Process Development for GMP-Grade Full Extract Cannabis Oil: Towards Standardized Medicinal Use
<b>Background/Objectives:</b> The industrial extraction and purification processes of <i>Cannabis sativa</i> L. compounds are critical steps in creating formulations with reliable and reproducible therapeutic and sensorial attributes. <b>Methods:</b> For this stud...
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MDPI AG
2025-06-01
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| Online Access: | https://www.mdpi.com/1999-4923/17/7/848 |
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| author | Maria do Céu Costa Ana Patrícia Gomes Iva Vinhas Joana Rosa Filipe Pereira Sara Moniz Elsa M. Gonçalves Miguel Pestana Mafalda Silva Luís Monteiro Rodrigues Anthony DeMeo Logan Marynissen António Marques da Costa Patrícia Rijo Michael Sassano |
| author_facet | Maria do Céu Costa Ana Patrícia Gomes Iva Vinhas Joana Rosa Filipe Pereira Sara Moniz Elsa M. Gonçalves Miguel Pestana Mafalda Silva Luís Monteiro Rodrigues Anthony DeMeo Logan Marynissen António Marques da Costa Patrícia Rijo Michael Sassano |
| author_sort | Maria do Céu Costa |
| collection | DOAJ |
| description | <b>Background/Objectives:</b> The industrial extraction and purification processes of <i>Cannabis sativa</i> L. compounds are critical steps in creating formulations with reliable and reproducible therapeutic and sensorial attributes. <b>Methods:</b> For this study, standardized preparations of chemotype I were chemically analyzed, and the sensory attributes were studied to characterize the extraction and purification processes, ensuring the maximum retention of cannabinoids and minimization of other secondary metabolites. The industrial process used deep-cooled ethanol for selective extraction. <b>Results:</b> Taking into consideration that decarboxylation occurs in the process, the cannabinoid profile composition was preserved from the herbal substance to the herbal preparations, with wiped-film distillation under deep vacuum conditions below 0.2 mbar, as a final purification step. The profiles of the terpenes and cannabinoids in crude and purified Full-spectrum Extract Cannabis Oil (FECO) were analyzed at different stages to evaluate compositional changes that occurred throughout processing. Subjective intensity and acceptance ratings were received for taste, color, overall appearance, smell, and mouthfeel of FECO preparations. <b>Conclusions:</b> According to sensory analysis, purified FECO was more accepted than crude FECO, which had a stronger and more polarizing taste, and received higher ratings for color and overall acceptance. In contrast, a full cannabis extract in the market resulted in lower acceptance due to taste imbalance. The purification process effectively removed non-cannabinoids, improving sensory quality while maintaining therapeutic potency. Terpene markers of the flower were remarkably preserved in SOMAÍ’s preparations’ fingerprint, highlighting a major qualitative profile reproducibility and the opportunity for their previous separation and/or controlled reintroduction. The study underscores the importance of monitoring the extraction and purification processes to optimize the cannabinoid content and sensory characteristics in cannabis preparations. |
| format | Article |
| id | doaj-art-45cb2c7427e34799994a4fe07aa5e086 |
| institution | DOAJ |
| issn | 1999-4923 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj-art-45cb2c7427e34799994a4fe07aa5e0862025-08-20T02:47:05ZengMDPI AGPharmaceutics1999-49232025-06-0117784810.3390/pharmaceutics17070848Process Development for GMP-Grade Full Extract Cannabis Oil: Towards Standardized Medicinal UseMaria do Céu Costa0Ana Patrícia Gomes1Iva Vinhas2Joana Rosa3Filipe Pereira4Sara Moniz5Elsa M. Gonçalves6Miguel Pestana7Mafalda Silva8Luís Monteiro Rodrigues9Anthony DeMeo10Logan Marynissen11António Marques da Costa12Patrícia Rijo13Michael Sassano14CBIOS—Universidade Lusófona’s Research Center for Biosciences & Health Technologies, Campo Grande 376, 1749-024 Lisboa, PortugalCBIOS—Universidade Lusófona’s Research Center for Biosciences & Health Technologies, Campo Grande 376, 1749-024 Lisboa, PortugalSOMAÍ Pharmaceuticals, R. 13 de Maio 52, 2580-507 Carregado, PortugalSOMAÍ Pharmaceuticals, R. 13 de Maio 52, 2580-507 Carregado, PortugalSOMAÍ Pharmaceuticals, R. 13 de Maio 52, 2580-507 Carregado, PortugalSOMAÍ Pharmaceuticals, R. 13 de Maio 52, 2580-507 Carregado, PortugalINIAV, Instituto Nacional de Investigação Agrária e Veterinária I.P., Quinta do Marquês, 2780-157 Oeiras, PortugalINIAV, Instituto Nacional de Investigação Agrária e Veterinária I.P., Quinta do Marquês, 2780-157 Oeiras, PortugalINIAV, Instituto Nacional de Investigação Agrária e Veterinária I.P., Quinta do Marquês, 2780-157 Oeiras, PortugalCBIOS—Universidade Lusófona’s Research Center for Biosciences & Health Technologies, Campo Grande 376, 1749-024 Lisboa, PortugalSOMAÍ Pharmaceuticals, R. 13 de Maio 52, 2580-507 Carregado, PortugalSOMAÍ Pharmaceuticals, R. 13 de Maio 52, 2580-507 Carregado, PortugalSOMAÍ Pharmaceuticals, R. 13 de Maio 52, 2580-507 Carregado, PortugalCBIOS—Universidade Lusófona’s Research Center for Biosciences & Health Technologies, Campo Grande 376, 1749-024 Lisboa, PortugalSOMAÍ Pharmaceuticals, R. 13 de Maio 52, 2580-507 Carregado, Portugal<b>Background/Objectives:</b> The industrial extraction and purification processes of <i>Cannabis sativa</i> L. compounds are critical steps in creating formulations with reliable and reproducible therapeutic and sensorial attributes. <b>Methods:</b> For this study, standardized preparations of chemotype I were chemically analyzed, and the sensory attributes were studied to characterize the extraction and purification processes, ensuring the maximum retention of cannabinoids and minimization of other secondary metabolites. The industrial process used deep-cooled ethanol for selective extraction. <b>Results:</b> Taking into consideration that decarboxylation occurs in the process, the cannabinoid profile composition was preserved from the herbal substance to the herbal preparations, with wiped-film distillation under deep vacuum conditions below 0.2 mbar, as a final purification step. The profiles of the terpenes and cannabinoids in crude and purified Full-spectrum Extract Cannabis Oil (FECO) were analyzed at different stages to evaluate compositional changes that occurred throughout processing. Subjective intensity and acceptance ratings were received for taste, color, overall appearance, smell, and mouthfeel of FECO preparations. <b>Conclusions:</b> According to sensory analysis, purified FECO was more accepted than crude FECO, which had a stronger and more polarizing taste, and received higher ratings for color and overall acceptance. In contrast, a full cannabis extract in the market resulted in lower acceptance due to taste imbalance. The purification process effectively removed non-cannabinoids, improving sensory quality while maintaining therapeutic potency. Terpene markers of the flower were remarkably preserved in SOMAÍ’s preparations’ fingerprint, highlighting a major qualitative profile reproducibility and the opportunity for their previous separation and/or controlled reintroduction. The study underscores the importance of monitoring the extraction and purification processes to optimize the cannabinoid content and sensory characteristics in cannabis preparations.https://www.mdpi.com/1999-4923/17/7/848medicinal cannabisdeep-cooled ethanolextraction flow chartsensory evaluationfull-spectrum cannabinoid extractcannabinoids |
| spellingShingle | Maria do Céu Costa Ana Patrícia Gomes Iva Vinhas Joana Rosa Filipe Pereira Sara Moniz Elsa M. Gonçalves Miguel Pestana Mafalda Silva Luís Monteiro Rodrigues Anthony DeMeo Logan Marynissen António Marques da Costa Patrícia Rijo Michael Sassano Process Development for GMP-Grade Full Extract Cannabis Oil: Towards Standardized Medicinal Use Pharmaceutics medicinal cannabis deep-cooled ethanol extraction flow chart sensory evaluation full-spectrum cannabinoid extract cannabinoids |
| title | Process Development for GMP-Grade Full Extract Cannabis Oil: Towards Standardized Medicinal Use |
| title_full | Process Development for GMP-Grade Full Extract Cannabis Oil: Towards Standardized Medicinal Use |
| title_fullStr | Process Development for GMP-Grade Full Extract Cannabis Oil: Towards Standardized Medicinal Use |
| title_full_unstemmed | Process Development for GMP-Grade Full Extract Cannabis Oil: Towards Standardized Medicinal Use |
| title_short | Process Development for GMP-Grade Full Extract Cannabis Oil: Towards Standardized Medicinal Use |
| title_sort | process development for gmp grade full extract cannabis oil towards standardized medicinal use |
| topic | medicinal cannabis deep-cooled ethanol extraction flow chart sensory evaluation full-spectrum cannabinoid extract cannabinoids |
| url | https://www.mdpi.com/1999-4923/17/7/848 |
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