Comparative qualitative study between specialties of azacitidine available in France

Pacqueu L. 1, Beausir A.1, Nachon P.1, Le Joubioux A.1
1 CH Lens, France

We compared the different azacitidine specialties provided by 5 pharmaceutical companies ACCORD (ACD), MYLAN (MYL), ZENTIVA (ZTV), BETAPHARM (BTM), CELGENE (CLG). The comparison was focused on ease of manipulation, stability and cost.

For 1 month pharmacy assistants of our centralized cytotoxic production unit prepared azacitidine syringes according to summary of use. Manipulation criteria observed were: dissolution of the powder, formation of precipitate, thickness of septum, frequency of septum coring and loss of product. The suppliers were contacted in view of obtain complementary stability information in case of reconstitution with refrigerate water for injection, possibility of frosting syringes and stability after thawing. Prices were obtain by purchase central UniHA.

The dissolution was difficult for Azacitidine CLG and very difficult for Azacitidine MYL. Products provided by the 3 other companies were easy to dissolve and no precipitate was seen. Septum was difficult to pierce for MYL azacitidine and septum coring was occasionally seen. CLG Vidaza was reconstituted using a needle that occurred frequent septum coring. There was no loss of product with BTM azacitidine, contrary to other laboratories specialties (near to 0.2 ml per vial). Stabilities of syringes with product reconstituted with refrigerate water were 22h for CLG and MYL, 2 days for BTM, 3 days for ACD and 4 days for ZTV, when stored in a refrigerator. Only MYL, ZTV, ACD and BTM companies provided data about stabilities of freezed syringes: 8h to 3 days after thawing (storage between 2 and 8°C). Prices range from 39€ (MYL) to 122€ (CLG).

Handling of MYL azacitidine appears less easy than azacitidine from others companies for whom the main discriminating point was the quantity of loss per vial. Products from ACD and ZTV have longer stability when syringes are stored between 2 and 8°C, and thus enable to prepare syringes with anticipation. This can respond to a problematic of subcontracting and collaboration with home hospitalization structures.

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