[Solutions for organ preservation and other cardioplegic liquid formulations. Role of the hospital pharmacist].
Solid organ transplantation is an increasing need and a well-established activity which requires maintaining the quality of the transplant from procurement through the entire, storage, transport and graft procedure. Solutions for organ preservation play a key role in this procedure, by minimizing the deleterious effects of both ischemia and reperfusion. As such, their qualitative and quantitative compositions have to be optimized and validated. The development strategy and formulations proposed for these solutions are analyzed in this review as well as the results of the clinical studies which have set up the relevant pharmacological and physicochemical criteria. The French regulatory status of these products is also discussed. A clear distinction has to be made between solutions for organ preservation which are classified as produits thérapeutiques annexes (therapeutic ancillary products) and cardioplegic liquid formulations which are considered as medicinal products and are subject to marketing approval. Finally, the roles of the hospital pharmacist in the evaluation, selection, purchase and proper use of these products are described.
Pradeau
D
D
Laboratoire de développement analytique et galénique, Ageps, 7, rue du Fer à Moulin, 75221 Paris cedex 05, France. dominique.pradeau@eps.aphp.fr
Stocco
J
J
Chaumeil
J-C
JC
D002314:Cardioplegic Solutions / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D006801:Humans; D019188:Organ Preservation Solutions / Q000737:chemistry*; D010595:Pharmacists; D010607:Pharmacy Service, Hospital; D015427:Reperfusion Injury / Q000503:physiopathology / Q000517:prevention & control; D014180:Transplantation / Q000009:adverse effects
D002314:Cardioplegic Solutions; D019188:Organ Preservation Solutions