Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by Design
In recent years, with the increasing patient population, the need for complex and patient-centric medications has increased enormously. Traditional manufacturing techniques such as direct blending, high shear granulation, and dry granulation can be used to develop simple solid oral medications. Howe...
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2024-12-01
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| author | Dinesh Nyavanandi Preethi Mandati Nithin Vidiyala Prashanth Parupathi Praveen Kolimi Hemanth Kumar Mamidi |
| author_facet | Dinesh Nyavanandi Preethi Mandati Nithin Vidiyala Prashanth Parupathi Praveen Kolimi Hemanth Kumar Mamidi |
| author_sort | Dinesh Nyavanandi |
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| description | In recent years, with the increasing patient population, the need for complex and patient-centric medications has increased enormously. Traditional manufacturing techniques such as direct blending, high shear granulation, and dry granulation can be used to develop simple solid oral medications. However, it is well known that “one size fits all” is not true for pharmaceutical medicines. Depending on the age, sex, and disease state, each patient might need a different dose, combination of medicines, and drug release pattern from the medications. By employing traditional practices, developing patient-centric medications remains challenging and unaddressed. Over the last few years, much research has been conducted exploring various additive manufacturing techniques for developing on-demand, complex, and patient-centric medications. Among all the techniques, nozzle-based additive manufacturing platforms such as pressure-assisted microsyringe (PAM) and fused deposition modeling (FDM) have been investigated thoroughly to develop various medications. Both nozzle-based techniques involve the application of thermal energy. However, PAM can also be operated under ambient conditions to process semi-solid materials. Nozzle-based techniques can also be paired with the hot melt extrusion (HME) process for establishing a continuous manufacturing platform by employing various in-line process analytical technology (PAT) tools for monitoring critical process parameters (CPPs) and critical material attributes (CMAs) for delivering safe, efficacious, and quality medications to the patient population without compromising critical quality attributes (CQAs). This review covers an in-depth discussion of various critical parameters and their influence on product quality, along with a note on the continuous manufacturing process, quality by design, and future perspectives. |
| format | Article |
| id | doaj-art-167876f057f54f26b978c4af3d6c330e |
| institution | Kabale University |
| issn | 1999-4923 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj-art-167876f057f54f26b978c4af3d6c330e2025-01-24T13:45:35ZengMDPI AGPharmaceutics1999-49232024-12-011711410.3390/pharmaceutics17010014Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by DesignDinesh Nyavanandi0Preethi Mandati1Nithin Vidiyala2Prashanth Parupathi3Praveen Kolimi4Hemanth Kumar Mamidi5Small Molecule Drug Product Development, Cerevel Therapeutics, Cambridge, MA 02141, USADepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USASmall Molecule Drug Product Development, Cerevel Therapeutics, Cambridge, MA 02141, USADivision of Pharmaceutical Sciences, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY 11201, USADepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USADrug Product Development, Continuus Pharmaceuticals, Woburn, MA 01801, USAIn recent years, with the increasing patient population, the need for complex and patient-centric medications has increased enormously. Traditional manufacturing techniques such as direct blending, high shear granulation, and dry granulation can be used to develop simple solid oral medications. However, it is well known that “one size fits all” is not true for pharmaceutical medicines. Depending on the age, sex, and disease state, each patient might need a different dose, combination of medicines, and drug release pattern from the medications. By employing traditional practices, developing patient-centric medications remains challenging and unaddressed. Over the last few years, much research has been conducted exploring various additive manufacturing techniques for developing on-demand, complex, and patient-centric medications. Among all the techniques, nozzle-based additive manufacturing platforms such as pressure-assisted microsyringe (PAM) and fused deposition modeling (FDM) have been investigated thoroughly to develop various medications. Both nozzle-based techniques involve the application of thermal energy. However, PAM can also be operated under ambient conditions to process semi-solid materials. Nozzle-based techniques can also be paired with the hot melt extrusion (HME) process for establishing a continuous manufacturing platform by employing various in-line process analytical technology (PAT) tools for monitoring critical process parameters (CPPs) and critical material attributes (CMAs) for delivering safe, efficacious, and quality medications to the patient population without compromising critical quality attributes (CQAs). This review covers an in-depth discussion of various critical parameters and their influence on product quality, along with a note on the continuous manufacturing process, quality by design, and future perspectives.https://www.mdpi.com/1999-4923/17/1/14additive manufacturingfused deposition modelingpressure-assisted microsyringesemi-solid extrusionhot melt extrusioncontinuous manufacturing |
| spellingShingle | Dinesh Nyavanandi Preethi Mandati Nithin Vidiyala Prashanth Parupathi Praveen Kolimi Hemanth Kumar Mamidi Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by Design Pharmaceutics additive manufacturing fused deposition modeling pressure-assisted microsyringe semi-solid extrusion hot melt extrusion continuous manufacturing |
| title | Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by Design |
| title_full | Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by Design |
| title_fullStr | Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by Design |
| title_full_unstemmed | Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by Design |
| title_short | Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and Pressure-Assisted Microsyringe Additive Manufacturing Platforms with Quality by Design |
| title_sort | enhancing patient centric drug development coupling hot melt extrusion with fused deposition modeling and pressure assisted microsyringe additive manufacturing platforms with quality by design |
| topic | additive manufacturing fused deposition modeling pressure-assisted microsyringe semi-solid extrusion hot melt extrusion continuous manufacturing |
| url | https://www.mdpi.com/1999-4923/17/1/14 |
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