MODİFİYE SALIMLI İSOSORBİT DİNİTRAT KÜRESEL GRANÜLLERİNİN ÜRETİMİ

Öz

Amaç: Bu çalışma, etkin maddenin kontrollü salımını yapan çok dozlu bir tıbbi form oluşturmak için farklı çözünme kinetiklerine sahip izosorbit dinitratın küresel matris pelletlerini elde etmeyi amaçlamıştır.

Gereç ve Yöntem: Küresel matris granüller ekstrüder-sferonizer yöntemi ile elde edilmiş ve farklı miktarlarda polimer kabuk ile kaplanmıştır. Elde edilen kürelerin çözünme profilleri, referans ilaç tabletleri ile karşılaştırılmıştır.

Sonuç ve Tartışma: Sonuçlar, küresel granüllerin kombinasyonunun, Cardicet Retard tabletlerinin çözünmesine benzer bir izosorbit dinitrat salım profili sağladığını göstermiştir. Hedef çözünme profili, kaplanmamış küresel granüller ve % 10'luk film kaplı kürelerin bir kombinasyonu kullanılarak elde edilmiştir. Benzerlik katsayısı (f2) 73.6'dır.

Anahtar Kelimeler

• İsosorbit dinitrat
• salım profili
• küresel matriks pelletler

MANUFACTURE OF SPHERICAL GRANULES OF ISOSORBIDE DINITRATE WITH MODIFIED RELEASE

Öz

Objective: This study was aimed to obtain spherical matrix pellets of isosorbide dinitrate with different dissolution kinetics to create a multidosage medicinal form with controlled release of the active substance.

Material and Method: Spherical matrix granules were obtained by extrusion-spherinization and coated with different amounts of polymer shell. Dissolution profiles of the obtained spheroids were compared with reference drug tablets.

Result and Discussion: The results showed that the combination of spherical granules provides an isosorbide dinitrate release profile similar to the dissolution of Cardicet Retard tablets. The target dissolution profile is achieved using a combination of uncoated spherical granules and spheroids with a 10% film coating. The similarity coefficient (f2) is 73.6.

Anahtar Kelimeler

• Isosorbide dinitrate
• release profile
• spherical matrix pellets

Kaynakça

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