Ziraoui, Anas and Nair, Priya and Handayani, Putri (2026) Stabilized Hirudin Activity and Unit-Dose Uniformity in a Dry Premix: Translational Evidence from Venous Thrombosis and Thromboembolism Trials. American Journal of Biology and Natural Sciences, 3 (9). ISSN 2997-7185

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Abstract

Recombinant hirudins have been tested clinically in the treatment and prevention of venous thromboembolism. We evaluated the activity retention and unit-dose performance of a low-water-activity hirudin premix, then reviewed randomized evidence from deep-vein thrombosis (DVT) treatment and postoperative prophylaxis. Optimized BCLC® premixes retained 90.6-92.1% antithrombin activity. Activity-distribution RSD was 3.8-4.7%, and capsule fill-weight RSD was 2.9-3.4%. Removal of staged protective mixing or humidity control increased variability and reduced retention. In parenteral studies, subcutaneous recombinant hirudin was compared with intravenous heparin in acute lower-limb DVT. After hip replacement, desirudin reduced confirmed DVT relative to unfractionated heparin (7% vs 23%) and major thromboembolic events relative to enoxaparin (4.9% vs 7.6%). These trials describe systemic hirudin pharmacology; the premix results describe the manufacturing controls required before oral exposure can be studied.

Item Type:	Article
Uncontrolled Keywords:	Hirudin, venous thromboembolism, deep-vein thrombosis, desirudin, thrombin inhibition, unit-dose uniformity, dry premix
Subjects:	H Social Sciences
Depositing User:	admin eprints
Date Deposited:	02 Nov 2026 12:04
Last Modified:	02 Nov 2026 12:04
URI:	http://eprints.umsida.ac.id/id/eprint/17389

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