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  1. Article ; Online: Proof of concept of a predictive model of drug release from long-acting implants obtained by fused-deposition modeling.

    Manini, Giuseppe / Benali, Samira / Raquez, Jean-Marie / Goole, Jonathan

    International journal of pharmaceutics

    2022  Volume 618, Page(s) 121663

    Abstract: In the pharmaceutical field, there is a growing interest in manufacturing of drug delivery dosage forms adapted to the needs of a large variety of patients. 3D printing has proven to be a powerful tool allowing the adaptation of immediate drug delivery ... ...

    Abstract In the pharmaceutical field, there is a growing interest in manufacturing of drug delivery dosage forms adapted to the needs of a large variety of patients. 3D printing has proven to be a powerful tool allowing the adaptation of immediate drug delivery dosage forms. However, there are still few studies focusing on the adaptation of long-acting dosage forms for patient suffering of neurological diseases. In this study, paliperidone palmitate (PP) was chosen as a model drug in combination with different polymers adapted for fused-deposition modeling (FDM). The impact of different printing parameters on the release of PP were investigated. The layer thickness and the infill percentage were studied using a quality by design approach. Indeed, by defining the critical quality attributes (CQA), a proof of concept of a prediction system, and a quality control system were studied through designs of experiments (DoE). The first part of this study was dedicated to the release of PP from a fix geometry. In the second part, the prediction system was developed to require only surface and surface to volume ratio. From that point, it was possible to get rid of a fix geometry and predict the amount of PP released from complex architectures.
    MeSH term(s) Drug Liberation ; Humans ; Paliperidone Palmitate ; Pharmaceutical Preparations ; Polymers ; Printing, Three-Dimensional ; Tablets ; Technology, Pharmaceutical
    Chemical Substances Pharmaceutical Preparations ; Polymers ; Tablets ; Paliperidone Palmitate (R8P8USM8FR)
    Language English
    Publishing date 2022-03-12
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 428962-6
    ISSN 1873-3476 ; 0378-5173
    ISSN (online) 1873-3476
    ISSN 0378-5173
    DOI 10.1016/j.ijpharm.2022.121663
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1409: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Paliperidone palmitate as model of heat-sensitive drug for long-acting 3D printing application.

    Manini, Giuseppe / Benali, Samira / Mathew, Allen / Napolitano, Simone / Raquez, Jean-Marie / Goole, Jonathan

    International journal of pharmaceutics

    2022  Volume 618, Page(s) 121662

    Abstract: In this work, two technologies were used to prepare long-acting implantable dosage forms in the treatment of schizophrenia. Hot-melt extrusion (HME) as well as fused deposition modelling (FDM) were used concomitantly to create personalized 3D printed ... ...

    Abstract In this work, two technologies were used to prepare long-acting implantable dosage forms in the treatment of schizophrenia. Hot-melt extrusion (HME) as well as fused deposition modelling (FDM) were used concomitantly to create personalized 3D printed implants. Different formulations were prepared using an amorphous PLA as matrix polymer and different solid-state plasticizers. Paliperidone palmitate (PP), a heat sensitive drug prescribed in the treatment of schizophrenia was chosen as model drug. After extrusion, different formulations were characterized using DSC and XRD. Then, an in vitro dissolution test was carried out to discriminate the formulation allowing a sustained drug release of PP. The formulation showing a sustained drug release of the drug was 3D printed as an implantable dosage form. By modulating the infill, the release profile was related to the proper design of tailored dosage form and not solely to the solubility of the drug. Indeed, different release profiles were achieved over 90 days using only one formulation. In addition, a stability test was performed on the 3D printed implants for 3 months. The results showed the stability of the amorphous state of PP, independently of the temperature as well as the integrity of the matrix and the drug.
    MeSH term(s) Drug Liberation ; Excipients ; Hot Temperature ; Paliperidone Palmitate ; Printing, Three-Dimensional ; Tablets ; Technology, Pharmaceutical/methods
    Chemical Substances Excipients ; Tablets ; Paliperidone Palmitate (R8P8USM8FR)
    Language English
    Publishing date 2022-03-12
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 428962-6
    ISSN 1873-3476 ; 0378-5173
    ISSN (online) 1873-3476
    ISSN 0378-5173
    DOI 10.1016/j.ijpharm.2022.121662
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1409: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  3. Article ; Online: Long-acting implantable dosage forms containing paliperidone palmitate obtained by 3D printing.

    Manini, Giuseppe / Deldime, Maud / Benali, Samira / Raquez, Jean-Marie / Goole, Jonathan

    International journal of pharmaceutics

    2021  Volume 603, Page(s) 120702

    Abstract: In this work, the versatility of pressure extrusion-based printing (PEBP) was used as 3D printing process to create long-acting implantable dosage forms. Different release profiles were achieved based on the drug concentration, the way of preparation and ...

    Abstract In this work, the versatility of pressure extrusion-based printing (PEBP) was used as 3D printing process to create long-acting implantable dosage forms. Different release profiles were achieved based on the drug concentration, the way of preparation and the design of the final implants. Polycaprolactone (PCL) was used as the polymer to sustain the release of the loaded drug. Paliperidone palmitate (PP), a BCS Class II drug, used in the treatment of schizophrenia, was used as the model drug. Two PP concentrations (e.g. 5 and 10% w/w) as well as two methods of preparation before the 3D printing process, mortar and pestle and cryogenic milling, were evaluated. The amorphous state of PP was obtained by using cryogenic milling and it was maintained after printing. Two designs were printed by PEBP, a ring and a disk, to evaluate their impact on the release profile of PP. During the in vitro dissolution tests, the implant design, the amount of PP, as well as the crystalline or amorphous state of PP have shown to influence the drug release profile. During the successive steps of preparation of the long-acting implants, blends and raw materials were characterized by DSC and XRD.
    MeSH term(s) Dosage Forms ; Drug Liberation ; Paliperidone Palmitate ; Polymers ; Printing, Three-Dimensional
    Chemical Substances Dosage Forms ; Polymers ; Paliperidone Palmitate (R8P8USM8FR)
    Language English
    Publishing date 2021-05-12
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 428962-6
    ISSN 1873-3476 ; 0378-5173
    ISSN (online) 1873-3476
    ISSN 0378-5173
    DOI 10.1016/j.ijpharm.2021.120702
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1409: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  4. Article ; Online: Feasibility study into the potential use of fused-deposition modeling to manufacture 3D-printed enteric capsules in compounding pharmacies.

    Nober, Christoph / Manini, Giuseppe / Carlier, Emeric / Raquez, Jean-Marie / Benali, Samira / Dubois, Philippe / Amighi, Karim / Goole, Jonathan

    International journal of pharmaceutics

    2019  Volume 569, Page(s) 118581

    Abstract: The purpose of this work was to investigate the feasibility to manufacture enteric capsules, which could be used in compounding pharmacies, by fused-deposition modeling. It is well-known that conventional enteric dip coating of capsules in community ... ...

    Abstract The purpose of this work was to investigate the feasibility to manufacture enteric capsules, which could be used in compounding pharmacies, by fused-deposition modeling. It is well-known that conventional enteric dip coating of capsules in community pharmacies or hospitals is a time-consuming process which is characterized by an erratic efficacy. Fused-deposition modeling was selected as a potential 3D printing method due its ease and low-cost implementation. Before starting to print the capsules, an effective sealing system was designed via a computer-aided design program. Hot melt extrusion was used to make printable enteric filaments. They were made of the enteric polymer, a plasticizer and a thermoplastic polymer, namely Eudragit® L100-55, polyethylene glycol 400 and polylactic acid, respectively. Riboflavine-5'-phosphate was selected as a coloured drug model to compare the efficacy of the 3D printed capsules to that of enteric dip coated capsules as they are currently produced in community pharmacies and hospitals. Different parameters of fabrication which could influence the dissolution profile of the model drug, such as the layer thickness or post-processing step, were studied. It was demonstrated that our 3D printed enteric capsules did not release the drug for 2 h in acid medium (pH 1.2). However, they completely dissolved within 45 min at pH 6.8 which allowed the release of a minimal amount of 85% w/w of drug as it was recommended by the European Pharmacopoeia 9th Edition for enteric products.
    MeSH term(s) Capsules ; Drug Compounding/methods ; Excipients/chemistry ; Feasibility Studies ; Pharmacies ; Plasticizers/chemistry ; Polyesters/chemistry ; Polyethylene Glycols/chemistry ; Polymethacrylic Acids/chemistry ; Printing, Three-Dimensional
    Chemical Substances Capsules ; Excipients ; Plasticizers ; Polyesters ; Polymethacrylic Acids ; methylmethacrylate-methacrylic acid copolymer (25086-15-1) ; Polyethylene Glycols (3WJQ0SDW1A) ; poly(lactide) (459TN2L5F5) ; polyethylene glycol 400 (B697894SGQ)
    Language English
    Publishing date 2019-07-29
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 428962-6
    ISSN 1873-3476 ; 0378-5173
    ISSN (online) 1873-3476
    ISSN 0378-5173
    DOI 10.1016/j.ijpharm.2019.118581
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1409: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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