
- the method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the glidants selected from a group consisting of colloidal anhydrous silica, talk, magnesium stearate, starch.
- the method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the lubricants selected from a group consisting of magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, glycerol behenate, glycerol monostearate, glycerol palmitostearate, polyethylene glycol, stearic acid.
- the method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the pharmaceutically acceptable excipients which simultaneously act as fillers, disintegrants, glidants and/or lubricants.
- the weighed quantities of perindopril ter/-erbumine, micronised crospovidone, Eudragit E PO, mannitol are mixed for about 30 min. Magnesium stearate is added to the obtained mixture, and the contents are thoroughly mixed.
- the resulting tablet mass is tableted using direct tableting method using Korsch XL200 rotary tablet press. The resulting tablets have a weight of 180 mg.
- Magnesium stearate 2.7 Procedure is identical to that in Example 1.
- the resulting tablets have a weight of 180 mg.
- Example 2 Procedure is identical to that in Example 1 except that micronised crospovidone is replaced with maize starch.
- the resulting tablets have a weight of 180 mg.
- the resulting tablets of the examples 1, 2, 3 and 4 were stored for 3 weeks at 50 0 C and 75% relative humidity.
- the same storage conditions are applied to Prestarium ® tablets - currently available on the market - containing 8 mg of perindopril tert-erbumine and excipients such as lactose monohydrate, colloidal anhydrous silica, lake and magnesium stearate. All of the tablets are tested for impurities content using an analytical method by high performance liquid chromatography (HPLC). The test is performed for storage intervals of 0, 1 and 3 weeks.
- the tablets of the example 1 are stored for 12 months at 30 0 C and 60% relative humidity.
- Prestarium ® tablets - currently available on the market - containing 8 mg of perindopril tert-erbumine and excipients such as lactose monohydrate, colloidal anhydrous silica, lake and magnesium stearate were stored under the same storage conditions. Both batches of the tablets are tested for impurities content using an analytical method by high performance liquid chromatography (HPLC). The test is performed for storage intervals of 0, 3, 6 and 12 months. The results for the content of total impurities and a separately determined form of perindopril diketopiperazine, also known as impurity F, are given in the table below.
- the pharmaceutical composition according to the invention is less toxic for patients.
- the pharmaceutical composition according to the invention can be considered to be of practical use for the entire group of ACE inhibitors, preferably perindopril, quinapril and ramipril.
Abstract
A pharmaceutical composition exhibiting improved stability comprising ACE inhibitor or pharmaceutically acceptable salt thereof as the active ingredient, alkali copolymer of butyl methacrylate and pharmaceutically acceptable excipients. A method for manufacturing of the pharmaceutical composition exhibiting improved stability comprising ACE inhibitor, or pharmaceutically acceptable salt thereof, as the active ingredient, consists in the mixing of the active ingredient, alkali copolymer of butyl methacrylate and pharmaceutically acceptable excipients in appropriate weight ratio, and, subsequently, tableting of the mixture using direct tableting method.
Description
Pharmaceutical composition exhibiting improved stability comprising ACE inhibitor or pharmaceutically acceptable salt thereof and method for manufacturing thereof.
The subject of the invention includes a pharmaceutical composition exhibiting improved stability comprising ACE inhibitor or pharmaceutically acceptable salt thereof and method for manufacturing thereof.
Inhibitors of angiotensin convertase (ACE) belong to a group of compounds used in the treatment of cardiovascular system and, particularly, arterial hypertension. The group of these compounds consists of, for example, perindopril, quinapril, ramipril. These compounds were first disclosed in patents EP 049658B, EP 049605B and EP 079022B. The problem associated with ACE inhibitors is that they are prone to degradation process due to cyclization, hydrolysis or oxidation. Being a degradation product of ACE inhibitors, the form of diketopiperazine produced in the cyclization process may be of particular disadvantage due to its toxicity. The prior art disclosed various solutions to this problem. The patent EP 280999B describes a pharmaceutical composition comprising ACE inhibitor as the active ingredient whereby the instability problem was overcome by using alkaline earth metal carbonate in combination with saccharide. The method for manufacturing of the composition includes wet granulation and tableting of the obtained granulate. The patent EP 108393 IB describes a pharmaceutical composition comprising ACE inhibitor as the active ingredient whereby the instability problem was overcome by using magnesium oxide in combination with a suitable amount of saccharide. The method for manufacturing of the composition includes wet granulation and tableting of the obtained granulate. The patent EP 468929B describes a pharmaceutical composition comprising a compound prone to degradation process as the active ingredient, in
particular ACE inhibitor stabilized by a hydrochloric acid donor selected from among e.g. glycine hydrochloride or glutamic acid hydrochloride.
The international patent application WO 2005/094793 described the method for manufacturing of the pharmaceutical composition comprising perindopril, or the salt thereof, consisting in the dry mixing of excipients mixture with at least one inorganic carbonate, and dry processing of the mixture obtained.
The objective of the present invention is to develop a new, pharmaceutical composition exhibiting improved stability comprising inhibitor of angiotensin convertase (ACE) or pharmaceutically acceptable salt thereof as the active ingredient.
Surprisingly it has been found that the presence of an alkali copolymer of butyl methacrylate and pharmaceutically acceptable excipients in a pharmaceutical composition comprising ACE inhibitor as the active ingredient ensures improved stability.
The pharmaceutical composition according to the present invention preferably comprises alkali copolymer of butyl methacrylate in the form of a powder, known under the trade name as Eudragit E PO. Additionally, the weight ratio of the content of alkali copolymer of butyl methacrylate to the content of the active ingredient should preferably be within 1 :2.5 to 2: 1.
The pharmaceutical composition according to the present invention preferably comprises ACE inhibitor selected from a group consisting of perindopril, quinapril, ramipril or combination thereof.
The pharmaceutical composition according to the present invention preferably comprises the pharmaceutically acceptable excipients selected from a group consisting of fillers, disintegrants, glidants and/or lubricants.
The pharmaceutical composition according to the present invention preferably takes the form of a tablet, capsule or powder for oral use.
The pharmaceutical composition according to the present invention preferably comprises fillers selected from a group consisting of lactose, microcrystalline cellulose, powdered cellulose, microcrystalline cellulose co-
processed with silica colloidal, sucrose, dextrose, fructose, dibasic calcium phosphate, tribasic calcium phosphate, starch and modified starch.
The pharmaceutical composition according to the present invention preferably comprises disintegrants selected from a group consisting of croscarmellose sodium, carboxymethylcellulose calcium, carboxymethylcellulose sodium, sodium starch glycolate, sodium alginate, starch, modified starch, microcrystalline cellulose and powdered cellulose.
The pharmaceutical composition according to the present invention preferably comprises glidants selected from a group consisting of colloidal anhydrous silica, talk, magnesium stearate, starch.
The pharmaceutical composition according to the present invention preferably comprises lubricants selected from a group consisting of magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, glycerol behenate, glycerol monostearate, glycerol palmitostearate, polyethylene glycol, stearic acid. The pharmaceutical composition according to the present invention may be comprised of the pharmaceutically acceptable excipients which simultaneously act as fillers, disintegrants, glidants and/or lubricants.
Additionally, the invention includes a method for manufacturing of a pharmaceutical composition exhibiting improved stability comprising inhibitor of angiotensin convertase (ACE) or pharmaceutically acceptable salt thereof as the active ingredient.
The method for manufacturing of the pharmaceutical composition according to the present invention consists in the mixing of the active ingredient, alkali copolymer of butyl methacrylate and pharmaceutically acceptable excipients in appropriate weight ratio, and, subsequently, tableting of the mixture using direct tableting method.
The method for manufacturing of the pharmaceutical composition according to the present invention is preferably carried out using alkali copolymer of butyl methacrylate in the form of a powder. Additionally, the weight ratio of the content of alkali copolymer of butyl methacrylate to the content of the active
ingredient in the pharmaceutical composition should preferably be within 1 :2.5 to 2:1.
The method for manufacturing of the pharmaceutical composition according to the present invention is carried out using ACE inhibitor selected from a group consisting of perindopril, quinapril, ramipril or combination thereof. The method for manufacturing of the pharmaceutical composition according to the present invention is carried out using the substances selected from a group consisting of fillers, disintegrants, glidants and lubricants as pharmaceutically acceptable excipients. The method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the fillers selected from a group consisting of lactose, microcrystalline cellulose, powdered cellulose, microcrystalline cellulose co-processed with silica colloidal, sucrose, dextrose, fructose, dibasic calcium phosphate, tribasic calcium phosphate, starch and modified starch.
The method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the disintegrants selected from a group consisting of croscarmellose sodium, carboxymethylcellulose calcium, carboxymethylcellulose sodium, sodium starch glycolate, sodium alginate, starch, modified starch, microcrystalline cellulose and powdered cellulose.
The method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the glidants selected from a group consisting of colloidal anhydrous silica, talk, magnesium stearate, starch.
The method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the lubricants selected from a group consisting of magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, glycerol behenate, glycerol monostearate, glycerol palmitostearate, polyethylene glycol, stearic acid.
The method for manufacturing of the pharmaceutical composition according to the present invention is carried out preferably using the pharmaceutically acceptable excipients which simultaneously act as fillers, disintegrants, glidants and/or lubricants.
The invention is illustrated by the following examples which in no way restrict its scope.
Example 1 [mg/tablet]
Perindopril tert-erbumine 8.0
Micronised crospovidone 18.0
Eudragit E PO 9.0
Mannitol 141.94 Colloidal anhydrous silica 0.36
Magnesium stearate 2.7
The weighed quantities of perindopril ter/-erbumine, micronised crospovidone, Eudragit E PO, mannitol are mixed for about 30 min. Magnesium stearate is added to the obtained mixture, and the contents are thoroughly mixed. The resulting tablet mass is tableted using direct tableting method using Korsch XL200 rotary tablet press. The resulting tablets have a weight of 180 mg.
Example 2 [mg/tablet]
Perindopril tert-erbumine 8.0
Micronised crospovidone 18.0
Eudragit E PO 18.0
Mannitol 132.94 Colloidal anhydrous silica 0.36
Magnesium stearate 2.7
Procedure is identical to that in Example 1. The resulting tablets have a weight of 180 mg.
Example 3 [mg/tablet]
Perindopril tert-erbumine 8.0
Maize starch 18.0
Eudragit E PO 9.0
Mannitol 141.94 Colloidal anhydrous silica 0.36
Magnesium stearate 2.7
Procedure is identical to that in Example 1 except that micronised crospovidone is replaced with maize starch. The resulting tablets have a weight of 180 mg.
Example 4
[mg/tablet]
Perindopril tert-erbumine 8.0
Micronised crospovidone 18.0 Eudragit E PO 4.5
Mannitol 146.44
Colloidal anhydrous silica 0.36
Magnesium stearate 2.7
Procedure is identical to that in Example 1. The resulting tablets have a weight of 180 mg.
Test for impurities content in tablets.
The resulting tablets of the examples 1, 2, 3 and 4 were stored for 3 weeks at 500C and 75% relative humidity. For the purposes of comparison, the same storage conditions are applied to Prestarium® tablets - currently available on the market - containing 8 mg of perindopril tert-erbumine and excipients such as
lactose monohydrate, colloidal anhydrous silica, lake and magnesium stearate. All of the tablets are tested for impurities content using an analytical method by high performance liquid chromatography (HPLC). The test is performed for storage intervals of 0, 1 and 3 weeks.
The results for the content of total impurities and the content of separately determined form of perindopril diketopiperazine, also known as impurity F, are given in the table below.
-* means impurities content above 0.1% were not detected
For the purposes of a further verification of the invention, the tablets of the example 1 are stored for 12 months at 300C and 60% relative humidity. As a comparison, Prestarium® tablets - currently available on the market - containing 8 mg of perindopril tert-erbumine and excipients such as lactose monohydrate, colloidal anhydrous silica, lake and magnesium stearate were stored under the same storage conditions. Both batches of the tablets are tested for impurities content using an analytical method by high performance liquid chromatography (HPLC). The test is performed for storage intervals of 0, 3, 6 and 12 months. The results for the content of total impurities and a separately determined form of perindopril diketopiperazine, also known as impurity F, are given in the table below.
-* means impurities content above 0.1% were not detected
The results of the test confirm that the pharmaceutical composition according to the invention exhibits improved stability.
Additionally, due to the fact that the form of diketopiperazine is absent, the pharmaceutical composition according to the invention is less toxic for patients.
Taking into account the chemical structure of perindopril the pharmaceutical composition according to the invention can be considered to be of practical use for the entire group of ACE inhibitors, preferably perindopril, quinapril and ramipril.
Claims
1. A pharmaceutical composition exhibiting improved stability comprising ACE inhibitor or pharmaceutically acceptable salt thereof as the active ingredient characterised in that the composition comprises alkali copolymer of butyl methacrylate and pharmaceutically acceptable excipients.
2. The pharmaceutical composition according to claim 1 characterised in that alkali copolymer of butyl methacrylate is in the form of a powder.
3. The pharmaceutical composition according to claim 1 characterised in that the weight ratio of the content of alkali copolymer of butyl methacrylate to the content of the active ingredient is between 1 :2.5 to 2:1.
4. The pharmaceutical composition according to claim 1 characterised in that ACE inhibitor has been selected from a group consisting of perindopril, quinapril, ramipril or combination thereof.
5. The pharmaceutical composition according to claim 1 characterised in that the composition takes the form of tablet, capsule or powder for oral use.
6. The pharmaceutical composition according to claim 1 characterised in that pharmaceutically acceptable excipients have been selected from a group consisting of fillers, disintegrants, glidants and/or lubricants.
7. The pharmaceutical composition according to claim 6 characterised in that fillers have been selected from a group consisting of lactose, microcrystalline cellulose, powdered cellulose, microcrystalline cellulose co-processed with silica colloidal, sucrose, dextrose, fructose, dibasic calcium phosphate, tribasic calcium phosphate, starch and modified starch.
8. The pharmaceutical composition according to claim 6 characterised in that disintegrants have been selected from a group consisting of croscarmellose sodium, carboxymethylcellulose calcium, carboxymethylcellulose sodium, sodium starch glycolate, sodium alginate, starch, modified starch, microcrystalline cellulose and powdered cellulose.
9. The pharmaceutical composition according to claim 6 characterised in that glidants have been selected from a group consisting of colloidal anhydrous silica, talk, magnesium stearate, starch.
10. The pharmaceutical composition according to claim 6 characterised in that lubricants have been selected from a group consisting of magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, glycerol behenate, glycerol monostearate, glycerol palmitostearate, polyethylene glycol, stearic acid.
11. A method for manufacturing of a pharmaceutical composition exhibiting improved stability comprising ACE inhibitor or pharmaceutically acceptable salt thereof as the active ingredient characterised in that the active ingredient, alkali copolymer of butyl methacrylate and pharmaceutically acceptable excipients are mixed in appropriate weight ratio, and, subsequently, the mixture is tableted using direct tableting method.
12. The method for manufacturing of the pharmaceutical composition according to claim 11 characterised in that alkali copolymer of butyl methacrylate is in the form of a powder.
13. The method for manufacturing of the pharmaceutical composition according to claim 11 characterised in that the weight ratio of the content of alkali copolymer of butyl methacrylate to the content of the active ingredient is between 1 :2.5 to 2:1.
14. The method for manufacturing of the pharmaceutical composition according to claim 11 characterised in that ACE inhibitor has been selected from a group consisting of perindopril, quinapril, ramipril or combination thereof.
15. The method for manufacturing of the pharmaceutical composition according to claim 11 characterised in that the pharmaceutically acceptable excipients have been selected from a group consisting of fillers, disintegrants, glidants and/or lubricants.
16. The method for manufacturing of the pharmaceutical composition according to claim 15 characterised in that fillers have been selected from a group consisting of lactose, microcrystalline cellulose, powdered cellulose, microcrystalline cellulose co-processed with silica colloidal, sucrose, dextrose, fructose, dibasic calcium phosphate, tribasic calcium phosphate, starch and modified starch.
17. The method for manufacturing of the pharmaceutical composition according to claim 15 characterised in that disintegrants have been selected from a group consisting of croscarmellose sodium, carboxymethylcellulose calcium, carboxymethyl cellulose sodium, sodium starch glycolate, sodium alginate, starch, modified starch, microcrystalline cellulose and powdered cellulose.
18. The method for manufacturing of the pharmaceutical composition according to claim 15 characterised in that glidants have been selected from a group consisting of colloidal anhydrous silica, talk, magnesium stearate, starch.
19. The method for manufacturing of the pharmaceutical composition according to claim 15 characterised in that lubricants have been selected from a group consisting of magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, glycerol behenate, glycerol monostearate, glycerol palmitostearate, polyethylene glycol, stearic acid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP08753858A EP2150240A1 (en) | 2007-04-27 | 2008-04-24 | Pharmaceutical composition exhibiting improved stability comprising ace inhibitor or pharmaceutically acceptable salt thereof and method for manufacturing thereof |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PL382311A PL382311A1 (en) | 2007-04-27 | 2007-04-27 | Pharmaceutical composition with improved stability containing inhibitor of acethylolinoesterasis or its pharmaceutically admitted salt and its production method |
| PLP.382311 | 2007-04-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2008133537A1 true WO2008133537A1 (en) | 2008-11-06 |
Family
ID=39709082
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/PL2008/000031 WO2008133537A1 (en) | 2007-04-27 | 2008-04-24 | Pharmaceutical composition exhibiting improved stability comprising ace inhibitor or pharmaceutically acceptable salt thereof and method for manufacturing thereof |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP2150240A1 (en) |
| PL (1) | PL382311A1 (en) |
| WO (1) | WO2008133537A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011034513A1 (en) | 2009-08-17 | 2011-03-24 | Mahmut Bilgic | The granules with improved solubility and stability |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5442008A (en) * | 1987-11-24 | 1995-08-15 | Hoechst Aktiengesellschaft | Stabilized polymer film coated compounds and stabilized formulations in compressed from using same |
| WO2002089775A1 (en) * | 2001-05-09 | 2002-11-14 | Ethypharm | Coated granules based on angiotensin-converting enzyme inhibitor |
| US20050186274A1 (en) * | 2004-02-20 | 2005-08-25 | Boehringer Ingelheim International Gmbh | Multilayer tablet |
| WO2007090721A1 (en) * | 2006-02-03 | 2007-08-16 | Evonik Röhm Gmbh | Pharmaceutical compositions containing mixtures of polymers and active agents poorly soluble in water |
-
2007
- 2007-04-27 PL PL382311A patent/PL382311A1/en not_active Application Discontinuation
-
2008
- 2008-04-24 WO PCT/PL2008/000031 patent/WO2008133537A1/en active Application Filing
- 2008-04-24 EP EP08753858A patent/EP2150240A1/en not_active Withdrawn
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5442008A (en) * | 1987-11-24 | 1995-08-15 | Hoechst Aktiengesellschaft | Stabilized polymer film coated compounds and stabilized formulations in compressed from using same |
| WO2002089775A1 (en) * | 2001-05-09 | 2002-11-14 | Ethypharm | Coated granules based on angiotensin-converting enzyme inhibitor |
| US20050186274A1 (en) * | 2004-02-20 | 2005-08-25 | Boehringer Ingelheim International Gmbh | Multilayer tablet |
| WO2007090721A1 (en) * | 2006-02-03 | 2007-08-16 | Evonik Röhm Gmbh | Pharmaceutical compositions containing mixtures of polymers and active agents poorly soluble in water |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011034513A1 (en) | 2009-08-17 | 2011-03-24 | Mahmut Bilgic | The granules with improved solubility and stability |
Also Published As
| Publication number | Publication date |
|---|---|
| EP2150240A1 (en) | 2010-02-10 |
| PL382311A1 (en) | 2008-11-10 |
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