TR201613875A1 - Ophthalmic composition suitable for the treatment of uveitis - Google Patents
Ophthalmic composition suitable for the treatment of uveitis Download PDFInfo
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- TR201613875A1 TR201613875A1 TR2016/13875A TR201613875A TR201613875A1 TR 201613875 A1 TR201613875 A1 TR 201613875A1 TR 2016/13875 A TR2016/13875 A TR 2016/13875A TR 201613875 A TR201613875 A TR 201613875A TR 201613875 A1 TR201613875 A1 TR 201613875A1
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- 239000000203 mixture Substances 0.000 title claims abstract description 54
- 206010046851 Uveitis Diseases 0.000 title claims abstract description 32
- 238000011282 treatment Methods 0.000 title claims abstract description 29
- 241000241413 Propolis Species 0.000 claims abstract description 23
- 229940069949 propolis Drugs 0.000 claims abstract description 23
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 34
- 239000002994 raw material Substances 0.000 claims description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 18
- 229920000858 Cyclodextrin Polymers 0.000 claims description 17
- 239000011780 sodium chloride Substances 0.000 claims description 17
- 239000000243 solution Substances 0.000 claims description 17
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 15
- 239000004327 boric acid Substances 0.000 claims description 15
- 235000010338 boric acid Nutrition 0.000 claims description 15
- -1 catasol Chemical compound 0.000 claims description 15
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 14
- 229910021538 borax Inorganic materials 0.000 claims description 13
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 13
- 235000010339 sodium tetraborate Nutrition 0.000 claims description 13
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 12
- 239000008367 deionised water Substances 0.000 claims description 12
- 229910021641 deionized water Inorganic materials 0.000 claims description 12
- 238000000034 method Methods 0.000 claims description 12
- 239000003755 preservative agent Substances 0.000 claims description 12
- 239000004328 sodium tetraborate Substances 0.000 claims description 12
- 239000002904 solvent Substances 0.000 claims description 12
- UQGFMSUEHSUPRD-UHFFFAOYSA-N disodium;3,7-dioxido-2,4,6,8,9-pentaoxa-1,3,5,7-tetraborabicyclo[3.3.1]nonane Chemical compound [Na+].[Na+].O1B([O-])OB2OB([O-])OB1O2 UQGFMSUEHSUPRD-UHFFFAOYSA-N 0.000 claims description 11
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 10
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- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 10
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 claims description 10
- 239000004698 Polyethylene Substances 0.000 claims description 8
- 239000003889 eye drop Substances 0.000 claims description 8
- 229920000573 polyethylene Polymers 0.000 claims description 8
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- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 6
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims description 6
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- GDSRMADSINPKSL-HSEONFRVSA-N gamma-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO GDSRMADSINPKSL-HSEONFRVSA-N 0.000 claims description 6
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- 239000011734 sodium Substances 0.000 claims description 6
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 5
- 229920001450 Alpha-Cyclodextrin Polymers 0.000 claims description 5
- 239000002253 acid Substances 0.000 claims description 5
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- 229920001223 polyethylene glycol Chemical class 0.000 claims description 5
- 230000002335 preservative effect Effects 0.000 claims description 5
- WRMNZCZEMHIOCP-UHFFFAOYSA-N 2-phenylethanol Chemical compound OCCC1=CC=CC=C1 WRMNZCZEMHIOCP-UHFFFAOYSA-N 0.000 claims description 4
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- VYGQUTWHTHXGQB-FFHKNEKCSA-N Retinol Palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C VYGQUTWHTHXGQB-FFHKNEKCSA-N 0.000 claims description 4
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 claims description 4
- 229960000686 benzalkonium chloride Drugs 0.000 claims description 4
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 4
- KWGKDLIKAYFUFQ-UHFFFAOYSA-M lithium chloride Chemical compound [Li+].[Cl-] KWGKDLIKAYFUFQ-UHFFFAOYSA-M 0.000 claims description 4
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- AQIXEPGDORPWBJ-UHFFFAOYSA-N pentan-3-ol Chemical compound CCC(O)CC AQIXEPGDORPWBJ-UHFFFAOYSA-N 0.000 claims description 4
- GHMLBKRAJCXXBS-UHFFFAOYSA-N resorcinol Chemical compound OC1=CC=CC(O)=C1 GHMLBKRAJCXXBS-UHFFFAOYSA-N 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- JHJLBTNAGRQEKS-UHFFFAOYSA-M sodium bromide Chemical compound [Na+].[Br-] JHJLBTNAGRQEKS-UHFFFAOYSA-M 0.000 claims description 4
- 230000001954 sterilising effect Effects 0.000 claims description 4
- 238000004659 sterilization and disinfection Methods 0.000 claims description 4
- JCIIKRHCWVHVFF-UHFFFAOYSA-N 1,2,4-thiadiazol-5-amine;hydrochloride Chemical compound Cl.NC1=NC=NS1 JCIIKRHCWVHVFF-UHFFFAOYSA-N 0.000 claims description 3
- 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 claims description 3
- 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 claims description 3
- 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 claims description 3
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 229910001508 alkali metal halide Inorganic materials 0.000 claims description 3
- 125000000217 alkyl group Chemical group 0.000 claims description 3
- 239000004359 castor oil Substances 0.000 claims description 3
- 235000019438 castor oil Nutrition 0.000 claims description 3
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 3
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- 229910052708 sodium Inorganic materials 0.000 claims description 3
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- YKLJGMBLPUQQOI-UHFFFAOYSA-M sodium;oxidooxy(oxo)borane Chemical compound [Na+].[O-]OB=O YKLJGMBLPUQQOI-UHFFFAOYSA-M 0.000 claims description 3
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- MDYZKJNTKZIUSK-UHFFFAOYSA-N tyloxapol Chemical class O=C.C1CO1.CC(C)(C)CC(C)(C)C1=CC=C(O)C=C1 MDYZKJNTKZIUSK-UHFFFAOYSA-N 0.000 claims description 3
- 229960004224 tyloxapol Drugs 0.000 claims description 3
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 claims description 2
- ZILVNHNSYBNLSZ-UHFFFAOYSA-N 2-(diaminomethylideneamino)guanidine Chemical compound NC(N)=NNC(N)=N ZILVNHNSYBNLSZ-UHFFFAOYSA-N 0.000 claims description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 2
- 101100248253 Arabidopsis thaliana RH40 gene Proteins 0.000 claims description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 2
- GHXZTYHSJHQHIJ-UHFFFAOYSA-N Chlorhexidine Chemical compound C=1C=C(Cl)C=CC=1NC(N)=NC(N)=NCCCCCCN=C(N)N=C(N)NC1=CC=C(Cl)C=C1 GHXZTYHSJHQHIJ-UHFFFAOYSA-N 0.000 claims description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 2
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims description 2
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- FPIPGXGPPPQFEQ-BOOMUCAASA-N Vitamin A Natural products OC/C=C(/C)\C=C\C=C(\C)/C=C/C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-BOOMUCAASA-N 0.000 claims description 2
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- 150000001298 alcohols Chemical class 0.000 claims description 2
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- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 claims description 2
- 235000001014 amino acid Nutrition 0.000 claims description 2
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- 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 claims description 2
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- 125000000484 butyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 2
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- SIYLLGKDQZGJHK-UHFFFAOYSA-N dimethyl-(phenylmethyl)-[2-[2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethoxy]ethyl]ammonium Chemical compound C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 SIYLLGKDQZGJHK-UHFFFAOYSA-N 0.000 claims description 2
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Abstract
Buluş, göz hastalıklarının tedavisinde kullanılan ilaçlar ile ilgilidir. Buluş, özellikle kronik göz hastalıklarından üveit hastalığının tedavisi için kullanıma uygun, Propolis içeren oftalmik kompozisyon ile ilgilidir.The invention relates to medicaments for use in the treatment of eye diseases. In particular, the invention relates to an ophthalmic composition comprising Propolis, suitable for use in the treatment of uveitis from chronic eye diseases.
Description
TARIFNAME Uveit hastaliginin tedavisinde kullanima uygun oftalmik kompozisyon Teknik Alan Bulus, göz hastaliklarinin tedavisinde kullanilan ilaçlar ile ilgilidir. Bulus, özellikle kronik göz hastaliklarindan üveit hastaliginin tedavisi için kullanima uygun, Propolis içeren oftalmik kompozisyon ile ilgilidir. DESCRIPTION Ophthalmic composition suitable for use in the treatment of uveitis disease Technical Area The invention relates to drugs used in the treatment of eye diseases. The invention is particularly Propolis, suitable for the treatment of uveitis, one of the chronic eye diseases. It relates to the ophthalmic composition containing
Teknigin Bilinen Durumu Uveit, gözün üvea adini verdigimiz iris, koroid ve silier cisimden olusan tabakalarinin bir grup enflamatuar hastaligidir. State of the Art Uveitis is the formation of layers of the eye consisting of the iris, choroid and ciliary body, which we call the uvea. It is a group of inflammatory diseases.
Göz; ortalama 2,5 cm çapinda küre seklindedir. En dista, beyaz sklera tabakasinin tam ortasinda, saat cami seklinde kornea tabakasi bulunmaktadir. Kontakt Iensin yerlestigi kismi olusturan kornea, gözün en öndeki bombeli damarsiz tabakasidir. Eyelash; It is spherical with an average diameter of 2.5 cm. Distal, white sclera layer In the middle of it, there is a corneal layer in the form of a clock glass. Contact Iensin The cornea, which forms the part where it is located, is the frontmost convex veinless layer of the eye.
Göz Kapaklari, gözü dis ortamdan koruyan kisimdir. Kapaklarin yapisindaki kaslar kirpma refleksi ile kapagin periyodik hareketini saglar. Iris, göze rengini veren damarsal tabakadir. Yapisindaki kaslarla kasilip gevsemesi ortasinda bosluk olan göz bebeginin büyüyüp küçülmesini saglar. Lens (mercek), irisin arkasinda 5 mm kalinliginda 9 mm çapinda seffaf damarsiz yapidir. Korneadan sonra göze giren isik isinlarini kiran ikinci tabakadir. Vitreus, Iensin gerisindeki bütün göz boslugunu dolduran jel gibi bir maddedir. Retina, gözün iç duvarini kaplayan sinir tabakasidir. The Eyelids are the part that protects the eye from the external environment. Muscles in the structure of the lids It provides periodic movement of the lid with the blink reflex. The iris is what gives the eye its color. is the vascular layer. with a space in the middle of the contraction and relaxation with the muscles in its structure It makes the pupil of the eye enlarge and shrink. Lens (lens), 5 mm behind the iris It is a transparent veinless structure with a diameter of 9 mm in thickness. Light entering the eye after the cornea It is the second layer that rents its rays. The vitreous covers the entire eye space behind the Iens. It is a gel-like substance that fills it. The retina is the nerve layer that covers the inner wall of the eye.
Göze giren isik isinlarinin bu tabakada odaklasmasiyla olusan görüntüyü elektriksel sinyallere çevirip göz sinirine iletir. The image formed by the focusing of the light rays entering the eye in this layer is electrically converts them into signals and transmits them to the optic nerve.
Göz yuvarlaginin ortasinda bulunan jel benzeri maddenin çevresini 3 tabakadan olusan bir kilif sarmaktadir. En dista sklera adi verilen beyaz kisim, en içte retina adi verilen ve görmemizi saglayan kisim, ortada da uvea bulunmaktadir. Orta tabakayi teskil eden uvea 3 bölümden olusmaktadir. -önde gözün rengini veren iris, -ortada silier (corpus ciliare), -geride ise gözün büyük bölümünün beslenmesini saglayan koroid (koroidea). It surrounds the gel-like substance in the middle of the eyeball with 3 layers. It is wrapped in a sheath. The outermost is the white part called the sclera, the innermost is called the retina. The part that is given to us and allows us to see is the uvea in the middle. middle layer The uvea is composed of 3 parts. -the iris, which gives the color of the eye, -middle ciliary (corpus ciliare), - in the back is the choroid (choroidea), which provides nutrition for most of the eye.
Uveanin iltihabina üveit denir. Uvea gözü besleyen damarlari bulundurur. Bu yapilarin iltihabi gözün tüm dokularini etkiler. Bu durum görmeyi ciddi sekilde tehdit eden durumlara neden olabilir. Uveit, gözün uvea adini verdigimiz iris, koroid ve kirpiksi cisimden olusan tabakalarinin hepsini veya birini etkileyebilir. Uvea ile ilgili hastaliklarin tani ve tedavisi, immunoloji (bagisiklik bilimi) ve genetik dallarindaki giderek artan gelismelerle desteklenmektedir. Inflammation of the uvea is called uveitis. The uvea contains the vessels that feed the eye. This Inflammation of the structures affects all tissues of the eye. This situation seriously threatens to see conditions may result. Uveitis is the iris, choroid and uvea of the eye, which we call the uvea. It can affect all or one of the layers consisting of the ciliary body. pertaining to the uvea diagnosis and treatment of diseases, immunology (immunology) and genetics supported by ever-increasing developments.
Uveit hastalarinin %30-40'inda üveitin nedeni tam olarak tespit edilememektedir. In 30-40% of uveitis patients, the cause of uveitis cannot be determined exactly.
Uveitler virüsler, mantarlar ve parazitler gibi etkenlerle olusabilecegi gibi, vücuttaki bir hastaligin gözdeki belirtisi olarak da ortaya çikabilir. Bu yüzden çesitli tahlillerle hastaliklari arastirmak gerekir. Ayrica kollajen doku ve otoimmün kaynakli olarak tanimladigimiz sistemik hastaliklar esliginde de üveit olusabilmektedir. Bunlara örnek olarak Behçet hastaligi, ankilozan spondilit ve romatoid artrit verilebilir. Uveitis can be caused by factors such as viruses, fungi and parasites, as well as a disease in the body. It can also occur as a symptom of the disease in the eye. Therefore, with various analyzes diseases should be investigated. In addition, collagen tissue and autoimmune origin Uveitis can also occur in the presence of systemic diseases we have defined. Examples of these Behçet's disease, ankylosing spondylitis and rheumatoid arthritis can be given as an alternative.
Uveit hastaliginin ile belirtileri asagida belirtildigi sekildedir. lsiga karsi hassasiyet, - Bulanik görme, . Gözde kizariklik, . Göz küresinde veya çevresinde siddetli agri, - Gözde uçusmalar, . Göz yasarmasi Günümüzde, üveit hastalarinin tedavisinde kortizonlu ilaç kullanilmaktadir. Bu ilacin yan etkileri oldukça fazladir. Kronik bir göz hastaligi olan üveit tedavisi için tamamen dogal ve bitkisel, antiinflamatuvar bir ilaca ihtiyaç duyulmaktadir. The symptoms of uveitis disease are as follows. sensitivity to smoke, - Blurred vision, . eye redness, . Severe pain in or around the eyeball - Favorite flights, . tearing eyes Today, cortisone medication is used in the treatment of uveitis patients. this medicine side effects are very high. For the treatment of uveitis, a chronic eye disease, completely A natural and herbal anti-inflammatory drug is needed.
Konu ile ilgili mevcut teknikte bilinen gelismeler asagida verilmektedir. The known developments in the current art related to the subject are given below.
EP174473681 yayin numarali patent basvurusu, “Göz kurulugu rahatsizliklarinin ve üveitin tedavisine ait usul” ile ilgilidir. Söz konusu basvuruda, göz kurulugu ve üveitin tedavisi için 5,6,7-trihidroksiheptanoik asit ve analoglarinin topikal kullanimi açiklanmaktadir. The patent application with the publication number EP174473681 states that “Dry eye disorders and relates to the method of treatment of uveitis. In the application in question, dry eye and uveitis Topical use of 5,6,7-trihydroxyheptanoic acid and its analogues for the treatment of is explained.
EP229504981 yayin numarali patent basvurusu, “Otoimmün hastaliklarin tedavisi" ile ilgilidir. Söz konusu basvuruda, myotrofik lateral skleroz ve üveit gibi belirli otoimmün hastaliklarin tedavisi için kullanilmak üzere bir amino alkol ve bunun fosfat türevleri açiklanmaktadir. Patent application with publication number EP229504981, "Treatment of autoimmune diseases" is relevant. Certain autoimmune conditions such as myotrophic lateral sclerosis and uveitis an amino alcohol and its phosphate derivatives for use in the treatment of diseases is explained.
TR 2013 06916 yayin numarali patent basvurusu, “Oftalmik farmasotik bilesimler” ile ilgilidir. Söz konusu basvuruda, süperfisyal bakteriyel infeksiyon veya bakteriyel oküler infeksiyon riski bulunan inflamatuar oküler vakalarin (örnegin palpebral ve bulber konjonktivada, kornea ve kürenin on segmentinde g'orülen inflamatuar durumlar, kronik anterior üveit ve kimyasal, radyasyon ya da termal yanmalardan kaynaklanan korneal yaralanma veya yabanci cisimlerin penetrasyonu) semptomatik ve/veya terapötik tedavisinde, inflamasyon tedavisi ve katarakt ameliyati sonrasinda infeksiyon profilaksisinde kullanilmak üzere, antibiyotik özellikteki etken maddenin ve/veya farmasotik olarak kabul edilebilir türevlerinin, kortikosteroid sinifinda yer alan etken madde vei'veya farmasotik olarak kabul edilebilir türevleri ile kombine tedavisini içeren farmasötik bilesimler açiklanmaktadir. Patent application with publication number TR 2013 06916, “Ophthalmic pharmaceutical compositions” is relevant. In the application in question, superficial bacterial infection or bacterial Inflammatory ocular cases (for example, palpebral and inflammatory inflammatory disease seen in the bulbar conjunctiva, cornea and anterior segment of the globe conditions, chronic anterior uveitis and chemical, radiation, or thermal burns. due to corneal injury or penetration of foreign bodies) symptomatic and/or therapeutic treatment, inflammation treatment and after cataract surgery of the active substance with antibiotic properties to be used in the prophylaxis of infection. and/or pharmaceutically acceptable derivatives of corticosteroids combined therapy with the active ingredient and its pharmaceutically acceptable derivatives Pharmaceutical compositions containing
Sonuç olarak yukarida anlatilan olumsuzluklardan dolayi ve mevcut çözümlerin konu hakkindaki yetersizligi nedeniyle ilgili teknik alanda bir gelistirme yapilmasi gerekli kilinmistir. As a result, due to the above-mentioned negativities and existing solutions It is necessary to make an improvement in the relevant technical field due to the inadequacy of the is locked.
Bulusun Kisa Açiklamasi Mevcut bulus, yukarida bahsedilen gereksinimleri karsilayan, tüm dezavantajlari ortadan kaldiran ve ilave bazi avantajlar getiren üveit hastaliginin tedavisinde kullanima uygun oftalmik kompozisyon ile ilgilidir. Brief Description of the Invention The present invention fulfills the above-mentioned requirements, has all the disadvantages in the treatment of uveitis, which eliminates the problem and brings some additional advantages. relates to the ophthalmic composition suitable for use.
Bulusun öncelikli amaci, üveit hastaliginin tedavisinde kullanilmak üzere, yan etkileri fazla olmayan bir ilaç elde edilmesini saglamaktir. The primary aim of the invention is to analyze the side effects of the disease for use in the treatment of uveitis. is to obtain a drug that is not too much.
Bulus, üveit hastaliginin tedavisinde kullanilmak üzere, dogal kaynakli yeni bir antiinflamatuvar ilaç gelistirilmesini amaçlamaktadir. The invention is a new, naturally derived product for use in the treatment of uveitis. It aims to develop anti-inflammatory drugs.
Bulusun bir amaci, üveit hastaliginin tedavisinde kortizonlu ilaç kullanilmasini ve üveit hastaligina sahip kisinin kortizonlu ilaçlarin yan etkilerinden etkilenmesini engellemektir. One aim of the invention is to use cortisone drugs in the treatment of uveitis and The person with uveitis is affected by the side effects of cortisone drugs. is to prevent.
Bulus ayrica, üveit hastaligi tedavisi için tamamen dogal ve bitkisel bir ilaç gelistirilmesini saglamayi amaçlamaktadir. The invention is also a completely natural and herbal medicine for the treatment of uveitis. aims to promote its development.
Bulusun bir diger amaci, üveit hastaliginin tedavisinde kullanilmak üzere, uygulanmasi kolay, kortizon gibi yan etkilere sahip olmayan, propolis içerikli dogal bir ilaç elde edilmesini saglamaktir. Another object of the invention is to be used in the treatment of uveitis disease. It is a natural propolis-containing product that is easy to apply, does not have side effects such as cortisone. to obtain medicine.
Bulusun diger bir amaci, üveit hastaliginin tedavisinde kullanilmak üzere alternatif bir göz damlasi (oftalmik damla) gelistirilmesini saglamaktir. Another object of the invention is to provide an alternative solution for use in the treatment of uveitis. to develop eye drops (ophthalmic drops).
Bulus, yukarida anlatilan amaçlarin yerine getirilmesi için, üveit hastaliginin tedavisinde kullanilmak üzere propolis içeren bir oftalmik kompozisyondan meydana gelmektedir. In order to fulfill the above-described purposes, the invention is aimed at treating uveitis. consists of an ophthalmic composition containing propolis for use in the treatment of is coming.
Bulusun amaçlarini gerçeklestirmek üzere, bahsedilen kompozisyon ayrica deiyonize su, koruyucu madde, tampon ajani, tonisite ajani, çözücü madde içermektedir. To achieve the objectives of the invention, said composition is also deionized. It contains water, preservative, buffering agent, tonicity agent, solvent.
Bahsedilen kompozisyon; agirlikça % 93 deiyonize su, agirlikça %12 koruyucu madde ve tampon ajani, agirlikça %0,8 tonisite ajani, agirlikça %4,5 çözücü madde ve agirlikça %0,5 propolis ihtiva etmektedir. The said composition; 93% by weight deionized water, 12% by weight preservative agent and buffering agent, 0.8% by weight tonicity agent, 4.5% by weight solvent and 0.5% by weight of propolis.
Bulusun alternatif bir yapilanmasinda, bahsedilen kompozisyon; Borik asit, Sodyum tetraborat, Sodyum klorür, Sodyum edta, Polietilen glikoI-40, P0lisorbat-20, Deiyonize su içermektedir. Bahsedilen kompozisyon; agirlikça % 1,0 Borik asit, agirlikça %02 Sodyum tetraborat, agirlikça %0,3 Sodyum klorür, agirlikça % 0,5 Sodyum edta, agirlikça °/o'l,5 Polietilen glikol-40, agirlikça % 3,0 Polisorbat-20, agirlikça %93 Deiyonize su ve agirlikça %O,5 propolis ihtiva etmektedir. Söz konusu alternatif oftalmik kompozisyonun elde edilme yöntemi olup, - Propolis hammaddesinin, Polietilen glikol-4O ve Polisorbat-20 hammaddeleri içinde çözülerek bir çözelti elde edilmesi, - Borik asit, sodyum tetraborat, sodyum klorür, sodyum edta hammaddelerinin deiyonize su içinde çözülmesi ile bir çözelti elde edilmesi, - Elde edilen çözeltilerin birbiri ile karistirilmasi, - pH degerinin ayarlanmasi, - homojenizasyon ve sterilizasyon islem adimlarini içermektedir. In an alternative embodiment of the invention, said composition; Boric acid, Sodium tetraborate, Sodium chloride, Sodium edta, Polyethylene glycol-40, P0lysorbate-20, Deionized contains water. The said composition; 1.0% by weight Boric acid, 02% by weight Sodium tetraborate, 0.3% by weight Sodium chloride, 0.5% by weight Sodium edta, °/0.5 wt% Polyethylene glycol-40, 3.0 wt% Polysorbate-20, 93% wt It contains deionized water and 0.5% propolis by weight. The alternative in question is the method of obtaining the ophthalmic composition, - Propolis raw materials, Polyethylene glycol-4O and Polysorbate-20 raw materials obtaining a solution by dissolving in - Boric acid, sodium tetraborate, sodium chloride, sodium edta raw materials Obtaining a solution by dissolving in deionized water, - Mixing the obtained solutions with each other, - Adjusting the pH value, - includes homogenization and sterilization process steps.
Bulusun amaçlarini gerçeklestirmek üzere bahsedilen kompozisyon tercihen göz damlasi formundadir. In order to achieve the objectives of the invention, said composition is preferably in droplet form.
Bulusun Detayli Açiklamasi Bu detayli açiklamada, bulus konusu üveit hastaliginin tedavisinde kullanima uygun oftalmik kompozisyon ve tercih edilen yapilanmalari, sadece konunun daha iyi anlasilmasina yönelik olarak ve hiçbir sinirlayici etki olusturmayacak sekilde açiklanmaktadir. Detailed Description of the Invention In this detailed description, the subject of the invention is suitable for use in the treatment of uveitis. ophthalmic composition and preferred configurations only for understanding and without any limiting effect is explained.
Bulus, üveit hastaliginin tedavisinde kullanilmak üzere propolis içeren bir kompozisyon ile ilgilidir. Söz konusu kompozisyon, tercihen oftalmik bir göz damlasi formunda olup, propolis ile birlikte koruyucu madde, tampon ajani, tonisite ajani, çözücü madde, deiyonize su içermesi mümkündür. Asagida Tablo 1'de bulus konusu oftalmik kompozisyonun elde edilmesinde kullanilan hammaddeler ve kullanim oranlari verilmektedir. The invention is a product containing propolis for use in the treatment of uveitis. It's about composition. Said composition is preferably an ophthalmic eye drop. It is in the form of propolis, as a preservative, buffering agent, tonicity agent, It is possible that the solvent contains deionized water. Subject of the invention in Table 1 below raw materials and use in obtaining the ophthalmic composition rates are given.
Tablo 1: Oftalmik kompozisyonun elde etmek için kullanilan hammaddeler ve kullanim oranlari Agirlikça Tercih Agirlikça Kullanilabilir Hammadde edilen miktar (%) miktar (%) Propolis 0,5 0,001-50 Koruyucu madde ve . 1,2 0,01-99,9 tampon ajani Tonisite ajani 0,8 0,01 -99,9 Çözücü madde 4,5 0,01-99,9 Deiyonize su 93 0,001-99,9 Asagida Tablo 2'de, bulusun alternatif bir yapilanmasini olusturan oftalmik g'oz damlasina ait 'Örnek bir formülasyon ve bu formülasyonu olusturan hammaddeler ile kullanim oranlari verilmektedir. Table 1: Raw materials used to obtain the ophthalmic composition and usage rates Preference by weight Can be used by weight Raw material amount (%) amount (%) Propolis 0.5 0.001-50 preservative and . 1.2 0.01-99.9 buffer agent Tonicity agent 0.8 0.01 -99.9 Solvent 4.5 0.01-99.9 Deionized water 93 0.001-99.9 In Table 2 below, the ophthalmic eye, which constitutes an alternative embodiment of the invention, with an exemplary formulation and the raw materials that make up this formulation. usage rates.
Tablo 2: Ornek formülasyon Hammadde Agirlikça Tercih Agirlikça Kullanilabilir edilen miktar (%) miktar (%) Propolis 0,5 0,001-50 Borik asit 1 0,01-99,9 Sodyum tetraborat 0,2 0,01-99,9 Sodyum klorür 0,3 0,01-99,9 Sodyum edta 0,5 0,01-99,9 Deiyonize su 93 0,01-99,9 Propolis, tamamen dogal antibiyotik olma özelligine sahip bir an ürünüdür. Table 2: Example formulation Raw Material Weight Can Be Used According To Preference amount removed (%) amount (%) Propolis 0.5 0.001-50 Boric acid 1 0.01-99.9 Sodium tetraborate 0.2 0.01-99.9 Sodium chloride 0.3 0.01-99.9 Sodium edta 0.5 0.01-99.9 Deionized water 93 0.01-99.9 Propolis is an instant product that has the feature of being a completely natural antibiotic.
Bayanlarda kemik erimelerinde, eklem romatizmalarinda, iltihapli rahatsizliklarda, yara, kesik ve bazi cilt hastaliklarinda, mide, bagirsak yaralari tedavisinde, üst solunum yolu rahatsizliklarinda, astim, bronsit, orta kulak iltihaplarinda, kötü agiz kokularinda, anti kanser içerigiyle kanser tedavilerinde kullanilmaktadir. In women, osteoporosis, joint rheumatism, inflammatory disorders, wounds, cuts and some skin diseases, stomach, intestinal wounds, upper respiratory tract disorders, asthma, bronchitis, middle ear infections, bad mouth It is used in its fragrances and in cancer treatments with its anti-cancer content.
Propolis ekstrakti topikal formda rejenerasyon sürecini hizlandirmak ve antimikrobiyal, antiinflamatuvar etkisinden yararlanmak için çesitli konjuktivitlerde, korneanin bakteriyel enfeksiyonlarinda, herpetik keratitte, epidemik keratokonjiktivitte, kornea ülserinde, kimyasal ve termal yaniklarda damla veya krem seklinde kullanilmis ve basarili sonuçlar elde edilmistir. Propolis extract in topical form to accelerate the regeneration process and in various conjunctivitis to benefit from its antimicrobial, anti-inflammatory effect, bacterial infections of the cornea, herpetic keratitis, epidemic Drops or cream for keratoconjunctivitis, corneal ulcer, chemical and thermal burns used and successful results were obtained.
Propolisin % 0.3-1.0'Iik ak'oz solüsyonunun korneanin kimyasal ve termik yaniklarinda ve herpetik keratitte daha etkili oldugu bildirilmistir. Propolisin % 1.0'Iik etanolik solüsyonunun ise topikal olarak damlatildiginda, göz içi basincini 4-5 mmHg düsürdügü ve diger antiglokom ilaçlarda mevcut olan yan etkileri göstermedigi tespit edilmistir. Corneanin chemical and thermal effects of 0.3-1.0% aqueous solution of propolis It has been reported to be more effective in burns and herpetic keratitis. 1.0% of propolis When the ethanolic solution is dripped topically, the intraocular pressure is reduced to 4-5 mmHg. It has been determined that it reduces the effects of antiglaucoma and does not show the side effects that are present in other antiglaucoma drugs. has been made.
Bulus kapsaminda, propolisin üveit hastaligi tedavisinde etkinligi tespit edilmis ve Propolis kullanilarak dogal kaynakli yeni bir antiinflamatuvar ilaç elde edilmesi saglanmistir. Bulus konusu oftalmik damla, kronik bir göz hastaligi olan üveit tedavisi için gelistirilmis tamamen dogal ve bitkisel bir üründür. Uygulanmasi kolay ve üveit hastaligi için kullanilan kortizon gibi yan etkileri yoktur. Within the scope of the invention, the efficacy of propolis in the treatment of uveitis was determined and Obtaining a new anti-inflammatory drug of natural origin using propolis has been provided. The subject of the invention is ophthalmic drops for the treatment of uveitis, a chronic eye disease. It is a completely natural and herbal product developed for Easy to apply and uveitis It does not have side effects such as cortisone used for the disease.
Borik asit (H3B03) : Suda çözünen, tatsiz, kokusuz, havada kararli ve beyaz kristaller seklinde inorganik bir maddedir. Antiviral ve antiseptik etkisi vardir. 8qu çözeltileri göz damlalarinda, gargaralarda, kozmetiklerde ve cilt Iosyonlarinda kullanilir. Kozmetik ve ilaçlarda borik asit; pH tamponu, emülsifiye edici ve orta derecede antiseptik olarak kullanilir. Boric acid (H3B03): Water soluble, tasteless, odorless, stable in air and white It is an inorganic substance in the form of crystals. It has antiviral and antiseptic effects. 8qu solutions in eye drops, mouthwashes, cosmetics and skin lotions. used. Boric acid in cosmetics and medicines; pH buffer, emulsifier and medium used as an antiseptic.
Sodyum tetraborat (Boraks) (Na2B407.10H20): Suda çözünebilen dogal bir borik asit tuzudur. Antiseptik özellige sahiptir. Bu sebeple sulu çözeltileri gargaralarda, göz damlalarinda, çesitli kozmetik ürünlerde, cilt Iosyonlarinda kullanilmaktadir. pH tamponu olarak kullanilmaktadir. Sodium tetraborate (Borax) (Na2B407.10H20): A natural water-soluble boric acid salt. It has antiseptic properties. For this reason, its aqueous solutions are used in mouthwashes, eye It is used in drops, various cosmetic products, skin lotions. pH used as a buffer.
Sodyum Klorür (NaCI) : Ozellikle göz ve burun, damla ve spreylerinde izotonik ortam olusturmak için kullanilmaktadir. Tonisite ayarlayici olarak kullanilmaktadir. Sodium Chloride (NaCl): Isotonic, especially in eye and nose drops and sprays used to create the environment. It is used as a tonicity adjuster.
Sodyum EDTA (Etilendiamintetraasetikasit sodyum tuzu) (C10H15N203): Suda çözünebilen ve sudan gelen bazi iyonlarin (özellikle Ca2+) tutulmasini saglayan bir kimyasaldir. Tonisite ayarlayici olarak kullanilmaktadir. Sodium EDTA (Ethylenediaminetetraacetic acid sodium salt) (C10H15N203): In water It is a soluble substance that retains some ions (especially Ca2+) from water. is chemical. It is used as a tonicity adjuster.
PEG 40 (Polietilen glikoI-40) : Hidrojene edilmis hint yagidir. Çözücü ajan olarak kullanilmistir. PEG 40 (Polyethylene glycol-40): It is hydrogenated castor oil. As a solvent used.
Tween 20 (Polisorbat-ZO) (C53H11402s) : Çözücü ajan olarak kullanilmaktadir. Tween 20 (Polysorbate-ZO) (C53H11402s) : It is used as a solvent agent.
Bulus konusu oftalmik damlanin örnek formülasyonuna (Tablo 2) ait üretim yöntemi, genel olarak, o Propolisin, Peg 40 ve Tween 20 hammaddesi içinde çözülmesi ile bir çözelti elde edilmesi, . Borik asit, sodyum tetraborat, sodyum klorür, sodyum edta hammaddelerinin su içinde çözülmesi ile bir çözelti elde edilmesi, . Elde edilen çözeltilerin birbiri ile karistirilmasi, o pH degerinin ayarlanmasi, o homojenizasyon ve sterilizasyon islem adimlarindan olusmaktadir. Production method of the sample formulation (Table 2) of the ophthalmic drop subject of the invention, generally, o A solution by dissolving propolis in Peg 40 and Tween 20 raw material obtaining, . Boric acid, sodium tetraborate, sodium chloride, sodium edta raw materials Obtaining a solution by dissolving it in water, . Mixing the obtained solutions with each other, o Adjusting the pH value, It consists of homogenization and sterilization process steps.
Tween 20 (Polisorbat-20) hammaddesi içinde çözülerek bir “A” çözeltisi elde edilmektedir. 1.1 gram borik asit, 0.199ram sodyum tetraborat, 0.22 gram sodyum klorür ve hammaddeleri, 40-50 0Cide 75 ml deiyonize su içinde çözülerek bir “B” çözeltisi elde edilmektedir. Elde edilen “A” ve ayarlanmaktadir. Elde edilen karisim, son olarak homojenizasyon ve sterilizasyonun saglanmasi için 0,22 um filtreden süzülmekte ve otoklavlanmaktadir. Otoklavlama sonrasi dolum islemi gerçeklestirilmektedir. Tween 20 (Polysorbate-20) is dissolved in the raw material and an “A” solution is obtained. is being done. 1.1 grams of boric acid, 0.199ram sodium tetraborate, 0.22 grams of sodium chloride and its raw materials, at 40-50 0C, 75 A solution “B” is obtained by dissolving it in ml of deionized water. The resulting "A" and is being set. The resulting mixture is finally homogenized and sterilized. It is filtered through a 0.22 µm filter and autoclaved to ensure Autoclaving After the filling process is carried out.
Uretim sirasinda sicaklik 50 0C üzerine çikmamalidir. Yapilan formülasyonun sterilizasyona tabii tutularak dolumu yapilmalidir. During production, the temperature should not exceed 50 0C. The formulation made It should be filled by subjecting it to sterilization.
Bulus konusu göz damlasi, her iki göze uygun miktarda damlatilmak sureti ile kullanilir. Herhangi bir zararli etkisi ya da yan etkisi söz konusu degildir. The eye drops subject to the invention are administered by instilling an appropriate amount into both eyes. used. There are no harmful effects or side effects.
Bulus konusu göz damlasi için viskozite ayarlayici ajan olarak; Polivinilalkol, polivinil prolidon, metilselüloz, hidroksipropilmetil selüloz, hidroksietil selüloz, karboksimetil selüloz veya hidroksipropil selüloz, veya hipromelloz, dekstran, jelatin, polioller; gliserin, polietilen glikol 300, polietilenglikol 400, polisorbat 80, propilenglikol, povidon, hyaluronik asit ve kondroidin sülfatin kullanilmasi mümkündür. Bu ajanlarin tümü agirlikça % 0,01-10 oraninda eklenebilir. As a viscosity adjusting agent for the eye drops of the invention; Polyvinyl alcohol, polyvinyl prolidon, methylcellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose or hydroxypropyl cellulose, or hypromellose, dextran, gelatin, polyols; glycerin, polyethylene glycol 300, polyethyleneglycol 400, polysorbate 80, propylene glycol, It is possible to use povidone, hyaluronic acid and chondroidin sulfate. These agents all can be added at the rate of 0.01-10% by weight.
Ayrica, söz konusu göz damlasi limitsiz oranda bazi antioksidanlari içerebilir. Bunlar, askorbik asit ve esterleri, sodyum bisülfit, butillenmis hidroksitoluen, butillenmis hidroksianisol, tokoferol ve kombinasyonlaridir. Bazi antioksidanlar mevcut bazi buluslarda agirlikça %0,005-0,5 oraninda vardir. In addition, the said eye drops may contain some antioxidants in an unlimited amount. These, ascorbic acid and its esters, sodium bisulfite, butylated hydroxytoluene, butylated hydroxyanisole, tocopherol and combinations. Some antioxidants are present it is present at a rate of 0.005-0.5% by weight in the inventions.
Bulus konusu goz damlasi, uygun poliolleri içerebilir. Bunlar, gliserin, etilen glikol, propilen glikol, sorbitol, mannitol, ksilitol, monosakkaritler, disakkaritler, trisakkaritler ve kombinasyonlaridir. Seçilmis bir Poliol ile monosakkaritler, disakkaritler ve trisakkaritler kombine olarak bulunabilir. The eye drops of the invention may contain suitable polyols. These are glycerin, ethylene glycol, propylene glycol, sorbitol, mannitol, xylitol, monosaccharides, disaccharides, trisaccharides and combinations. Monosaccharides, disaccharides and Trisaccharides can be found in combination.
Formülasyon ayrica, farmasötik uygunluktaki çesitli asit tuzlarini, tampon ya da koruyucu ajan olarak içerebilir. Belirtilen asitlerin tuzlari; hidroklorik, hidrobromik, sülfirik, nitrik, fosforik, maleik, asetik, salisilik, sitrik, borik, formik, malonik, süksinik asitlerin sodyum, kalsiyum ya da potasyum tuzlaridir. Ornegin; tampon ajani olarak, fosfat, sitrat, asetat e 2-(N-morfilino) etan sülfonik asit (MES) bulundurabilir. pH ayarlamak için tampon kullanilir ancak uygun pH fizyolojik pH dir. Mevcut potasyum sitrat, sitrik asit, sodyum bikarbonat, TRIS ve fosfat tamponlarin degisik kombinasyonlari (Na.sub.2HPO.sub4, NaH.sub.2PO.sub.4 ve KH.sub.2PO.sub.4) ve karisimlari gibi uygun tamponlar eklenebilir. Genellikle borat tampon olarak tercih edilir. Tamponlar agirlikça %0,05-2,5; % O,1-1,5 oraninda formülasyona eklenebilir. The formulation may also contain various pharmaceutically acceptable acid salts, buffer or may contain as a preservative. Salts of the specified acids; hydrochloric, hydrobromic, sulfuric, nitric, phosphoric, maleic, acetic, salicylic, citric, boric, formic, malonic, succinic are sodium, calcium or potassium salts of acids. For example; as a buffering agent, may contain phosphate, citrate, acetate and 2-(N-morphilino) ethane sulfonic acid (MES). Buffer is used to adjust pH, but the appropriate pH is physiological pH. Available potassium citrate, citric acid, sodium bicarbonate, TRIS and phosphate buffers combinations (Na.sub.2HPO.sub4, NaH.sub.2PO.sub.4 and KH.sub.2PO.sub.4) and Appropriate buffers such as mixtures may be added. Generally preferred as borate buffer. is done. Buffers 0.05-2.5% by weight; It can be added to the formulation at a rate of 0,1-1,5%.
Koruyucu olarak bu tip formülasyonlara eklenen kuarternar amonyum bilesikleri örnegin benzalkonyum klor'ur kullanilabilir. Benzalkonyum klor`ur N-benzil-N- (C.sub.8-C.sub18 alkil)-N,N-dimetilamonyumklorür olarak tanimlanir. Ayrica koruyucu olarak, A vitamini, E vitamini, C vitamini, retinil palmitat ve selenyum; aminoasitlerden, sistein ve methionin; sitrik asit ve sodyum sitrat ve yapay koruyucular timerosal ve alkil parabenler (metil paraben ve propil paraben) gibi antioksidanlar da eklenebilir. Diger koruyucular, oktadesildimetilbenzil amonyum klor'ur, heksametonium klorür, benzetonium klor'ur, fenol, katesol, resorsinol, sikloheksanol, 3-pentanol, m-kresol, fenilmerkurik nitrat, fenilmerkurik asetat veya fenilmerkurik borat, sodyum perborat, sodyum klor'ür; alkoller, klorob'ütanol, bütil veya benzil alkol veya fenil etanol; guanidin türevleri, klorheksidin veya poliheksametilen biguanidin, sodyum perborat, polikuadRTM., Germal.RTM.ll, sorbik asit ve stabilize oksikloro komplekslerdir (purite.RTM). En çok kullanilan benzalkonyum klor'ur poliheksametilen biguanid 0,1 ppm-BOOppm; polikuaternyum-1 0,1ppm-200ppm; hipoklorit, perklorit veya klorit bilesikleri 500ppm ya da daha az; stabilize hidrojen peroksit çözeltisi % 0,0001-0,1; p-hidroksibenzoik asit alkil esterleri ve karisimlari, kullanilir. Quaternary ammonium compounds added to such formulations as preservatives For example, benzalkonium chloride can be used. Benzalkonium chloride N-benzyl-N- It is defined as (C.sub.8-C.sub18 alkyl)-N,N-dimethylammonium chloride. In addition, protective as vitamin A, vitamin E, vitamin C, retinyl palmitate and selenium; from amino acids, cysteine and methionine; citric acid and sodium citrate and artificial preservatives such as thimerosal and alkyl parabens (methyl paraben and propyl paraben) antioxidants may also be added. Other preservatives, octadecyldimethylbenzyl ammonium chlorine, hexametonium chloride, benzetonium chloride, phenol, catasol, resorcinol, cyclohexanol, 3-pentanol, m-cresol, phenylmercuric nitrate, phenylmercuric acetate or phenylmercuric borate, sodium perborate, sodium chloride; alcohols, chloroethanol, butyl or benzyl alcohol or phenyl ethanol; guanidine derivatives, chlorhexidine or polyhexamethylene biguanidine, sodium perborate, polyquadRTM., Germal.RTM.ll, sorbic acid and stabilized oxychloro complexes (purite.RTM). The most commonly used benzalkonium chloride polyhexamethylene biguanide 0.1 ppm-BOOppm; polyquaternium-1 0.1ppm-200ppm; hypochlorite, perchlorite or chloride compounds 500ppm or less; stabilized hydrogen peroxide solution 0.0001-0.1%; p-hydroxybenzoic acid alkyl esters and mixtures, used.
Tonisite ayarlamasi iyonik ve non-iyonik olmak üzere iki sekilde yapilmaktadir. Iyonik tonisite ayarlamasinda alkali metal ya da metal halidler kullanilir. Bunlar, CaCI.sub.2, KBr, KCl, LiCl, Nal, NaBr veya NaCI, Na.sub.280 veya borik asittir. Non-iyonik ayarlamada ise üre, gliserol, sorbitol, mannitol, propilen glikol veya dektroz kullanilmaktadir. Tipik bir tonisitesi ayarlanmis çözelti % 0,9=luk NaCI ile ya da Formülasyonlarda ayrica çesitli çözücü ajanlar da kullanilir. Formülasyonun süspansiyon ya da emülsiyon olmasina göre çözücü ajan seçimi yapilir. Bunlar, tiloksapol, doymus yaglarin polietilen glikol esterleri, polietilen glikoller, gliserol eterleri, polisorbat 20, polisorbat 80, veya bunlarin karisimlaridir. Göz tarafindan en iyi tolare edilen ürün hint yaginin etilenoksit ile reaksiyonu ile elde edilen kremopor ELRTM. veya kremefor RH40.RTM. ürünleridir. Tonicity adjustment is made in two ways, ionic and non-ionic. Ionic Alkali metals or metal halides are used for tonicity adjustment. These are CaCl.sub.2, KBr is KCl, LiCl, Nal, NaBr or NaCl, Na.sub.280 or boric acid. non-ionic urea, glycerol, sorbitol, mannitol, propylene glycol or dextrose in adjustment is used. A typical tonicity adjusted solution is 0.9% with NaCl or Various solvents are also used in formulations. of the formulation The solvent agent is selected according to whether it is a suspension or an emulsion. These, tyloxapol, polyethylene glycol esters of saturated fats, polyethylene glycols, glycerol ethers, polysorbate 20, polysorbate 80, or mixtures thereof. most by eye The well tolerated product is cremopor, which is obtained by the reaction of castor oil with ethyleneoxide. ELRTM. or cremefor RH40.RTM. are products.
Diger bir örnekte, çözücü ajan olarak tiloksapol ya da siklodekstrin'dir. Formülasyon içindeki oranlari, kullanilan aktif madde konsantrasyonuna baglidir. Mesela, çözücü ajan formülasyondaki aktif bilesenin 0,1 ile 5000 kati arasinda bir oranda bulunabilir. Çözücü ajan olarak sadece siklodekstrin bilesigi kullanilmaz. Alta-, beta-, veya gama- siklodekstrin, alkillenmis, hidroksialkillenmis, karboksialkillenmis veya alkiloksikarbonil-alkillenmis türevleri, veya mono-, veya diglikosil-alfa-, beta-, veya gama-siklodekstrin, mono- veya dimaltosil-alfa-, beta-, veya gama-siklodekstrin veya panosil-siklodekstrin, bilesikleri de kullanilabilir. In another example, it is tyloxapol or cyclodextrin as the dissolving agent. Formulation The proportions in it depend on the concentration of the active substance used. For example, the solvent The agent may be present at a ratio of 0.1 to 5000 times the active ingredient in the formulation. Only cyclodextrin compound is not used as a solvent. Alta-, beta-, or gamma- cyclodextrin, alkylated, hydroxyalkylated, carboxyalkylated or alkyloxycarbonyl-alkylated derivatives, or mono-, or diglycosyl-alpha-, beta-, or gamma-cyclodextrin, mono- or dimaltosyl-alpha-, beta-, or gamma-cyclodextrin or panacyl-cyclodextrin, compounds may also be used.
Claims (17)
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| TR2016/13875A TR201613875A1 (en) | 2016-10-04 | 2016-10-04 | Ophthalmic composition suitable for the treatment of uveitis |
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