TABLETING AND EVALUATION OF MULTIPLE-UNIT COMPOSITION OF ISOSORBIDE DINITRATE WITH MODIFIED RELEASE

Öz

Objective: This study was aimed to create a multiple-unit dosage form of isosorbide dinitrate by pressing spherical matrix granules into tablets, selecting the optimal technology parameters and evaluating the obtained tablets. Material and Method: The tablet cores were prepared from mixtures of active matrix granules and shock-absorbing auxiliary granules in various ratios using diverse tabletting forces. The dissolution profiles of the obtained tablet compositions were evaluated in comparison with the reference preparation. Result and Discussion: An optimal ratio of spheroids with the active component with auxiliary granules along with optimal compression parameters were determined. The resulting as multiple-unit tablets exhibited a release profile similar to that of Cardicket Retard. Used technological approach makes it possible to regulate the dissolution profile of tablets by changing the ratio of active granules with different kinetics of the active substance release.

Anahtar Kelimeler

• Active substance release profile
• as multiple-unit tablets
• isosorbide dinitrate
• spherical matrix granules

İZOSORBİD DİNİTRATIN MODİFİYE SALIM YAPAN ÇOK BİRİMLİ BİLEŞİMİNİN TABLET ŞEKLİNDE BASILMASI VE DEĞERLENDİRİLMESİ

Öz

Amaç: Bu çalışma, küresel matris granüllerinin tabletler şeklinde basılmasıyla izosorbid dinitratın çok birimli dozaj formunu oluşturmayı, optimum teknoloji parametrelerini seçmeyi ve elde edilen tabletleri değerlendirmeyi amaçlamıştır. Gereç ve Yöntem: Tablet çekirdekleri, çeşitli oranlarda ve çeşitli tabletleme kuvvetleri kullanılarak aktif matris granülleri ve yardımcı granüllerin karışımlarından hazırlandı. Elde edilen tablet bileşimlerinin çözünme hızı profilleri, referans ürün ile karşılaştırılarak değerlendirildi. Sonuç ve Tartışma: Used technological approach makes it possible to regulate the dissolution profile of tablets by changing the ratio of active granules with different kinetics of the active substance release. Aktif sferoidler ve yardımcı granüllerin optimum oranı, optimum basınç parametresi ile belirlendi. Elde edilen çok birimli tabletler Cardicket Retard'ınkine benzer etkin madde salım profili göstermişti. Kullanılan teknolojik yaklaşım, etkin maddenin farklı kinetiklerle salımı ile aktif granüllerin oranı kullanılarak tabletlerin çözünme profilini düzenlemeyi mümkün kılmaktadır.

Anahtar Kelimeler

• Aktif maddenin salım profili
• izosorbid dinitrat
• küresel matris granülleri
• multidozlu tabletler

Kaynakça

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