Batch preparation of a speciality to reconstitute: case of cyclophosphamide

Introduction

Cyclophosphamide (CPM) is the first International Nonproprietary Names prepared by the anticancer drugs preparation unit. Diluted in 0.9% NaCl, the preparation is stable during 28 days (Stabilis® 4.0) thus meeting the criteria for batch preparations. The unit, which owns BAXA® Repeater pump, has adopted in March 2014 a Pharmashaker® from Medical Dispensing Systems developed to reconstitute powder-form cytotoxic drugs automatically. The aim of our study was to define batches and procedure preparations of CPM while a checking the quality of the process to optimize our production.

Material and method

A retrospective study of prescribed doses of CPM was performed on the first quarter of 2014 from a mining Chimio® software. Analytical control preparations was performed by HPLC on separating column.

Results

The 3 most commonly prescribed dosages of CPM (44 % of prescriptions) are 1000 mg (76/month), 1200 mg (52/month) and 1400 mg (54/month). The preparation of 3 lots of 40 bags covers nearly 70 % of the monthly requirements of these dosages. The procedure, conditioned by the use of two facilities, requires an organization from D-1: reconstitution of vials with the Pharmashaker® and at D-Day: distribution of the mother pouch to daughter pouches with the pump. Quality aspect is improved: the results of analytical tests have been significantly better at 17 CPM campaigns ranging from ± 3 % versus ± 15 % for preparations magistral operator-dependent (16 hospital pharmacy technicians).

Discussion and Conclusion

Having lots of CPM is multiply important. This allows honoring almost 1 of 3 CPM prescription. The use of two devices enabled the production of large batches that were not feasible manually, while improving the working conditions of hospital pharmacy technicians (decrease risks of musculoskeletal disorders).