{"title":"摘要已撤回","authors":"","doi":"10.1136/ejhpharm-2019-eahpconf.149","DOIUrl":null,"url":null,"abstract":"Background The emergence of novel potent active pharmaceutical ingredients (APIs) and genetic tests highlight the necessity of creating personalised medicinal formulations, containing amounts of APIs tailored to suit each patient’s individual needs. Also, polypharmacy and lack of adherence to pharmacotherapy indicates the need for manufacturing formulations that can incorporate more than one APIs to facilitate patient compliance. Purpose 3D printing of pharmaceutical formulations can provide a solution to the aforementioned issues. Moreover, the ability of 3D printing to create elaborate dosage forms paves the way for the introduction of complex formulations into clinical practice. With that perspective, we created three different pharmaceutical dosage forms via 3D printing. Material and methods For the creation of the 3D printed formulations a fused deposition modelling (FDM) 3D printer was used. The first formulation, a three-layered, ring-shaped formulation containing hydrochlorothiazide (HCTZ) aimed at inducing zero-order release kinetics of the API.1 The second one comprised an insoluble matrix with its bottom consisting of a polymer with pH-dependent solubility and loaded with beads containing the chemotherapeutic agent 5-Fluorouracil (5-FU). This formulation was designed to release the API at high pH values in order to select the site of release in the gastrointestinal tract.2 The third one incorporated two APIs with different dosage regimens (metformin and glimepiride) into matrices with distinct release properties for combined pharmacotherapy using a single dosage form (poly-pills).3 Dissolution tests were conducted in order to assess in vitro performance of the formulations, performed at conditions simulating different segments of human gastrointestinal tract according to USP specifications. Results All formulations were functional, as the first presented the desired zero-order release of HCTZ (R2=0.990), the second released 5-FU at pH values>7.2, indicating its capability for targeted colonic delivery, and the third one released both APIs within acceptable time margins (achieving immediate release of glimepiride and sustained release of metformin, in 2 and 8 hours respectively), indicating the potential for co-administration of APIs with different dosage regimens in the same personalised dosage form. Conclusion 3D printing can revolutionise pharmacotherapy in numerous ways. In this work we presented three of them: personalisation, API combination and release modulation by shape modifications. References and/or acknowledgements 1. https://www.sciencedirect.com/science/article/pii/S1773224717302721 2. https://link.springer.com/article/10.1208%2Fs12249-018-1084-2 3. https://www.sciencedirect.com/science/article/pii/S0928098718301799?via%3Dihub No conflict of interest.","PeriodicalId":335223,"journal":{"name":"Section 3: Production and Compounding","volume":"162 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"3PC-068 Abstract withdrawn\",\"authors\":\"\",\"doi\":\"10.1136/ejhpharm-2019-eahpconf.149\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background The emergence of novel potent active pharmaceutical ingredients (APIs) and genetic tests highlight the necessity of creating personalised medicinal formulations, containing amounts of APIs tailored to suit each patient’s individual needs. Also, polypharmacy and lack of adherence to pharmacotherapy indicates the need for manufacturing formulations that can incorporate more than one APIs to facilitate patient compliance. Purpose 3D printing of pharmaceutical formulations can provide a solution to the aforementioned issues. Moreover, the ability of 3D printing to create elaborate dosage forms paves the way for the introduction of complex formulations into clinical practice. With that perspective, we created three different pharmaceutical dosage forms via 3D printing. Material and methods For the creation of the 3D printed formulations a fused deposition modelling (FDM) 3D printer was used. The first formulation, a three-layered, ring-shaped formulation containing hydrochlorothiazide (HCTZ) aimed at inducing zero-order release kinetics of the API.1 The second one comprised an insoluble matrix with its bottom consisting of a polymer with pH-dependent solubility and loaded with beads containing the chemotherapeutic agent 5-Fluorouracil (5-FU). This formulation was designed to release the API at high pH values in order to select the site of release in the gastrointestinal tract.2 The third one incorporated two APIs with different dosage regimens (metformin and glimepiride) into matrices with distinct release properties for combined pharmacotherapy using a single dosage form (poly-pills).3 Dissolution tests were conducted in order to assess in vitro performance of the formulations, performed at conditions simulating different segments of human gastrointestinal tract according to USP specifications. Results All formulations were functional, as the first presented the desired zero-order release of HCTZ (R2=0.990), the second released 5-FU at pH values>7.2, indicating its capability for targeted colonic delivery, and the third one released both APIs within acceptable time margins (achieving immediate release of glimepiride and sustained release of metformin, in 2 and 8 hours respectively), indicating the potential for co-administration of APIs with different dosage regimens in the same personalised dosage form. Conclusion 3D printing can revolutionise pharmacotherapy in numerous ways. In this work we presented three of them: personalisation, API combination and release modulation by shape modifications. References and/or acknowledgements 1. https://www.sciencedirect.com/science/article/pii/S1773224717302721 2. https://link.springer.com/article/10.1208%2Fs12249-018-1084-2 3. https://www.sciencedirect.com/science/article/pii/S0928098718301799?via%3Dihub No conflict of interest.\",\"PeriodicalId\":335223,\"journal\":{\"name\":\"Section 3: Production and Compounding\",\"volume\":\"162 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Section 3: Production and Compounding\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1136/ejhpharm-2019-eahpconf.149\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Section 3: Production and Compounding","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.149","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Background The emergence of novel potent active pharmaceutical ingredients (APIs) and genetic tests highlight the necessity of creating personalised medicinal formulations, containing amounts of APIs tailored to suit each patient’s individual needs. Also, polypharmacy and lack of adherence to pharmacotherapy indicates the need for manufacturing formulations that can incorporate more than one APIs to facilitate patient compliance. Purpose 3D printing of pharmaceutical formulations can provide a solution to the aforementioned issues. Moreover, the ability of 3D printing to create elaborate dosage forms paves the way for the introduction of complex formulations into clinical practice. With that perspective, we created three different pharmaceutical dosage forms via 3D printing. Material and methods For the creation of the 3D printed formulations a fused deposition modelling (FDM) 3D printer was used. The first formulation, a three-layered, ring-shaped formulation containing hydrochlorothiazide (HCTZ) aimed at inducing zero-order release kinetics of the API.1 The second one comprised an insoluble matrix with its bottom consisting of a polymer with pH-dependent solubility and loaded with beads containing the chemotherapeutic agent 5-Fluorouracil (5-FU). This formulation was designed to release the API at high pH values in order to select the site of release in the gastrointestinal tract.2 The third one incorporated two APIs with different dosage regimens (metformin and glimepiride) into matrices with distinct release properties for combined pharmacotherapy using a single dosage form (poly-pills).3 Dissolution tests were conducted in order to assess in vitro performance of the formulations, performed at conditions simulating different segments of human gastrointestinal tract according to USP specifications. Results All formulations were functional, as the first presented the desired zero-order release of HCTZ (R2=0.990), the second released 5-FU at pH values>7.2, indicating its capability for targeted colonic delivery, and the third one released both APIs within acceptable time margins (achieving immediate release of glimepiride and sustained release of metformin, in 2 and 8 hours respectively), indicating the potential for co-administration of APIs with different dosage regimens in the same personalised dosage form. Conclusion 3D printing can revolutionise pharmacotherapy in numerous ways. In this work we presented three of them: personalisation, API combination and release modulation by shape modifications. References and/or acknowledgements 1. https://www.sciencedirect.com/science/article/pii/S1773224717302721 2. https://link.springer.com/article/10.1208%2Fs12249-018-1084-2 3. https://www.sciencedirect.com/science/article/pii/S0928098718301799?via%3Dihub No conflict of interest.