DE3925252A1 - COMBINATION PREPARATION OF GALLOPAMIL AND XIPAMID - Google Patents
COMBINATION PREPARATION OF GALLOPAMIL AND XIPAMIDInfo
- Publication number
- DE3925252A1 DE3925252A1 DE3925252A DE3925252A DE3925252A1 DE 3925252 A1 DE3925252 A1 DE 3925252A1 DE 3925252 A DE3925252 A DE 3925252A DE 3925252 A DE3925252 A DE 3925252A DE 3925252 A1 DE3925252 A1 DE 3925252A1
- Authority
- DE
- Germany
- Prior art keywords
- gallopamil
- xipamide
- xipamid
- tablets
- acid
- 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.)
- Withdrawn
Links
- XQLWNAFCTODIRK-UHFFFAOYSA-N Gallopamil Chemical compound C1=C(OC)C(OC)=CC=C1CCN(C)CCCC(C#N)(C(C)C)C1=CC(OC)=C(OC)C(OC)=C1 XQLWNAFCTODIRK-UHFFFAOYSA-N 0.000 title claims abstract description 13
- 229960000457 gallopamil Drugs 0.000 title claims abstract description 13
- MTZBBNMLMNBNJL-UHFFFAOYSA-N xipamide Chemical compound CC1=CC=CC(C)=C1NC(=O)C1=CC(S(N)(=O)=O)=C(Cl)C=C1O MTZBBNMLMNBNJL-UHFFFAOYSA-N 0.000 title claims abstract description 12
- 238000002360 preparation method Methods 0.000 title abstract description 3
- 229960000537 xipamide Drugs 0.000 claims abstract description 11
- 239000003814 drug Substances 0.000 claims abstract description 4
- 229940079593 drug Drugs 0.000 abstract description 3
- 239000003826 tablet Substances 0.000 description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 8
- 239000000203 mixture Substances 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- 239000008101 lactose Substances 0.000 description 4
- 235000019359 magnesium stearate Nutrition 0.000 description 4
- 229920002261 Corn starch Polymers 0.000 description 3
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 3
- 239000001913 cellulose Substances 0.000 description 3
- 229920002678 cellulose Polymers 0.000 description 3
- 239000008120 corn starch Substances 0.000 description 3
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 description 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 2
- 206010020772 Hypertension Diseases 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- WNLRTRBMVRJNCN-UHFFFAOYSA-N adipic acid Chemical compound OC(=O)CCCCC(O)=O WNLRTRBMVRJNCN-UHFFFAOYSA-N 0.000 description 2
- 229940072056 alginate Drugs 0.000 description 2
- 235000010443 alginic acid Nutrition 0.000 description 2
- 229920000615 alginic acid Polymers 0.000 description 2
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 239000011777 magnesium Substances 0.000 description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 2
- BMYNFMYTOJXKLE-UHFFFAOYSA-N 3-azaniumyl-2-hydroxypropanoate Chemical compound NCC(O)C(O)=O BMYNFMYTOJXKLE-UHFFFAOYSA-N 0.000 description 1
- OKCRIUNHEQSXFD-UHFFFAOYSA-N 5-[2-(3,4-dimethoxyphenyl)ethyl-methylamino]-2-propan-2-yl-2-(3,4,5-trimethoxyphenyl)pentanenitrile;hydrochloride Chemical compound Cl.C1=C(OC)C(OC)=CC=C1CCN(C)CCCC(C#N)(C(C)C)C1=CC(OC)=C(OC)C(OC)=C1 OKCRIUNHEQSXFD-UHFFFAOYSA-N 0.000 description 1
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 239000005711 Benzoic acid Substances 0.000 description 1
- 206010052895 Coronary artery insufficiency Diseases 0.000 description 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- OFOBLEOULBTSOW-UHFFFAOYSA-N Propanedioic acid Natural products OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 description 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000001361 adipic acid Substances 0.000 description 1
- 235000011037 adipic acid Nutrition 0.000 description 1
- 230000001476 alcoholic effect Effects 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 235000010233 benzoic acid Nutrition 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000001882 diuretic effect Effects 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 239000001530 fumaric acid Substances 0.000 description 1
- 235000011087 fumaric acid Nutrition 0.000 description 1
- 229960005145 gallopamil hydrochloride Drugs 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 235000011167 hydrochloric acid Nutrition 0.000 description 1
- 230000001077 hypotensive effect Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 239000004922 lacquer Substances 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 238000012153 long-term therapy Methods 0.000 description 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 1
- 239000011976 maleic acid Substances 0.000 description 1
- 235000006408 oxalic acid Nutrition 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 229940068918 polyethylene glycol 400 Drugs 0.000 description 1
- 238000011321 prophylaxis Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 239000002966 varnish Substances 0.000 description 1
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
- A61K31/275—Nitriles; Isonitriles
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Die Erfindung betrifft ein Kombinationspräparat aus Gallopamil und Xipamid.The invention relates to a combination preparation of gallopamil and Xipamide.
Es ist bekannt, daß sich Gallopamil (5-[(3,4-Dimethoxyphenethyl)methyl- amino[2-isopropyl-2-(3,4,5-trimethoxyphenyl)valeronitril, DE 11 54 810) u. a. zur Prophylaxe und Langzeittherapie von chronischer Koronarinsuffizienz und Angina pectoris eignet (vgl. Rote Liste 1988 Nr. 26 094). Weiter ist bekannt, daß Xipamid (4-Chlor-2′,6′-dimethyl-5-sulfamoylsalicylamid, DE 12 70 544) gute diuretische Eigenschaften besitzt und gegen Hypertonie eingesetzt wird (Rote Liste 1988 Nr. 35 037).It is known that gallopamil (5 - [(3,4-dimethoxyphenethyl) methyl] amino [2-isopropyl-2- (3,4,5-trimethoxyphenyl) valeronitrile, DE 11 54 810) u. a. for the prophylaxis and long-term therapy of chronic coronary insufficiency and angina pectoris (see Red List 1988 No. 26 094). It is further known that xipamide (4-chloro-2 ', 6'-dimethyl-5-sulfamoylsalicylamide, DE 12 70 544) has good diuretic properties and against hypertension (Rote Liste 1988 Nr. 35 037).
Es wurde nun gefunden, daß beide Wirkstoffe im Kombination miteinander überraschende Wirkungen zeigen.It has now been found that both active ingredients in combination with each other show surprising effects.
Gegenstand der Erfindung ist ein Arzneimittel, welches Gallopamil und Xipamid in Gewichtsverhältnis von 25 : 1 bis 3 : 1 enthält.The invention relates to a drug which gallopamil and Xipamide in weight ratio of 25: 1 to 3: 1 contains.
Das Gewichtsverhältnis von Gallopamil zu Xipamid liegt vorzugsweise zwischen 20 : 1 und 5 : 1.The weight ratio of gallopamil to xipamide is preferably between 20: 1 and 5: 1.
Das Gallopamil wird vorzugsweise als Salz für die Kombination verwendet. Zur Salzbildung kommen beispielsweise Bromwasserstoffsäure, Phosphorsäure, Schwefelsäure, Oxalsäure, Maleinsäure, Fumarsäure, Milchsäure, Weinsäure, Adipinsäure, Benzolsäure und insbesondere Salzsäure in Betracht.The gallopamil is preferably used as a salt for the combination. For example, hydrobromic acid, phosphoric acid, Sulfuric acid, oxalic acid, maleic acid, fumaric acid, lactic acid, tartaric acid, Adipic acid, benzoic acid and hydrochloric acid in particular into consideration.
Das Gallopamil bzw. dessen Salz wird vorzugsweise als Depotform in die Kombination eingesetzt.The gallopamil or its salt is preferably used as depot form in the Combination used.
Das Arzneimittel enthält die beiden Wirkstoffe zusammen und wird in Form von Tabletten, Filmtabletten, Kapseln oder Dragees angewendet. Diese Formen lassen sich in üblicher Weise herstellen.The drug contains the two active ingredients together and gets into shape of tablets, film-coated tablets, capsules or dragees. These Shapes can be produced in the usual way.
Die neue Kombination besitzt eine überraschend gute blutdrucksenkende Wirkung. Sie läßt sich daher gut zur Behandlung des Blutdruckhochdrucks verwenden. Das gilt besonders im Bereich niereninsuffizienter Patienten.The new combination has a surprisingly good hypotensive Effect. It is therefore good for the treatment of high blood pressure use. This is especially true in the area of kidney-deficient patients.
Auf einer Tablettenpresse wurde in üblicher Weise Tabletten folgender Zusammensetzung gepreßt:On a tablet press tablets were in the usual way following Composition pressed:
50 mg Gallopamil-Hydrochlorid
5 mg Xipamid
100 mg Maisstärke
30 mg Milchzucker
5 mg Hydroxymethylpropylcellulose
1 mg Magnesiumstearat
9 mg Cellulose50 mg gallopamil hydrochloride
5 mg of xipamide
100 mg of corn starch
30 mg lactose
5 mg hydroxymethylpropylcellulose
1 mg of magnesium stearate
9 mg of cellulose
Die Wirkstoffe wurden zusammen mit Maisstärke und Milchzucker gemischt, dann mit einer alkoholischen Lösung von Hydroxymethylpropylcellulose granuliert. Nach Zumischung von Magnesiumstearat und Cellulose wurden in herkömmlicher Art Tabletten mit einem Gewicht von 200 mg gepreßt. Die Tabletten wurden anschließend mit einem Filmlack aus Hydroxymethylpropylcellulose, der als Zusatzstoff Polyethylenglycol 400 und als Pigment Talkum und Titandioxid enthielt, überzogen.The active ingredients were mixed together with corn starch and lactose, then with an alcoholic solution of hydroxymethylpropylcellulose granulated. After admixture of magnesium stearate and cellulose were in conventional type tablets pressed with a weight of 200 mg. The Tablets were then treated with a hydroxymethylpropylcellulose film lacquer, as an additive polyethylene glycol 400 and as a pigment Talc and titanium dioxide coated.
-
a) Es wurden in üblicher Weise ein Granulat folgender Zusammensetzung (in
mg) hergestellt:
Gallopamil · HCl 100 Na-Alginat 240 ®Eudragit RL 92 PVP 13 Mg-Stearat 4 Cellulosepulver 31 Gallopamil · HCl 100 Na alginate 240 ®Eragragit RL 92 PVP 13 Mg stearate 4 cellulose powder 31 - Dazu wurden Gallopamil · HCl, Na-Alginat und ®Eudragit RL trocken in einem Mischer gemischt, unter Rühren mit einer wäßrigen Lösung von PVP befeuchtet, durch ein Sieb getrieben und in einem Wirbelschichttrockner getrocknet, erneut über ein Sieb gegeben und mit Mg-Stearat und Cellulosepulver vermischt.For this purpose, gallopamil · HCl, Na alginate and ®Eragragit RL were dry in mixed with a mixer, with stirring with an aqueous solution of PVP moistened, driven through a sieve and in one Dried fluidized bed dryer, again placed on a sieve and with Mg stearate and cellulose powder mixed.
- ®Eudragit RL ist ein Polyacrylmethacrylsäureester der Firma Röhm Pharma GmbH, Darmstadt. ®Eragragit RL is a polyacrylmethacrylic ester from Röhm Pharma GmbH, Darmstadt.
-
b) Analog a) wurde ein Granulat folgender Zusammensetzung hergestellt:
Xipamid|10 mg Lactose 40 mg Maisstärke 35 mg Cellulose 10 mg PVP 4,5 mg Magnesiumstearat 0,5 mg Xipamide | 10 mg lactose 40 mg corn starch 35 mg cellulose 10 mg PVP 4.5 mg magnesium stearate 0.5 mg - Die vier zuerst genannten Bestandteile wurden gemischt, mit einer ethanolischen Lösung von PVP granuliert, getrocknet, gesiebt und anschließend mit Magnesiumstearat vermischt.The four first mentioned ingredients were mixed, with one granulated, dried, sieved and ethanolic solution of PVP then mixed with magnesium stearate.
- c) In einer Zweischichttablettenpresse wurden Tabletten gepreßt, deren erste Schicht 480 g Gallopamil-Granulat und deren zweite Schicht 100 mg Xipamid-Granulat enthielt. Die so erhaltenen Tabletten mit 100 mg Gallopamil und 10 mg Xipamid wurden anschließend analog Beispiel 1 mit einem Lack überzogen.c) In a two-layer tablet press tablets were pressed, the first layer 480 g gallopamil granules and their second layer Contained 100 mg of xipamide granules. The tablets thus obtained with 100 mg gallopamil and 10 mg xipamide were then analogously Example 1 coated with a varnish.
Es wurden in üblicher Weise Bolus-Tabletten der Zusammensetzung des Beispiels 2a hergestellt und auf einer Kapselabfüllmaschine zusammen mit einer Mischung aus 45 mg Lactose und 5 mg Xipamid in Hartgelatinesteckkapseln abgefüllt. Die Bolus-Tabletten hatten ein Oblong-Format mit den Abmessungen 6 mm × 15 mm.There were in the usual way bolus tablets of the composition of Example 2a and assembled on a capsule filling machine with a mixture of 45 mg lactose and 5 mg xipamide in Bottled hard gelatin cachets. The bolus tablets had one Oblong format with the dimensions 6 mm × 15 mm.
Claims (1)
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE3925252A DE3925252A1 (en) | 1989-07-29 | 1989-07-29 | COMBINATION PREPARATION OF GALLOPAMIL AND XIPAMID |
| PCT/EP1990/001191 WO1991001735A1 (en) | 1989-07-29 | 1990-07-20 | Combined preparation consisting of gallopamil and xipamide |
| AU59587/90A AU5958790A (en) | 1989-07-29 | 1990-07-20 | Combined preparation consisting of gallopamil and xipamide |
| ZA905912A ZA905912B (en) | 1989-07-29 | 1990-07-27 | Gallopamil/xipamide combination product |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE3925252A DE3925252A1 (en) | 1989-07-29 | 1989-07-29 | COMBINATION PREPARATION OF GALLOPAMIL AND XIPAMID |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE3925252A1 true DE3925252A1 (en) | 1991-01-31 |
Family
ID=6386182
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE3925252A Withdrawn DE3925252A1 (en) | 1989-07-29 | 1989-07-29 | COMBINATION PREPARATION OF GALLOPAMIL AND XIPAMID |
Country Status (4)
| Country | Link |
|---|---|
| AU (1) | AU5958790A (en) |
| DE (1) | DE3925252A1 (en) |
| WO (1) | WO1991001735A1 (en) |
| ZA (1) | ZA905912B (en) |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3724644A1 (en) * | 1987-07-25 | 1989-02-02 | Knoll Ag | PRODUCTS, INCLUDING GALLOPAMIL AND PRAZOSINE |
-
1989
- 1989-07-29 DE DE3925252A patent/DE3925252A1/en not_active Withdrawn
-
1990
- 1990-07-20 AU AU59587/90A patent/AU5958790A/en not_active Abandoned
- 1990-07-20 WO PCT/EP1990/001191 patent/WO1991001735A1/en unknown
- 1990-07-27 ZA ZA905912A patent/ZA905912B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO1991001735A1 (en) | 1991-02-21 |
| ZA905912B (en) | 1992-03-25 |
| AU5958790A (en) | 1991-03-11 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 8130 | Withdrawal |