Multi-dose formulation and clinical deployment of [Y]Y-labeled hydroxyapatite (HA) microparticles for radiation synovectomy in India- the inherent intricacies.

The present article describes intricate details involved in the formulation and quality control of 113 ready to use doses of [Y]Y-labeled hydroxyapatite (HA) microparticles for clinical use in radiation synovectomy using Y produced by (n,γ) route. Yttrium-90 was produced with a specific activity of 720 ± 95 MBq/mg of Y and radionuclidic purity of >99.9%. Optimized protocol developed for one-step formulation of [Y]Y-HA microparticles was adopted to prepare the clinical doses (400 ± 50 MBq Y in each dose) in 20 batches. The radiochemical purity of the product was >99.0% in all 20 batches and all other quality control parameters were as per the monogram approved for its clinical use in India. More than 100 patients suffering from inflammatory joint diseases of mainly knee joints were treated with doses of [Y]Y-HA microparticles. Clinical investigations post-treatment demonstrated the effectiveness of the formulation in the management of the disease.