Material Considerations for Fused-Filament Fabrication of Solid Dosage Forms

Material choice is a fundamental consideration when it comes to designing a solid dosage form. The matrix material will ultimately determine the rate of drug release since the physical properties (solubility, viscosity, and more) of the material control both fluid ingress and disintegration of the dosage form. The bulk properties (powder flow, concentration, and more) of the material should also be considered since these properties will influence the ability of the material to be successfully manufactured. Furthermore, there is a limited number of approved materials for the production of solid dosage forms. The present study details the complications that can arise when adopting pharmaceutical grade polymers for fused-filament fabrication in the production of oral tablets. The paper also presents ways to overcome each issue. Fused-filament fabrication is a hot-melt extrusion-based 3D printing process. The paper describes the problems encountered in fused-filament fabrication with Kollidon® VA64, which is a material that has previously been utilized in direct compression and hot-melt extrusion processes. Formulation and melt-blending strategies were employed to increase the printability of the material. The paper defines for the first time the essential parameter profile required for successful 3D printing and lists several pre-screening tools that should be employed to guide future material formulation for the fused-filament fabrication of solid dosage forms

Transfer and Optimisation of Injection Moulding Manufacture of Medical Devices Using Scientific Moulding Principles

Scientific moulding, also known as decoupled injection moulding, is a production methodology used to develop and determine robust moulding processes resilient to fluctuations caused by variation in temperature and viscosity. Scientific moulding relies on the meticulous collection of data from the manufacturing process, especially inputs of time (fill, pack/hold), temperature (melt, barrel, tool), and pressure (injection, hold, etc.). This publication presents a use case where scientific moulding was used to enable the transfer and optimisation of an injection moulding process from an Arburg 221M injection moulding machine to an Arburg 375 V model. The part was an endovascular aneurysm repair dilator device where a polypropylene hub was moulded over a high-density polyethylene dilator insert. Upon transfer, multiple studies were carried out, including material rheology study during injection, gate freeze study, cavity balance of the moulding tool, and pressure loss analysis. A design of experiments was developed and carried out on the process with a variety of effects and responses. The developed process cycle time was compared to that achieved theoretically using mathematical modelling and the original process cycle time. The studies resulted in the identification of optimum parameters for injection speed, holding time, holding pressure, cooling time, and mould temperature. The process was verified by completing a 32-shot study and recording part weights and dimensional measurements to confirm repeatability and consistency of the process. The output from the study was a reduction in cycle time by 12.05 s from the original process. A cycle time of 47.28 s was theoretically calculated for the process, which is within 6.6% of the practical experiment results (44.15 s)

Transfer and Optimisation of Injection Moulding Manufacture of Medical Devices Using Scientific Moulding Principles

Scientific moulding, also known as decoupled injection moulding, is a production methodology used to develop and determine robust moulding processes resilient to fluctuations caused by variation in temperature and viscosity. Scientific moulding relies on the meticulous collection of data from the manufacturing process, especially inputs of time (fill, pack/hold), temperature (melt, barrel, tool), and pressure (injection, hold, etc.). This publication presents a use case where scientific moulding was used to enable the transfer and optimisation of an injection moulding process from an Arburg 221M injection moulding machine to an Arburg 375 V model. The part was an endovascular aneurysm repair dilator device where a polypropylene hub was moulded over a high-density polyethylene dilator insert. Upon transfer, multiple studies were carried out, including material rheology study during injection, gate freeze study, cavity balance of the moulding tool, and pressure loss analysis. A design of experiments was developed and carried out on the process with a variety of effects and responses. The developed process cycle time was compared to that achieved theoretically using mathematical modelling and the original process cycle time. The studies resulted in the identification of optimum parameters for injection speed, holding time, holding pressure, cooling time, and mould temperature. The process was verified by completing a 32-shot study and recording part weights and dimensional measurements to confirm repeatability and consistency of the process. The output from the study was a reduction in cycle time by 12.05 s from the original process. A cycle time of 47.28 s was theoretically calculated for the process, which is within 6.6% of the practical experiment results (44.15 s)

Hybrid Manufacturing of Acrylonitrile Butadiene Styrene (ABS) via the Combination of Material Extrusion Additive Manufacturing and Injection Molding

Acrylonitrile Butadiene Styrene (ABS) is a common thermoplastic polymer that has been widely employed in the manufacturing industry due to its impact resistance, tensile strength, and rigidity. Additive manufacturing (AM) is a promising manufacturing technique being used to manufacture products with complex geometries, but it is a slow process producing mechanically inferior products when compared to traditional production processes like injection molding (IM). Thus, our hybrid manufacturing (HM) process combining materials extrusion AM and IM to create a single article was investigated in this study, in which eleven batches of specimens were made and extensively tested. These include the AM, IM, and hybrid manufactured (HYM) samples, in which the HYM samples were made by inserting AM substrates into the IM tool and were varied in infill density of AM preforms and geometries. The HYM samples outperformed AM parts in terms of mechanical performance while retaining customizability dependent on the HYM processing parameters, and the best mechanical performance for HYM samples was found to be comparable to that of IM samples, implying that the overmolding process in HM had primarily improved the mechanical performance of AM products. This work leads to a deeper knowledge of applications to confirm the optimal component fabrication in high design flexibility and mass production

Hybrid Manufacturing of Oral Solid Dosage Forms via Overprinting of Injection-Molded Tablet Substrates

Since 3D printing allows for patient-specific dosage forms, it has become a major focus in pharmaceutical research. However, it is difficult to scale up drug product manufacturing. Injection molding has been used in conjunction with hot-melt extrusion to mass produce drug products, but making tailored solid dosage forms with this technology is neither cost-effective nor simple. This study explored the use of a combination of fused filament fabrication and injection molding to create patient-specific solid dosage forms. A tablet fixation and location template was used to overprint directly on injection-molded tablet bases, and theophylline was combined with polycaprolactone and Kollidon® VA64 via hot-melt extrusion to produce the filament. Dynamic mechanical analysis was used to evaluate the brittleness of the filament, and differential scanning calorimetry was used to analyze the thermal results. The results showed that theophylline had a flow promoting effect on the polymer blend and that overprinted tablets were manufactured faster than 3D-printed tablets. Drug release studies also showed that overprinted tablets released faster than injection-molded tablets. This method demonstrates the potential of hybrid manufacturing for the pharmaceutical industry as a means of bridging the gap between personalized dosage forms and mass production

Applications of Digital Twin across Industries: A Review

One of the most promising technologies that is driving digitalization in several industries is Digital Twin (DT). DT refers to the digital replica or model of any physical object (physical twin). What differentiates DT from simulation and other digital or CAD models is the automatic bidirectional exchange of data between digital and physical twins in real-time. The benefits of implementing DT in any sector include reduced operational costs and time, increased productivity, better decision making, improved predictive/preventive maintenance, etc. As a result, its implementation is expected to grow exponentially in the coming decades as, with the advent of Industry 4.0, products and systems have become more intelligent, relaying on collection and storing incremental amounts of data. Connecting that data effectively to DTs can open up many new opportunities and this paper explores different industrial sectors where the implementation of DT is taking advantage of these opportunities and how these opportunities are taking the industry forward. The paper covers the applications of DT in 13 different industries including the manufacturing, agriculture, education, construction, medicine, and retail, along with the industrial use case in these industries

Applications of Digital Twin across Industries: A Review

One of the most promising technologies that is driving digitalization in several industries is Digital Twin (DT). DT refers to the digital replica or model of any physical object (physical twin). What differentiates DT from simulation and other digital or CAD models is the automatic bidirectional exchange of data between digital and physical twins in real-time. The benefits of implementing DT in any sector include reduced operational costs and time, increased productivity, better decision making, improved predictive/preventive maintenance, etc. As a result, its implementation is expected to grow exponentially in the coming decades as, with the advent of Industry 4.0, products and systems have become more intelligent, relaying on collection and storing incremental amounts of data. Connecting that data effectively to DTs can open up many new opportunities and this paper explores different industrial sectors where the implementation of DT is taking advantage of these opportunities and how these opportunities are taking the industry forward. The paper covers the applications of DT in 13 different industries including the manufacturing, agriculture, education, construction, medicine, and retail, along with the industrial use case in these industries

Mass Customization of Polylactic Acid (PLA) Parts via a Hybrid Manufacturing Process

Mass customization is the development of items tailored to specific customers, but produced at low unit cost in high-volume. In this context, hybrid manufacturing (HM) combines fused deposition modeling (FDM) and injection molding (IM) to fabricate a single personalized part with minimum manufacturing cost. In this technique, inserts with different physical features are first FDM-fabricated and then IM-overmolded. This study investigated the effect of hybrid FDM-IM production technology, FDM insert geometry on mechanical properties, and micro-structural evolution of Polylactic Acid (PLA) samples. The findings indicated a comparable tensile properties of FDM-IM samples (68.38 MPa) to IM batch (68.95 MPa), emphasizing the potential of HM in the manufacturing industry. Maximum tensile stress of FDM-IM specimens shows an upward trend due to the increased infill density of preforms. In addition, overmolding interface direction results in a big gap for the maximum tensile strengths between half-length series specimens (12.99 MPa to 19.09 MPa) and half-thickness series specimens (53.83 MPa to 59.92 MPa). Furthermore, four joint configurations resulted in different mechanical performances of finished specimens, in which the female cube sample exhibits the highest tensile stress (68.38 MPa), while the batch with male T joint shows a lower value in maximum tensile strength (59.51 MPa), exhibiting a similar tensile performance with the half-thickness 75% batch without joint configuration. This study lays the groundwork for using HM to produce bespoke and mechanically improved parts over FDM alone