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地拉罗司对铁质积聚有多大的疗效呢?

Author: Medicalhalo
Release time: 2025-10-19 11:44:20

Developed by Novartis and currently the only oral iron chelator, deferasirox was approved by the FDA in November 2005 for use in patients 2 years and older with chronic iron overload caused by blood transfusions. Deferasirox was approved by the European Commission in December 2012. Deferasirox is used to treat chronic iron overload in patients aged 10 and above with non-transfusion-dependent thalassemia (NTDT) syndrome who require chelation therapy due to contraindications or insufficiency of deferoxamine mesylate therapy. Deferasirox is a commonly used drug to relieve iron accumulation.

The clinical study screened and optimized the prescription of deferasirox dispersible tablets. The disintegration time limit and 30-minute cumulative dissolution were used as inspection indicators. The dosage of diluent microcrystalline cellulose (MCC) and lactose, the mass ratio of disintegrant cross-linked povidone (PVPP), and the dosage of cosolvent sodium dodecyl sulfate (SDS) were used as factors. The L9(34) orthogonal test table was used to design the test plan. The prescription of deferasirox dispersible tablets was screened and verified. The results showed that the optimized prescription was 12.5% ​​MCC, 27.5% lactose, 18% PVPP (internally added), and 1.0% SDS. In the verification test, deferasirox dispersible tablets completely disintegrated within 120 s, with an average 30-minute cumulative dissolution of 86.0%, which has great advantages over ordinary tablets. It can be seen that the dissolution rate, disintegration time and other indicators of deferasirox dispersible tablets prepared according to this prescription meet the requirements.

Deferasirox adverse reactions >10% Increased serum creatinine, abdominal pain, nausea, vomiting, diarrhea, proteinuria, irritation, headache, cough, nasopharyngitis, sore throat, influenza, rash; 1-10% respiratory infection, bronchitis, increased ALT, joint pain, back pain, acute Tonsillitis, rhinitis, fatigue, ear infection, transaminases, urticaria; <1% allergic reaction angioedema, cytopenia including agranulocytosis, neutropenia, thrombocytopenia, leukocytoclastic vasculitis.

Storage: Store at room temperature 25°C (77°F); excursions allowed 15-30°C (59-86°F). Protect from moisture.

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