DE2507635A1 - Pharmazeutische praeparate und verfahren zu ihrer herstellung - Google Patents
Pharmazeutische praeparate und verfahren zu ihrer herstellungInfo
- Publication number
- DE2507635A1 DE2507635A1 DE19752507635 DE2507635A DE2507635A1 DE 2507635 A1 DE2507635 A1 DE 2507635A1 DE 19752507635 DE19752507635 DE 19752507635 DE 2507635 A DE2507635 A DE 2507635A DE 2507635 A1 DE2507635 A1 DE 2507635A1
- Authority
- DE
- Germany
- Prior art keywords
- digoxin
- preparation according
- solution
- water
- weight
- 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.)
- Granted
Links
- 238000000034 method Methods 0.000 title claims description 15
- 239000000825 pharmaceutical preparation Substances 0.000 title claims description 12
- 238000004519 manufacturing process Methods 0.000 title claims description 6
- LTMHDMANZUZIPE-PUGKRICDSA-N digoxin Chemical compound C1[C@H](O)[C@H](O)[C@@H](C)O[C@H]1O[C@@H]1[C@@H](C)O[C@@H](O[C@@H]2[C@H](O[C@@H](O[C@@H]3C[C@@H]4[C@]([C@@H]5[C@H]([C@]6(CC[C@@H]([C@@]6(C)[C@H](O)C5)C=5COC(=O)C=5)O)CC4)(C)CC3)C[C@@H]2O)C)C[C@@H]1O LTMHDMANZUZIPE-PUGKRICDSA-N 0.000 claims description 144
- LTMHDMANZUZIPE-AMTYYWEZSA-N Digoxin Natural products O([C@H]1[C@H](C)O[C@H](O[C@@H]2C[C@@H]3[C@@](C)([C@@H]4[C@H]([C@]5(O)[C@](C)([C@H](O)C4)[C@H](C4=CC(=O)OC4)CC5)CC3)CC2)C[C@@H]1O)[C@H]1O[C@H](C)[C@@H](O[C@H]2O[C@@H](C)[C@H](O)[C@@H](O)C2)[C@@H](O)C1 LTMHDMANZUZIPE-AMTYYWEZSA-N 0.000 claims description 143
- 229960005156 digoxin Drugs 0.000 claims description 143
- LTMHDMANZUZIPE-UHFFFAOYSA-N digoxine Natural products C1C(O)C(O)C(C)OC1OC1C(C)OC(OC2C(OC(OC3CC4C(C5C(C6(CCC(C6(C)C(O)C5)C=5COC(=O)C=5)O)CC4)(C)CC3)CC2O)C)CC1O LTMHDMANZUZIPE-UHFFFAOYSA-N 0.000 claims description 143
- 239000002775 capsule Substances 0.000 claims description 75
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 71
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 42
- 238000002360 preparation method Methods 0.000 claims description 32
- 239000002904 solvent Substances 0.000 claims description 27
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 25
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 17
- 229920001223 polyethylene glycol Polymers 0.000 claims description 11
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 8
- 241000124008 Mammalia Species 0.000 claims description 8
- 239000002202 Polyethylene glycol Substances 0.000 claims description 8
- 230000002496 gastric effect Effects 0.000 claims description 8
- 229920000159 gelatin Polymers 0.000 claims description 8
- 235000019322 gelatine Nutrition 0.000 claims description 8
- 235000011187 glycerol Nutrition 0.000 claims description 8
- 108010010803 Gelatin Proteins 0.000 claims description 7
- 239000008273 gelatin Substances 0.000 claims description 7
- 235000011852 gelatine desserts Nutrition 0.000 claims description 7
- 229940068918 polyethylene glycol 400 Drugs 0.000 claims description 7
- 238000004090 dissolution Methods 0.000 claims description 6
- 239000011877 solvent mixture Substances 0.000 claims description 6
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 4
- 239000007916 tablet composition Substances 0.000 claims description 3
- 239000011888 foil Substances 0.000 claims description 2
- 239000000463 material Substances 0.000 claims description 2
- 239000004014 plasticizer Substances 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 239000012046 mixed solvent Substances 0.000 claims 3
- 239000003086 colorant Substances 0.000 claims 1
- 238000000605 extraction Methods 0.000 claims 1
- 239000007903 gelatin capsule Substances 0.000 description 14
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 12
- 206010019280 Heart failures Diseases 0.000 description 11
- 210000002966 serum Anatomy 0.000 description 11
- 239000000203 mixture Substances 0.000 description 6
- 238000010521 absorption reaction Methods 0.000 description 5
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 description 5
- 229930182470 glycoside Natural products 0.000 description 5
- 150000002338 glycosides Chemical class 0.000 description 5
- 230000036765 blood level Effects 0.000 description 4
- 230000001965 increasing effect Effects 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 238000012423 maintenance Methods 0.000 description 4
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 description 4
- 239000006184 cosolvent Substances 0.000 description 3
- 230000037406 food intake Effects 0.000 description 3
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 3
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 2
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 2
- 206010070863 Toxicity to various agents Diseases 0.000 description 2
- 230000002159 abnormal effect Effects 0.000 description 2
- 230000003177 cardiotonic effect Effects 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 239000000178 monomer Substances 0.000 description 2
- VJZLQIPZNBPASX-OJJGEMKLSA-L prednisolone sodium phosphate Chemical compound [Na+].[Na+].O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)COP([O-])([O-])=O)[C@@H]4[C@@H]3CCC2=C1 VJZLQIPZNBPASX-OJJGEMKLSA-L 0.000 description 2
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 description 2
- 239000013589 supplement Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 210000002700 urine Anatomy 0.000 description 2
- 229940058015 1,3-butylene glycol Drugs 0.000 description 1
- 206010003658 Atrial Fibrillation Diseases 0.000 description 1
- 206010003662 Atrial flutter Diseases 0.000 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 239000001828 Gelatine Substances 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- -1 Polyethylene Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 208000003734 Supraventricular Tachycardia Diseases 0.000 description 1
- 206010042602 Supraventricular extrasystoles Diseases 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 239000001089 [(2R)-oxolan-2-yl]methanol Substances 0.000 description 1
- 208000022531 anorexia Diseases 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 235000019437 butane-1,3-diol Nutrition 0.000 description 1
- 229940097217 cardiac glycoside Drugs 0.000 description 1
- 239000002368 cardiac glycoside Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 206010061428 decreased appetite Diseases 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000001066 destructive effect Effects 0.000 description 1
- MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 210000001198 duodenum Anatomy 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- XXMIOPMDWAUFGU-UHFFFAOYSA-N hexane-1,6-diol Chemical compound OCCCCCCO XXMIOPMDWAUFGU-UHFFFAOYSA-N 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 238000007373 indentation Methods 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 229940063699 lanoxin Drugs 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 210000002445 nipple Anatomy 0.000 description 1
- 239000003605 opacifier Substances 0.000 description 1
- LPMXVESGRSUGHW-HBYQJFLCSA-N ouabain Chemical compound O[C@@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@H]1O[C@@H]1C[C@@]2(O)CC[C@H]3[C@@]4(O)CC[C@H](C=5COC(=O)C=5)[C@@]4(C)C[C@@H](O)[C@@H]3[C@@]2(CO)[C@H](O)C1 LPMXVESGRSUGHW-HBYQJFLCSA-N 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 229920006255 plastic film Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229940113115 polyethylene glycol 200 Drugs 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 229930002534 steroid glycoside Natural products 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- BSYVTEYKTMYBMK-UHFFFAOYSA-N tetrahydrofurfuryl alcohol Chemical compound OCC1CCCO1 BSYVTEYKTMYBMK-UHFFFAOYSA-N 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 230000036325 urinary excretion Effects 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
Classifications
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US44496174A | 1974-02-22 | 1974-02-22 | |
| US45300074A | 1974-03-19 | 1974-03-19 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DE2507635A1 true DE2507635A1 (de) | 1975-08-28 |
| DE2507635C2 DE2507635C2 (en, 2012) | 1991-07-25 |
Family
ID=27034126
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE19752507635 Granted DE2507635A1 (de) | 1974-02-22 | 1975-02-21 | Pharmazeutische praeparate und verfahren zu ihrer herstellung |
Country Status (14)
| Country | Link |
|---|---|
| JP (1) | JPS50126822A (en, 2012) |
| AU (2) | AU501549B2 (en, 2012) |
| CA (1) | CA1096307A (en, 2012) |
| DE (1) | DE2507635A1 (en, 2012) |
| ES (1) | ES434971A1 (en, 2012) |
| FI (1) | FI750489A7 (en, 2012) |
| FR (1) | FR2261752B1 (en, 2012) |
| GB (1) | GB1506016A (en, 2012) |
| IE (1) | IE41620B1 (en, 2012) |
| IL (1) | IL46682A (en, 2012) |
| IT (1) | IT1233251B (en, 2012) |
| LU (1) | LU71894A1 (en, 2012) |
| NL (1) | NL7502121A (en, 2012) |
| SE (1) | SE426549B (en, 2012) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2513601A1 (de) * | 1974-04-01 | 1975-10-02 | Scherer Ltd R P | Pharmazeutische praeparate |
| DE3445237C1 (de) * | 1984-12-12 | 1986-06-05 | R.P. Scherer GmbH, 6930 Eberbach | Weichgelatinekapseln und Verfahren zu ihrer Herstellung |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4002718A (en) * | 1974-10-16 | 1977-01-11 | Arnar-Stone Laboratories, Inc. | Gelatin-encapsulated digoxin solutions and method of preparing the same |
| DE2805165A1 (de) * | 1977-02-09 | 1978-08-10 | Christiaens Sa A | Gitoxin enthaltendes arzneimittel und verfahren zu seiner herstellung |
| IT1158722B (it) * | 1977-07-08 | 1987-02-25 | Simes | Composizione farmaceutica per il trattamento delle turbe del sonno |
| JPS5625428U (en, 2012) * | 1979-08-03 | 1981-03-09 | ||
| US4366145A (en) * | 1981-06-24 | 1982-12-28 | Sandoz, Inc. | Soft gelatin capsule with a liquid ergot alkaloid center fill solution and method of preparation |
| US4994260A (en) * | 1982-05-28 | 1991-02-19 | Astra Lakemedel Aktiebolag | Pharmaceutical mixture |
| SE8203953D0 (sv) * | 1982-06-24 | 1982-06-24 | Astra Laekemedel Ab | Pharmaceutical mixture |
| DE3529694A1 (de) * | 1985-08-20 | 1987-02-26 | Scherer Gmbh R P | Gelatinekapseln und verfahren zu ihrer herstellung |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2434849A1 (de) * | 1973-07-20 | 1975-02-06 | Scherer Ltd R P | Herzstaerkende dosierungseinheit mit einer ein praeparat enthaltenden kapsel |
-
1975
- 1975-02-21 FI FI750489A patent/FI750489A7/fi not_active Application Discontinuation
- 1975-02-21 ES ES434971A patent/ES434971A1/es not_active Expired
- 1975-02-21 CA CA220,535A patent/CA1096307A/en not_active Expired
- 1975-02-21 NL NL7502121A patent/NL7502121A/xx active Search and Examination
- 1975-02-21 DE DE19752507635 patent/DE2507635A1/de active Granted
- 1975-02-21 JP JP50021803A patent/JPS50126822A/ja active Pending
- 1975-02-21 IL IL46682A patent/IL46682A/xx unknown
- 1975-02-21 LU LU71894A patent/LU71894A1/xx unknown
- 1975-02-21 IE IE371/75A patent/IE41620B1/en unknown
- 1975-02-21 GB GB7327/75A patent/GB1506016A/en not_active Expired
- 1975-02-21 AU AU78440/75A patent/AU501549B2/en not_active Expired
- 1975-02-21 FR FR7505457A patent/FR2261752B1/fr not_active Expired
- 1975-02-21 SE SE7501967A patent/SE426549B/xx not_active IP Right Cessation
-
1979
- 1979-05-28 AU AU47500/79A patent/AU520082B2/en not_active Ceased
-
1983
- 1983-11-28 IT IT8349395A patent/IT1233251B/it active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2434849A1 (de) * | 1973-07-20 | 1975-02-06 | Scherer Ltd R P | Herzstaerkende dosierungseinheit mit einer ein praeparat enthaltenden kapsel |
Non-Patent Citations (2)
| Title |
|---|
| B.HELWIG, Moderne Arzneimittel, 4.Aufl., 1972, S. 992-993 * |
| HAGERS Handbuch der Pharmazeutischen Praxis, Bd.VIIA, S.482-489, (1971) * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2513601A1 (de) * | 1974-04-01 | 1975-10-02 | Scherer Ltd R P | Pharmazeutische praeparate |
| DE3445237C1 (de) * | 1984-12-12 | 1986-06-05 | R.P. Scherer GmbH, 6930 Eberbach | Weichgelatinekapseln und Verfahren zu ihrer Herstellung |
| US4891229A (en) * | 1984-12-12 | 1990-01-02 | Werner Brox | Soft gelatin capsules and processes for their manufacture |
Also Published As
| Publication number | Publication date |
|---|---|
| IL46682A (en) | 1979-07-25 |
| GB1506016A (en) | 1978-04-05 |
| FR2261752B1 (en, 2012) | 1978-07-21 |
| IE41620B1 (en) | 1980-02-13 |
| SE7501967L (en, 2012) | 1975-08-25 |
| IT1233251B (it) | 1992-03-24 |
| AU520082B2 (en) | 1982-01-14 |
| JPS50126822A (en, 2012) | 1975-10-06 |
| ES434971A1 (es) | 1977-05-16 |
| IT8349395A0 (it) | 1983-11-28 |
| CA1096307A (en) | 1981-02-24 |
| AU501549B2 (en) | 1979-06-21 |
| IE41620L (en) | 1975-08-22 |
| DE2507635C2 (en, 2012) | 1991-07-25 |
| AU7844075A (en) | 1976-08-26 |
| SE426549B (sv) | 1983-01-31 |
| LU71894A1 (en, 2012) | 1975-12-09 |
| FR2261752A1 (en, 2012) | 1975-09-19 |
| FI750489A7 (en, 2012) | 1975-08-23 |
| IL46682A0 (en) | 1975-04-25 |
| NL7502121A (nl) | 1975-08-26 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 8110 | Request for examination paragraph 44 | ||
| 8176 | Proceedings suspended because of application no: |
Ref document number: 2434849 Country of ref document: DE Format of ref document f/p: P |
|
| 8178 | Suspension cancelled | ||
| D2 | Grant after examination | ||
| 8364 | No opposition during term of opposition | ||
| 8339 | Ceased/non-payment of the annual fee |