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SI9300115A - Topical use of local anaesthetic agents and a pharmaceutical preparation for rheumatoid arthritis and a method for the treatment thereof - Google Patents

Topical use of local anaesthetic agents and a pharmaceutical preparation for rheumatoid arthritis and a method for the treatment thereof Download PDF

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SI9300115A
SI9300115A SI19939300115A SI9300115A SI9300115A SI 9300115 A SI9300115 A SI 9300115A SI 19939300115 A SI19939300115 A SI 19939300115A SI 9300115 A SI9300115 A SI 9300115A SI 9300115 A SI9300115 A SI 9300115A
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rheumatoid arthritis
lidocaine
pharmaceutical preparation
topical
treatment
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SI19939300115A
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Slovenian (sl)
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Hans Christer Arvid Evers
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Aktiebolaget Astra
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • A61K31/24Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
    • A61K31/245Amino benzoic acid types, e.g. procaine, novocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles

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  • Dispersion Chemistry (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Use of one or more local anaesthetic agents, especially lidocaine and prilocaine, for the manufacture of a topical pharmaceutical preparation with curing effect on rheumatoid arthritis.

Description

POVRŠINSKA UPORABA LOKALNIH ANESTETIKOV IN FARMACEVTSKEGA PRIPRAVKA PRI REVMATOIDNEM ARTRITISU, TER NAČIN NJEGOVEGA ZDRAVLJENJASURFACE USE OF LOCAL ANESTHETICS AND PHARMACEUTICAL PREPARATION IN RHEUMATOID ARTHRITIS AND THE METHOD OF ITS TREATMENT

P 1132-1P 1132-1

1993-02-081993-02-08

POVRŠINSKA UPORABA LOKALNIH ANESTETIKOV IN FARMACEVTSKEGA PRIPRAVKA PRI REVMATOIDNEM ARTRITISU, TER NAČIN NJEGOVEGA ZDRAVLJENJASURFACE USE OF LOCAL ANESTHETICS AND PHARMACEUTICAL PREPARATION IN RHEUMATOID ARTHRITIS AND THE METHOD OF ITS TREATMENT

Področje patentne zahteveClaim area

Predložena patentna zahteva se nanaša na uporabo pripravka, za lokalno aplikacijo na kožo, in vsebuje enega ali več lokalnih anestetikov, ali njihovih farmacevtsko sprejemljivih soli, za zdravljenje revmatoidnega artritisa, in z njim povezanim vneljem.The present claim relates to the use of a preparation for topical application to the skin and contains one or more topical anesthetics, or pharmaceutically acceptable salts thereof, for the treatment of rheumatoid arthritis, and related inflammation.

Osnova za patentno zahtevoThe basis of the claim

Revmatoidni artritis je bolezen, s pretežno neznano etiologijo. V večini primerov je to kronično obolenje, ki ga spremlja bolečina in invalidnost, posebaj v poznejših stadijih obolenja. Revmatoidni artritis (RA) obravnavamo kot vnetno obolenje, pri katerem pride do simetričnega povečanja sklepov in kit Widenfalk B. je odkril več znakov, ki nakazujejo da je debli povzročitelj RA tudi živčni sistem.Rheumatoid arthritis is a disease with a largely unknown etiology. In most cases, this is a chronic illness accompanied by pain and disability, especially in the later stages of the disease. Rheumatoid arthritis (RA) is considered to be an inflammatory condition in which there is a symmetric enlargement of the joints and the Widenfalk B. kit has detected several signs suggesting that the obese RA is also a nervous system.

Widenfalk B. Spinalno stična povezava za simetrično refleksni odgovor.”, Scand. J. Plast Reconstr. Hand. Surg. 24: str. 207212, (1990), in Simpatična inervacija normalnega in revmatoidno sinergičnega tkiva.”, Scand. J. Plast Reconstr. Hand. Surg. 25: str. 31-31, (1991), Widenfalk B. et al. Izvor simpatične in senzorne inervacije komolčnega sklepa pri podganah: Retrogradna študija aksona, označenega z aglutinini iz pšeničnih kalčkov konjugiranimi s hrenovo peroksidazo.”, The J. of Comparative Neurology 271: str. 313-318, (1988) m Widenfalk B., Wiberg M. Izvor simpatične in senzorne inervacije kolenskega sklepa.”,Widenfalk B. Spin-joint connection for symmetrically reflex response. ”, Scand. J. Plast Reconstr. Hand. Surg. 24: p. 207212, (1990), and Sympathetic innervation of normal and rheumatoid synergistic tissue. ”, Scand. J. Plast Reconstr. Hand. Surg. 25: p. 31-31, (1991), Widenfalk B. et al. Origin of sympathetic and sensory innervation of the elbow joint in rats: A retrograde study of an axon labeled with horseradish peroxidase-conjugated wheat germ agglutinins. ”, The J. of Comparative Neurology 271: p. 313-318, (1988) m Widenfalk B., Wiberg M. The origin of sympathetic and sensory innervation of the knee joint. ”,

Anat EmbryoL 180: str. 317-323, (1989). Znak, ki kaže, da je RA povzročen na ta način, je ugotovitev, da pri pacientu, kiAnat EmbryoL 180: p. 317-323 (1989). A sign indicating that RA is caused in this way is the finding that in a patient who

P 1132-1 trpi, zaradi tega obolenja in istočasno boleha za cerebrovasularno ležijo z delno paralizo telesa, v paraliziranem delu telesa, kjer je moten živčni prenos, ne opazimo vnetnega procesa. Po vbrizganju protivnetne učinkovine, npr. steroida, v sklep pacientu, obolelim za RA, po tovrstni opazimo vidno izboljšanje bolezni, zato smatramo, da je to terapija izbire za taka obolenja. Injiciranje v sklep je boleč klinični postopek, in v primeru RA je na več mestih, npr. na rokah, potrebnih mnogo injekcij. Zato, da bi zmanjšali bolečine pri tem postopku, pogosto steroidu dodamo lokalni anestetik, da zmanjšamo ali odstranimo bolečino, zaradi lokalnega draženja steroidne raztopine. Raztopni dodajamo lokalni anestetik predvsem z namenom blokade bolečine na mestu injiciranja. Ugotovili so, da lokalni anestetik vpliva na nastanek tkivnega vnetnega odgovora, kot je opisano v mnogih publikacijah.P 1132-1 suffers from this disease and, at the same time, suffers from cerebrovascular disease with partial paralysis of the body, no inflammatory process is observed in the paralyzed part of the body where the nervous transmission is impaired. After injection of an anti-inflammatory agent, e.g. of steroids, in the joint of a patient with RA, a marked improvement in the disease is observed after this, so we consider it to be the therapy of choice for such diseases. Injection into the joint is a painful clinical procedure, and in the case of RA it is in several places, e.g. on the hands, many injections are needed. Therefore, to reduce pain in this procedure, a steroid anesthetic is often added to the steroid to reduce or eliminate pain, due to local irritation of the steroid solution. A topical anesthetic is added to the solution mainly to block the injection site pain. A local anesthetic has been found to influence the formation of a tissue inflammatory response, as described in many publications.

Mehanizem protivnetnega delovanja lokalnih anstetikov je v glavnem neznan, in je definiran kot rezultat kombinacije blokade živčnega prenosa in učinka na lokalne mediatorje vnetja. Opazen zaščitni učinek lokalnih anestetikov, napram standardizirani poskusni poškodbi, je raziskal Ohlsen at el., Lokalni anestetiki, ki modificirajo dermalni odgovor na žarčenje. Acta Oncologica 26, (1987), Fasc. 6, str. 467-476.The mechanism of anti-inflammatory action of local anesthetics is largely unknown and is defined as the result of a combination of blockage of nerve transmission and effect on local inflammatory mediators. The observed protective effect of local anesthetics against standardized trial injury was investigated by Ohlsen at el., Local anesthetics modifying the dermal response to radiation. Acta Oncologica 26, (1987), Fasc. 6, p. 467-476.

V poskusni študiji na zajcih, je avtor ugotovil, da vnetni odgovor v kožnem tkivu živali, ki ga povzroči visoko energetsko sevanje, lahko opazno modificiramo aU celo popolnoma preprečimo s površinsko aplikacijo lokalnega anestetika (krema Emla), nanesenega na kožo poskusnih živaU pred in po poškodbi tkiva z žarčenjem. Rezultati te študije kažejo, da je po površinski aplikaciji možno zagotoviti zadostno tkivno koncentracijo lokalnega anestetika, da se zmanjša vnetni odgovor celo v globjih plasteh pod površinsko, na kožo, nanešenim pripravkom.In an experimental study in rabbits, the author found that the inflammatory response in the skin tissue of an animal caused by high energy radiation can be markedly modified aU even completely prevented by topical application of a local anesthetic (Emla cream) applied to the skin of experimental live before and after tissue damage by irradiation. The results of this study show that after surface application, it is possible to provide sufficient tissue concentration of a local anesthetic to reduce the inflammatory response even in deeper layers beneath the superficial, skin-applied preparation.

P 1132P 1132

Opis patentne zahteveDescription of the claim

Pri tej raziskavi nas je zanimalo, če mogoče ima površinsko apliciran lokalni anestetik ugodne učinke tudi v primerih RA, ali zmanjša vnetni odgovor v sklepih, ki so oddaljeni od zdravljene kože na rokah pacienta, obolelim za RA. Pacientom s prodromalnim simptomom RA, ki ga spremljata Še bolečina in zmanjšana gibljivost obeh rok, so aplicirali pripravek z lokalnim anestetikom (krema Emla) na sklepe in okoliške kožne površine. Površinski anestetik so nanesli pod okluzivno obvezo in levo neposredno na kožo za dve uri. To terapijo so ponavljali dvakrat dnevno dva dni. Po tej terapiji, je bolečina popolnoma izginila, gibljivost zdravljene roke se je normalizirala. Izboljšanje po tej terapiji je trajalo dlje kot teden dni, kar kaže, da trajanje pozitivnega učinka ni neposredno povezano z učinkom lokalnega anestetika, če smo tak učinek, preiskušali s tehniko zbadanja z buciko, je trajal le okrog 5 ur, Juhlin L. & Evers H.In this study, we were interested in whether a topically applied topical anesthetic may also have beneficial effects in RA cases, or reduce the inflammatory response in joints distant from the treated skin on the hands of a patient with RA. Patients with prodromal RA symptom, accompanied by pain and decreased mobility of both hands, were administered a local anesthetic preparation (Emla cream) to the joints and surrounding skin surfaces. The surface anesthetic was applied under occlusive dressing and left directly on the skin for two hours. This therapy was repeated twice daily for two days. After this therapy, the pain disappeared completely, the mobility of the treated arm returned to normal. Improvement after this therapy lasted longer than a week, suggesting that the duration of the positive effect was not directly related to the effect of local anesthetic, if we tested this effect with the pumpkin piercing technique, it only lasted about 5 hours, Juhlin L. & Evers H.

'EMLA: nov površinski anestetik., Adv. Dermatol. 5. str. 75-92, (1990). Pozitivni učinek, ki ga izzove lokalni anestetik pri takem pacientu, je potemtakem verjetno povezan z začasno prekinitvijo reakcije, ki teče v začaranem krogu, in jo drugače povzroči vnetno obolenje (RA).'EMLA: a new surface anesthetic., Adv. Dermatol. 5. p. 75-92 (1990). The positive effect elicited by a local anesthetic on such a patient is therefore likely to be associated with a temporary interruption of the reaction in the vicious cycle and otherwise caused by inflammatory disease (RA).

Zato, da bi še bolj utemeljili ugodne učinke, ki se kažejo po površinskem zdravljenju pacientov z RA, po aplikacijo sestave z lokalnim anestetikom, smo zdravili roke petih pacientov, z diagnosticiranim revmatoidnim artritisom.In order to further substantiate the beneficial effects of superficial treatment of RA patients following the administration of a topical anesthetic, we treated the hands of five patients with diagnosed rheumatoid arthritis.

Eksperimentalni podatkiExperimental data

Pet pacientov, z diagnosticiranim aktivnim revmatoidnim artritisom, smo zdravili lokalno, z nanašanjem EMLA na kožo, dva tedna. Pri vseh petih pacientih smo zasledil pozitiven učinek zdravljenja, zmanjšala se je bolečina in nastajanje otekline na prizadetih sklepih. Opaziti je bilo izboljšano gibljivost sklepovFive patients diagnosed with active rheumatoid arthritis were treated locally with EMLA application to the skin for two weeks. All five patients experienced a positive treatment effect, reducing pain and swelling on the affected joints. Improved joint motility was observed

P 1132-1 objektivo in subjektivno. Pri vseh pacientih je učinek trajal več kot dva tedna, vendar je le pri enem pacientu, tudi šest mesecev po terapiji, otekanje popolnoma izginilo.P 1132-1 lens and subjective. In all patients, the effect lasted for more than two weeks, but in only one patient, even six months after therapy, did the swelling disappear completely.

Farmacevtski pripravki, označeni s tem, da se zanje zahteva patentna zaščitaPharmaceutical preparations characterized in that they are subject to patent protection

Površinski pripravek z lokalnim anestetikom, je označen s tem, da ima sposobnost prodirati skozi nepoškodovano kožo, zaradi svojih farmacevtskih lastnosti, ali prehajati v kožo in pod njo ležeča tkiva, s pomočjo iontoforeze, ali dodatka pospeševalca penetracije (npr. DMSO, DMA ali Azone®),Topical preparation with a local anesthetic, characterized in that it has the ability to penetrate intact skin due to its pharmaceutical properties, or to penetrate into and into underlying skin through iontophoresis, or the addition of a penetration enhancer (eg DMSO, DMA or Azone ®),

Pripravek naj vsebuje najmanj en lokalni anestetik v obliki baze ali njegove farmacevtsko sprejemljive soli, ali evtektične zmesi lokalnih anestetikov aminoamidnega tipa (npr. lidokain, prilokain, bupivakain, ropivakain, itd.).The preparation should contain at least one local anesthetic in the form of a base or a pharmaceutically acceptable salt thereof, or an eutectic mixture of local aminoamide type anesthetics (eg lidocaine, prilocaine, bupivacaine, ropivacaine, etc.).

Lokalni anestetik(i) je (so) vgrajeni v gel, emulzijo, kremo, mazilo, raztopino za razprševanje ali pripravek, ki tvori film na koži.The topical anesthetic (s) is (are) embedded in a gel, emulsion, cream, ointment, spray solution or film-forming preparation on the skin.

Lokalni anestetik(e) je možno vgraditi v farmacevtski pripravek s podaljšanim sproščanjem aktivne učinkovin(e). Na tak način dosežemo dovolj visoko koncentracijo aktivne spojine skozi daljši Čas, zato pogostejše menjavnju obvez ni potrebno.The topical anesthetic (s) can be incorporated into a sustained release pharmaceutical ingredient (s). In this way, a sufficiently high concentration of the active compound is achieved over a longer period of time, so a more frequent change of commitments is not necessary.

Dodaten način aplikacije pripravka z lokalnim anestetikom je, uporaba sterilnega ali nesterilnega obliža prepojenega s pripravkom, ki vsebuje lokalni anestetik.An additional method of administering the preparation with a local anesthetic is to use a sterile or non-sterile patch soaked with a preparation containing a local anesthetic.

Pripravek, z lokalnim anestetikom, vsebuje med 0.25 utežnih % in 20 utežnih % lokalnega(ih) anestetika(ov), najbolj zažeijeno med 5% in 10%.The preparation, with a local anesthetic, contains between 0.25% by weight and 20% by weight of local anesthetic (s), most preferably between 5% and 10%.

P 1132-1P 1132-1

Farmacevtski pripravkiPharmaceutical preparations

Primer 1: 1% GELExample 1: 1% GEL

Lidokinijev klorid monohidrat Hidroksipropilmetilceluloza 400 cps 2M natrijev hidroksid do pH 6.3-6.7Lidokinium chloride monohydrate Hydroxypropyl methylcellulose 400 cps 2M sodium hydroxide up to pH 6.3-6.7

10.8 kg 24.5 kg10.8 kg 24.5 kg

Voda za injekcijeWater for injections

q.s. adq.s. ad

1000 11000 1

Lidokainijev klorid monohidrat in hidroksipropilmetilcelulozo raztopimo v vodi za injekcije. pH uravnamo na 6.3 do 6.7 z natrijevim hidroksidom in dopolnimo z vodo do 1000 litrov.Lidocaine chloride monohydrate and hydroxypropylmethylcellulose are dissolved in water for injection. Adjust the pH to 6.3 to 6.7 with sodium hydroxide and make up to 1000 liters with water.

Primer 2: 2% GELExample 2: 2% GEL

Lidokainijev klorid monohidrat Hidroksipropilmetilceluloza 4000 cps 2M natrijev hidroksid do pH 6.2-6.6Lidocaine hydrochloride monohydrate Hydroxypropyl methylcellulose 4000 cps 2M sodium hydroxide to pH 6.2-6.6

8.65 kg 9.8 kg8.65 kg 9.8 kg

Voda za injekcijeWater for injections

q.s. adq.s. ad

400 1400 1

Lidokainijev klorid monohidrat in hidroksipropilmetilcelulozo raztopimo v vodi za injekcije. pH uravnamo na 6.2 do 6.6 z natrijevim hidroksidom in dopolnimo z vodo do 400 1. Nastali gel avtoklaviramo.Lidocaine chloride monohydrate and hydroxypropylmethylcellulose are dissolved in water for injection. The pH was adjusted to 6.2 to 6.6 with sodium hydroxide and made up to 400 with water. The resulting gel was autoclaved.

Primer 3: RAZTOPINA 40 mg/mlExample 3: 40 mg / ml solution

Lidokainijev klorid monohidrat 4.28 kgLidocaine hydrochloride monohydrate 4.28 kg

2M natrijev hidroksid do pH 6.5-6.7 « 0.46 kg2M sodium hydroxide to pH 6.5-6.7 «0.46 kg

Prečiščena voda q.s ad 95.56 kgPurified water q.s ad 95.56 kg

Lidokain raztopimo v vodi. Dodamo natrijev hidroksid, da uravnamo pH na 6.5-6.7. Pripravljeno raztopino avtokalviramo.Dissolve lidocaine in water. Sodium hydroxide was added to adjust the pH to 6.5-6.7. The prepared solution is autocalibrated.

P 1132-1P 1132-1

Primer 4: EMULZIJSKA KREMAExample 4: EMULSION CREAM

LidokainLidocaine

Miglyol® 812 Arlatone® 289 Carbopol® 934 VodaMiglyol® 812 Arlatone® 289 Carbopol® 934 Water

10-0 g 27.6 g 9.0 g10-0 g 27.6 g 9.0 g

1.0 g ad 100.0 g1.0 g ad 100.0 g

Emulzijo pripravimo tako, da lidokain raztopimo v olju (Miglyol® 812), ter raztalimo skupaj z emulgatorjem (Arlatone® 289). Vroči mešanici dodamo manjšo količino vode. Nastalo mešanico ohladimo in dodamo gel, ki ga tvorita sredstvo za zgoščevanje (Carbopol® 934) in voda. Nastalo kremo homogeniziramo do premera velikosti oljnih kapljic < 3 μ.The emulsion was prepared by dissolving lidocaine in oil (Miglyol® 812) and melted together with the emulsifier (Arlatone® 289). Add a small amount of water to the hot mixture. The resulting mixture was cooled and a gel formed by the thickening agent (Carbopol® 934) and water was added. The resulting cream is homogenized to an oil droplet size <3 μ.

Miglyol® 812 je trdna kokosova maščoba z srednje dolgimi verigami. Arlatone® 289 je ester maščobne kisline z polioksietilenom in Carbopol® 934 je vinilni polimer z aktivnimi karboksilnimi skupinamiMiglyol® 812 is a medium-chain solid coconut fat. Arlatone® 289 is a fatty acid ester with polyoxyethylene and Carbopol® 934 is a vinyl polymer with active carboxyl groups

Primer 5:Example 5:

LidokainLidocaine

Miglyol® 812 Arlatone® 289 Carbopol® 934 Voda adMiglyol® 812 Arlatone® 289 Carbopol® 934 Water ad

5.0 g 13.8 g 4.5 g 1-0 g5.0 g 13.8 g 4.5 g 1-0 g

100.0 g100.0 g

Emulzijsko kremo pripravimo kot je opisano pri primeru 4.The emulsion cream was prepared as described in Example 4.

ΊΊ

P 1132-1 P 1132-1 Primer 6: Example 6: Lidokain Lidocaine 2.5 g 2.5 g Miglyol® 812 Miglyol® 812 6.9 g 6.9 g Arlatone® 289 Arlatone® 289 2.25 g 2.25 g Carbopol® 934 Carbopol® 934 1.0 g 1.0 g Voda ad Water ad 100.0 g 100.0 g

Emulzijsko kremo pripravimo kot je opisano pri primeru 4.The emulsion cream was prepared as described in Example 4.

Primer 7:Example 7:

Prilokain, baza 52 gPriloocaine, base 52 g

Lidokain 48 gLidocaine 48 g

Dve kristalinični spojini z lokalno anestetičnim delovanjem natehtamo skupaj, in jih segrejemo na 30°C, da se spojini raztaliti in tvorita homogeno olje. Mešanica kristalov ima tališče pri 22°C. Nato mešanico nanesemo na papirnat nosilec,The two crystalline compounds with locally anesthetic action are weighed together and heated to 30 ° C to melt the compounds to form a homogeneous oil. The crystalline mixture has a melting point at 22 ° C. The mixture is then applied to a paper carrier,

1.5 mg/cm2 Primemo velik nosilec, apliciramo na prizadete sklepe. Do sedaj poznan najboljši način uporabe te inovacije je uporaba preparata, označenega v primeru 7.1.5 mg / cm 2 A large carrier is applied, applied to the affected joints. The best way to use this innovation so far is to use the preparation indicated in Example 7.

P 1132-1P 1132-1

ZaključkiConclusions

Glede na predloženo inovacijo, smo ugotovili, da so bili pacienti, z revmatoidnim artritisom, uspešno zdravljeni, kar se tiče bolečine in gibljivosti rok, z ekskluzivno uporabo površinsko apliciranege pripravka z lokalnim anestetikom. Paciente so opazovali še šest mesecev, po končani lokalni terapiji z lokalnim anestetikom.According to the proposed innovation, we have found that patients with rheumatoid arthritis have been successfully treated with regard to pain and motility of the hands with the exclusive use of a topically applied topical preparation with a local anesthetic. Patients were monitored for six months after completing topical local anesthetic therapy.

Claims (7)

PATENTNI ZAHTEVKIPATENT APPLICATIONS 1. Uporaba enega ali več lokalnih anestetikov ali njihovih farmacevtsko sprejemljivih soli, označenih s tem, da se uporabljajo za izdelavo površinskega farmacevtskega preparata, brez konzervansov, z zdravilnim delovanjem na revmatoidni artritis.Use of one or more topical anesthetics or their pharmaceutically acceptable salts, characterized in that they are used for the manufacture of a preservative-free surface pharmaceutical preparation with a therapeutic effect on rheumatoid arthritis. 2. Uporaba, po zahtevku 1, označena s tem, da se preparat uporabi, zaradi njegovih zdravilnih učinkov na revmatoidni artritis, na rokah.Use according to claim 1, characterized in that the preparation is used on the hands due to its therapeutic effects on rheumatoid arthritis. 3. Uporaba, po zahtevku 1, označena s tem, da je lokalni anestetik evtektična zmes lidokaina in prilokaina.Use according to claim 1, characterized in that the local anesthetic is a eutectic mixture of lidocaine and prilocaine. 4. Uporaba, po zahtevku 1, označena s tem, da je lokalni anestetik lidokain.Use according to claim 1, characterized in that the topical anesthetic is lidocaine. 5. Uporaba, po zahtevku 3, označena s tem, da sta lidokain in prilokain v obliki baze.Use according to claim 3, characterized in that lidocaine and prilocaine are in base form. 6. Uporaba, po zahtevku 4, označena s tem, da je lidokain v obliki klorida.Use according to claim 4, characterized in that the lidocaine is in the form of chloride. 7. Lokalni anestetiki ali njihove farmacevtsko sprejemljive soli, označene s tem, da se uporabljajo za površinsko zdravljenje revmatoidnega artritisa.7. Local anesthetics or their pharmaceutically acceptable salts, characterized in that they are used for the surface treatment of rheumatoid arthritis. ZaFor Aktiebolag Astra:Aktiebolag Astra: PATENTNA PISARNAPATENT OFFICE LJUBLJANA SLJUBLJANA S P 1132-1P 1132-1 IZVLEČEKABSTRACT POVRŠINSKA UPORABA LOKALNIH ANESTETIKOV IN FARMACEVTSKEGA PRIPRAVKA PRI REVMATOIDNEM ARTRITISU, TER NAČIN NJEGOVEGA ZDRAVLJENJASURFACE USE OF LOCAL ANESTHETICS AND PHARMACEUTICAL PREPARATION IN RHEUMATOID ARTHRITIS AND THE METHOD OF ITS TREATMENT Uporaba enega ali več lokalnih anestetikov, posebaj Edokaina in prEokama, za izdelavo površinskega farmacevtskega preparata, ki zdravi revmatoidni artritis.Use of one or more topical anesthetics, in particular Edoocaine and prEokam, for the manufacture of a topical pharmaceutical preparation that treats rheumatoid arthritis.
SI19939300115A 1992-03-12 1993-03-11 Topical use of local anaesthetic agents and a pharmaceutical preparation for rheumatoid arthritis and a method for the treatment thereof SI9300115A (en)

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SE9200762A SE9200762D0 (en) 1992-03-12 1992-03-12 NEW TOPICAL USE

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DE19526031A1 (en) * 1995-07-17 1997-01-23 Liedtke Pharmed Gmbh Method and composition of a topical therapy for back pain and muscle tension
US5993836A (en) * 1998-04-28 1999-11-30 Castillo; James G. Topical anesthetic formulation
AU7847800A (en) 1999-10-15 2001-04-30 Mayo Foundation For Medical Education And Research Topical anesthetics useful for treating cancer, autoimmune diseases and ischemia
US8119694B2 (en) 2008-08-15 2012-02-21 Arcion Therapeutics, Inc. High concentration local anesthetic formulations
WO2011074015A2 (en) 2009-12-17 2011-06-23 Themis Medicare Limited Novel composition of pharmaceutical product to treat sexual dysfunction
EP3775116A4 (en) * 2018-04-05 2022-03-23 Bausch Health Ireland Limited Polymeric emulsion delivery systems
CN111840553A (en) * 2019-04-15 2020-10-30 湖州依诺唯新药物制剂有限公司 Lipid pharmaceutical preparation and application thereof

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US4628052A (en) * 1985-05-28 1986-12-09 Peat Raymond F Pharmaceutical compositions containing dehydroepiandrosterone and other anesthetic steroids in the treatment of arthritis and other joint disabilities
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