TR201603775A1 - Anti̇bakteri̇yel farmasöti̇k terki̇pler - Google Patents
Anti̇bakteri̇yel farmasöti̇k terki̇pler Download PDFInfo
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- TR201603775A1 TR201603775A1 TR2016/03775A TR201603775A TR201603775A1 TR 201603775 A1 TR201603775 A1 TR 201603775A1 TR 2016/03775 A TR2016/03775 A TR 2016/03775A TR 201603775 A TR201603775 A TR 201603775A TR 201603775 A1 TR201603775 A1 TR 201603775A1
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- 235000019408 sucralose Nutrition 0.000 description 1
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- 238000009495 sugar coating Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
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- 229960000943 tartrazine Drugs 0.000 description 1
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- 229960003080 taurine Drugs 0.000 description 1
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- 229940072172 tetracycline antibiotic Drugs 0.000 description 1
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- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
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- PLSARIKBYIPYPF-UHFFFAOYSA-H trimagnesium dicitrate Chemical compound [Mg+2].[Mg+2].[Mg+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O PLSARIKBYIPYPF-UHFFFAOYSA-H 0.000 description 1
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- 229940046009 vitamin E Drugs 0.000 description 1
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Classifications
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Mevcut buluş; duyarlı Rickettsiae, Chlamydia, Mycoplasma ve gram negatif ve gram pozitif bakterilerin neden olduğu enfeksiyonlar, Chlamydia trachomatis'in neden olduğu komplikasyonsuz üretrit, endoservikal ve rektal enfeksiyonlar; intestinal amebiozis; ağır seyreden akne, trahom tedavileri, Lymphogranuloma venereum ile Granulama inguinale'nin tedavileri, Staphylococcus aureus, Streptokoklar ve Staphylococcus pneumoniae gibi gram pozitif mikroorganizmaların neden olduğu pnömoni, bronkopnömoni, toplum kaynaklı bakteriyel pnömoni, komplike deri ve yumuşak doku infeksiyonları ile komplike intraabdominal infeksiyonlar, veba, veba profilaksisi, sinüzit, bronşit, bronşiyolit, farenjit, larengotrakeit, tonsilit, septik boğaz iltihapları, sinüzit, orta kulak iltihabı ve mikst bakteriyel enfeksiyonların profilaktik, semptomatik veya terapötik tedavisinde kullanılmak üzere antibiyotik özellikteki antibakteriyel uygun etken maddenin ve/veya farmasötik olarak kabul edilebilir türevlerinin monoterapisini ve/veya diğer uygun etken maddeler ile kombine tedavisini içeren farmasötik bileşim/ler ile ilgilidir.
Description
TARIFNAME
ANTIBAKTERIYEL FARMASÖTIK TERKIPLER
BULUSUN ILGILI OLDUGU ALAN
Mevcut bulus; duyarli Rickettsiae, Chlamydia, Mycoplasma ve gram negatif ve gram
pozitif bakterilerin neden oldugu enfeksiyonlar, Chlamydia trachomatis'in neden oldugu
komplikasyonsuz üretrit, endoservikal ve rektal enfeksiyonlar; intestinal amebiozis; agir
seyreden akne, trahom tedavileri, Lymphogranuloma venereuin ile Granulama
inguinale'nin tedavileri, Staphylococcus aureus, Streptokoklar ve Staphylococcus
pneumoniae gibi gram pozitif mikroorganizmalarin neden oldugu pnömoni,
bronkopnömoni, topluin kaynakli bakteriyel pnömoni, komplike deri ve yumusak doku
infeksiyonlari ile komplike intraabdominal infeksiyonlar, veba, veba profilaksisi, sinüzit,
bronsit, bronsiyolit, farenjit, larengotrakeit, tonsilit, septik bogaz iltihaplari, sinüzit, orta
kulak iltihabi ve mikst bakteriyel enfeksiyonlarin profilaktik, semptomatik veya terapötik
tedavisinde kullanilmak üzere antibiyotik özellikteki antibakteriyel uygun etken maddenin
ve/Veya farmasötik olarak kabul edilebilir türevlerinin monoterapisini ve/veya diger uygun
etken maddeler ile kombine tedavisini içeren farmasötik bilesim/ler ile ilgilidir.
Mevcut bulus; antibiyotik özellikteki antibakteriyel uygun etken maddenin Tetrasiklin,
pentahidroksi-ö-metil-l,ll-dioksonaftasen-Z-karboksamid (Formül 1) ve/veya farmasötik
olarak kabul edilebilir türevleri oldugu farrnasötik bilesim/ler ile ilgilidir.
Formül I:
Ayrica bulus, Tetrasiklin ve/veya farmasötik olarak kabul edilebilir türevlerini içeren
farmasötik bilesimlerin oral uygulama için uygun olan formülasyonlarini ve profilaktik,
semptomatik veya terapötik kullanimlarini da kapsamaktadir.
ÖNCEKI TEKNIK (TEKNIGIN BILINEN DURUMU)
Tetrasiklinler 1950'li yillardan bu yana kullanilan genis spektrumlu antibiyotiklerdir.
Tetrasiklinlerin antibakteriyel etkilerinin yaninda önemli anti-inflamatuvar aktivite
gösterdikleri de bilinmektedir. Tetrasiklinler bugün bir grup antibiyotige verilen genel
isimdir, tetrasiklin de bu antibiyotiklerden birisidir. Bu antibiyotik ciddi infeksiyonlarin
tedavisinde kullanilir. Gram negatif, Gram pozitif, atipik ve anaerob mikroorganizmalar ile
antibiyotik dirençli bakterilere etkilidir. Diger tetrasiklinlere benzer antibakteriyel
aktivitesine ragmen tetrasiklin dirençli organizmalara karsi daha potenttir. Grampozitif ve
gram negatif bakterilerin çoguna, bazi anaerobik bakterilere, riketsiyalara, klamidyalara,
spiroketlere, Mycoplasinadara, Leptospiradara, Actinomycesdere ve bazi protozonlara
karsi etkilidirler.
Tetrasiklin antibiyotikler, antibakteriyel spektrumlari bakimindan genellikle fark
göstermezler; ancak belirli bir mikroorganizma türüne karsi etki güçleri arasinda kisitli
ölçüde bir fark bulunabilir. Bir tetrasikline rezistan olan mikroorganizma degerlerine de
rezistandir. Aralarinda farmakokinetik yönden önemli farkliliklar vardir. Bu nedenle
tatrasiklin antibiyotikler kisa (tetrasiklin ve oksitetrasiklin), orta (demetilklortetrasiklin ve
metasiklin) ve uzun (doksisiklin ve minosiklin) etki süreliler olmak üzere üç gruba
Tetrasiklinler amfoterik inaddeler olup asitler ve bazlar ile tuz olusturma yetenegine
sahiptirler. Serbest seklinin çözünürlügü sinirli oldugu için genellikle hidroklorür tuzlari
veya fosfat kompleksleri kullanilir. Sudaki solüsyonlari asidiktir ve klortetrasiklin
disindakiler Oldukça dayaniklidir (Kayaalp S.O,Tibbi Farmakoloji, 1.Ci'lt, Hacettepe Tas
Barsaklarda belirli bazi bakteri türleri bulunur ve bunlar sindirime yardimci olurlar.
Barsaklar ve diger karin içi organlar yaralandiginda, nonnalde zarar vermeden barsaklarda
yasayan bu bakteriler hastaliklara neden olabilir. Karin içi (intraabdominal) enfeksiyonlara
genellikle iki ya da daha çok mikroorganizma neden olur. Enfeksiyon ciddi ise ya da altta
yatan baska bir duruma bagli ise “komplike enfeksiyon” olarak adlandirilir. Bu
enfeksiyonlara genellikle birden çok mikroorganizma yol açtigindan genis etki spektrumlu
antibiyotiklerle tedavi edilmeleri gerekir. Antibiyotik tedavisinin yani sira gereken cerrahi
girisimler yapilir.
tedavi edilmesi için tetrasiklin kullanimindan bahsedilmekte, Bacillus anthracis karsi aktif
olan ve dar spektrumlu olarak bilinen tetrasiklin bilesikler anlatilmaktadir.
BULUSUN AÇIKLAMASI
Mevcut bulus; duyarli Rickettsiae, Chlamydia, Mycoplasma ve gram negatif ve gram
pozitif bakterilerin neden oldugu enfeksiyonlar, Chlamydia trachomatis'in neden oldugu
komplikasyonsuz üretrit, endoservikal ve rektal enfeksiyonlar; intestinal amebiozis; agir
seyreden akne, trahom tedavileri, Lymphogranuloma venereum ile Granulama
inguinale'nin tedavileri, Staphylococcus aureus, Streptokoklar ve Staphylococcus
pneumoniae gibi gram pozitif inikroorganizmalarin neden oldugu pnömoni,
bronkopnömoni, toplum kaynakli bakteriyel pnömoni, komplike deri ve yumusak doku
infeksiyonlari ile komplike intraabdominal infeksiyonlar, veba, veba profilaksisi, sinüzit,
bronsit, bronsiyolit, farenjit, larengotrakeit, tonsilit, septik bogaz iltihaplari, sinüzit, orta
kulak iltihabi ve mikst bakteriyel enfeksiyonlarin profilaktik, semptomatik veya terapötik
tedavisinde kullanilmak üzere antibiyotik özellikteki antibakteriyel uygun etken maddenin
ve/veya farmasötik olarak kabul edilebilir türevlerinin monoterapisini ve/Veya diger uygun
etken maddeler ile kombine tedavisini içeren farmasötik bilesim/ler ile ilgilidir.
Mevcut bulusun bir diger yönü; oral uygulamaya yönelik antibiyotik özellikteki
antibakteriyel uygun etken madde ve/veya farmasötik olarak kabul edilebilir türevlerini ve
farrnasötik olarak kabul edilebilir uygun yardimci maddeleri içeren farmasötik
bilesim/lerin hazirlanmasi ile ilgilidir.
Bulusta kullanilan antibiyotik özellikteki antibakteriyel uygun etken madde; klortetrasiklin,
demetilklortetrasiklin, metasiklin, minosiklin, oksitetrasiklin, doksisiklin, tetrasiklin,
tigesiklin, kloinosiklin ve demeklosiklin ve/veya farmasötik olarak kabul edilebilir
türevleri arasindan tercihen tetrasiklin hidroklorür olarak seçilir.
Bulusta “farmasötik olarak kabul edilebilir türevleri” terimi ile farmasötik olarak kabul
edilebilir uygun tuzlar, esterler, solvatlar, hidratlar, koinpleksler, polimorflar,
enantiyomerler, önilaçlar, asit adisyon tuzlari, analoglar, izomerler, rasematlar, ainidler,
enantiyomer tuzlari, bazik tuzlar, konjugeler, tautomerler, anhidratlar, anhidritler, bazlar,
asitler, eterler, kristal ve amorf formlar veya serbest formlarindan bir veya daha fazlasi
ifade edilmektedir.
Oral uygulama için hazirlanan farmasötik bilesim kati ya da sivi dozaj formlarinda olabilir.
Bu dozaj formlari; tablet (kaplama içermeyen, çignenebilir, agizda çözünen, dagilabilen,
suda dagilabilen, film kapli, tek tabakali, çift tabakali, barsakta açilan kaplamali, mini
tablet, kontrollü salimli, sürekli salimli, hemen salimli, uzatilmis salimli, geciktirilmis
salimli, degistirilmis salimli, bukkal), kapsül (sert, yumusak, enterik kapli, film kapli,
kontrollü salimli, sürekli salirnli, hemen salimli, uzatilmis salimli, geciktirilmis salimli,
degistirilmis salimli), toz, granül, kaplet, disk, agizda çözünen film, yigin toz (çok dozlu),
pellet, sase, suda dagilabilen toz, suda dagilabilen granül, efervesan tablet, efervesan
granül, efervesan toz, mikrokapsül, dental tabletler, pilül, surup, solüsyon, süspansiyon,
eliksir, damla, posyon, emülsiyon veya sprey gibi bir dozaj sekli halinde formüle edilebilir.
Oral kullanilmak üzere hazirlanan tablet/ ler bir veya daha fazla kaplama içerebilir.
Kaplanmis tabletler; etken maddeyi genellikle çekirdek kisminda, kismen çekirdekte ve
kismende kaplamada veya yalniz kaplamada ihtiva eden formüller seklinde hazirlanir.
Kaplama maddeleri fizyolojik bakimdan zararsiz olmali ve etken madde ile geçimsiz
olmamalidir.
Kaplama tipleri ; seker kaplama, film kaplama ve bagirsakta çözünen (enterik) kaplama
olarak sayilabilir.
Seker kaplamali tabletler, sekerden meydana gelen bir kaplamaya sahip olan sikistirilmis
tabletlerdir. Söz konusu kaplama renklendirilmis olabilir ve rahatsiz edici bir tada veya
kokuya sahip olan etkin maddelerin kaplanmasi ve oksidasyona karsi hassasiyet gösteren
malzemelerin korunmasi bakimindan son derece faydalidir.
Film kaplamali tabletler, suda çözünebilen bir malzeme kullanilarak uygulanan ince bir
katman veya filmle kaplanmis, sikistirilmis tabletlerdir. Bu dogrultuda, film Olusturucu
özelliklere sahip olan bir dizi polimerik malzeme kullanilabilir. Film kaplamalar, seker
kaplamalar ile ayni genel özelliklere sahip olmakla beraber kaplama islemi için gerekli
süreyi önemli ölçüde azaltmak gibi önemli ek bir avantaji beraberinde getirir.
Kaplamanin Amaçlari ;
o Etken maddenin isik, oksijen ve neme karsi korunmasi
o Etken maddenin istenmeyen kokusunun ve tadinin inaskelenmesi
o Tabletin estetik görüntüsünün düzeltilmesi
0 Çok az boyar madde ile renkli tabletlerin elde edilmesi
o Tabletin hasta tarafindan kolay yutulabilirliginin arttirilmasi
o Üretim, ambalajlama ve tasima sirasinda mekanik dayanikliligin artmasi
o Etken maddenin sindirim salgilarina karsi korunmasi
0 Yan etkilerden, örnegin mide iritasyonundan kaçinilmasi
o Ilacin taninmasinin kolaylastirilmasi, dolayisiyla ilaç kullaniminda güvenligin
artmasi
o Etken maddenin kararliliginin arttirilmasi
o Kontrollü salim karakteristiklerinin düzenlenebilmesi
olarak sayilabilir.
Bulustaki farrnasötik formülasyon/lar bir veya daha fazla tabaka içerebilir. Yeterli
terapötik etkiyi saglamak ve yan etkileri minimuma indirmek amaciyla ilacin saliminin
kontrolünü saglamak için tabaka/lar degistirilmis, modifiye, kontrollü, uzatilmis, sürekli,
hemen veya geciktirilmis salimli bir farmasötik dozaj formlarinin bir veya daha fazlasi ile
formüle edilebilir.
Farmakokinetik özellikleri, kullanim beklentilerine uygun olmayan, örnegin yarilanma
ömrü kisa olan, istenmeyen etkileri ortaya çikaracak biçimde hizli/yüksek doruk
konsantrasyona ulasan, çesitli nedenlerden biyoyararlanimi iyi olmayan v.b. ilaçlar için
farmasötik biçimleri degistirilerek , mide barsak kanalinda serbestlenme pateinleri amaca
daha uygun hale getirilmis preparatlar gelistirilmektedir. Bunlar çoklukla degistirilmis,
kontrollü, yavaslatilmis ve uzatilmis salinimli fonnülasyonlar olarak anilmaktadir.
Degistirilmis salinimli formülasyonlarin bilesimleri islevleri açisindan önem tasir.
Degistirilmis salinimli ilaç formülasyonlari, daha pahali olabilmelerine ragmen, hastanin
tedaviye uyumunun tedavi basarisinda önemli oldugu kisa yarilanma ömürlü, doruk
konsantrasyona hizli ulasan, farmakokinetigi degiskenlik gösteren ilaçlar için daha
kullanislidir ve son tahlilde tedavi maliyetini azaltirlar. Degistirilmis salim sistemleri
transdermal sistemler ve oral sistemler olarak sinitlandirilir. Geciktirilmis salim
sistemlerinde etkin maddenin sistemden salimi belli bir bölgede olmaktadir. Genellikle
enterik kapli tabletler için kullanilir.
Enterik kaplama fonnülasyonun stabilitesini arttirmak, asit kaynakli bozunmalari önlemek
için kullanilan madde veya madde karisimlari olarak ifade edilir. Bu enterik kaplamalar
ayrismaya baslamadan önce mide asidine direnç göstermekte ve ayni zamanda midenin alt
kisminda veya ince bagirsagin üst kisminda yavas bir ilaç salinimini saglamaktadir.
Bulusta tablet/lerin hazirlanmasinda direk kompresyon, yas veya kuru granülasyon
uygulanabilir.
Direkt kompresyon maddenin fiziksel yapisini bozmadan toz haline getirilmis materyalin
sikistirilmasi ile elde edilmesinden olusmaktadir. Direk sikistirma araci olarak yaygin
sekilde çalisilmis olan yardimci madde mikrokristalin selulozdur(Avice1, FMC).
Dozaj formlarinin hazirlanmasinda birçok teknikten yararlanilmaktadir. Bunlardan biri de
granülasyon yöntemidir. Granülasyon; ince toz partiküllerin büyümesi seklinde
tanimlanmaktadir. Farmasötik amaçli granülasyon; tabletleme için bir ön hazirlik
asamasidir, ayni zamanda, sert j elatin kapsüle doldurma veya granülün bir final ürün olarak
bir pakete yerlestirilerek kullanimi amaciyla da uygulanmaktadir.
Granülasyonun amaci, karisima istirak eden toz maddenin partiküllerinin birim ilacinin %
miktarlarina esdeger olacak agirlikta bir ünite olusturmaktir. Farmasötik toz karisimlarin
(etken madde veya yardimci maddeler) ayrismalarini engelleyerek bir ünite içerisinde
homojen bir sekilde kalmalarini saglamak gerekmektedir bu da granülasyon ile
mümkündür.
Granülasyonda seçilecek yöntemler 3 ana kategoride siniflandirilabilir: yas granülasyon,
kuru granülasyon ve diger granülasyon yöntemleri.
Yas Granülasyon: Yas granülasyon yönteminde, yüksek hizli akiskan yatak granülasyon,
püskürterek kurutma ve ekstrüsyon pelletleme yöntemleri kullanilmaktadir. Yas
granülasyonda, etken madde ve baglayici madde (solüsyon) belirli sürede karistirilir, yas
olarak elenir ve akiskan yatakli kurutucuda kurutulur. Kurutulan bu karisim diger dolgu
maddeleri ile birlikte belirli bir homojenlige gelinceye kadar karistirilir. Karisimin son 3-5
dakikasinda kaydirici eklenir. Elde edilen final karisimdan örnekler alinir ve laboratuvara
gönderilir. Laboratuvar sonucuna göre tablet basimina yada istenilen farmasötik fonn için
asamalara geçilebilir.
Yas granülasyon yöntemleri:
1. Yas granülasyon yöntemi (Klasik yöntem)
2. Akiskan yatak yöntemiyle granülasyon
3. Spray-Drying (püskürterek kurutma) yöntemi ile granülasyon
4. Mikrogranülasyon yöntemi
. Ekstrüsyon-Spheronizasyon yöntemi
6. Yüksek hiza sahip karistiricilarla granüle hazirlama yöntemi
Yas granülasyon islemi su sirayi izlemektedir:
° Toz maddelerle karistirilmasi,
- Baglayici ilavesiyle toz karisimin partiküllerinin kümelesmesinin saglanmasi, (Bu
isleme granülasyon denir.)
yatakli kurutucular kullanilmasi,
- Kurutma isleminden sonra kuru ögütme yapilmasi,
- Çift konik ya da V tipi karistiricilarda homojenize edilmesi
karisima final ürün denir.)
° Tablet basimina yada istenilen farmasötik form için asamalara geçilmesidir.
Kuru Granülasyon: Kuru granülasyon yönteminde, ön kompresyon ve silindirler arasi
sikistirma yöntemleri kullanilmaktadir. Kuru granülasyonda genellikle formüldeki
kaydiricinin l/3ӟ diger toz karisimlarina karistirilir. Bunun nedeni tozlarin silindirlere
yapismasini engeller. Kaydiricinin geri kalani kuru granülasyondan sonra karisima eklenir
ve 3-5 dakika karistirilir. Karisim sonrasinda olusan final karisimdan örnekler alinir ve
çesitli testler için laboratuvara gönderilir. Laboratuvar sonucuna göre tablet basimina yada
istenilen farrnasötik form için asamalara geçilebilir.
Kapsüller; tek dozda ilaç konmaya mahsus jelatin, selüloz esterleri, polivinil alkol Vb.
maddelerden biriyle yapilmis kaplardir. Kapsüllere dozlar, kati ve yarikati maddeler,
kapsülü eritmeyen sivi ilaçlar konabilir. Kapsüller genel olarak ikiye ayrilir; sert/iki parçali
kapsüller ve yumusak kapsüller.
Sert kapsüller: kab ve kapak kismi olinak üzere iki parçadan ibarettir. Tadi aci, yutulmasi
zor, havadan çabuk bozulan tozlar ile absorbsiyonu hizli olmasi istenen ilaçlarin kapsül
içinde verilmesi öngörülür. Sert jelatin kapsüllerin esas maddesi makromoleküler bir
protein olan yüksek degerli jelatinden ibarettir. Sert jelatin kapsüller jelatin, Arap zamki,
boya ve su karisimindan özel teknikler ve özel inakinelerle hazirlanir. Sert kapsüller
daldirrna (dipping) yöntemi ile hazirlanir. Bu yöntemin prensibi paslanmaz çelikten
yapilmis çubuklarin eritilmis kapsül duvari çözeltisine batirilarak bu çubuklarin yüzeyinde
kapsül duvari filminin olusturulmasidir. Jelatin, boyalar, koruyucu maddeler ve su , sert
jelatin kapsül duvarini olusturan maddelerdir.
Sert kapsüllere toz, granül, pellet, tablet, sivi, ve yari kati sekiller doldurulabilir.
Kapsüllere doldurulan her türlü formülasyon için iki temel gereklilik söz konudur.Kapsüle,
fomiülasyon dogru dozda doldurulmalidir ve etkin madde hastanin tedavisi için kapsülden
yeterli miktarda salinmalidir. Sert jelatin kapsül formülasyonlarinin hazirlanmasi amaciyla
etkin madde, dolgu maddeleri, akis özelliklerini düzelten maddeler, glidantlar, sürtünmeyi
önleyiciler, lubrikantlar, dagiticilar, yüzey etkin maddeleri kullanilir.
Yumusak kapsüller: jelatin gliserin, sorbitol, arap zamki ve su karisimlari ile hazirlanan tek
parçadan ibaret yuvarlak, elips ve tüp biçiminde kapsüllerdir. Gerekli olan maddeler
konulduktan sonra açilmamak üzere kapatilirlar. Yumusak kapsüller,sivi bir içerigin jelatiii
kapsül duvari ile çevrelenmesi ile hazirlanir. Sert kapsüllere göre daha esnektirler.
Yumusak kapsüller yuvarlak, oval, oblong (dikdörtgen çubuk) veya tüp seklinde
olabilirler. Tek parçadan olusurlar. Yumusak jelatin kapsüllere genelde çözelti veya
süspansiyon seklindeki sivi ilaç sekilleri doldurulur. Ancak yari kati ve tozlar da
doldurulabilir. Yumusak kapsüllerin imalati, çözünmeyen maddeler, dozu düsük etkin
maddeler, yüksek aktivite gösteren bilesikler, oksijene duyarli maddeler, tadi kötü
maddeler için uygundur. Yumusak jelatin kapsüllerin üretiminde, kapsül duvarinin
hazirlanmasi, materyalin doldurulmasi ve kapsülün kapatilmasi birbirini takip eden bir dizi
islemden olusur.
Mevcut bulustaki oral kullanim için hazirlanan farrnasötik formülasyon; farmasötik olarak
kabul edilebilir uygun etken maddeler yaninda baglayici madde, dagitici madde, dolgu
maddesi, tamponlayici ajan, yüzey aktif madde, lubrikant, glidant, seyreltici madde,
koruyucu madde, aroina ajani, tatlandirici madde, viskozite arttirici madde, köpük önleyici
ajan, çözünürlük arttirici ajan, antistatik ajan, islatici madde, pH ayarlayici madde,
renklendirici madde, kaplama maddesi, çözücü, yuinusatici madde, einülgatör, tasiyici,
geçirgenlestirici madde, antioksidan, selat yapici ajan, alkalilestirici ajan, fotokoruyucu
ajan, kivam arttirici madde, izotoni ayarlayici ajan, jel yapici ajan, mikrobiyal koruyucu
madde, sertlestirici ajan, sivag, salim kontrol edici ajan, plastifiyan, antiadherent, film
yapici ajan, opaklastirici madde, nemlendirici madde, granülasyon çözücüsü ve
stabilizörün de dahil oldugu gruptan seçilen bir veya daha fazla yardimci madde içerebilen
bir bilesimi tanimlar.
Bulusta “baglayici madde” terimi; içerikteki maddeleri bir arada tutmak, tablet, pellet veya
granüllerin gerekli olan mekanik güçte formüle edilmesini saglamak ve düsük aktif dozaj
birimlerine hacim vermek için kullanilan madde veya madde karisimlari olarak ifade
edilmektedir. Baglayici madde olarak; prejelatinize misir nisastasi, prejelatinize nisasta,
hidroksi propil nisasta, jelatin, mikrokristalin selüloz, selüloz, zamklar, polivinil pirolidon,
polimetakrilatlar, sodyum karboksi metil selüloz, nisasta, parafînler, stearik asit, zamklar,
metil selüloz, etil selüloz, polietilenglikol, magnezyum alüminyum silikat, karboksi
metilselüloz, hidroksi propilselüloz, hidroksi etilselüloz, propilen glikol, polioksietilen-
polipropilen kopolimeri, polietilen ester, polietilen sorbitan ester, polietilen oksit,
polisakkaritler, polaksamerler, aljinik asitler, kolajen, albuinin, krospovidon, povidoii,
kopovidon, maltodekstrin, hipromelloz veya bunlarin karisimlari kullanilabilir.
Bulusta “dagitici madde” terimi, dozaj formunun su içinde kolay ve hizli bir sekilde
dagilmasini saglayan maddeler olarak ifade edilmektedir. Dagitici madde olarak; agar agar,
kalsiyum karbonat, sodyum karbonat, aljinik asit, patates nisastasi, misir nisastasi, bugday
nisastasi, prejelatinize nisasta, sodyum nisasta glikolat gibi nisastalar, mikrokristalin
selüloz, çapraz-bagli polivinil pirolidon, sodyuin aljinat, hidroksipropil selüloz, çapraz
bagli hidroksipropil selüloz, kroskarmelloz sodyum, kil, iyon degistirici reçine,
krospovidon, ksilitol, D-sorbitol, D-mannitol, laktoz, sükroz, üre, yüksek molekül agirlikli
polimerler, povidon, aljinik asit, ksantan zamki, kolloidal silikon dioksit veya bunlarin
karisimlari kullanilabilir.
Bulusta “dolgu maddesi” terimi; tablet ya da kapsüllerin üretim için pratik, hasta
kullanimina uygun büyüklükte olmasi için kullanilan madde veya madde karisimlari olarak
ifade edilmektedir. Dolgu maddesi olarak; talk, laktoz, sukroz, dekstrin, mannitol, laktilol,
laktitol, ksilitol, sorbitol, izomalt, mikrokristalin selüloz, toz selüloz, dekstroz, dekstrat,
prejelatinize nisasta, modifiye nisasta, misir nisastasi, laktoz anhidröz, laktoz monohidrat,
dibazik kalsiyum fosfat, silisik asit, kaolin, hidroksi propil metilselüloz, tribazik kalsiyum
fosfat, polihidrik alkoller veya selüloz eterleri, kalsiyum hidrojen fosfat dihidrat, kalsiyum
sülfat trihidrat, selüloz kalsiyum sülfat, kalsiyum sülfat dihidrat, inaltodekstrin, kalsiyum
karbonat, kaolin, sodyum hidroksit veya bunlarin karisimlari kullanilabilir.
Bulusta “tamponlayici ajan” terimi, kompozisyonun asitlik ve bazligini düzenleyen
maddeler olarak ifade edilmektedir. Tamponlayici ajan olarak; sitrik asit anhidrus, sodyum
sitrat dihidrat, sodyuin fosfat, sodyum dihidrojen fosfat, potasyuin sitrat, fosforik asit,
amonyum hidroksit, sitrik asit, diizopropanolamin, sodyum karbonat, sodyum silikat,
disodyum oitofosfat, kalsiyum karbonat, magnezyum karbonat, magnezyum hidroksit,
magnezyum alüminat, dietanol amin, sodyum aljinat, etilendiamin, meglümin, hidroklorik
asit, laktik asit, sodyum sitrat, sodyum hidroksit, trietanolamin, trolamine, sodyum
benzoat, sodyum hidrojen karbonat veya bunlarin karisimlari kullanilabilir.
Bulusta “yüzey aktif madde” terimi suda veya sulu bir çözeltide çözündügünde yüzey
gerilimini etkileyen kimyasal bilesigi ifade etmektedir. Yüzey aktif madde olarak
polisorbatlar, sodyumlauril sülfat, sodyumstearil fumarat, non-iyonik polioksietilen
polioksipropilen ko-polimeri, hekzadesil trimetil amonyum bromür, alkil polietilen oksit,
polokzamerler, oktil glukozid, yag asitlerinin seker esterleri ve gliseritleri, dodesil betain,
dodesil dinietilamiii oksit, polioksil stearat, sodyum stereat, polietilen glikoller, L-lösin,
alkil benzen sülfonat, yag asitleri, kuaterner amonyum bilesikleri veya bunlarin karisimlari
kullanilabilir.
Bulusta “lubrikant” sürtünmeyi azaltan veya engelleyen bir toz karisiminin akis
özelliklerini iyilestiren ajan veya ajan karisimlari olarak ifade edilmektedir. Lubrikant
olarak; talk, kalsiyum stearat, magnezyum stearat, alüminyum stearat, polietilen glikol,
tristearin, stearik asit, sodyum lauril sülfat, magnezyum lauril sülfat, kolloidal silikon
dioksit, stearik asit, sodyum stearil fumarat, polioksietilen glikol, oleik asit, tripalmitil,
potasyum oleat, hidrojene bitkisel yaglar, lösin, alanin, glisin, kaprilik asit, gliseril behenat,
gliseril palmitostearat, sodyum benzoat, sodyum asetat, fumarik asit, çinko stearat, çinko
oleat, çinko palmitat, parafinler, yag alkolleri veya bunlarin karisimlari kullanilabilir.
Bulusta “glidant” terimi; tablet basimi aninda matris bosluguna materyalin akisini
kolaylastiran ekstra küçük partiküllü, dansitesi düsük madde olarak ifade edilmektedir.
Glidant olarak; talk, magnezyum stearat, hidrojene nebati yag, kalsiyum stearat, stearik
asit, kolloidal silikon dioksit, sodyum stearilfumarat, polioksietilenglikol, lösin, sodyum
benzoat, sodyum klorür, sodyum asetat, sodyum fumarat, silika, kolloidal anhidrus silika,
polietilenglikol, selüloz türevleri, nisasta veya bunlarin karisimlari kullanilabilir.
Bulusta “seyreltici madde” terimi; tablet ya da kapsüllerin üretim için pratik, hasta
kullanimina uygun büyüklükte olmasi için kullanilan madde veya madde karisimlari olarak
ifade edilmektedir. Seyreltici madde olarak; laktoz, maltoz, sukroz, dekstrin, mannitol,
laktilol, ksilitol, sorbitol, izoinalt, mikrokristalin selüloz, dekstroz, dekstrat, prejelatinize
nisasta, modifiye nisasta, misir nisastasi, laktoz anhidröz, laktoz monohidrat, dibazik
kalsiyum fosfat, hidroksi propil metilselüloz, tribazik kalsiyum fosfat, polihidrik alkoller
veya selüloz eterleri, kalsiyum hidrojen fosfat dihidrat, kalsiyum sülfat trihidrat, kalsiyum
sülfat dihidrat, maltodekstrin, kalsiyum karbonat, kaolin, sodyum hidroksit veya bunlarin
karisimlari kullanilabilir.
Bulusta “koruyucu madde” terimi; su ve suda çözünen, yag ve yagda çözünen maddelerin
mikroorganizmalara karsi korunmasini saglayan maddeler olarak ifade edilmektedir.
Komyucu madde olarak 2-fen0ksietanol, sodyum benzoat, benzoik asit, benzil alkol,
etilendiamintetraasetik asit, sodyum metil parahidroksi benzoat, sodyum propil para
hidroksi benzoat, sorbik asit, potasyum sorbat, benzetonyum klorür, klorokresol,
benzalkonyum klorür, butil paraben, metil paraben, propil paraben, etil paraben, butil
hidroksi anisol (BHA), butil hidroksi toluen (BHT), kalsiyuin asetat, sitrik asit, disodyum
edetat, gliserin, propil gallat, sodyum bisülfît, sodyum sitrat, sodyum metabisülfit, borik
asit, sorbik asit, sodyum propionat, propilen glikol veya bunlarin karisimlari kullanilabilir.
Bulusta “aroma ajani” terimi, karisima aroma katmak için kullanilan maddeler olarak ifade
edilmektedir. Aroma ajani olarak; dogal aroma yaglari (nane yagi, keklik üzümü yagi,
maydanoz yagi, portakal yagi, üzüm, turunç, greyfurt, limon yagi, vb.), portakal aromasi,
muz aromasi, seftali aromasi, greyfurt aromasi, limon aromasi, elma aromasi, çilek
aromasi, vanilya aromasi, nane aromasi, tutti-ûiritti aromasi, frambuaz aromasi, mentol,
mentan, anetol, tarçin, metil salisilat, okaliptal, adaçayi, bögürtlen, sitrus meyvalari veya
bunlarin karisimlari kullanilabilir.
Bulusta “tatlandirici madde” olarak; sodyum sakkarin, sakkaroz, D-glukoz, galaktoz,
ksiloz, maltoz, maltodekstrin, maltol, eritritol, laktitol, izomalt, izomaltol, misir surubu, D-
triptofan, glisirizik asit, inonoamonyum glisirrizinat, fruktoz, maltitol, dekstroz, sükroz,
ksilitol, sorbitol, mannitol, laktoz, aspaitam, asesülfam potasyum, neohesperidin
dihidrokalkon, sükraloz, sodyum siklamat veya bunlarin karisimlari kullanilabilir.
Bulusta “viskozite arttirici madde” terimi, sivinin kalinligini arttirarak yavas akmasini
saglayan bir ajan veya ajan karisimlari olarak ifade edilmektedir. Viskozite arttirici madde
olarak; ksantan zamki, guar zamki, aeacia, povidon, aljinik asit, etilselüloz, jelatin,
hidroksietil selüloz, hidroksipropil selüloz, setil alkol, polivinil pirolidon, hidroksi propil
metil selüloz, polidekstroz, karragenan, metil selüloz, sukroz, sorbitol, ksilitol,
hidroksipropil metilselüloz, polivinil alkol, ketearil alkol, kolloidal silikon dioksit veya
bunlarin karisimlari kullanilabilir.
Bulusta “köpük önleyici ajan” terimi ürün saklanirken köpürme reaksiyonunun baslamasini
engelleyerek ürünü mevcut sistemde bulunan suya karsi stabilize eden maddeler olarak
ifade edilmektedir. Köpük önleyici ajan olarak; simetikon einülsiyon, dimetilsiloksan,
silikon yagi, monosodyum karbonat, susuz trimagnezyum disitrat veya bunlarin karisimlari
kullanilabilir. Köpük önleyici ajan dogrudan efervesan granüle veya dis fazda tabletin
diger eksipiyanlarina toz halde karistirilarak veya hem efervesan granüle hem de tabletin
eksipiyan karisimina paylastirilarak ilave edilebilir.
Bulusta çözünürlük arttirici ajan olarak; sodyum kazeinat, polisorbat, metakrilikasit
kopolimeri veya bunlarin karisimlari kullanilabilir.
Bulusta “antistatik ajan” terimi; içerikteki statik elektrigi azaltan veya elimine etmek için
kullanilan madde veya madde karisimlari olarak ifade edilmektedir. Bahsi geçen antistatik
ajan olarak; uzun zincirli alifatik aminler ve amidler, kuarterner amonyum tuzlari, fosforik
asit esterleri, polietilen glikol esterleri, polioller, mono ve digliserid, yag asit esterleri veya
bunlarin karisimlari kullanilabilir.
Bulusta “islatici madde” terimi hidrofobik ilaçlarin dispersiyon ortaminda kolayca
dagilmasina yardim etmek amaciyla kullanilan maddeler olarak ifade edilmektedir. Islatici
madde olarak; sodyum lauril sülfat, sodyum doküsat, polisorbatlar, sorbitan monolaurat,
oktoksinol-9, nonoksinol-lO, poloksamerler, sodyum karboksimetil selüloz, bentonit,
benzalkonyum klorür, tetradesiltrimetil amonyum bromür, setilpiridinyum klorür, gliseril
monostearat, makrogol setostearil eter, sorbitan tristearat, alumiiiyum magnezyum silikat
veya bunlarin karisimlari kullanilabilir.
Bulusta “pH ayarlayici madde” terimi, kompozisyonun asitlik ve bazligini düzenleyen
maddeler olarak ifade edilmektedir. pH ayarlayici madde olarak; sitrik asit anhidrus,
sodyum sitrat dihidrat, sodyum fosfat, sodyum dihidrojen fosfat, potasyum sitrat, fosforik
asit, ainonyum hidroksit, sitrik asit, diizopropanolamin, sodyuin karbonat, sodyuin silikat,
disodyum ortofosfat, kalsiyum karbonat, magnezyum karbonat, magiiezyum hidroksit,
magnezyum alüminat, dietanol amin, sodyum aljinat, etilendiamin, meglümin, hidroklorik
asit, laktik asit, sodyum sitrat, sodyum hidroksit, sodyum klorür, trietanolamin, trolamine,
sodyum benzoat, sodyum hidrojen karbonat veya bunlarin karisimlari kullanilabilir.
Bulusta “renklendirici madde” terimi hos bir görünüs veren ve iki formülasyon arasinda
optik olarak ayirt edilme saglayan maddeler olarak ifade edilmektedir. Renklendirici
madde olarak, bunlarla sinirli kalmamakla birlikte, sari demir oksit, kirmizi demir oksit
gibi demir oksit pigmentleri, ß-karoten, kirmizi pancar tozu, klorofil, tartrazin, sari
portakal, kinolin sarisi, eritrosin, titanyum dioksit pigmentleri, karamel, gün batimi sarisi
veya bunlarin karisimlari kullanilabilir.
Bulusta “kaplama maddesi” terimi formülasyon içerigini havadaki nein tarafindan
bozunmaya karsi korumak ve tadi hos olmayan formlari yutma kolayligi saglamak için
kullanilan madde veya madde karisimlari olarak ifade edilmektedir. Kaplama maddesi
olarak; metil selüloz, hidroksietilselüloz, hidroksibutilselüloz, hidroksipropilmetilselüloz,
etil selüloz, hidroksimetil selüloz, hidroksipropilselüloz, karboksimetiletilselüloz, sodyum
karboksimetil amilopektin, polivinil asetat ftalat, polioksietilen glikol, polivinil
alkol(0padry çesitleri), polivinil asetal dietil aminoasetat, aminoalkil metakrilat kopolimer,
metakrilik asit kopolimeri, hidroksipropil metil selüloz asetat, dioksi metil selüloz süksinat,
karboksi metil etil selüloz, poliakrilik asitler, metakrilik asit kopolimerleri, metil akrilat,
etilakrilat, metilmetakrilat, etilmetakrilat, akrilik ve metakrilik asit esterleri, hipromelloz,
hipromelloz ftalat, hipromelloz asetat süksinat, hidroksimetil selüloz süksinat asetat,
selüloz butirat ftalat, selüloz hidrojen ftalat, selüloz propiyanat ftalat, selüloz asetat ftalat,
hidroksipropilmetilselüloz ftalat, selüloz asetat trimelitat, jelatin, selak, hint yagi, kitosan,
aljinik asit, Irlanda yosunlari, galaktomanonlar, tragakant, Hint tutkali, arap zamki, guar
zamki, ksantan zamki veya bunlarin karisimlari kullanilabilir.
Çözücü olarak satlastirilmis su, etil alkol, metil alkol, isopropil alkol, butil alkol gibi
alkoller, aseton, diaseton, polioller, polieterler, esterler, alkil ketonlar, metilen klorür, metil
asetat, etil asetat, izopropil asetat, kastor yagi, etilen glikol monoetil eter, dietilen glikol
monobutil eter, dietilen glikol monoetil eter, dimetil sülfoksit, dimetil formamid,
tetrahidrofuran veya bunlarin karisimlari kullanilabilir.
Bulusta “yumusatici madde” terimi; cilt üzerinde ince bir film tabakasi olusturarak suyun
uçmasina engel olan maddeler olarak ifade edilmektedir. Yumusatici madde olarak vazelin,
kati vazelin, sivi parafin, sorbitol, gliserin, hidrokarbonlar, lanolin, mumlar, yag asitleri,
setil alkol, oktildodekanol, kaprilik/ kaprik trigliserit, setil stearil alkol, kakao yagi,
diizopropil adipat, gliserin, polihidrik alkoller ve polieter türevleri, polihidrik alkol
esterleri, gliseril monooleat, gliseril stearat, linoleik asit, oleik asit, polipropilen glikol-15
stearil eter (PPG-lS stearil eter), polietilen glikol, polioksietilen glikol yagli alkol eterleri,
polioksipropilen stearil eter, propilen glikol stearat, stearik asit, stearil alkol, fosfolipidler,
lesitin, steoroller, kolesterol, kolesterol yag asidi esterleri ve amidleri, üre, gliseril
monostearat, isopropil miristat, isopropi] palinitat, ketostearil alkol, dimetikon, mineral
yaglar, beyaz kati parafin, setearil alkol veya bunlarin karisimlari kullanilabilir. Ayrica
hint yagi, Hindistan cevizi yagi, zeytinyagi ve bitkisel mumlar gibi bitkisel yumusatici
ajanlar da kullanilabilir.
Bulusta “emülgatör” terimi, birbiri içerisinde karismayan iki sivi faz arasinda homojen
dagilimi saglayan maddeler olarak ifade edilmektedir. Emülgatör olarak polietilen glikol
stearat, polisorbat, poligliseril oleat, polioksietilen lauril eter, etoksillenmis lanolin, stearil
alkol, setostearil alkol, makrogol setostearil, gliseril monostearat, seti] alkol, polioksietilen
lauril alkol, polioksi etilen sorbitan monostearat, polioksietilen stearat, sorbitan
monostearat, propilen glikol stearat, alüminyum nisasta oktenilsuksinat, amonyum
hidroksit, beyaz bir balmumu, sentetik bir balmumu, karbomer, setearil alkol,
siklometikon, digliseritler, dimetikon, disodyum monooleamido sülfosüksinat,
pentaeritritol, gliseritler, gliseril nioiiooleat, gliseril stearat, lanolin, magnezyum hidrojene
stearat, mineral yag, monogliseridler, polietilen glikol, polietilen glikol distearat, polietilen
glikol monosetil eter, polietilen glikol monostearat, polioksietilen glikol, polioksil
setostearil eter, polioksil stearat, simetikon, sorbitan monolaurat, sorbitan monooleat,
sorbitan inonopalinitat, sorbitan palmitat, stearik asit, trietanolamiii veya sodyum lauril
sülfat veya bunlarin karisimlari kullanilabilir.
Bulusta “tasiyici” olarak propilen glikol, saflastirilmis su, hint yagi, diizopropil adipat,
etoksilatli alkol, yagli alkol sitrat, gliserin, heksilen glikol, izopropil alkol, izopropil
miristat, izopropil palmitat, mineral yag, fosforik asit, polietilen tereftalat glikol, polietilen
glikol, polietilen glikol nionostearat, polioksil ketostearil eter, polioksipropilen stearil eter,
polisorbat, oktildodekanol, propilen karbonat, doymus yag asidi trigliseritler, benzoik asit,
etanol veya bunlarin karisimlari kullanilabilir.
Bulusta “geçirgenlestirici madde” terimi, tükürügün penetrasyonunu kolaylastiran ve
böylece tabletin daha iyi dagilmasina katkida bulunan bir hidrofil ag olusmasini saglayan
maddeler olarak ifade edilmektedir. Geçirgenlestirici madde olarak çökeltilmis silisler,
maltodekstrinler, ß-siklodekstrinler veya bunlarin karisimlari kullanilabilir.
Bulusta “antioksidan” terimi serbest radikallerin neden oldugu oksidasyonlari önleyen,
serbest radikalleri yakalama ve stabilize etme yetenegine sahip maddeler olarak ifade
edilmektedir. Antioksidan olarak; tokoferol (E vitamini), askorbik asit (C Vitamini), A
Vitamini, K Vitamini gibi Vitaminler, karotenoitler, karotenler (ömegin; a-karoten, ß-
karoten, likopen, lutein, zeaksantin), mineraller (Se, Zn), butil hidroksi anisol (BHA), butil
hidroksi toluen (BHT), etilgalat, propilgalat, dodesilgalat, taurin, organosülfi'ir bilesikleri
(allium, alil sülfit, indoller), düsük molekül agirlikli antioksidanlar (GSH-Px, ürik asit)
veya bunlarin karisimlari kullanilabilir.
Bulusta selat yapici ajan olarak EDTA (etilen diamin tetraasetik asit), disodyum EDTA
(disodyum etilen diamin tetraasetik asit) veya kalsiyum EDTA (kalsiyum etilen diamin
tetraasetik asit) veya bunlarin karisimlari kullanilabilir.
Bulusta alkalilestirici ajan olarak; sodyum karbonat, sodyum hidrojen karbonat, sodyum
hidroksit, sodyum silikat, primer aminler, sekonder aminler, tersiyer aminler, siklik
aminler, kalsiyum gliserofosfat, kalsiyum glukonat, kalsiyum asetat, N,N°
dibenziletilendiamin, dietanolamin, etilendiamin, meglümin, disodyum hidrojen ortofosfat,
sodyum alüminat, kalsiyum karbonat, kalsiyum hidroksit, magnezyum karbonat,
magnezyum hidroksit, magnezyum sülfat, monosodyum glutamat, polakrillin sodyum,
sodyum aljinat, dibazik kalsiyum fosfat, tribazik kalsiyum fosfat, kalsiyum sülfat,
magnezyum asetat, magnezyum silikat, magnezyum alüminat, magnezyum oksit veya
bunlarin karisimlari kullanilabilir.
Bulusta fotokoruyucu ajan olarak; demir oksit türevleri, metal oksitler, titanyum oksit veya
bunlarin karisimlari kullanilabilir.
Bulusta “kivam arttirici madde” terimi fonnülasyonlarin çesitli basinç ve kuvvetlere karsi
güçlendirilmesi için kullanilan maddeler olarak ifade edilmektedir. Kivam arttirici madde
olarak; setil alkol, alüminyum stearat, dimetikon, setearil alkol, stearil alkol, arap zamki,
kitre zamki, aljinat, karragen, ksantan zamki, guar zamki, setostearil alkol, setil esterlerin
inuinu, dekstrin, gliseril monostearat, hidroksipropil selüloz, kaolin, polietilen beyaz
vazelin, propilen glikol stearat, nisasta, mum, beyaz mum, bentonit, balmumu, beyaz
balmumu, sentetik balmumu, parafin, beyaz kati paratin, beyaz yumusak paratin, kati
vazelin, pektin, karbomer, polivinilprolidon veya bunlarin karisimlari kullanilabilir.
Bulusta “izotoni ayarlayici ajan” terimi, standart referans madde ile ayni osinotik basinca
sahip maddeler olarak ifade edilmektedir. Bahsi geçen izotoni ayarlayici ajan olarak;
sodyum klorür, mannitol, sorbitol, borik asit, potasyum nitrat, glukoz veya bunlarin
karisimlari kullanilabilir.
Bulusta “jel yapici ajan” olarak karbopol, karbomer, hidroksi propilmetilselüloz,
metilselüloz, sodyum karboksi metilselüloz, poliakrilat polimerleri veya bunlarin
karisimlari kullanilabilir.
Bulusta “mikrobiyal koruyucu madde” terimi mikrobiyal aktiviteye karsi koruyan
maddeler olarak ifade edilmektedir. Bahsi geçen mikrobiyal koruyucu madde olarak;
sodyum benzoat, sodyum metil para hidroksibeiizoat, sodyum propil para hidroksibenzoat,
benzalkonyum klorit, borik asit, sorbik asit, etanol veya bunlarin karisimlari kullanilabilir.
Bulusta “sertlestirici ajan; terimi formülasyonlarin çesitli basinç ve kuvvetlere karsi
güçlendirilmesi için kullanilan maddeler olarak ifade edilmektedir. Sertlestirici ajan olarak;
setil alkol, alüminyum stearat, dimetikon, setearil alkol, stearil alkol, arap zamki, kitre
zamki, aljinat, karragen, ksantan zamki, guar zamki, setostearil alkol, setil esterlerin
mumu, dekstrin, gliseril monostearat, hidroksipropil selüloz, kaolin, polietilen beyaz
vazelin, propilen glikol stearat, nisasta, mum, beyaz mum, bentonit, balmumu, beyaz
balmumu, sentetik balmumu, parafin, beyaz kati parafin, kati vazelin, pektin, karbomer,
polivinilprolidon veya bunlarin karisimlari kullanilabilir.
Bulusta sivag olarak; makrogol türevleri, vazelin, mumla modifiye vazelin, sivi vazelin,
beyaz vazelin, lanolin veya lanolin türevleri, hint yagi, hindistan cevizi yagi, zeytinyagi,
pamuk tohumu yagi gibi bitkisel yaglar, polietilen glikol, parafin, anhidröz, beyaz
yumusak parafin veya bunlarin karisimlari kullanilabilir.
Bulusta “salim kontrol edici ajan” olarak; polivinil asetat ftalat, polietilen glikol-polivini]
alkol kopolimeri, poliakrilik asit türevleri, polisakkarit türevleri, metakrilat polimeri,
polimetakrilat, etil metakrilat kopolimeri, metakrilik asit-metilinetakrilat kopolimeri,
metakrilik asit-etil akrilat kopolimeri, polilaktik asit, polilaktik asit kopolimeri,
polivinilpirolidon, polivinilalkol, gliserit, polietilen oksit, gliseril behenat, metakrilik asit
kopolimeri, hidroksipropil metil selüloz, hidroksipropil selüloz, hidroksipropil metil
selüloz asetat, karboksi metil etil selüloz, sodyum karboksi metil selüloz, etil selüloz, inetil
akrilat, etilakrilat, metilmetakrilat, etilmetakrilat, akrilik ve metakrilik asit esterleri,
sodyum aljinat, hiproinelloz ftalat, hipromelloz asetat süksinat, selüloz butirat ftalat,
selüloz hidrojen ftalat, selüloz propiyanat ftalat, selüloz asetat ftalat, selüloz asetat
trimelitat, jelatin, selak, ksantan zamki veya bunlarin karisimlari kullanilabilir.
Bulusta “plastifiyan” terimi, kaplamanin esnekligini arttirmak, filmin kirilma riskini
azaltmak ve filmin çekirdege adhezyonunu arttirmak için kullanilan maddeler olarak ifade
edilmektedir. Polimerle geçimli olmalari ve uçucu özellikte olmamalari gerekmektedir.
Plastifiyan olarak; polietilen glikoller (Makrogol), gliserin, propilen glikol, asetil sitrat,
amil oleat, miristil asetat, butil oleat, butil stearat, triasetin, dietilftalat, asetillenmis
monogliseridler veya bunlarin karisimlari kullanilabilir.
Bulusta “antiadherent” terimi, pürüzlü tablet yüzeyi olusmasini önleyen maddeler olarak
ifade edilmektedir. Antiadherent olarak; talk, kolloidal silikoii dioksit (Aerosil, Syloid,
Cab-O-Sil), magnezyum stearat, misir nisastasi, magnezyum trisilikat veya bunlarin
karisimlari kullanilabilir.
Bulusta “film yapici ajan” terimi, bir baglayicinin bir film, örnegin ince tabaka veya örtü
olusturmak için gerekli komponentler olarak ifade edilmektedir. Film yapici ajan olarak;
polivinil alkol-kismen hidrolize, metil selüloz, etil selüloz, hidroksipropil selüloz,
hidroksietil selüloz, hidroksipropil metil selüloz, polietilen glikol, polietilen oksit,
Makrogol, jelatin veya bunlarin karisimlari kullanilabilir.
Bulusta “opaklastirici madde ” terimi, istenilen sistemi opak hale getirmek için ilave edilen
maddeler olarak ifade edilmektedir. Opaklastirici madde olarak; titanyum dioksit, kalsiyum
karbonat, çinko asetat, alüminyum stearat, çinko stearat veya bunlarin karisimlari
kullanilabilir.
Bulusta “nemlendirici madde” terimi; preparat ile hava arasindaki nem miktarini
düzenleyen ve kontrol eden maddeler olarak ifade edilmektedir. Nemlendirici madde
olarak; gliserin, sorbitol, propilen glikol, üre, kolloidal yapidaki maddeler, likit parafin,
vazelin (petrolatum), sivi vazelin, selüloz ve selüloz yapisindaki maddeler, zamklar (kitre),
bazi elektrolitler (Al tuzlari, civa tuzlari borax) veya bunlarin karisimlari kullanilabilir.
Bulusta granülasyon çözücüsü olarak saflastirilmis su, etil alkol, metil alkol, isopropil
alkol, butil alkol gibi alkoller, metilen klorür veya bunlarin karisimlari kullanilabilir.
Bulusta “stabilizör” terimi; eklendiginde kristallenmeyi ya da faz ayrimini önleyen
maddeler olarak ifade edilmektedir. Stabilizör olarak benzoik asit, edetik asit, salisilik asit,
sorbik asit, sodyum dehidroasetat, tokoferol, butillenmis hidroksianisol, butillenmis
hidroksitoluen, propilgallat, kastor yagi, oleil alkol, poloksamer ve poloksaminler
(polioksietilen ve polioksipropilen blok kopolimeri), ksantan zamki, sorbitan yag
asitlerinin etoksillenmis esterleri, polisorbat 80 veya Tween 80 gibi polisorbatlar,
etoksillenmis mono- ve digliseritler, etoksillenmis lipidler, etoksillenmis yag alkolleri veya
yag asitleri, diasetil fosfat, fosfatidil gliserol, doymus veya doymamis yag asitleri, sodyum
kolat, sodyuin glikolat, sodyum taurokolat, paraoksibenzoik asit, etilen diamin tetraasetik
asit (EDTA), dietilen triamin penta asetik asit veya bunlarin karisimlari kullanilabilir.
Mevcut bulustaki Tetrasiklin ve/veya farmasötik olarak kabul edilebilir türevleri için
uygun olan formülasyonlarina ait doz araligi 25-1500mg; tercihen SOmg, lOOmg, 250mg
ve 500mg olup hastanin bireysel ihtiyaçlarina ve uzmanin degerlendirmesine göre
ayarlanmaktadir.
Bulus esas olarak antibiyotik özellikteki antibakteriyel Tetrasiklin ve/veya farmasötik
olarak kabul edilebilir türevlerinin monoterapi olarak tek basina kullanildigi veya kombine
tedavi olarak kullanildigi farmasötik bilesim/ler ile ilgilidir. Bulusun farmasötik
bilesim/lerinin tablet ve/veya kapsül formunda olmasi temeldir. Böylece elde edilen
farmasötik formülasyon/lar sasirtici bir sekilde fiziksel ve kimyasal kararlilik açisindan
oldukça stabil bir davranis sergilemistir. Ayrica yeterli terapötik etkiyi saglamak ve yan
etkileri minimuma indirmek için sasirtici bir sekilde etkili olduklari belirlenmistir.
Claims (1)
- ISTEMLER . Oral kullanilmak üzere antibiyotik özellikteki antibakteriyel uygun etken inadde ve/Veya farrnasötik olarak kabul edilebilir türevlerinin monoterapi olarak tek basina veya kombinasyon halinde kullanildigi farmasötik bilesim/lerin hazirlanmasi. . Istem 1”deki gibi farmasötik bilesim/ler olup özelligi; antibiyotik özellikteki aiitibakteriyel uygun etken maddenin klortetrasiklin, demetilklortetrasiklin, inetasiklin, minosiklin, oksitetrasiklin, doksisiklin, tetrasiklin, tigesiklin, klomosiklin ve demeklosiklin ve/veya farmasötik olarak kabul edilebilir türevleri arasindan seçilmesidir. . Istem 1”deki gibi farmasötik bilesim/ler olup özelligi; antibiyotik özellikteki antibakteriyel uygun etken maddenin tercihen tetrasiklin hidroklorür olmasidir. . Istem 17deki gibi farmasötik bilesim/ler olup özelligi; tablet (kaplama içermeyen, çignenebilir, agizda çözünen, dagilabilen, suda dagilabilen, film kapli, tek tabakali, çift tabakali, barsakta açilan kaplamali, mini tablet, kontrollü salimli, sürekli salimli, hemen salimli, uzatilmis salimli, geciktirilmis salimli, degistirilmis salimli, bukkal), kapsül (sert, yumusak, enterik kapli, film kapli, kontrollü salimli, sürekli salimli, hemen salimli, uzatilmis salimli, geciktirilmis salimli, degistirilmis salimli), toz, granül, kaplet, disk, agizda çözünen film, yigin toz (çok dozlu), pellet, sase, suda dagilabilen toz, suda dagilabilen granül, efervesan tablet, efervesan granül, efervesan toz, mikrokapsül, dental tabletler, pilül, surup, solüsyon, süspansiyon, eliksir, damla, posyon, emülsiyon veya sprey arasindan seçilen bir veya daha fazla farmasötik dozaj formunu içermesidir. . Istem 4”deki gibi farrnasötik bilesim/ler olup özelligi; farmasötik dozaj formunun tercihen tablet ve/veya kapsül olmasidir. . Istem 4°deki gibi farmasötik bilesim/ler olup özelligi; tablet ve/Veya kapsül/lerin hazirlanmasinda granülasyon yöntem/lerinin kullanilmasidir. . Yukaridaki istemlerden herhangi birine göre farmasötik bilesim/ler olup özelligi; Tetrasiklin ve/veya farmasötik olarak kabul edilebilir türevleri için uygun olan formülasyonlarina ait doz araliginin 25-15001ng olmasidir. . Yukaridaki istemlerden herhangi birine göre farmasötik bilesim/ler olup özelligi; duyarli Rickettsiae, Chlamydia, Mycoplasma ve gram negatif ve gram pozitif bakterilerin neden oldugu enfeksiyonlar, Chlamydia trachomatis'in neden oldugu komplikasyonsuz üretrit, endoservikal ve rektal enfeksiyonlar; intestinal amebiozis; agir seyreden akne, trahom tedavileri, Lymphogranuloma venereum ile Granulama inguinale'nin tedavileri, Staphylococcus aureus, Streptokoklar ve Staphylococcus pneumoniae gibi gram pozitif mikroorganizmalarin neden oldugu pnömoni, bronkopnömoni, toplum kaynakli bakteriyel pnömoni, komplike deri ve yumusak doku infeksiyonlari ile komplike intraabdominal infeksiyonlar, veba, veba profilaksisi, sinüzit, bronsit, bronsiyolit, farenjit, larengotrakeit, tonsilit, septik bogaz iltihaplari, sinüzit, orta kulak iltihabi ve inikst bakteriyel enfeksiyonlarin protilaktik, seinptomatik veya terapötik tedavisinde endike olmasidir.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
TR2016/03775A TR201603775A1 (tr) | 2016-03-23 | 2016-03-23 | Anti̇bakteri̇yel farmasöti̇k terki̇pler |
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TR2016/03775A TR201603775A1 (tr) | 2016-03-23 | 2016-03-23 | Anti̇bakteri̇yel farmasöti̇k terki̇pler |
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