Hot melt extrusion paired fused deposition modeling 3D printing to develop hydroxypropyl cellulose based floating tablets of cinnarizine

Vo, Anh; Zhang, Jiaxiang; Nyavanandi, Dinesh; Bandari, Suresh; Repka, Michael A.

doi:10.1016/j.carbpol.2020.116519

Cited by 90 publications

(35 citation statements)

References 38 publications

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“…These dosage forms have the potential to tailor therapies with the most efficient, as well as effective response and safety margins [ 3 ]. In recent times, researchers have been exploring the applications of different 3-D printing platforms for producing pharmaceutical dosage forms [ 4 ] such as selective laser sintering (SLS) [ 5 , 6 , 7 ], stereolithographic 3-D printing (SLA) [ 8 ], binder jet printing [ 9 ], and fused deposition modeling (FDM) based 3-D printing [ 10 ]. The current literature lacks insights on the impact of processing parameters such as fill density on the performance of these dosage forms which we have attempted to explore as a part of this research study.…”

Section: Introductionmentioning

confidence: 99%

Novel On-Demand 3-Dimensional (3-D) Printed Tablets Using Fill Density as an Effective Release-Controlling Tool

et al. 2020

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This research demonstrates the use of fill density as an effective tool for controlling the drug release without changing the formulation composition. The merger of hot-melt extrusion (HME) with fused deposition modeling (FDM)-based 3-dimensional (3-D) printing processes over the last decade has directed pharmaceutical research towards the possibility of printing personalized medication. One key aspect of printing patient-specific dosage forms is controlling the release dynamics based on the patient’s needs. The purpose of this research was to understand the impact of fill density and interrelate it with the release of a poorly water-soluble, weakly acidic, active pharmaceutical ingredient (API) from a hydroxypropyl methylcellulose acetate succinate (HPMC-AS) matrix, both mathematically and experimentally. Amorphous solid dispersions (ASDs) of ibuprofen with three grades of AquaSolveTM HPMC-AS (HG, MG, and LG) were developed using an HME process and evaluated using solid-state characterization techniques. Differential scanning calorimetry (DSC), powder X-ray diffraction (pXRD), and polarized light microscopy (PLM) confirmed the amorphous state of the drug in both polymeric filaments and 3D printed tablets. The suitability of the manufactured filaments for FDM processes was investigated using texture analysis (TA) which showed robust mechanical properties of the developed filament compositions. Using FDM, tablets with different fill densities (20–80%) and identical dimensions were printed for each polymer. In vitro pH shift dissolution studies revealed that the fill density has a significant impact (F(11, 24) = 15,271.147, p < 0.0001) and a strong negative correlation (r > −0.99; p < 0.0001) with the release performance, where 20% infill demonstrated the fastest and most complete release, whereas 80% infill depicted a more controlled release. The results obtained from this research can be used to develop a robust formulation strategy to control the drug release from 3D printed dosage forms as a function of fill density.

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Section: Introductionmentioning

confidence: 99%

Novel On-Demand 3-Dimensional (3-D) Printed Tablets Using Fill Density as an Effective Release-Controlling Tool

et al. 2020

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“…Some specific components of the formulations, such as stearic acid [ 60 , 148 ] and stearyl alcohol [ 149 ] are necessary as a processing aid for HME. In addition, low Tg polymers such as HPC [ 60 , 61 , 62 , 150 ], Gelucire ® [ 119 ] and poly(vinylpyrrolidone- random -vinyl acetate) (PVP/VA) [ 150 ] are commonly used.…”

Section: Multi-unit Low-density Systemsmentioning

confidence: 99%

“…Dumpa et al have fabricated, by means of HME/3D printing technologies, filaments of HPC/EC, which were used for the manufacture of core–shell gastroretentive floating tablets with pulsatile delivery of theophylline (the lag time for the pulsatile release of the drug was from 30 min to 6 h) [ 61 ]. The same group has recently reported the preparation of floating tablets for the administration of cinnarizine using HPC and Kollidon ® PVP/VA64 ( random copolymer of vinylpyrrolidone and vinyl acetate, ratio 60:40) as matrix forming polymers [ 150 ].…”

Section: Multi-unit Low-density Systemsmentioning

confidence: 99%

In-Depth Study into Polymeric Materials in Low-Density Gastroretentive Formulations

et al. 2020

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The extensive use of oral dosage forms for the treatment of diseases may be linked to deficient pharmacokinetic properties. In some cases the drug is barely soluble; in others, the rapid transit of the formulation through the gastrointestinal tract (GIT) makes it difficult to achieve therapeutic levels in the organism; moreover, some drugs must act locally due to a gastric pathology, but the time they remain in the stomach is short. The use of formulations capable of improving all these parameters, as well as increasing the resident time in the stomach, has been the target of numerous research works, with low-density systems being the most promising and widely explored, however, there is further scope to improve these systems. There are a vast variety of polymeric materials used in low-density gastroretentive systems and a number of methods to improve the bioavailability of the drugs. This works aims to expedite the development of breakthrough approaches by providing an in-depth understanding of the polymeric materials currently used, both natural and synthetic, their properties, advantages, and drawbacks.

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“…The FDM printing method has proven to be a suitable technique for the development and production of 3D printed oral dosage forms. Immediate release tablets [22,23], gastro retentive tablets [24], bilayer tablets [25], tablets with modified release characteristics [26][27][28] and many more manufactured in the FDM 3D printing process are described in the literature. These dosage forms require the manufacturing of API-loaded filaments prior to printing, which is being achieved by hot melt extrusion or filament impregnation with organic solvents.…”

Section: Introductionmentioning

confidence: 99%

Supercritical Fluid Technology for the Development of 3D Printed Controlled Drug Release Dosage Forms

2021

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Supercritical CO2 loading of preformed 3D printed drug carriers with active pharmaceutical ingredients (APIs) shows great potential in the development of oral dosage forms for future personalized medicine. We designed 3D printed scaffold like drug carriers with varying pore sizes made from polylactic acid (PLA) using a fused deposition modelling (FDM) 3D printer. The 3D printed drug carriers were then loaded with Ibuprofen as a model drug, employing the controlled particle deposition (CPD) process from supercritical CO2. Carriers with varying pore sizes (0.027–0.125 mm) were constructed and loaded with Ibuprofen to yield drug-loaded carriers with a total amount of 0.83–2.67 mg API (0.32–1.41% w/w). Dissolution studies of the carriers show a significantly decreasing dissolution rate with decreasing pore sizes with a mean dissolution time (MDT) of 8.7 min for the largest pore size and 128.2 min for the smallest pore size. The API dissolution mechanism from the carriers was determined to be Fickian diffusion from the non-soluble, non-swelling carriers. Using 3D printing in combination with the CPD process, we were able to develop dosage forms with individually tailored controlled drug release. The dissolution rate of our dosage forms can be easily adjusted to the individual needs by modifying the pore sizes of the 3D printed carriers.

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Hot melt extrusion paired fused deposition modeling 3D printing to develop hydroxypropyl cellulose based floating tablets of cinnarizine

Cited by 90 publications

References 38 publications

Novel On-Demand 3-Dimensional (3-D) Printed Tablets Using Fill Density as an Effective Release-Controlling Tool

Novel On-Demand 3-Dimensional (3-D) Printed Tablets Using Fill Density as an Effective Release-Controlling Tool

In-Depth Study into Polymeric Materials in Low-Density Gastroretentive Formulations

Supercritical Fluid Technology for the Development of 3D Printed Controlled Drug Release Dosage Forms

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