EP1735001A2 - Compositions pharmaceutiques destinees au traitement de maladies de la peau contenant une combinaison d'epinastine et d'un ou plusieurs mineraux ou d'une ou plusieurs matieres premieres - Google Patents

Compositions pharmaceutiques destinees au traitement de maladies de la peau contenant une combinaison d'epinastine et d'un ou plusieurs mineraux ou d'une ou plusieurs matieres premieres

Info

Publication number
EP1735001A2
EP1735001A2 EP05716230A EP05716230A EP1735001A2 EP 1735001 A2 EP1735001 A2 EP 1735001A2 EP 05716230 A EP05716230 A EP 05716230A EP 05716230 A EP05716230 A EP 05716230A EP 1735001 A2 EP1735001 A2 EP 1735001A2
Authority
EP
European Patent Office
Prior art keywords
calcium
potassium
magnesium
pharmaceutically acceptable
phosphate
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Withdrawn
Application number
EP05716230A
Other languages
German (de)
English (en)
Inventor
Tetsuo Hayashi
Shinichiro Katsuyama
Minoru Okada
Norimitsu Umehara
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boehringer Ingelheim International GmbH
Boehringer Ingelheim Pharma GmbH and Co KG
Original Assignee
Boehringer Ingelheim International GmbH
Boehringer Ingelheim Pharma GmbH and Co KG
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharma GmbH and Co KG filed Critical Boehringer Ingelheim International GmbH
Priority to EP05716230A priority Critical patent/EP1735001A2/fr
Publication of EP1735001A2 publication Critical patent/EP1735001A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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    • A61K36/74—Rubiaceae (Madder family)
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/90—Smilacaceae (Catbrier family), e.g. greenbrier or sarsaparilla
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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Definitions

  • compositions for the treatment of skin diseases comprising a combination of epinastine and one or more additional minerals or one or more crude drugs
  • the present invention relates to pharmaceutical compositions for the treatment of skin diseases.
  • the compositions described in the present invention are highly effective for the treatment of skin diseases associated with allergic reactions among a variety of symptoms derived from skin diseases.
  • these compositions comprise an antihistaminic-effective amount of epinastine or a pharmaceutically acceptable salt thereof and one or more additional pharmaceutically acceptable minerals as pharmacologically active compounds.
  • these compositions comprise an antihistaminic-effective amount of epinastine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable crude drugs as pharmacologically active compounds.
  • the compositions may also comprise pharmaceutically acceptable additives.
  • the present invention relates to the use of these compositions to treat symptoms such as pruritus (itching), derived from skin diseases such as urticaria, eczema, and skin irritation, prurigo and psoriasis vulgaris.
  • itching derived from skin diseases such as urticaria, eczema, and skin irritation, prurigo and psoriasis vulgaris.
  • Urticaria a synonym of wheal, is a transient edema. The disease is characterized by a sudden onset of itchy sensation on skin, followed by developing well-defined eruption swelling up like weal and growing into a size of nail plate to palm exacerbated by scratching. Although the symptoms disappear within a couple of minutes to hours and may not leave any skin disorder, episodes of development into eruption are likely to recur.
  • Causes of urticaria may include autosensitization, sensitizations associated with difficult menstruation, pregnancy, foods, medicines and insect stings, abnormal responses to heat, cold, mechanical stimuli and light, remote responses to bacterial infections, gastrointestinal, hepatic, and renal disease, an endocrinopathic involvement, and psychological factors.
  • Eczema or dermatitis is the most major skin disease, characterized by inflammatory response on skin. Eczema and dermatitis are often referred altogether as eczematous dermatitis group.
  • the diseases are often caused by pathological interactions caused by external stimuli (numbers of chemicals, fragrances, metals, detergents, medicines, plants, bacteria, insects, sunlight, heat, cold, dryness), internal abnormalities (local abnormalities such as perspiration, abnormal sebum secretion, abnormal keratosis, and systemic abnormalities such as atopic disposition, infection site, digestive disorder, renal dysfunction, endocrine disturbance), and bodily condition.
  • Eczematous dermatitis group includes contact dermatitis, atopic dermatitis, seborrheic dermatitis, nummular eczema, autosensitization dermatitis, and lichen simplex chronicus Nidal.
  • Housewives' eczema, keratodermia tylodes palmaris progressiva, diaper dermatitis, and photocontact dermatitis are classified as atypical contact dermatitis.
  • the group may include diffuse neurodermatitis, stasis dermatitis, infectious eczematoid dermatitis, and perioral dermatitis. Broadly, it may also include radiodermatitis, scald (burn), and frostbite.
  • Pruritus is a disease characterized by an onset of itchy sensation (itching) on apparently normal skin. Range of affected lesion divides pruritus into general pruritus and localized pruritus. The disease is derived from a variety of causes, and often develops as a symptom of systemic disease.
  • Prurigo presents extreme itching and is papule or urticaria-like nodule that progress to chronic or recurrent disorder, and can be broadly classified into prurigo acuta including strophulus infantum, lichen urticatus, prurigo aestiralis, prurigo simplex acuta, prurigo subacuta such as prurigo simplex subacuta, and prurigo chronica including chronica multiformis, prurigo nodularis, prurigo hebra, and prurigo simplex chronica. Mechanisms of the pathogenesis are unrevealed.
  • Insect sting in prurigo acuta, and diabetes mellitus, hepatopathy, leukemia, Hodgkin's disease, visceral cancer, and polycythemia in prurigo chronica are thought of as causatives.
  • Psoriasis vulgaris is an inflammatory skin disease, and presents histological characteristics of epidermal hyperplasia and inflammatory cellular infiltration. Eruption typically develops on head, extension side of extremities, and some parts of truncus which are in particular likely to come in contact with mechanical compression, in almost a half of which pruritus is observed. Immuno logical abnormalities may be concerned as a cause of disease.
  • compositions combining antihistaminic compounds are of the frequent choice for treatment of these symptoms including itchy sensation caused from skin diseases.
  • the present invention provides in a first embodiment pharmaceutical compositions and dosage forms comprising epinastine or a pharmaceutically acceptable salt thereof and one or more additional pharmaceutically acceptable minerals as pharmacologically active compounds for the prevention and/or treatment of skin diseases, preferably skin diseases associated with allergic reactions that exert its significant utility to achieve effective improvements.
  • the present invention provides furthermore pharmaceutical compositions and dosage forms comprising epinastine or a pharmaceutically acceptable salt thereof and one or more additional pharmaceutically acceptable crude drugs as pharmacologically active compounds for the prevention and/or treatment of skin diseases, preferably skin diseases associated with allergic reactions that exert its significant utility to achieve effective improvements.
  • the present invention furthermore provides a pharmaceutical pack comprising a pharmaceutical composition comprising epinastine or a pharmaceutically acceptable salt thereof as active agent and a pharmaceutical composition comprising one or more additional pharmaceutically acceptable minerals as pharmacologically active compound for joined or timely shifted administration, for the prevention and/or treatment of skin diseases, preferably skin diseases associated with allergic reactions that exert its significant utility to achieve effective improvements.
  • a pharmaceutical pack comprising a pharmaceutical composition comprising epinastine or a pharmaceutically acceptable salt thereof as active agent and a pharmaceutical composition comprising one or more additional pharmaceutically acceptable minerals as pharmacologically active compound for joined or timely shifted administration, for the prevention and/or treatment of skin diseases, preferably skin diseases associated with allergic reactions that exert its significant utility to achieve effective improvements.
  • the present invention provides a pharmaceutical pack comprising a pharmaceutical composition comprising epinastine or a pharmaceutically acceptable salt thereof as active agent and a pharmaceutical composition comprising one or more additional pharmaceutically acceptable crude drugs as pharmacologically active compound for joined or timely shifted administration, for the prevention and/or treatment of skin diseases, preferably skin diseases associated with allergic reactions that exert its significant utility to achieve effective improvements
  • the present invention provides the use of the above mentioned pharmaceutical compositions in the manufacture of a medicament for the treatment of skin diseases by employing highly effective pharmaceutical compounds for significant improvements on symptoms of skin disease accompanying itching, particularly urticaria, eczema, skin fit, dermatitis, pruritus, eruption, and psoriasis vulgaris accompanying itchy sensation.
  • the present invention relates to pharmaceutical compositions, dosage forms and packs for the prevention and/or treatment of skin diseases, comprising an antihistaminic-effective amount of epinastine or its pharmaceutically acceptable salt thereof and one or more additional pharmaceutically acceptable minerals as pharmacologically active compounds.
  • the present invention relates furthermore to pharmaceutical compositions, dosage forms and packs for the prevention and/or treatment of skin diseases, comprising an antihistaminic- effective amount of epinastine or its pharmaceutically acceptable salt thereof and one or more additional pharmaceutically acceptable crude drugs as pharmacologically active compounds.
  • Epinastine ( ⁇ ) 3 - amino - 9, 13b - dihydro - 1H - dibenz [c, f] imidazo [1,5-a] azepine, the hydrochloride thereof respectively, is a drug possessing Hi-antihistaminic properties. It primarily has been used to treat allergic reaction of the eyes and the nasal mucosa.
  • the pharmaceutical compositions, dosage forms and packs of the present invention comprise epinastine in the form of a salt such as the hydrochloride, hydrobromide, oxalate, nitrate, sulfonate, fumarate, maleate, sulfate, and phosphate or the free base.
  • epinastine hydrochloride is a salt such as the hydrochloride, hydrobromide, oxalate, nitrate, sulfonate, fumarate, maleate, sulfate, and phosphate or the free base.
  • Preferred is epin
  • the amount of epinastine or a pharmacologically acceptable salt thereof depends on the application route.
  • the daily dose of epinastine or a pharmacologically acceptable salt thereof in equivalent quantity to epinastine hydrochloride for an adult is about 2 to 20 mg per day, depending on the severity and stage of the disease, the weight of the patient and further parameters known to the skilled person.
  • Preferred are daily doses of 5 to 15 mg, and particularly preferred are daily doses of 7.5 to 12.5 mg.
  • the daily dose can be administered at one time per day (e.g. 1 tablet per day) or divided over the day, for example three times a day (e.g. 3 tablets three times daily).
  • the content of epinastine or a pharmacologically salt thereof in equivalent quantity to epinastine hydrochloride per dose unit for oral administration is in the range of 0.2 to 20 mg, preferably 0.5 to 15, particularly preferred 0.75 to 12.5 mg.
  • the dose in equivalent quantity to epinastine hydrochloride is in the range of 1 to 50 mg per 1 g of dosage form, preferably in the range from 2 to 30 mg per 1 g of dosage form, and more preferably in the range from 5 to 15 mg per 1 g of dosage form.
  • the pharmaceutical compositions comprise an antihistaminic-effective amount of epinastine or a pharmaceutically acceptable salt thereof and one or more additional pharmaceutically acceptable minerals.
  • Minerals in the meaning of the present invention are pharmaceutically acceptable compounds comprising one or more elements from the group consisting of calcium, zinc, iron, phosphorus, magnesium, potassium, copper, iodine, manganese, selenium, chromium, and molybdenum. One or more compounds of these minerals may be used to formulate this invention.
  • Minerals used in this invention may include synthetic compounds such as chemical synthetic compounds and enzymatic synthetic compounds, as well as natural products or its separated and purified form.
  • the form may include mineral, salt, oxide, protein complex, complex of protein split product, polysaccharide complex, complex of polysaccharide split product, modified starch complex, cyclodextrin complex, metalloenzyme including minerals such as superoxide dismutase, glutathione peroxidase, and acid phosphatase, metal activating enzyme of phosphoglucomutase, enzyme or coenzyme including metal out side of the active center.
  • the preferred minerals in the meaning of this embodiment of the present invention are selected from the group consisting of: calcium gluconate, calcium hydrogen phosphate, dibasic calcium phosphate anhydrous, calcium glycerophosphate, calcium lactate, precipitated calcium carbonate, calcium chloride, calcium carbonate, calcium hydroxide, calcium citrate, calcium L-aspartate, calcium L-glutamate, calcium glycerophosphate, calcium 5'- ribonucleotide, calcium sulfate, tricalcium phosphate, calcium propionate, calcium dihydrogen phosphate (monobasic calcium phosphate), calcium dihydrogen pyrophosphate, carboxymethyl cellulose calcium, calcium stearoyl-2-lactylate, calcium oxide, zinc sulfate, zinc gluconate, zinc undecylenate, zinc oxide, zinc carbonate, zinc chloride, zinc yeast, iron, ferrous sulfate, ferric citrate, sodium ferrous citrate, ferrous gluconate, ferric pyr
  • compositions of this embodiment of the present invention may also include other pharmacologically active compositions such as antihistamines other than epinastine including diphenhydramine, chlorpheniramine, carbinoxamine, diphenylpyraline, and promethazine, antiphlogistics including glycyrrhizinic acid (glycyrrhizin), dipotassium glycyrrhizinate, potassium glycyrrhizinate, monoammonium glycyrrhizinate, di-ammonium glycyrrhizinate, glycyrrhetinic acid, and tranexamic acid, group B vitamins and vitamin-like active substances including vitamin Bi, vitamin B 6 , vitamin B 12 , niacin, pantothenic acid, biotin, folic acid, orotic acid, lipoic acid, p-aminobenzoic acid, inositol, carn
  • the amount of the minerals to formulate this embodiment of the present invention varies depending on the type of mineral used, for oral use given daily to an adult, it lies about in the range from 0.3 ⁇ g to 4000 mg, and for topical use it lies about in the range from 0.1 mg/g to 8O0 mg/g.
  • combination amount of respective mineral to formulate this embodiment of the present invention for given daily to an adult are as follows:
  • Combination amount of calcium as calcium comprising mineral lies preferably in the range within 25O0 mg, more preferably in the range from 10 mg to 600 mg, most preferably in the range from 30 mg to 300 mg.
  • Combination amount of zinc as zinc comprising mineral lies preferably in the range within 30 mg, more preferably in the range from 0.02 mg to 24 mg, most preferably in the range from 0.12 mg to 12 mg.
  • Combination amount of iron as iron comprising mineral lies preferably in the range within 40 mg, more preferably in the range from 0.01 mg to 20 mg, most preferably in the range from 0.1 mg to 10 mg.
  • Combination amount of phosphorus as phosphorus comprising mineral lies preferably in the range within 4000 mg, more preferably in the range from 1 mg to 2000 mg, most preferably in the range from 7 mg to 700 mg.
  • Combination amount of magnesium as magnesium comprising mineral lies preferably in the range within 700 mg, more preferably in the range from 1 mg to 640 mg, most preferably in the range from 3.2 mg to 320 mg.
  • Combination amount of potassium as potassium comprising mineral lies preferably in the . range within 4000 mg, more preferably in the range from 1 mg to 3000 mg, most preferably in the range from 2-mg to 2000 mg.
  • Combination amount of copper as copper comprising mineral lies preferably in the range within 9 mg, more preferably in the range from 0.001 mg to 3.6 mg, most preferably in the range from 0.01 mg to 1.8 mg.
  • Combination amount of iodine as iodine comprising mineral lies preferably in the range within 3 mg, more preferably in the range from 10 ⁇ g to 1000 ⁇ g, most preferably in the range from 1.5 ⁇ g to 150 ⁇ g.
  • Combination amount of manganese as manganese comprising mineral lies preferably in the range within 20 mg, more preferably in the range from 0.01 mg to 10 mg, most preferably in the range from 0.04 mg to 4 mg.
  • Combination amount of selenium as selenium comprising mineral lies preferably in the range within 250 ⁇ g, more preferably in the range from 0.01 ⁇ g to 150 ⁇ g, most preferably in the range from 0.5 ⁇ g to 55 ⁇ g.
  • Combination amount of chromium as chromium comprising mineral lies preferably in the range within 250 ⁇ g, more preferably in the range from 0.01 ⁇ g to 150 ⁇ g, most preferably in the range from 0.3 ⁇ g to 35 ⁇ g.
  • Combination amount of molybdenum as molybdenum comprising mineral lies preferably in the range within 250 ⁇ g, more preferably in the range from 0.01 ⁇ g to 150 ⁇ g, most preferably in the range from 0.3 ⁇ g to 30 ⁇ g.
  • the combination amount as mineral lies normally in the range within 800 mg/g, more preferably in the range from 0.1 mg/g to 500 mg/g, most preferably in the range from 0.45 mg/g to 450 mg/g of composition.
  • minerals for oral use comprise calcium. It is preferable to use one or more calcium comprising minerals selected from calcium gluconate, calcium hydrogen phosphate, dibasic calcium phosphate anhydrous, calcium glycerophosphate, calcium lactate, and/or precipitated calcium carbonate.
  • the amount of calcium to formulate the present invention given daily to an adult lies preferably in the range from 30 mg to 300 mg.
  • minerals for topical use comprise zinc. It is particularly preferable to use one or more zinc comprising minerals selected from zinc oxide and/or zinc undecylenate.
  • Zinc oxide may be used as zinc oxide starch powder. The amount of zinc lies preferably in the range from 0.45 mg/g to 450 mg/g of composition.
  • compositions described in this embodiment of the present invention may be orally given at once or in divided doses, and may be topically applied at once or in divided doses directly onto the affected legion of skin. Dose adjustment of epinastine and mineral may reflect age, body weight, and manifesting symptoms.
  • the invention relates to pharmaceutical compositions for oral use providing for an rapid release of epinastine or a pharmaceutically acceptable salt thereof and providing for sustained release of all or a part of the one or more pharmaceutically acceptable minerals.
  • a part of or all of the mineral, used as sustained release component may be combined with the rapid release component of epinastine (or with epinastine and a part of the mineral).
  • said further active component may be divided into a sustained release component or a rapid release component according to the pharmacokinetic characteristic of each active component.
  • These rapid release components and sustained release components may either be packaged in each dosing unit combining one another after being separately prepared as different formulations, or be prepared as a unit formulation. For example, rapid release tablet and sustained release tablet are packed for one package, or rapid release tablet and sustained release capsule are packed for one package.
  • Unit formulations may include for example multilayer tablets combining rapid release layer(s) and sustained release layer(s), granules combining rapid release granules and sustained release granules or capsules filled with such granules, hard capsules filled with a combination of small rapid release tablet(s) and small sustained release tablet(s), and dry syrup or suspension syrup using microcapsules or -microspheres as sustained release components.
  • Such above mentioned multilayer tablets may provide for sustained release of all or a part of the one or more pharmaceutically acceptable minerals and for an rapid release of epinastine or a pharmaceutically acceptable salt thereof.
  • Such a two layer tablet may comprise a first layer A, providing for the rapid release of epinastine, containing epinastine or a pharmaceutically acceptable salt thereof and optionally a part of the pharmaceutically acceptable mineral and a second layer B, providing for the sustained release of the one or more minerals, containing all or a part of the one or more pharmaceutically acceptable minerals.
  • the two layer tablet may additionally contain a tablet coating consisting of pharmaceutically acceptable excipients.
  • Each layer of the two layer tablet is in contact with each other in a portion of their surface, but provides independent release profiles for both active substances mentioned before.
  • the pharmaceutical compositions comprise an antihistaminic-effective amount of epinastine or a pharmaceutically acceptable salt thereof and one or more additional pharmaceutically acceptable crude drugs.
  • crude drugs used in the present invention include fragrant wormwood flower (Artemisiae capillariflos), gardenia fruit (Gardeniae fructus), rhubarb (Rhei rhizoma), bupleurum root (Bupleuri radix), glehnia root (Glehniae radix cum rhizoma), poria sclerotium (Poria), cherry bark (Pruni jamasakura bark), platycodon root (Platycodi radix), ginger (Zingiberis rhizoma), aralia cordata root (Arali e cardatae rhizoma), schizonepeta spike (Schizonepetae spica), glycyrrhiza (Glycyrrhizae
  • compositions of this embodiment of the present invention may also include other pharmacologically active compositions such as pharmaceutically acceptable minerals including calcium, zinc, iron, phosphorus, magnesium, potassium, copper, iodine, manganese, selenium, chromium, and molybdenum comprising minerals, for example the minerals described above, antihistamines other than epinastine.
  • pharmaceutically acceptable minerals including calcium, zinc, iron, phosphorus, magnesium, potassium, copper, iodine, manganese, selenium, chromium, and molybdenum comprising minerals, for example the minerals described above, antihistamines other than epinastine.
  • vitamin-like active substances including vitamin Bi, vitamin B 6 , vitamin B ⁇ 2 , niacin, pantothenic acid, biotin, folic acid, orotic acid, lipoic acid, p-aminobenzoic acid, inositol, carnitine, and choline, antioxidant vitamins and antioxidant vitamin-like substances including vitamin C, vitamin E, vitamin A, ubiquinone, pangamic acid, and
  • combination amount of the pharmaceutically acceptable crude drugs to formulate the present invention varies depending on the type of the crude drug used, for oral use given daily to an adult, it lies about in the range from 5 mg to 30000 mg as crude drug substance, and for topical use, it lies about in the range from 0.1 mg/g to 800 mg/g as crude drug substance.
  • combination amount of respective crude drug for oral use to formulate the present invention for given daily to an adult are as follows:
  • Combination amount of crude drug such as fragrant wormwood flower, ginger, glycyrrhiza and coix seed lies preferably in the range within 30000 mg, more preferably in the range from 15 mg to 20000 mg, most preferably in the range from 30 mg to 10000 mg as crude drug substance.
  • Combination amount of crude drug such as gardenia fruit, rhubarb, bupleurum root, glehnia root, poria sclerotium, aralia cordata root, schizonepeta spike, smilax rhizome and ground ivy herb lies preferably in the range within 10000 mg, more preferably in the range from 10 mg to 7500 mg, most preferably in the range from 20 mg to 5000 mg as crude drug substance.
  • Combination amount of crude drug such as cherry bark, platycodon root and forsythia fruit lies preferably in the range within 5000 mg, more preferably in the range from 5 mg to 4000 mg, most preferably in the range from 10 mg to 2500 mg as crude drug substance.
  • the combination amount as crude drug lies normally in the range from 0.1 mg/g to 800 mg/g, more preferably in the range from 0.1 mg/g to 500 mg/g, most preferably in the range from 0.45 mg/g to 450 mg/g as crude drug substance.
  • compositions of this embodiment of the present invention may be orally given at once or in divided doses, and topically applied at once or in divided doses directly onto the affected legion of skin. Dose adjustment of epinastine and crude drug may reflect age, body weight, and manifesting symptoms.
  • the invention relates to pharmaceutical compositions for oral use providing for an rapid release of epinastine or a pharmaceutically acceptable salt thereof and providing for sustained release of all or a part of the one or more pharmaceutically acceptable crude drugs.
  • part of or all of the crude drug, used as sustained release component may be combined with the rapid release component of epinastine (or with epinastine and part of crude drug).
  • said further active component may be divided into sustained release component or rapid release component according to the pharmacokinetic characteristic of each active component.
  • Rapid release components and sustained release components may either be packaged in each dosing unit combining one another after being separately prepared as different formulations, or be prepared as a unit formulation.
  • rapid release tablet and sustained release tablet are packed for one package, or rapid release tablet and sustained release capsule are packed for one package.
  • Unit formulations may include for example multilayer tablets combining rapid release layer(s) and sustained release layer(s), granules combining rapid release granules and sustained release granules or capsules filled with such granules, hard capsules filled with a combination of small rapid release tablet(s) and small sustained release tablet(s), and dry syrup or suspension syrup using microcapsules or microspheres as sustained release components.
  • compositions described in the present invention can be used in any oral form such as tablets, granules, fine granules, powders, capsules, caplets, soft capsules, pills, suspensions, emulsions, oral solutions, syrups, dried syrups, chewable forms, effervescent tablets, drops, and oral fast-dispersing tablets, and in any topical form such as creams, ointments, gel ointments, suppositories, poultices, tapes, topical solutions, aerosols, lotions, and foams.
  • preparation formed into microparticles such as microcapsule, nanocapsules, microspheres, nanospheres, liposomes may be also included in the aforementioned compositions.
  • Such above mentioned multilayer tablets may provide for sustained release of all or a part of the one or more pharmaceutically acceptable crude drugs and for a rapid release of epinastine or a pharmaceutically acceptable salt thereof.
  • a two layer tablet may comprise a first layer A, providing for the rapid release of epinastine, containing epinastine or a pharmaceutically acceptable salt thereof and optionally a part of the pharmaceutically acceptable crude drugs and a second layer B, providing for the sustained release of the one or more crude drugs, containing all or a part of the one or more pharmaceutically acceptable crude drugs.
  • the two layer tablet may additionally contain a tablet coating consisting of pharmaceutically acceptable excipients. Each layer of the two layer tablet is in contact with each other in a portion of their surface, but provides independent release profiles for both active substances mentioned before.
  • compositions of the present invention such as stability, release, continuance, disintegration, distinglation, dissolution, concealment of taste, improvement in usage, etc. can be adjusted by addition of additives known in the art.
  • the pharmaceutically active substance can be dispensed in separate granules, multi-layer granules, multi-layer tablets or dry coated tablets, tablets of separated granules, microcapsules, etc.
  • Coating preparations such as sugar coated tablets, film coated tablets, coated granules, and effervescent tablets or effervescent granules can be included as well as chewable preparations, in the mouth dissolving preparations, matrix preparations, together with comminutions, solid solutions, etc.
  • Sweetening agents, refrigerants, antioxidants or stabilizing agents, agents adjusting a certain pH- value can be added as well as agents influencing the viscosity, the osmotic pressure or the salt concentration.
  • the following additives also can be added: excipients, bases, binders, disintegrators, lubricants, superplasticizers, coating agents, sugar coating agents, plasticizers, antifoaming agents, polish, foaming agents, antistatic agents, desiccant, moisturizing agents, surfactant, solubilizer, buffer agents, resolvents, solubilizing agents, solvents, diluents, stabilizers, emulsifying agents, suspension, suspending agents, dispersing agents, isotonizing agents, aerosol propellant, adsorbents, reducing agents, antioxidant, backing, wetting agents, wet modifier, filler, extender, adhesives, viscous agent, softeners, pH modifiers, antiseptics, preservatives, sweetening agents, corrigent, refrigerative agents, flavoring agents, perfume, fragrance, coloring matters, etc. Any of these additives may be used in the regular composing methods, and no limitation is imposed on such composition methods.
  • preparations can be manufactured in the usual manner, e.g. by adding preparation additives to the pharmacologically active substance.
  • compositions described in the present invention are explained by examples which follow. However, the present invention of the pharmaceutical compositions is not limited to these examples. Examples
  • the following ingredients were homogeneously mixed.
  • the resulted mixed particles were compressed with a mold to prepare tablets of 300 mg each.
  • the following ingredients were homogeneously mixed.
  • the resulted mixed particles were divided into portions of 600 mg to prepare powder compositions.
  • a layer and B layer were processed through a regular method to provide mixed particles, respectively, and the particles were compressed to form two layer tablet of 300 mg (A layer 60 mg, B layer 240 mg) each.
  • the following ingredients were dissolved in sterile purified water, added with sodium hydrate to adjust at pH 5, and diluted with sterile purified water to get a total volume of 20 L.
  • the resulted solution was transferred in portions of 50 mL into glass bottles to provide oral solutions.
  • Example 5 Sugarcoated tablet
  • the following ingredients were processed through a regular method to provide mixed particles, and the particle was compressed to form tablets of 240 mg each.
  • Epinastine hydrochloride 10 g Calcium hydrogen phosphate 250 g Dipotassium glycyrrhizinate 200 g Pyridoxine hydrochloride 50 g Riboflavin butyrate 12 g Lactose 640 g Corn starch 406 g Microcrystalline cellulose 306 g Low substituted hydroxypropylcellulose 130 g Hydroxypropylcellulo se 90 g Light anhydrous silicic acid 45 g Talc 12 g Magnesium stearate 9 g
  • the equal volume mixture of ethyl alcohol contained 5% weight/volume of hydroxypropylmethylcellulose and purified water to give increase in weight/volume by 10 mg per one tablet.
  • 2% weight/volume of talc, 2% weight/volume of titanium oxide, 3% weight/volume of calcium carbonate, 1% weight/volume of powdered acacia, and aqueous solution containing 60% weight/volume of purified sucrose were used to coat tablets to give increase in weight/volume by 150 mg per one tablet.
  • aqueous solution containing 60% weight/volume purified sucrose was used to coat tablets to give increase in weight/volume by 30 mg per one tablet.
  • sugarcoated tablets were prepared.
  • the following ingredients were processed through a regular method to form a cream of a total weight of 1 kg, added with sodium citrate to adjust at pH 5.
  • Epinastine hydrochloride 10.0 g Zinc undecylenate 30.0 g Glycyrrhetinic acid 10.0 g Pyridoxine hydrochloride 1.0 g Medium chain fatty acid triglyceride 200.0 g Propylene glycol 150.0 g Glyceryl monostearate 80.0 g Polyoxyethylene cetyl ether 40.0 g Diisopropyl adipate 50.0 g Citric acid 0.1 g Sodium citrate Adequate amount Antiseptics Adequate amount Purified water Adequate amount
  • the following ingredients were homogeneously mixed.
  • the resulted mixed particles were compressed with a mold to prepare tablets of 250 mg each.
  • Example 9 Powder The following ingredients were homogeneously mixed. The resulted mixed particles were divided into portions of 800 mg to prepare powder compositions.
  • the following ingredients were prepared as granules through a regular method to prepare mixed particles, and packed to give an amount of 1500 mg per one pack for granules.
  • the following ingredients were processed through a regular method to provide. mixed particles, and the particle was compressed to form tablets of 200 mg each.
  • the tablets were transferred into a coating pan, and coated using coating solution.
  • the equal volume mixture of ethyl alcohol contained 5% weight/volume of ) hydroxypropylmethylcellulose and purified water to give increase in weight/volume by 10 mg per one tablet.
  • film-coated tablets were prepared.
  • the following ingredients were dissolved in sterile purified water, added with sodium hydrate to adjust at pH 5, and diluted with sterile purified water to get a total volume of 20 L.
  • the resulted solution was transferred in portions of 50 mL into glass bottles to provide oral solutions.
  • the following ingredients were processed through a regular method to form an ointment of a total weight of 1 kg.

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Abstract

L'invention concerne des compositions pharmaceutiques destinées au traitement des maladies de la peau. En particulier, ces compositions sont hautement efficaces pour le traitement des maladies de la peau associées à des réactions allergiques parmi divers symptômes dérivés des maladies de la peau. Ces compositions contiennent une dose efficace sur le plan antihistaminique d'épinastine ou d'un sel pharmaceutiquement acceptables de cette dernière et d'un ou plusieurs minéraux supplémentaires pharmaceutiquement acceptables ou d'une ou plusieurs matières premières pharmaceutiquement acceptables. Ces compositions peuvent également contenir des additifs pharmaceutiquement acceptables.
EP05716230A 2004-03-24 2005-03-19 Compositions pharmaceutiques destinees au traitement de maladies de la peau contenant une combinaison d'epinastine et d'un ou plusieurs mineraux ou d'une ou plusieurs matieres premieres Withdrawn EP1735001A2 (fr)

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EP05716230A EP1735001A2 (fr) 2004-03-24 2005-03-19 Compositions pharmaceutiques destinees au traitement de maladies de la peau contenant une combinaison d'epinastine et d'un ou plusieurs mineraux ou d'une ou plusieurs matieres premieres

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EP04007080 2004-03-24
EP04007079 2004-03-24
EP05716230A EP1735001A2 (fr) 2004-03-24 2005-03-19 Compositions pharmaceutiques destinees au traitement de maladies de la peau contenant une combinaison d'epinastine et d'un ou plusieurs mineraux ou d'une ou plusieurs matieres premieres
PCT/EP2005/002947 WO2005089803A2 (fr) 2004-03-24 2005-03-19 Compositions pharmaceutiques destinees au traitement de maladies de la peau contenant une combinaison d'epinastine et d'un ou plusieurs mineraux ou d'une ou plusieurs matieres premieres

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JP5291324B2 (ja) * 2007-11-01 2013-09-18 沢井製薬株式会社 口腔内崩壊錠
JP6009791B2 (ja) * 2012-03-28 2016-10-19 ホーユー株式会社 Ｈｄｃ活性化阻害剤、ｈｄｃ活性化阻害剤組成物、鎮痒剤及び鎮痒剤組成物
RU2521247C2 (ru) * 2012-06-15 2014-06-27 Федеральное государственное бюджетное образовательное учреждение высшего профессионального образования "Белгородская государственная сельскохозяйственная академия имени В.Я. Горина" ПРЕПАРАТ ДЛЯ ЛЕЧЕНИЯ ПАЛЬЦЕВОГО ДЕРМАТИТА КРУПНОГО РОГАТОГО СКОТА (Dermatitis digitalis)
WO2014148136A1 (fr) * 2013-03-19 2014-09-25 岐阜市 Composé ayant une activité anti-allergique et son utilisation
CN103977243B (zh) * 2014-06-06 2018-01-23 青岛市中心医院 一种治疗尿毒症顽固性皮肤瘙痒的药物及其制备方法
CN104547157A (zh) * 2015-01-29 2015-04-29 陈文斌 修复剖腹产伤口疤痕的外敷剂及制备方法
JP7205074B2 (ja) * 2017-05-02 2023-01-17 大正製薬株式会社 固形組成物
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