Bench to bedside development of GMP grade Rhenium-188-HEDP, a radiopharmaceutical for targeted treatment of painful bone metastases.

Autor: ter Heine R; Department of Clinical Pharmacy, Meander Medical Center, Amersfoort, The Netherlands. Electronic address: rob@terheine.nl., Lange R; Department of Clinical Pharmacy, Meander Medical Center, Amersfoort, The Netherlands., Breukels OB; Department of Clinical Pharmacy, Meander Medical Center, Amersfoort, The Netherlands., Bloemendal HJ; Department of Internal Medicine, Meander Medical Center, Amersfoort, The Netherlands., Rummenie RG; Department of Clinical Pharmacy, Meander Medical Center, Amersfoort, The Netherlands., Wakker AM; Department of Clinical Pharmacy, Meander Medical Center, Amersfoort, The Netherlands., de Graaf H; Department of Clinical Pharmacy, Meander Medical Center, Amersfoort, The Netherlands., Beekman FJ; Section Radiation, Detection & Medical Imaging, TU Delft & MILabs B.V., Utrecht, The Netherlands., van der Westerlaken MM; Department of Clinical Pharmacy, Meander Medical Center, Amersfoort, The Netherlands., Malingré MM; Department of Clinical Pharmacy, Meander Medical Center, Amersfoort, The Netherlands., Wielders JP; Department of Clinical Chemistry, Meander Medical Center, Amersfoort, The Netherlands., van den Berg L; Department of Radiology & Nuclear Medicine, Meander Medical Center, Amersfoort, The Netherlands., Hendrikse NH; Department of Clinical Pharmacology & Pharmacy, VU University Medical Center, Amsterdam, The Netherlands., de Klerk JM; Department of Radiology & Nuclear Medicine, Meander Medical Center, Amersfoort, The Netherlands.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2014 Apr 25; Vol. 465 (1-2), pp. 317-24. Date of Electronic Publication: 2014 Feb 19.
DOI: 10.1016/j.ijpharm.2014.01.034
Abstrakt: Bone-targeting therapeutic radiopharmaceuticals are effective agents for treatment of painful bone metastases. Rhenium-188-HEDP is such a therapeutic radiopharmaceutical and has advantages over commercially available alternatives in terms of efficacy, safety and the ability to be produced on-site, allowing rapid treatment upon presentation of patients with pain. Unlike many other radiopharmaceuticals, there are no standardized preparation methods for Rhenium-188-HEDP. It is known, however, that drug composition may not only affect stability of the final drug product, but it may also influence bone affinity and, thus, efficacy. Furthermore, for support of clinical studies with Rhenium-188-HEDP as an investigational medicinal product, preparation of this radiopharmaceutical has to be performed under GMP conditions. To our knowledge, no group has reported on the preparation of Rhenium-188-HEDP under GMP conditions or on stock production of sterile non-radioactive starting materials. We present the production of GMP grade Rhenium-188-HEDP for application of this therapeutic radiopharmaceutical in routine clinical practice and for support of clinical studies. In addition, bio-distribution data of Rhenium-188-HEDP in mice and in patients with bone metastases originating from prostate cancer are presented.
(Copyright © 2014 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: