DE9213914U1 - Ampoule and infusion solution of thioctic acid in the form of the water-soluble salts of thioctic acid - Google Patents
Ampoule and infusion solution of thioctic acid in the form of the water-soluble salts of thioctic acidInfo
- Publication number
- DE9213914U1 DE9213914U1 DE9213914U DE9213914U DE9213914U1 DE 9213914 U1 DE9213914 U1 DE 9213914U1 DE 9213914 U DE9213914 U DE 9213914U DE 9213914 U DE9213914 U DE 9213914U DE 9213914 U1 DE9213914 U1 DE 9213914U1
- Authority
- DE
- Germany
- Prior art keywords
- thioctic acid
- solution
- water
- ampoule
- soluble salts
- 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.)
- Expired - Lifetime
Links
- AGBQKNBQESQNJD-SSDOTTSWSA-N (R)-lipoic acid Chemical compound OC(=O)CCCC[C@@H]1CCSS1 AGBQKNBQESQNJD-SSDOTTSWSA-N 0.000 title claims description 33
- AGBQKNBQESQNJD-UHFFFAOYSA-N alpha-Lipoic acid Natural products OC(=O)CCCCC1CCSS1 AGBQKNBQESQNJD-UHFFFAOYSA-N 0.000 title claims description 32
- 235000019136 lipoic acid Nutrition 0.000 title claims description 32
- 229960002663 thioctic acid Drugs 0.000 title claims description 32
- 150000003839 salts Chemical class 0.000 title claims description 12
- 239000003708 ampul Substances 0.000 title claims description 8
- 239000003978 infusion fluid Substances 0.000 title claims description 6
- 229940126601 medicinal product Drugs 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000000243 solution Substances 0.000 description 32
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 22
- 229910052757 nitrogen Inorganic materials 0.000 description 11
- 239000007924 injection Substances 0.000 description 8
- 238000002347 injection Methods 0.000 description 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- 239000012895 dilution Substances 0.000 description 5
- 238000010790 dilution Methods 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 239000008215 water for injection Substances 0.000 description 5
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 description 3
- 238000011109 contamination Methods 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 239000011148 porous material Substances 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000000725 suspension Substances 0.000 description 3
- NQRYJNQNLNOLGT-UHFFFAOYSA-N Piperidine Chemical compound C1CCNCC1 NQRYJNQNLNOLGT-UHFFFAOYSA-N 0.000 description 2
- KAESVJOAVNADME-UHFFFAOYSA-N Pyrrole Chemical compound C=1C=CNC=1 KAESVJOAVNADME-UHFFFAOYSA-N 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 125000004432 carbon atom Chemical group C* 0.000 description 2
- CVSVTCORWBXHQV-UHFFFAOYSA-N creatine Chemical compound NC(=[NH2+])N(C)CC([O-])=O CVSVTCORWBXHQV-UHFFFAOYSA-N 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- XZUAPPXGIFNDRA-UHFFFAOYSA-N ethane-1,2-diamine;hydrate Chemical compound O.NCCN XZUAPPXGIFNDRA-UHFFFAOYSA-N 0.000 description 2
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 2
- 230000008014 freezing Effects 0.000 description 2
- 238000007710 freezing Methods 0.000 description 2
- VKYKSIONXSXAKP-UHFFFAOYSA-N hexamethylenetetramine Chemical compound C1N(C2)CN3CN1CN2C3 VKYKSIONXSXAKP-UHFFFAOYSA-N 0.000 description 2
- 238000001802 infusion Methods 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 description 2
- 230000000474 nursing effect Effects 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 229940124597 therapeutic agent Drugs 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 2
- 229960000281 trometamol Drugs 0.000 description 2
- HXKKHQJGJAFBHI-UHFFFAOYSA-N 1-aminopropan-2-ol Chemical compound CC(O)CN HXKKHQJGJAFBHI-UHFFFAOYSA-N 0.000 description 1
- HZAXFHJVJLSVMW-UHFFFAOYSA-N 2-Aminoethan-1-ol Chemical compound NCCO HZAXFHJVJLSVMW-UHFFFAOYSA-N 0.000 description 1
- VHUUQVKOLVNVRT-UHFFFAOYSA-N Ammonium hydroxide Chemical compound [NH4+].[OH-] VHUUQVKOLVNVRT-UHFFFAOYSA-N 0.000 description 1
- 239000004475 Arginine Substances 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-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-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
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 1
- 206010067125 Liver injury Diseases 0.000 description 1
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
- 239000004472 Lysine Substances 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 208000001907 Mushroom Poisoning Diseases 0.000 description 1
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 description 1
- 206010036030 Polyarthritis Diseases 0.000 description 1
- WUGQZFFCHPXWKQ-UHFFFAOYSA-N Propanolamine Chemical compound NCCCO WUGQZFFCHPXWKQ-UHFFFAOYSA-N 0.000 description 1
- LCTONWCANYUPML-UHFFFAOYSA-M Pyruvate Chemical compound CC(=O)C([O-])=O LCTONWCANYUPML-UHFFFAOYSA-M 0.000 description 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 1
- 230000001476 alcoholic effect Effects 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 150000008044 alkali metal hydroxides Chemical class 0.000 description 1
- 125000002947 alkylene group Chemical group 0.000 description 1
- 125000005263 alkylenediamine group Chemical group 0.000 description 1
- 150000004716 alpha keto acids Chemical class 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 239000000908 ammonium hydroxide Substances 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 206010003246 arthritis Diseases 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 230000019522 cellular metabolic process Effects 0.000 description 1
- 239000005515 coenzyme Substances 0.000 description 1
- 229960003624 creatine Drugs 0.000 description 1
- 239000006046 creatine Substances 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 235000001727 glucose Nutrition 0.000 description 1
- 231100000234 hepatic damage Toxicity 0.000 description 1
- 235000010299 hexamethylene tetramine Nutrition 0.000 description 1
- 239000004312 hexamethylene tetramine Substances 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 125000004435 hydrogen atom Chemical class [H]* 0.000 description 1
- 229940102223 injectable solution Drugs 0.000 description 1
- 230000008818 liver damage Effects 0.000 description 1
- 208000019423 liver disease Diseases 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 208000030159 metabolic disease Diseases 0.000 description 1
- 229960005181 morphine Drugs 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 238000005895 oxidative decarboxylation reaction Methods 0.000 description 1
- WEYVCQFUGFRXOM-UHFFFAOYSA-N perazine Chemical compound C1CN(C)CCN1CCCN1C2=CC=CC=C2SC2=CC=CC=C21 WEYVCQFUGFRXOM-UHFFFAOYSA-N 0.000 description 1
- 229960002195 perazine Drugs 0.000 description 1
- 210000000578 peripheral nerve Anatomy 0.000 description 1
- 208000030428 polyarticular arthritis Diseases 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 229940030966 pyrrole Drugs 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 150000005846 sugar alcohols Chemical class 0.000 description 1
- 229940005605 valeric acid Drugs 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 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
- A61K31/33—Heterocyclic compounds
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
- A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
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)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
92 184 PH92 184 PH
Ampulle und Infusionslösung von Thioctsäure In Form der wasserlöslichen Salze der ThioctsäureAmpoule and infusion solution of thioctic acid In the form of the water-soluble salts of thioctic acid
BeschreibungDescription
A1pha-L1ponsäure (Thioctsäure) 1st chemisch eine l^-Dithiacyclopentan-S-valeriansäure:Alpha-L-ponic acid (thioctic acid) is chemically a l^-dithiacyclopentane-S-valeric acid:
Thioctsäure ist Bestandteil des ZeI Istoffwechsels und wird daher In vielen Pflanzen und tierischen Organismen gefunden. Sie wirkt als eines der Coenzyme bei der oxydativen Decarboxylierung von Pyruvat und anderen alpha-Ketosäuren .Thioctic acid is a component of cell metabolism and is therefore found in many plants and animal organisms. It acts as one of the coenzymes in the oxidative decarboxylation of pyruvate and other alpha-keto acids.
Thioctsäure wird seit längerer Zelt bei verschiedenen Erkrankungen eingesetzt, so u.a. bei Lebererkrankungen, bei Leberschädigungen durch Pilzvergiftungen sowie bei diabetischer und alkoholischer Poly&eegr;europath1e, einer mit Stoffwechsel er krankungen e1 &eegr; hergehen den Veränderung peripherer Nerven.Thioctic acid has been used for a long time to treat various diseases, including liver diseases, liver damage caused by mushroom poisoning, and diabetic and alcoholic polyarthritis, a change in peripheral nerves associated with metabolic diseases.
Bei der Therapie mit Thioctsäure wird, vornehmlich 1m Anfangsstad 1 um der Behandlung, die I &eegr;Jekt1 ons1ösung eingesetzt. Die bisher verfügbaren Lösungen hatten jedoch den Nachteil, daß sie von der Verträglichkeit her nicht optimal waren. So berichteten Patienten von Schmerzen bei der Injektion oder auch Brennen an der Injektionsstelle.In therapy with thioctic acid, the injection solution is used, primarily in the initial stages of treatment. However, the solutions available to date had the disadvantage that they were not optimally tolerated. Patients reported pain during the injection or burning at the injection site.
Üblicherwelse behalf man sich so, daß die handelsübliche I &eegr; jekt1 ons1ösung vom Arzt oder Pflegepersonal 1 &eegr; geeigneter Weise verdünnt und die Verdünnung anschließend injiziert wurde.The usual solution was that the commercially available injection solution was diluted in an appropriate manner by the doctor or nursing staff and the dilution was then injected.
So beschreibt die DE-OS 38 40 076 eine injizierbare Lösung von Thioctsäuresalzen mit Trometamol als Salzbildner, ohne das Problem der Handhabungssicherheit zu erwähnen.For example, DE-OS 38 40 076 describes an injectable solution of thioctic acid salts with trometamol as a salt former, without mentioning the problem of handling safety.
Es 1st bekannt, daß das Pflegepersonal in Krankenhäusern Immmer knapper wird und daher die Forderung nach möglichst einfacher und schneller Handhabung von Therapeut!ka besteht. Dieser Forderung kommt eine Injekt1 ons-/Infus 1onsl ösung entgegen, die lagerstabil und ohne komplizierte Verdünnung direkt anwendbar 1st (ready-to-use-Form). Bei deren Verwendung wird einerseits Vorbereitungsarbeit eingespart, andererseits die Arzneimittel sicherheit erhöht: So kommt es nicht zu Verwechslungen durch ungenügend etikettierte Lösungen, müssen doch Lösungen bisher nach dem Verdünnen entsprechend neu bezeichnet werden. Außerdem 1st das Kontami &eegr; at 1 onsr1siko durch unsterile Arbeitsweise bei dem Öffnen der Ampullen, Aufziehen der Lösung aus verschiedenen Ampullen und Einspritzen in die Verdünnungs1ösung entsprechend reduziert. Diese Arbe 1tsschr 1 tte entfallen bei Verwendung der fertig einsetzbaren Lösung.It is known that nursing staff in hospitals are becoming increasingly scarce and that there is therefore a demand for the simplest and quickest possible handling of therapeutic agents. This demand is met by an injection/infusion solution that is stable in storage and can be used directly without complicated dilution (ready-to-use form). Using this solution saves on preparation work on the one hand, and on the other hand increases drug safety: This means that there is no confusion due to inadequately labeled solutions, as solutions previously had to be relabeled accordingly after dilution. In addition, the risk of contamination is reduced accordingly due to non-sterile working methods when opening the ampoules, drawing the solution from different ampoules and injecting it into the dilution solution. These steps are eliminated when using the ready-to-use solution.
Da bekannterweise das Hilfspersonal, das In Krankenhäusern für diese Tätigkeit abgestellt werden kann, Immer knapper wird, besteht die Forderung nach möglichst einfacher und schneller Handhabung von Therapeut 1ka. Dieser Forderung kommt eine Darreichungsform entgegen, welche die gesamte zu app11 &zgr; 1 er ende Menge an Injektionslösung in einem Behältnis enthält. Weiterer Gegenstand der Erfindung 1st also eine Ampulle oder Stechflasche, die 300-800 mg Thioctsäure enthält. Hierbei liegt die Thioctsäure in Form ihrer Salze vor. Als Salzbildner kommen zum Beispiel übliche Basen beziehungsweise Kationen In Frage, die 1n der Salzform physiologisch verträglich sind.As it is well known that the number of auxiliary personnel that can be assigned to this task in hospitals is becoming increasingly scarce, there is a demand for the simplest and quickest possible handling of therapeutic agents. This requirement is met by a dosage form that contains the entire amount of injection solution to be administered in one container. Another subject of the invention is therefore an ampoule or vial that contains 300-800 mg of thioctic acid. The thioctic acid is in the form of its salts. Common bases or cations that are physiologically acceptable in the salt form can be used as salt formers.
Bei der Handhabung einer derartigen Darreichungsform sind wesentlich weniger Manipulationen per Hand erforderlich, was auch das Risiko einer bakteriellen Kontamination mit allen sich daraus ergebenden Konsequenzen beträchtlich veringert: Die Ampulle wird geöffnet, die Lösung entnommen und Injiziert oder zur Verdünnung In eine Trägerlösung eingegeben und anschließend die Gesamtlösung Infundiert. Das Risiko einer Vermischung mit anderen, gleichzeitig geöffneten Ampullen 1st Null.When handling such a dosage form, significantly less manual manipulation is required, which also significantly reduces the risk of bacterial contamination with all the resulting consequences: The ampoule is opened, the solution is removed and injected or added to a carrier solution for dilution and then the entire solution is infused. The risk of mixing with other ampoules opened at the same time is zero.
Die erfindungsgemäßen Lösungen sind durch Anwendung eines Überschusses an basischer Komponente, also einer höheren Menge als äquimolar, auf einen basischen pH-Wert von 7.6 bis ca. 8.8 eingestellt.The solutions according to the invention are adjusted to a basic pH value of 7.6 to approx. 8.8 by using an excess of basic component, i.e. a higher than equimolar amount.
Beispiele hierfür sind:Examples for this are:
Alkall- und Erdal kai 1 met al 1e, Ammon1umhydrox1d,Alkali and earth alkali metal hydroxide, ammonium hydroxide,
Als weiterer Vorteil ist die vereinfachte Lagerhaltung und der geringere Verwaltungsaufwand In der Apotheke zu erwähnen .Another advantage is the simplified storage and the lower administrative effort in the pharmacy.
Gegenstand der Erfindung ist also eine Lösung von a-L1ponsaure In Form ihrer wasserlöslichen Salze mit einer Konzentration von 0,4 - 16 g pro Liter.The subject of the invention is therefore a solution of a-L1ponic acid in the form of its water-soluble salts with a concentration of 0.4 - 16 g per liter.
Bei der Therapie mit Thioctsaure wird, vornehmlich im Anfangsstadium der Behandlung, die I &eegr;jektions1ösung eingesetzt. Die bisher verfügbaren Ampullen, die die Injektionslösung enthalten, verfügen über eine Dosierung von maximal 250 mg Thioctsaure. Die Applikation pro Anwendung beträgt jedoch 600 mg als E1nmaldos1s.In therapy with thioctic acid, the injection solution is used, primarily in the initial stage of treatment. The ampoules currently available that contain the injection solution have a maximum dosage of 250 mg thioctic acid. However, the application per application is 600 mg as a single dose.
Für den Arzt bedeutet dies, daß er mehrere Ampullen öffnen, den Inhalt abmessen und in einem Behältnis vereinigen muß und erst dann mit der Applikation beginnen kann. Diese Handhabung ist umständlich, da aus mehreren Ampullen die Lösung mit Hilfe einer Kanüle herausgesaugt werden muß. Da die Ampullen zuerst alle geöffnet und erst anschließend die Lösung herausgesaugt wird, besteht die Gefahr, daß die bereits geöffneten Ampullen auf einer Unterlage abgestellt, durch Unachtsamkeit umgeworfen werden und ihr Inhalt verlorengeht und diese Handhabung die Ursache von Verschmutzungen ist.For the doctor, this means that he has to open several ampoules, measure the contents and combine them in a container before he can begin the application. This is a laborious process because the solution has to be sucked out of several ampoules using a cannula. Since the ampoules are all opened first and only then is the solution sucked out, there is a risk that the already opened ampoules will be placed on a surface, knocked over by carelessness and their contents will be lost, and this handling will cause contamination.
basische Aminosäuren wie Arginin und Lysin, Amine der Formel NR1R2R3, worin die Reste R1, R2 und R3 gleich oder verschieden sind und Wasserstoff, C1-C4-AIlCyI oder C1-C4-Oxyalky1 bedeuten wie beispielsweise Mono-und Diethanolamin, 1-Am1&eegr;o-2-propanol, 3-AmIno-1-propanol; Alkylendiamine mit einer A1ky1enkette aus 2 bis 6-C-Atomen wie Ethylendiamin oder Hexamethylentetramin, gesättigte cyclische Aminoverbindungen mit 4-6 Ri&eegr;gkoh1 enstoffatomen wie Piperidin, P1peraz1n, Pyrrol IdIn-Morphol1n; N-Methy 1glucami&eegr;, Creatin, Trometamol.basic amino acids such as arginine and lysine, amines of the formula NR 1 R 2 R 3 , in which the radicals R 1 , R 2 and R 3 are the same or different and are hydrogen, C 1 -C 4 -alkyl or C 1 -C 4 -oxyalkyl such as, for example, mono- and diethanolamine, 1-amino-2-propanol, 3-amino-1-propanol; alkylenediamines with an alkylene chain of 2 to 6 carbon atoms such as ethylenediamine or hexamethylenetetramine, saturated cyclic amino compounds with 4-6 carbon atoms such as piperidine, perazine, pyrrole or morphine; N-methylglucamine, creatine, trometamol.
Die Lösungen können gegebenenfalls durch Zusatz weiterer Substanzen auf den gleichen osomotischen Druck wie Blut eingestellt werden. Hierzu können beispielsweise folgende Substanzen verwendet werden:The solutions can be adjusted to the same osmotic pressure as blood by adding additional substances. The following substances can be used for this purpose:
Natriumchlorid, Zuckeralkohole wie Sorbit, Xylit oder Mannit oder Glucose. Es wird soviel von den genannten Substanzen zugesetzt, bis die Gefrierpunktserniedrigung der Lösung äquivalent 1st der Gefrierpunktserniedrigung von Körperf1üss1gke1ten (0,52 bis 0,560C) .Sodium chloride, sugar alcohols such as sorbitol, xylitol or mannitol or glucose. Add enough of the substances mentioned until the freezing point depression of the solution is equivalent to the freezing point depression of body fluids (0.52 to 0.56 ° C).
Die Konzentration der Thioctsäure (in Form ihrer wasserlöslichen Salze) beträgtThe concentration of thioctic acid (in the form of its water-soluble salts) is
0,4 bis 16 g/L1ter, vorzugsweise 1,6 bis 10 g/Liter, insbesondere 2,4 bis 6 g/Li ter0.4 to 16 g/litre, preferably 1.6 to 10 g/litre, in particular 2.4 to 6 g/litre
Die Menge an Thioctsäure 1n einer Ampulle liegt zwischen 300 mg und 800 mg.The amount of thioctic acid in one ampoule is between 300 mg and 800 mg.
Th 1octsäure-I &eegr;fus 1 ons1ösung mit 2,4 g Thioctsäure pro L1 terThioctic acid-I ηfus 1 ion solution with 2.4 g thioctic acid per L1 ter
0,6 kg Thioctsäure werden 1 &eegr; 100 1 Wasser für Injektionszwecke suspendiert, das intensiv mit Stickstoff begast wird. Zu dieser Suspension werden 0,21 kg Et hy1endiaminhydrat gegeben. Anschließend wird unter weiterer St1ckstoffbegasung bis zur Auflösung der Thioctsäure gerührt. Zu dieser Lösung werden 2,0 kg Natriumchlorid gegeben, unter Rühren aufgelöst und mit Wasser für Injektionszwecke unter weiterer St1ckstoffbegasung auf 250 Liter aufgefüllt. Die Lösung wird durch ein Membranfilter der Porenweite 0,22 &mgr;&pgr;&igr; filtriert und unter aseptischen Bedingungen In Infus 1 onsf1aschen zu 250 ml abgefült. Bei der Abfüllung wird mit Stickstoff vor- und nachbegast. Jedes Behältnis enthält 600 mg Thioctsäure als Ethylendiaminsalz.0.6 kg of thioctic acid are suspended in 1 η 100 l of water for injection, which is intensively gassed with nitrogen. 0.21 kg of ethylendiamine hydrate are added to this suspension. The mixture is then stirred with further nitrogen gassing until the thioctic acid dissolves. 2.0 kg of sodium chloride are added to this solution, dissolved with stirring and filled up to 250 liters with water for injection, with further nitrogen gassing. The solution is filtered through a membrane filter with a pore size of 0.22 μιγ and filled into 250 ml infusion bottles under aseptic conditions. During filling, the mixture is pre- and post-gassed with nitrogen. Each container contains 600 mg of thioctic acid as ethylenediamine salt.
Th 1octsäure-I &eegr;fus 1 ons1ösung mit 12 g Thioctsäure pro L1 terThioctic acid-I ηfus 1 ion solution with 12 g thioctic acid per L1 ter
0,6 kg Thioctsäure werden in 40 1 Wasser für I &eegr; jekt1 onszwecke suspendiert, das intensiv mit Stickstoff begast wird. Zu dieser Suspension werden 0,21 kg Et hy1endiami &eegr;hydrat gegeben. Anschließend wird unter weiterer Stickstoffbegasung bis zur Auflösung der Thioctsäure gerührt. Zu dieser Lösung werden 0,13 kg Natriumchlorid gegeben, unter Rühren aufgelöst und mit Wasser für Injektionszwecke unter weiterer St1ckstoffbegasung auf 50 Liter aufgefüllt. Die Lösung wird durch ein Membranfilter der Porenweite 0,22 &mgr;&eegr;&igr; filtriert und unter aseptischen Bedingungen In Infusionsf1aschen zu 50 ml abgefült. Bei der Abfüllung wird mit Stickstoff vor- und nachbegast. Jedes Behältnis enthält 600 mg Thioctsäure als Ethylendi aminsal&zgr; .0.6 kg of thioctic acid is suspended in 40 l of water for injection purposes, which is intensively gassed with nitrogen. 0.21 kg of ethylendiamine hydrate is added to this suspension. The mixture is then stirred with further nitrogen gassing until the thioctic acid dissolves. 0.13 kg of sodium chloride is added to this solution, dissolved with stirring and made up to 50 liters with water for injection purposes with further nitrogen gassing. The solution is filtered through a membrane filter with a pore size of 0.22 μm and filled into 50 ml infusion bottles under aseptic conditions. During filling, the solution is pre- and post-gassed with nitrogen. Each container contains 600 mg of thioctic acid as ethylenediamine salt.
Thi octsäure-Ampul1eThioctic acid ampoule
10 kg Thioctsäure werden In 330 Liter Wasser für Injektionszwecke suspendiert, das intensiv mit Stickstoff begast wird. Zu dieser Suspension werden 3,53 kg Et hy 1 endiami &eegr;hydrat gegeben und die entstehende Lösung unter weiterer Begasung mit Stickstoff auf 400 Liter aufgefüllt. Nach intensivem Mischen wird die Lösung durch ein Membranfilter der Porenweite 0,2 &mgr;&igr;&eegr; filtriert und unter aseptischen Bedingungen zu jeweils 24 ml in Ampullen oder Stechkappenflaschen gefüllt. Bei der Abfüllung wird mit Stickstoff vor- und nachbegast. Jedes Behältnis enthält 600 mg Thioctsäure als Et hy I end 1 aminsal &zgr;.10 kg of thioctic acid are suspended in 330 liters of water for injection, which is intensively gassed with nitrogen. 3.53 kg of ethyl 1 endiamine hydrate are added to this suspension and the resulting solution is made up to 400 liters with further gassing with nitrogen. After intensive mixing, the solution is filtered through a membrane filter with a pore size of 0.2 με and filled into 24 ml ampoules or perforated cap bottles under aseptic conditions. During filling, the solution is pre- and post-gassed with nitrogen. Each container contains 600 mg of thioctic acid as ethyl 1 endiamine sal ζ.
Claims (5)
Priority Applications (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE9213914U DE9213914U1 (en) | 1992-10-15 | 1992-10-15 | Ampoule and infusion solution of thioctic acid in the form of the water-soluble salts of thioctic acid |
| BE9300910A BE1007420A3 (en) | 1992-10-15 | 1993-09-03 | BULBS AND ACID SOLUTION INFUSION Thioctic FORM OF SALT WATER SOLUBLE ACID Thioctic. |
| FR9311052A FR2696933B3 (en) | 1992-10-15 | 1993-09-16 | Ampoules and thioctic acid infusion solution in the form of water-soluble salts of thioctic acid. |
| PT101388A PT101388B (en) | 1992-10-15 | 1993-10-14 | THEMATIC ACID INFUSION SOLUTIONS IN THE FORM OF ITS SOLUTIONS IN WATER AND AMPOLA FOR PARENTERAL APPLICATION |
| NL9301781A NL9301781A (en) | 1992-10-15 | 1993-10-14 | Ampoule and infusion solution of thioctic acid in the form of the water-soluble salts of thioctic acid. |
| ES09302159A ES2063713B1 (en) | 1992-10-15 | 1993-10-14 | AMPOULE AND SOLUTION FOR INFUSION OF THIOCTIC ACID IN THE FORM OF WATER SOLUBLE SALTS OF THIOCTIC ACID. |
| ITTO930761A IT1260996B (en) | 1992-10-15 | 1993-10-15 | SOLUTION VIAL FOR INFUSION OF TIOTIC ACID IN THE FORM OF WATER SOLUBLE SALT OF TIOTIC ACID. |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE9213914U DE9213914U1 (en) | 1992-10-15 | 1992-10-15 | Ampoule and infusion solution of thioctic acid in the form of the water-soluble salts of thioctic acid |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE9213914U1 true DE9213914U1 (en) | 1992-12-03 |
Family
ID=6884846
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE9213914U Expired - Lifetime DE9213914U1 (en) | 1992-10-15 | 1992-10-15 | Ampoule and infusion solution of thioctic acid in the form of the water-soluble salts of thioctic acid |
Country Status (7)
| Country | Link |
|---|---|
| BE (1) | BE1007420A3 (en) |
| DE (1) | DE9213914U1 (en) |
| ES (1) | ES2063713B1 (en) |
| FR (1) | FR2696933B3 (en) |
| IT (1) | IT1260996B (en) |
| NL (1) | NL9301781A (en) |
| PT (1) | PT101388B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4433764A1 (en) * | 1994-09-22 | 1996-03-28 | Asta Medica Ag | Dosage forms containing alpha-lipoic acid, solid salts of R-thioctic acid with improved release and bioavailability |
| ITMI20111975A1 (en) * | 2011-10-28 | 2013-04-29 | Labomar S R L | COMPOSITIONS INCLUDING A SALT OF AN ORGANIC ACID. |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE29506604U1 (en) * | 1995-04-25 | 1995-06-14 | Asta Medica Ag, 01277 Dresden | Ready infusion set |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0427246A2 (en) * | 1989-11-09 | 1991-05-15 | ASTA Medica Aktiengesellschaft | Pharmaceutical compositions comprising sulfur containing carboxylic acids as the active agent as well as their use for combatting retroviruses |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE1095991B (en) * | 1959-05-09 | 1960-12-29 | Chemiewerk Homburg Zweignieder | Process for the preparation of a stable and injectable solution containing 1,2-dithia-cyclopentane-3-valeric acid |
| JPS3814940B1 (en) * | 1961-03-04 | 1963-08-15 | ||
| JPS3922715B1 (en) * | 1962-03-29 | 1964-10-13 | ||
| DE1668887B2 (en) * | 1968-03-15 | 1976-06-16 | CA SALT OF 1,2-DITHIA-CYCLOPENTANE - EQUAL 3- VALERIAN ACID (THIOCTIC ACID) | |
| JPS4526516B1 (en) * | 1968-07-08 | 1970-09-01 | ||
| JPS6066955A (en) * | 1983-09-19 | 1985-04-17 | Kiyaraban:Kk | Preparation of dressing |
| IT1213141B (en) * | 1984-02-17 | 1989-12-14 | Dobrivoje Tomic | PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF DIABETES AND DISEASES AND HEPATIC DYSFUNCTIONS. |
| DE3512911A1 (en) * | 1985-04-11 | 1986-10-16 | Degussa Ag, 6000 Frankfurt | METHOD FOR PRODUCING 1,2-DITHIOLAN-3-PENTANIC ACID (THIOCTSAEURE) |
| EP0318891B1 (en) * | 1987-12-04 | 1992-01-02 | ASTA Medica Aktiengesellschaft | Injectable solution of thioctic acid containing trometamole and/or basic amino acids |
| ES2115589T3 (en) * | 1989-11-09 | 1998-07-01 | Asta Medica Ag | MEDICATION CONTAINING R-ALPHA-LIPONIC ACID OR S-ALPHA-LIPONIC ACID AS AN ACTIVE SUBSTANCE. |
-
1992
- 1992-10-15 DE DE9213914U patent/DE9213914U1/en not_active Expired - Lifetime
-
1993
- 1993-09-03 BE BE9300910A patent/BE1007420A3/en not_active IP Right Cessation
- 1993-09-16 FR FR9311052A patent/FR2696933B3/en not_active Expired - Lifetime
- 1993-10-14 NL NL9301781A patent/NL9301781A/en active Search and Examination
- 1993-10-14 PT PT101388A patent/PT101388B/en not_active IP Right Cessation
- 1993-10-14 ES ES09302159A patent/ES2063713B1/en not_active Expired - Fee Related
- 1993-10-15 IT ITTO930761A patent/IT1260996B/en active IP Right Grant
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0427246A2 (en) * | 1989-11-09 | 1991-05-15 | ASTA Medica Aktiengesellschaft | Pharmaceutical compositions comprising sulfur containing carboxylic acids as the active agent as well as their use for combatting retroviruses |
Non-Patent Citations (1)
| Title |
|---|
| Rote Liste 1991 Nr.66 015 Amp.10 ml Herausgeber: Bundesverband der Pharmazeutischen Industrie e.V., Frankfurt a.M. * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4433764A1 (en) * | 1994-09-22 | 1996-03-28 | Asta Medica Ag | Dosage forms containing alpha-lipoic acid, solid salts of R-thioctic acid with improved release and bioavailability |
| ITMI20111975A1 (en) * | 2011-10-28 | 2013-04-29 | Labomar S R L | COMPOSITIONS INCLUDING A SALT OF AN ORGANIC ACID. |
Also Published As
| Publication number | Publication date |
|---|---|
| BE1007420A3 (en) | 1995-06-13 |
| PT101388B (en) | 1999-09-30 |
| ITTO930761A1 (en) | 1995-04-15 |
| ITTO930761A0 (en) | 1993-10-15 |
| ES2063713A1 (en) | 1995-01-01 |
| ES2063713B1 (en) | 1995-07-16 |
| FR2696933B3 (en) | 1994-09-23 |
| FR2696933A3 (en) | 1994-04-22 |
| PT101388A (en) | 1994-09-30 |
| NL9301781A (en) | 1994-05-02 |
| IT1260996B (en) | 1996-04-29 |
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