Preclinical safety of negatively charged microspheres (NCMs): Optimization of radiolabeling for in vivo and ex vivo biodistribution studies after topical administration on full-thickness wounds in a rat model
[Display omitted] Negatively charged microspheres (NCMs) are postulated as a new form of treatment for chronic wounds. Despite the efficacy shown at clinical level, more studies are required to demonstrate their safety and local effect. The objective of the work was to confirm the lack of NCM system...
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Published in | European journal of pharmaceutics and biopharmaceutics Vol. 177; pp. 61 - 67 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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Elsevier B.V
01.08.2022
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Abstract | [Display omitted]
Negatively charged microspheres (NCMs) are postulated as a new form of treatment for chronic wounds. Despite the efficacy shown at clinical level, more studies are required to demonstrate their safety and local effect. The objective of the work was to confirm the lack of NCM systemic absorption performing a biodistribution study of the NCMs in an open wound rat animal model. To this end, radiolabeling of NCMs with technetium-99 m was optimized and biodistribution studies were performed by in vivo SPEC/CT imaging and ex vivo counting during 24 h after topical administration. The studies were performed on animals treated with a single or repeated dose to study the effect of macrophages during a prolonged treatment. NCM radiolabeling was achieved in a simple, efficient and stable manner with high yield. SPECT/CT images showed that almost all NCMs (about 85 %) remained on the wound for 24 h either after single or multiple administrations. Ex vivo biodistribution studies confirmed that there was no accumulation of NCMs in any organ or tissue except in the wound area, suggesting a lack of absorption. In conclusion, NCMs can be considered safe as local wound treatment since they remain at the administration area. |
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AbstractList | Negatively charged microspheres (NCMs) are postulated as a new form of treatment for chronic wounds. Despite the efficacy shown at clinical level, more studies are required to demonstrate their safety and local effect. The objective of the work was to confirm the lack of NCM systemic absorption performing a biodistribution study of the NCMs in an open wound rat animal model. To this end, radiolabeling of NCMs with technetium-99m was optimized and biodistribution studies were performed by in vivo SPEC/CT imaging and ex vivo counting during 24 h after topical administration. The studies were performed on animals treated with a single or repeated dose to study the effect of macrophages during a prolonged treatment. NCM radiolabeling was achieved in a simple, efficient and stable manner with high yield. SPECT/CT images showed that almost all NCMs (about 85 %) remained on the wound for 24 h either after single or multiple administrations. Ex vivo biodistribution studies confirmed that there was no accumulation of NCMs in any organ or tissue except in the wound area, suggesting a lack of absorption. In conclusion, NCMs can be considered safe as local wound treatment since they remain at the administration area. [Display omitted] Negatively charged microspheres (NCMs) are postulated as a new form of treatment for chronic wounds. Despite the efficacy shown at clinical level, more studies are required to demonstrate their safety and local effect. The objective of the work was to confirm the lack of NCM systemic absorption performing a biodistribution study of the NCMs in an open wound rat animal model. To this end, radiolabeling of NCMs with technetium-99 m was optimized and biodistribution studies were performed by in vivo SPEC/CT imaging and ex vivo counting during 24 h after topical administration. The studies were performed on animals treated with a single or repeated dose to study the effect of macrophages during a prolonged treatment. NCM radiolabeling was achieved in a simple, efficient and stable manner with high yield. SPECT/CT images showed that almost all NCMs (about 85 %) remained on the wound for 24 h either after single or multiple administrations. Ex vivo biodistribution studies confirmed that there was no accumulation of NCMs in any organ or tissue except in the wound area, suggesting a lack of absorption. In conclusion, NCMs can be considered safe as local wound treatment since they remain at the administration area. |
Author | Erhard, Álvaro Quincoces, Gemma Navas, Cristina Gainza, Garazi Peñuelas, Iván Vairo, Claudia Collantes, María Pareja, Félix Ecay, Margarita Villullas, Silvia |
Author_xml | – sequence: 1 givenname: María surname: Collantes fullname: Collantes, María email: mcollant@unav.es organization: Translational Molecular Imaging Unit (UNIMTRA), Clínica Universidad de Navarra, Avenida Pío XII, 31080 Pamplona, Spain – sequence: 2 givenname: Claudia surname: Vairo fullname: Vairo, Claudia organization: BioKeralty Research Institute AIE, Albert Einstein, 25-E3, 01510 Miñano, Spain – sequence: 3 givenname: Álvaro surname: Erhard fullname: Erhard, Álvaro organization: Translational Molecular Imaging Unit (UNIMTRA), Clínica Universidad de Navarra, Avenida Pío XII, 31080 Pamplona, Spain – sequence: 4 givenname: Cristina surname: Navas fullname: Navas, Cristina organization: Translational Molecular Imaging Unit (UNIMTRA), Clínica Universidad de Navarra, Avenida Pío XII, 31080 Pamplona, Spain – sequence: 5 givenname: Silvia surname: Villullas fullname: Villullas, Silvia organization: BioKeralty Research Institute AIE, Albert Einstein, 25-E3, 01510 Miñano, Spain – sequence: 6 givenname: Margarita surname: Ecay fullname: Ecay, Margarita organization: Translational Molecular Imaging Unit (UNIMTRA), Clínica Universidad de Navarra, Avenida Pío XII, 31080 Pamplona, Spain – sequence: 7 givenname: Félix surname: Pareja fullname: Pareja, Félix organization: Nuclear Medicine Department, Clínica Universidad de Navarra, Avenida Pío XII, 31080 Pamplona, Spain – sequence: 8 givenname: Gemma surname: Quincoces fullname: Quincoces, Gemma organization: RADIOMIN Research Group, Radiopharmacy Unit, Clínica Universidad de Navarra, Avenida Pío XII, 31080 Pamplona, Spain – sequence: 9 givenname: Garazi surname: Gainza fullname: Gainza, Garazi email: garazi.gainza@keralty.com organization: BioKeralty Research Institute AIE, Albert Einstein, 25-E3, 01510 Miñano, Spain – sequence: 10 givenname: Iván surname: Peñuelas fullname: Peñuelas, Iván organization: Translational Molecular Imaging Unit (UNIMTRA), Clínica Universidad de Navarra, Avenida Pío XII, 31080 Pamplona, Spain |
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Keywords | DTPA Radiolabeling TLC SnCl2 VOIs Wound Biodistribution Technetium-99m SPECT SPECT/CT [99mTc]TcO4 Negatively charged microspheres 99mTc-NCMs Topical administration NCMs biodistribution wound radiolabeling negatively charged microspheres topical administration technetium-99m |
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Negatively charged microspheres (NCMs) are postulated as a new form of treatment for chronic wounds. Despite the efficacy shown at clinical... Negatively charged microspheres (NCMs) are postulated as a new form of treatment for chronic wounds. Despite the efficacy shown at clinical level, more studies... |
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Title | Preclinical safety of negatively charged microspheres (NCMs): Optimization of radiolabeling for in vivo and ex vivo biodistribution studies after topical administration on full-thickness wounds in a rat model |
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