TR201613452A1 - Hi̇perparati̇roi̇di̇zm tedavi̇si̇ i̇çi̇n formülasyonlar - Google Patents
Hi̇perparati̇roi̇di̇zm tedavi̇si̇ i̇çi̇n formülasyonlar Download PDFInfo
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- TR201613452A1 TR201613452A1 TR2016/13452A TR201613452A TR201613452A1 TR 201613452 A1 TR201613452 A1 TR 201613452A1 TR 2016/13452 A TR2016/13452 A TR 2016/13452A TR 201613452 A TR201613452 A TR 201613452A TR 201613452 A1 TR201613452 A1 TR 201613452A1
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- 239000007940 sugar coated tablet Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
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- 238000012360 testing method Methods 0.000 description 1
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- 230000007704 transition Effects 0.000 description 1
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- LADGBHLMCUINGV-UHFFFAOYSA-N tricaprin Chemical compound CCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCC)COC(=O)CCCCCCCCC LADGBHLMCUINGV-UHFFFAOYSA-N 0.000 description 1
- 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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Abstract
Mevcut buluş; paratiroid hormonu (PTH) oluşumu ve salımını bloke etmek, hemodiyalize giren kronik böbrek yetmezliği olan hastalarda sekonder hiperparatiroidizm önlenmesi ve tedavisinin semptomatik ve/veya profilaktik ve/veya terapötik tedavisinde kullanılmak üzere anti-paratiroid hormon ajanı, vitamin D analoğu olan uygun etken madde ve/veya farmasötik olarak kabul edilebilir türevlerinin monoterapi olarak tek başına kullanıldığı ve/veya bu etken maddenin diğer uygun aktif ajan/lar ile kombine tedavi olarak kullanıldığı farmasötik bileşim/ler ile ilgilidir.
Description
TARIFNAME
HIPERPARATIROIDIZM TEDAVISI IÇIN FORMÜLASYONLAR
Mevcut bulus; paratiroid hormonu (PTH) olusumu ve salimini bloke etmek, hemodiyalize
giren kronik böbrek yetmezligi olan hastalarda sekonder hiperparatiroidizm önlenmesi ve
tedavisinin semptomatik ve/veya profilaktik ve/Veya terapötik tedavisinde kullanilmak
üzere anti-paratiroid hormon ajani, vitamin D analogu olan uygun etken madde ve/veya
farmasötik olarak kabul edilebilir türevlerinin monoterapi olarak tek basina kullanildigi
ve/veya bu etken maddenin diger uygun aktif ajan/lar ile kombine tedavi olarak
kullanildigi farmasötik bilesim/ler ile ilgilidir.
Mevcut bulus, anti-paratiroid hormon ajani, vitamin D analogu olan Parikalsitol,
,7-dien-1,3-diol (Formül I) ve/veya farmasötik olarak kabul edilebilir türevleri oldugu
monoterapi olarak tek basina kullanildigi ve/veya bu etken maddenin diger uygun ajan/lar
ile kombine tedavi olarak kullanildigi farmasötik bilesim/ ler ile ilgilidir.
Formül I:
Ayrica bulus, Parikalsitol ve/veya farmasötik olarak kabul edilebilir türevlerinin
monoterapi olarak tek basina kullanildigi veya bu etken maddenin diger uygun ajan/lar ile
kombine tedavi olarak kullanildigi farmasötik bilesim/lerin oral ve/veya parenteral
uygulama için uygun olan formülasyonlarmi ve profilaktik ve/veya semptomatik ve/veya
terapötik kullanimlarini da kapsamaktadir.
ÖNCEKI TEKNIK (TEKNIGIN BILINEN DURUMU)
Kronik böbrek yetmezligi (KBY), glomerül filtrasyon hizinin (GFR) böbrek
fonksiyonlarinda tespit edilebilir düzeyde degisikliklere neden olacak kadar, kalici bir
sekilde azaldigi durum olarak tanimlanabilir.
Parikalsitol D vitamini bilesiktir. Paratiroid hormonu (PTH) olusumu ve salimini bloke
etmek suretiyle çalisir. Parikalsitol, sentetik bir D vitamini analogudur. Intravenöz yoldan
kronik böbrek hastaligi (5.düzey; diyalize gereksinim duyulan renal yetmezlik) ile iliskili
sekonder hiperparatirodizmin tedavi profilaksisinde kullanilir. Parikalsitol oral yoldan 3 ve
4. düzeydeki kronik böbrek yetmezligi ile iliskili hiperparatiroidizmin tedavi ve
önlenmesinde endikedir.
D vitamini reseptör aktivatörlerinin, vasküler kalsifikasyonunun nedenlerinden biri olan
sekonder hiperparatiroidism tedavisinde kullaniini yaygindir. Buna ragmen, tedavi edici
dozlari adinamik kemik hastaligi, hiperkalsemi ve/veya hiperfosfatemiye yol açmak
suretiyle vasküler kalsifikasyona neden olmaktadir (Goodman WG, Ramirez JA, Belin TR,
Chon Y, Gales B, Segre GV, et al. Development of adyiiamic bone in patients with secondary
LD, Yohay DA, Carroll BA, Spritzer CE, Minda SA, Bartholoniay D, et al. Prospective trial of
pulse oral versus intravenous calcitriol treatinent of hyperparathyroidisin in ESRD. Kidney Int
baskilanmasi açisindan daha selektif oldugu ve ayni zamanda hiperkalsemi ve
hiperfosfatemi yapici etkisinin daha az oldugu bilinmektedir (Drüeke TB. Which vitamin D
Hiperparatiroidizm üç sekilde ortaya çikar;
0 Primer hiperparatiroidizm
o Sekonder hiperparatiroidizm
Sekonder hiperparatiroidizm, düsük kalsiyum veya yüksek fosfor düzeylerine bagli olarak
artis gösterir. Kronik böbrek yetmezliginin sik görülen bir komplikasyonudur
Sekonder hiperparatiroidizm (SHPT) son dönem böbrek hastaligi olan hastalarin büyük
kisminda böbreklerden D vitamini üretiminin azalmasina bagli olarak gelisir
(https: //WWW.abbott.coni.tr/tedavi_alanlari_ve_ilac/sekonder.aspx).
farmasötik sivi formülasyondan bahsedilmektedir.
USZOl4187520 numarali patent dökümaninda parenteral uygulama için hazirlanan aktif
madde ve yardimci maddelerden olusan farmasötik formülasyonda; D vitamininin aktif
madde olarak kullanildigi ve aktif maddenin parikalsitol veya bir asteri, izomeri, solvati,
hidrati veya polimorflarindan biri oldugundan bahsedilmektedir.
BULUSUN AÇIKLAMASI
Mevcut bulus; paratiroid hormonu (PTH) olusumu ve salimini bloke etmek, hemodiyalize
giren kronik böbrek yetmezligi olan hastalarda sekonder hiperparatiroidizm Önlenmesi ve
tedavisinin semptomatik ve/veya profilaktik ve/veya terapötik tedavisinde kullanilmak
üzere anti-paratiroid hormon ajani, vitamin D analogu olan uygun etken madde ve/veya
farmasötik olarak kabul edilebilir türevlerinin monoterapi olarak tek basina kullanildigi
ve/veya bu etken maddenin diger uygun aktif ajan/lar ile kombine tedavi olarak
kullanildigi farmasötik bilesim/ler ile ilgilidir.
Mevcut bulusun bir diger yönü; oral ve/veya parentera] kullanilmak üzere anti-paratiroid
hormon ajani, Vitamin D analogu olan uygun etken madde ve/veya farmasötik olarak kabul
edilebilir türevlerinin monoterapi olarak tek basina kullanildigi ve/veya bu etken maddenin
diger uygun aktif ajan/lar ile kombine tedavi olarak kullanildigi farmasötik bilesim/lerin
hazirlanmasi ile ilgilidir.
Bulusta kullanilan anti-paratiroid hormon ajani, Vitamin D analogu olan uygun etken
inadde bunlarla sinirli olmamakla birlikte, dokserkalsiferol, parikalsitol, kolekalsiferol,
ergokalsiferol, kalsitriol ve/veya farmasötik türevleri arasindan tercihen parikalsitol olarak
seçilir.
Bulusta “farmasötik olarak kabul edilebilir türevleri” terimi ile farmasötik olarak kabul
edilebilir uygun tuzlar, esterler, solvatlar, hidratlar, kompleksler, polimorflar,
enantiyomerler, önilaçlar, asit adisyon tuzlari, analoglar, izomerler, rasematlar, amidler,
enantiyomer tuzlari, bazik tuzlar, konjugeler, tautomerler, anhidratlar, anhidritler, bazlar,
asitler, eterler, kristal ve amorf formlar veya serbest formlarindan bir veya daha fazlasi
ifade edilinektedir.
Oral uygulama için hazirlanan farmasötik bilesim/ler 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 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 gibi bir dozaj sekli halinde
formüle edilebilir.
Mevcut bulusta oral kullanilmak üzere hazirlanan tablet/ler bir veya daha fazla kaplama
içerebilir.
Kaplanmis tabletler; etken maddeyi genellikle çekirdek kisminda, kismen çekirdekte ve
kismende kaplairiada 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 kaplainaya sahip olan sikistirilmis
tabletlerdir. Söz konusu kaplama renklendirilmis olabilir ve rahatsiz edici bir tada veya
kokuya sahip olan etkin maddelerin kaplaninasi 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 maskelenmesi
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 farmasötik forinülasyon bir veya daha fazla tabaka içerebilir. Yeterli terapötik
etkiyi saglamak ve yan etkileri minimuma indirmek ainaciyla ilacin saliminin kontrolünü
saglamak için tabakalar degistirilmis, kontrollü, uzatilmis, sürekli, hemen veya
geciktirilmis salimli bir farmasötik dozaj formlarinin bir veya daha fazlasi ile formüle
edilebilir.
Geciktirilmis salim sistemlerinde etkin maddenin sistemden salimi belli bir bölgede
olmaktadir. Genellikle enterik kapli tabletler için kullanilir.
Enterik kaplama formülasyonun stabilitesini arttirmak, asit kaynakli bozuninalari 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 (Avicel, 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 jelatin kapsüle doldurma veya granülün bir final ürün olarak
bir pakete yerlestirilerek kullaniini 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 Graiiülasyon: Yas granülasyoii 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 form 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 isleini su sirayi izlemektedir:
- 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 1/3ӟ diger toz karisimlarina karistirilir. Bunun nedeni tozlarin silindirlere
yapismasini engeller. Kaydiricmm 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 farmasötik 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 olmak 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 makinelerle 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,
formülasyon dogru dozda doldurulmalidir ve etkin madde hastanin tedavisi için kapsülden
yeterli miktarda salinmalidir. Sert jelatin kapsül forrnülasyonlarinin 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 jelatin
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.
Parenteral uygulama için hazirlanan farmasötik bilesim/ler, ampul, flakon, infüzyon veya
liyofilize toz içeren dozaj formlarinda olabilir.
Parenteral enjeksiyon intraperitonal, intravenöz, infüzyon, intramüsküler, subkutan veya
intradermal yollarla uygulanabilir.
Intravenöz (IV) enjeksiyon, enjektör içindeki ilacin igne araciligi ile dogrudan ven (toplar
damar) içerisine verilmesi islemidir. Ilaçlarin derhal etki etmesi istendigi acil durumlarda
(kardiak arrest gibi), hastanin ciddi enfeksiyon riski altinda oldugu durumlarda ilaçlarin
tedavi edici kan düzeylerinin devamli olarak saglanabilmesi için veya ilaçlarin yüksek
derecede alkali olup kas ve cilt alti dokusunu tahris ettigi durumlarda intravenöz yol
kullanilir.
lV yolun diger parenteral yollara göre önemli bir avantaji, büyük hacimdeki solüsyonlarin
bu yolla verilebilmesidir. Ayrica doku içine enjeksiyon agri yapan veya nekroza neden
olabilen bazi irritan ilaçlari, intravenöz olarak agri olusturmaksizin vermek mümkündür
(örnegin kanser tedavisinde kullanilan bazi ilaçlar) çünkü damar çeperi agrili uyaranlara
duyarsizdir ve ayrica ilaç igne ucundan çikar çikmaz kan ile dilüe olur; ancak, bu
nitelikteki ilaçlari verirken solüsyonun, damar disindaki doku içine kaçirilinamasina dikkat
edilmelidir.
Mevcut bulustaki hazirlanan farmasötik 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, aroma ajani, tatlandirici madde, viskozite arttirici madde, köpük önleyici ajan,
çözünürlük arttirici ajan, antistatik ajan, islatici madde, pH ayarlayici madde, renklendirici
madde, kaplama maddesi, çözücü, yumusatici madde, emülgatör, 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, neinlendirici 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, parafinler, 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, albumin, krospovidon, povidon,
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, sodyum 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
poliinerler, 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, maltodekstrin, 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,
gliseri] palmitostearat, sodyum benzoat, sodyum asetat, fuinarik 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, izomalt, 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 koruninasini saglayan maddeler olarak ifade edilmektedir.
Komyucu madde olarak 2-fen0ksietanol, sodyum benzoat, benzoik asit, benzil alkol,
etilendiamintetraasetik asit, sodyum inetil 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 bisülfit, sodyum sitrat, sodyuin 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,
inentan, anetol, tarçin, metil salisilat, okaliptal, adaçayi, bögürtlen, sitrus meyvalari veya
bunlarin karisiinlari 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, monoamonyum glisirrizinat, fruktoz, inaltitol, dekstroz, sükroz,
ksilitol, sorbitol, mannitol, laktoz, aspartam, 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, acacia, 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 emülsiyon, 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, aluminyum 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, magnezyum 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 saIlastirilmis 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
inonostearat, isopropil miristat, isopropil palmitat, ketostearil alkol, dimetikon, mineral
yaglar, beyaz kati parafm, 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, setil 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,
siklometikoii, digliseritler, dimetikon, disodyum monooleamido sülfosüksinat,
peiitaeritritol, gliseritler, gliseril moiiooleat, 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 monopalmitat, sorbitan palmitat, stearik asit, trietanolamin 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, polietileii glikol monostearat, 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. Geçirgenlestiriei madde olarak çökeltilinis 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 (örnegim d-karoten, ß-
karoten, likopen, lutein, zeaksantin), mineraller (Se, Zn), butil hidroksi anisol (BHA), butil
hidroksi toluen (BHT), etilgalat, propilgalat, dodesilgalat, taurin, organosülfiir 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 aniiiiler, 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
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, 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 hidroksibenzoat, sodyum propil para hidroksibenzoat,
benzalkonyuin 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-polivinil
alkol kopolimeri, poliakrilik asit türevleri, polisakkarit türevleri, metakrilat polimeri,
polimetakrilat, etil metakrilat kopolimeri, metakrilik asit-metilmetakrilat kopoliineri,
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 inetakrilik 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 geçiinli 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
moiiogliseridler veya bunlarin karisimlari kullanilabilir.
Bulusta “antiadherent” terimi, pürüzlü tablet yüzeyi olusmasini önleyen maddeler olarak
ifade edilmektedir. Antiadherent olarak; talk, kolloidal silikon 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;
poliviiiil 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 diainin tetraasetik
asit (EDTA), dietilen triamin penta asetik asit veya bunlarin karisimlari kullanilabilir.
Mevcut bulustaki uygun etken madde ve/veya farmasötik olarak kabul edilebilir türevlerini
içeren farmasötik bilesimlerdeki Parikalsitol miktari; 0,1-500mcg tercihen lmcg, 2mcg,
4mcg, Smcg, 10mcg olup hastanin bireysel ihtiyaçlarina ve uzmanin degerlendirilmesine
göre ayarlanmaktadir.
Bulus esas olarak oral ve/veya parenteral kullanilmak üzere anti-paratiroid horinon ajani,
Vitamin D analogu olan Parikalsitol ve/veya farmasötik olarak kabul edilebilir türevlerinin
monoterapi olarak tek basina kullanildigi ve/veya bu etken maddenin diger uygun aktif
ajan/lar ile kombine tedavi olarak kullanildigi farmasötik bilesim/lerin hazirlanmasiyla
ilgilidir. Bulusun parenteral uygulama için hazirlanan farmasötik bilesim/lerinin ampul
formunda olmasi temeldir. Bulusun bir diger özelligi oral uygulama için hazirlanan
farmasötik bilesim/lerin tercihen tablet ve/veya kapsül formunda olmasidir. Böylece elde
edilen farmasötik formülasyon/lar sasirtici bir sekilde fiziksel ve kimyasal kararlilik
açisindan oldukça stabil bir davranis sergilemistir. Ayrica yeterli terapötik etkiyi saglama
ve yan etkileri minumuina indirmek için sasirtici bir sekilde etkili olduklari belirlenmistir.
Claims (10)
- . Oral ve/veya parenteral kullanilmak üzere anti-paratiroid horinon ajani, vitamin D analogu olan uygun etken madde ve/veya farmasötik olarak kabul edilebilir türevlerinin monoterapi olarak tek basina kullanildigi ve/veya bu etken maddenin diger uygun aktif ajan/lar ile kombine tedavi olarak kullanildigi farmasötik bilesim/lerin hazirlanmasi
- . Istem 1”deki gibi farmasötik bilesim/ler olup özelligi; anti-paratiroid hormon ajani, vitamin D analogu olan uygun etken maddenin dokserkalsiferol, parikalsitol, kolekalsiferol, ergokalsiferol, kalsitriol ve/veya farmasötik olarak kabul edilebilir türevleri arasindan seçilmesidir.
- . Istem l”deki gibi farmasötik bilesim/ler olup özelligi; anti-paratiroid hormon ajani, vitamin D analogu olan uygun etken maddenin tercihen parikalsitol 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 saliinli, 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, sprey, ampul, flakon, infüzyon veya liyofilize toz arasindan seçilen bir veya daha fazla farmasötik dozaj formunu içermesidir.
- . Istem l,deki gibi fannasötik bilesim/ler olup özelligi; oral kullanilmak üzere hazirlanan farmasötik bilesim/ lerin tercihen tablet ve/Veya kapsül formunda olmasidir.
- . Istem l”deki gibi farmasötik bilesim/ler olup özelligi; parenteral kullanilmak üzere hazirlanan farmasötik bilesim/ lerin tercihen ampul formunda olmasidir.
- . Istem 1'de belirtilen farmasötik bilesim/ler olup özelligi; parenteral uygulamanin intraperitonal, intravenöz, infüzyon, intramüsküler, subkutan veya intraderinal uygulama yollari arasindan seçilmesidir.
- . Istem 77de belirtilen farmasötik bilesim/ler olup özelligi; parenteral uygulamanin tercihen intravenöz uygulama olmasidir.
- 9. Yukaridaki istemlerden herhangi birine göre farmasötik bilesim/ler olup Özelligi; Parikalsitol ve/veya farmasötik olarak kabul edilebilir türevlerini içeren farrnasötik bilesimlerdeki parikalsitol miktarinin O.1-500mcg olmasidir.
- 10. Yukaridaki istemlerden herhangi birine göre fannasötik bilesim/ler olup özelligi; 5 paratiroid hormonu (PTH) olusumu ve salimini bloke etmek, hemodiyalize giren kronik böbrek yetmezligi olan hastalarda sekonder hiperparatiroidizm önlenmesi ve tedavisinin semptomatik ve/veya profilaktik ve/veya terapötik tedavisinde endike olmasidir.
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