Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the <sup>68</sup>Zn(p,n)<sup>68</sup>Ga Reaction and Their Regulatory Aspects
Designing and implementing various radionuclide production methods guarantees a sustainable supply, which is important for medical use. The use of medical cyclotrons for radiometal production can increase the availability of gallium-68 (<sup>68</sup>Ga) radiopharmaceuticals. Although gen...
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| Format: | Article |
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MDPI AG
2022-12-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/15/1/70 |
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| author | Zarif Ashhar Muhammad Fakhrurazi Ahmad Fadzil Muhamad Faiz Othman Nor Azah Yusof Muhammad Adib Abdul Onny Noratikah Mat Ail Siti Fatimah Abd Rahman |
| author_facet | Zarif Ashhar Muhammad Fakhrurazi Ahmad Fadzil Muhamad Faiz Othman Nor Azah Yusof Muhammad Adib Abdul Onny Noratikah Mat Ail Siti Fatimah Abd Rahman |
| author_sort | Zarif Ashhar |
| collection | DOAJ |
| description | Designing and implementing various radionuclide production methods guarantees a sustainable supply, which is important for medical use. The use of medical cyclotrons for radiometal production can increase the availability of gallium-68 (<sup>68</sup>Ga) radiopharmaceuticals. Although generators have greatly influenced the demand for <sup>68</sup>Ga radiopharmaceuticals, the use of medical cyclotrons is currently being explored. The resulting <sup>68</sup>Ga production is several times higher than obtained from a generator. Moreover, the use of solid targets yields end of purification and end of synthesis (EOS) of up to 194 GBq and 72 GBq, respectively. Furthermore, experiments employing liquid targets have provided promising results, with an EOS of 3 GBq for [<sup>68</sup>Ga]Ga-PSMA-11. However, some processes can be further optimized, specifically purification, to achieve high <sup>68</sup>Ga recovery and apparent molar activity. In the future, <sup>68</sup>Ga will probably remain one of the most in-demand radionuclides; however, careful consideration is needed regarding how to reduce the production costs. Thus, this review aimed to discuss the production of <sup>68</sup>Ga radiopharmaceuticals using Advanced Cyclotron Systems, Inc. (ACSI, Richmond, BC, Canada) Richmond, Canada and GE Healthcare, Wisconsin, USA cyclotrons, its related factors, and regulatory concerns. |
| first_indexed | 2024-03-09T11:28:28Z |
| format | Article |
| id | doaj.art-66d20ac142c243228c170678376925ba |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-09T11:28:28Z |
| publishDate | 2022-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-66d20ac142c243228c170678376925ba2023-11-30T23:57:14ZengMDPI AGPharmaceutics1999-49232022-12-011517010.3390/pharmaceutics15010070Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the <sup>68</sup>Zn(p,n)<sup>68</sup>Ga Reaction and Their Regulatory AspectsZarif Ashhar0Muhammad Fakhrurazi Ahmad Fadzil1Muhamad Faiz Othman2Nor Azah Yusof3Muhammad Adib Abdul Onny4Noratikah Mat Ail5Siti Fatimah Abd Rahman6Pharmacy Department, National Cancer Institute, Putrajaya 62250, MalaysiaPharmacy Department, National Cancer Institute, Putrajaya 62250, MalaysiaFaculty of Pharmacy, Universiti Teknologi Mara, Puncak Alam 42300, MalaysiaDepartment of Chemistry, Faculty of Science, Universiti Putra Malaysia, Serdang 43400, MalaysiaNuclear Medicine Department, National Cancer Institute, Putrajaya 62250, MalaysiaPharmacy Department, National Cancer Institute, Putrajaya 62250, MalaysiaSchool of Electrical and Electronic Engineering, Engineering Campus, Universiti Sains Malaysia, Nibong Tebal 14300, MalaysiaDesigning and implementing various radionuclide production methods guarantees a sustainable supply, which is important for medical use. The use of medical cyclotrons for radiometal production can increase the availability of gallium-68 (<sup>68</sup>Ga) radiopharmaceuticals. Although generators have greatly influenced the demand for <sup>68</sup>Ga radiopharmaceuticals, the use of medical cyclotrons is currently being explored. The resulting <sup>68</sup>Ga production is several times higher than obtained from a generator. Moreover, the use of solid targets yields end of purification and end of synthesis (EOS) of up to 194 GBq and 72 GBq, respectively. Furthermore, experiments employing liquid targets have provided promising results, with an EOS of 3 GBq for [<sup>68</sup>Ga]Ga-PSMA-11. However, some processes can be further optimized, specifically purification, to achieve high <sup>68</sup>Ga recovery and apparent molar activity. In the future, <sup>68</sup>Ga will probably remain one of the most in-demand radionuclides; however, careful consideration is needed regarding how to reduce the production costs. Thus, this review aimed to discuss the production of <sup>68</sup>Ga radiopharmaceuticals using Advanced Cyclotron Systems, Inc. (ACSI, Richmond, BC, Canada) Richmond, Canada and GE Healthcare, Wisconsin, USA cyclotrons, its related factors, and regulatory concerns.https://www.mdpi.com/1999-4923/15/1/70cyclotron targetryradiopharmaceuticalsolid targetliquid targetGood Manufacturing Practices (GMP) |
| spellingShingle | Zarif Ashhar Muhammad Fakhrurazi Ahmad Fadzil Muhamad Faiz Othman Nor Azah Yusof Muhammad Adib Abdul Onny Noratikah Mat Ail Siti Fatimah Abd Rahman Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the <sup>68</sup>Zn(p,n)<sup>68</sup>Ga Reaction and Their Regulatory Aspects Pharmaceutics cyclotron targetry radiopharmaceutical solid target liquid target Good Manufacturing Practices (GMP) |
| title | Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the <sup>68</sup>Zn(p,n)<sup>68</sup>Ga Reaction and Their Regulatory Aspects |
| title_full | Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the <sup>68</sup>Zn(p,n)<sup>68</sup>Ga Reaction and Their Regulatory Aspects |
| title_fullStr | Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the <sup>68</sup>Zn(p,n)<sup>68</sup>Ga Reaction and Their Regulatory Aspects |
| title_full_unstemmed | Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the <sup>68</sup>Zn(p,n)<sup>68</sup>Ga Reaction and Their Regulatory Aspects |
| title_short | Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the <sup>68</sup>Zn(p,n)<sup>68</sup>Ga Reaction and Their Regulatory Aspects |
| title_sort | cyclotron production of gallium 68 radiopharmaceuticals using the sup 68 sup zn p n sup 68 sup ga reaction and their regulatory aspects |
| topic | cyclotron targetry radiopharmaceutical solid target liquid target Good Manufacturing Practices (GMP) |
| url | https://www.mdpi.com/1999-4923/15/1/70 |
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