Research Article
Print
Research Article
Novel propranolol-loaded gastro-floating 3D-printed devices with zero-order release kinetics
expand article infoDareena Jaiseri‡, Supusson Pengnam‡, Praneet Opanasopit‡, Tanasait Ngawhirunpat‡, Theerasak Rojanarata‡, Prasopchai Patrojanasophon‡, Teeratas Kansom‡, Thapakorn Charoenying‡
‡ Silpakorn University, Nakhon Pathom, Thailand

Corresponding author: Thapakorn Charoenying ( charoenying_t@su.ac.th )

Academic editor: Milen Dimitrov
© 2024 Dareena Jaiseri, Supusson Pengnam, Praneet Opanasopit, Tanasait Ngawhirunpat, Theerasak Rojanarata, Prasopchai Patrojanasophon, Teeratas Kansom, Thapakorn Charoenying.
This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Citation: Jaiseri D, Pengnam S, Opanasopit P, Ngawhirunpat T, Rojanarata T, Patrojanasophon P, Kansom T, Charoenying T (2024) Novel propranolol-loaded gastro-floating 3D-printed devices with zero-order release kinetics. Pharmacia 71: 1-8. https://doi.org/10.3897/pharmacia.71.e133399
Open Access

Abstract

Currently, fused deposition modeling (FDM) is a 3D printing technology that has been most widely used to develop innovative drug delivery approaches for overcoming the limitations of oral drug administration. Propranolol has a short plasma half-life and is well soluble in acidic environments. Thus, this study aimed to develop a gastro-floating 3D printed device (GFD) to sustain the release of propranolol in the stomach as a gastro-retentive drug delivery system. The polylactic acid (PLA) was selected to fabricate the GFD. An air chamber was included in the interior construction of the GFD design for buoyancy. The number of open channels on the side wall of GFD was modified to regulate release. The propranolol gel formulation was composed of a mixture of propranolol and polyvinylpyrrolidone (PVP) at the weight ratio of 6:5 and was then loaded into GFDs using a syringe. GFD exhibited a floating ability of more than 24 h with low standard deviation (SD) values of weight variation and shape dimension. The propranolol release from GFD shows sustained release properties in the simulated gastric environment without lag time. The 4 and 5 channels of GFD exhibited sustained drug release for 6 h. In addition, the duration of sustained release for 8 h was achieved from the GFD with 2 and 3 channels. The kinetic release of propranolol from GFDs was the best fit with zero-order. Thus, the GFDs could be designed to control the drug release according to each patient, which has the potential for applying personalized gastro-retentive drug delivery in various medications.

Graphical abstract

Keywords

fused deposition modeling, gastro-retentive drug delivery systems, personalized medicine, sustained release

Introduction

Three-dimensional (3D) printing technology, also known as additive manufacturing, is a method of fabrication rapid prototyping (Cohen et al. 2009). The 3D printing has been applied in various fields such as construction, medicine, automobile and aerospace, biomedical, pharmaceutical, and many other fields (Trenfield et al. 2018a; Vaz and Kumar 2021). In addition, the pharmaceutical field was also considering applying 3D printing to medical delivery applications. The U.S. Food and Drug Administration (FDA) approved a levetiracetam tablet (Spritam®) manufactured using 3D printing technology in July 2015. This development signifies the FDA’s acknowledgment of the potential of 3D printing technology in the pharmaceutical industry. The Spritam® product was produced by binder jetting, which presented an extremely porous structure and could rapidly disperse in the mouth (about 11 s) (Trenfield et al. 2018b). Subsequently, 3D printing has been used to develop drug delivery systems for improving efficiency, such as drug-device fabrication for controlled-release, immediate-release, floating properties, microneedles, transdermal patches, as well as producing dosage forms with a specific and precise dose on demand, personalized medicine, and so on (Cader et al. 2019). There are various types of 3D printers (Brambilla et al. 2021); however, fused deposition modeling (FDM) 3D printers are the most popular and widely used in the pharmaceutical field due to their inexpensiveness, accessibility, ease of use, and reproducibility (Cailleaux et al. 2021). The principle of FDM 3D printing was extruding a polymer filament through a heated nozzle and printing on a build plate; these processes were repeated steps layer-by-layer to create a 3D object. Furthermore, FDM offers the potential to develop innovative approaches for drug delivery that address and overcome existing limitations and disadvantages (Maroni et al. 2017; Araújo et al. 2019).

Oral drug administration is the most widely used due to easy access, low costs, and good patient compliance (He et al. 2019). However, the oral drug delivery systems have many limitations due to physiological, gastrointestinal, and biochemistry factors, which limit the permeability, bioavailability, and gastric residence time. Thus, the obstacles of oral drug administration must use innovative drug delivery approaches (Lou et al. 2023). Currently, gastro-floating devices are developed from 3D printing and can be used as gastro-floating drug delivery systems (Charoenying et al. 2023). According to the previous article, hot melt extrusion and FDM were used to construct the gastro-floating tablets to control release for 10 h. This made it feasible to create drug-loaded filaments for 3D-printed tablets (Giri et al. 2020). However, the hot melt extrusion and FDM using a high temperature to melt materials and active pharmaceutical ingredients can be a limitation of this method since it may lead to the chemical degradation of the thermally sensitive drugs (Huang et al. 2017).

Propranolol has several limitations, such as poor bioavailability (approximately 25%) due to the hepatic first-pass metabolism and a relatively short plasma half-life of 2 to 5 h (Patel et al. 2007). The solubility of propranolol shows high concentration in an acid buffer or acidic environment at pH 1.2 (225 mg/mL). Conversely, it is very unstable in a base buffer or alkaline environment and has lower solubility at pH 6.8 (130 mg/mL) (Chaturvedi et al. 2010). Therefore, the gastro-retentive drug delivery systems (GRDDs) were selected to overcome this limitation. Jagdale et al. (2009) developed gastro-floating propranolol tablets with various polymers to prepare tablets by direct compression. The in vitro release of the formulation prepared by HPMC K4M could float and be sustained for 18 h with 92% drug release. However, an in vivo X-ray imaging study presented that the tablet remained in the stomach for 4 h (Jagdale et al. 2009). Alqahtani et al. (2023) fabricated the gastro retentive floating device (GRFD) containing propranolol tablets to increase stomach retention duration and control drug release. The GRFD, composed of polyvinyl alcohol (PVA) and polylactic acid (PLA), was designed as a round-shaped shell with a central hole size of 1 to 4 mm. The GRFDs fabricated with PVA filament exhibited approximately 3 h of floating ability, and in vitro drug release was > 90% within 2 h. In contrast, PLA GRFD showed sustained release and floating time over 24 h. However, the PLA GRFD exhibited a release lag time of 30–60 minutes (Alqahtani et al. 2023). Thus, there is still an inadequate floating period and release lag time for the gastro-floating propranolol tablets. Xu et al. (2019) fabricated a PVA 3D-printed device containing paracetamol prepared as a drug gel using PVA polymer. The results show that the device’s design could predict the release profile of the drug (Xu et al. 2019). Moreover, a drug gel-loaded 3D-printed device easily varies the potency of the drug for personalization. Because the drug gel and the device were prepared using the same water-soluble polymer (PVA). Thus, controlling the drug release profile depended on the dissolving rate of the device and internal drug gel design. Moreover, the types of polymers used for fabricating this system might be limited.

Thus, this study aimed to develop a novel gastro-floating 3D printed device (GFD) containing propranolol gel for controlling drug release in the stomach, with different polymers between the device and gel formulation. PLA filament was used to fabricate GFD due to hydrophobic polymer to improve floating and sustained release ability. The GFD was designed to have an air chamber on the top of the GFD for buoyancy and opening channels located on the device’s side wall to overcome the lag time release problem. The various channel numbers (2–5 channels) of GFD were conducted for sustained release properties. Polyvinyl-pyrrolidone (PVP) was selected to prepare the propranolol gel because the PVP exhibits a slower release profile than PVA (Józó et al. 2021). The morphology, weight variation, and floating ability of GFD and propranolol-loaded GFD were investigated. The drug dissolution profiles and kinetic release of propranolol from GFD with various numbers of channels were evaluated.

Materials and methods

Materials

Propranolol HCl was supported by the Government Pharmaceutical Organization (GPO) (GPO, Thailand). PLA filament was purchased from Shenzhen eSun Industrial Co., Ltd. (Shenzhen, China). Polyvinyl-pyrrolidone (PVP) powder (MW ~1,300,000) and sodium chloride (NaCl) were purchased from Sigma-Aldrich (Steinheim, Germany). Hydrochloric acid fuming 37% w/w (HCl) used for the dissolution medium was obtained from Merck KGaA (Darmstadt, Germany). All other reagents used in this study were of analytical grade.

Design of a gastro-floating 3D printed device (GFD)

The GFD models were sketched by Autodesk® Fusion 360TM Student software (v. 2.0.7819) (Autodesk Inc., USA) and exported as a stereolithography (.stl) file. The GFD was designed with a flat-face plain tablet (diameter 14 mm, thickness 10 mm). For floating ability, an internal structure was designed with an air chamber at the top of the tablet (height = 3 mm). The GFD varied the number of empty channels (2, 3, 4, and 5 channels) at a side wall of the device. A cylindrical, empty shape with a radius of 4 mm was created to contain propranolol HCl gel to control the drug release rates. The dimension of the GFD is shown in Fig. 1.

Figure 1. 

The dimension of GFD; A the dimension of the whole GFD; B the vertical cross-section of the GFD shows the location of the air chamber (2, 3, 4, and 5 channels); and C the internal structure by a horizontal cross-section of the device to show the pattern for a number of channels (2, 3, 4, and 5 channels).

Printing of tablets

The GFD were obtained using the slicer software used to set the printing in PrusaSlicer software (v.2.6.1), and a commercial FDM 3D printer (Prusa i3 MK3, Prusa Research S.R.O., Prague, Czech Republic) with an extruder head (nozzle diameter: 0.4 mm) and an extrusion temperature of 215 °C was used to fabricate the GFD. The PLA filaments, with a 1.75 ± 0.05 mm diameter, were used to feed the printed material for GFD fabrication. The printing time for speed while extruding was 45 mm/s, and the speed while traveling was set as 180 mm/s. The infill layer height was 0.2 mm, and the infill pattern and infill percentage were set with rectilinear and 15%, respectively.

Characterization of GFD

The GFD appearance profile was investigated using a Dino-lite edge am 7915 mzt® digital microscope (AnMo Electronics Corporation, New Taipei City, Taiwan). The accurate weight of the tablet was determined by weighing every 20 pieces independently of each piece using the analytical balance and is given in mg as mean ± SD of 20 tablets. The tablets’ thickness, diameter, and channel diameter were measured using a digital caliper (Zhejiang Deqing Syntek Electronic Technology CO., LTD., Deqing, China).

Preparation of propranolol gel

Propranolol gel was prepared by dissolving propranolol and PVP in deionized water at a weight ratio of 6:5:9, respectively. Then heat at 80 °C and stir until completely dissolved. The propranolol gel was placed into a vacuum chamber to remove the air bubbles. Then, the drug gel was filled into the empty channel of the GFD using a syringe with a needle. The GFD-loaded drug gel was weighed using a digital balance, Sartorius® series-CP224S (Data Weighing Systems, Inc., Illinois, United States), to evaluate the weight of the drug gel. Then, the GFD-loaded drug gel was dried in a hot air oven at 60 °C for 12 h.

The floating ability of propranolol-loaded GFD

The floating properties of propranolol-loaded GFD were conducted with a dissolution tester (DT 720, ERWEKA GmbH, Heusenstamm, Germany). The HCl solutions (pH 1.2) at 37 ± 0.5 °C were selected to simulate the gastric environment, and the paddle rotation speed was set at 75 rpm. The floating lag time and total floating time were recorded.

In-vitro dissolutions of propranolol-loaded GFD

According to USP dissolution apparatus II guidelines, the dissolution profiles were performed using a dissolution tester (DT 720, ERWEKA GmbH, Heusenstamm, Germany). In-vitro drug release profiles for the propranolol-loaded GFD and traditional propranolol tablet (n = 6) were placed into the vessel that contained HCl solution pH 1.2 (simulated gastric fluid (SGF), 900 mL) at the temperature of 37 ± 0.5 °C and a paddle rotation speed of 75 rpm. The samples (2 ml) were withdrawn from the dissolution media at each time point 5, 15, and 30 min, 1, 2, 4, 6, 8, 12, and 24 h. The solution was immediately replaced with 2 ml of freshly prepared medium to maintain the volume. The sample was filtered using 0.45 μm nylon. The drug content was measured by ultraviolet-visible (UV-vis) spectrophotometry analysis at λ = 292 nm using a multimode microplate reader (VICTOR® Nivo™ multimode plate readers, PerkinElmer).

Drug release kinetics

The drug release kinetics were analyzed to investigate the effect of GFD geometry design and drug gel on the drug release profile. The experimental data were calculated and compared to the zero-order, first-order, and Higuchi models. The result was calculated using a correlation coefficient (R2) to determine once the equations were fitted with the drug release profile.

Statistics analysis

The experimental results were shown as the mean ± standard deviation (SD) for triplicate samples. The data was then analyzed using a student’s t-test. Differences were considered statistically significant when p < 0.05.

Results and discussion

Characterization of GFD

The GFDs were fabricated using FDM with PLA. A digital microscope was used to evaluate the appearance and morphology of the printed tablets. The appearance and morphology of the GFDs and propranolol-loaded GFDs are shown in Fig. 2. The smooth surface was observed from GFDs. The white color of GFD was achieved because of the color of the PLA filament. According to previous articles, these results indicated that the 3D printing process produces objects in the same color as the feed material (Tagami et al. 2017). The layer patterns of GFD were obtained when zooming at high magnification (100X) because of the principle of FDM, in which the object is printed by a layer-by-layer technique (Masood 2014; Mwema et al. 2020). The propranolol gel was syringe-filled into the empty channel of the GFD, and satisfactory propranolol-loaded GFD characteristics were obtained in Fig. 2E.

Figure 2. 

Photographic of GFD: A 2 channels and surface enlargement; B 3 channels; C 4 channels; D 5 channels; and E propranolol-loaded GFD.

The weight variation of GFD was measured using an analytical balance, and the results are shown in Table 1. The dimensions of the GFD were evaluated in terms of diameter, height, and channel diameter. The results show that all GFD sizes were similar to the designed GFD model, as shown in Table 1. The low standard deviation values of weight variation and dimensions highlighted the great precision and minimal shape error of the FDM 3D printing. These results are based on the previous article, which mentions that FDM is a machine that has the highest accuracy with a minimum shape error of 0.05% (Alsoufi and Elsayed 2018). Moreover, the size of the channel affects the duration of drug release. Therefore, the channel diameter and number of channels are important factors in further drug release profiles.

Table 1.
Download as
CSV
XLSX

The dimensions and weight variation of the GFD and the weight variation of propranolol-loaded GFD and propranolol gel.

Number of channels Diameter (mm) Height (mm) Channel diameter (mm) Weight of GFD (n = 20) (mg) Weight of propranolol-loaded GFD (n = 20) (mg) Weight of propranolol gel (n = 20) (mg)
2 14.05 ± 0.03 10.04 ± 0.03 4.04 ± 0.02 954.09 ± 0.30 1140.79 ± 0.31 186.70 ± 0.01
3 14.04 ± 0.04 10.01 ± 0.03 4.03 ± 0.03 952.10 ± 0.26 1209.30 ± 0.27 257.20 ± 0.01
4 14.01 ± 0.05 10.06 ± 0.02 4.04 ± 0.04 943.60 ± 0.26 1272.00 ± 0.29 328.40 ± 0.03
5 14.04 ± 0.02 10.04 ± 0.03 4.06 ± 0.03 920.90 ± 0.23 1304.90 ± 0.29 384.00 ± 0.06

The floating ability of propranolol-loaded GFD

The floating ability of propranolol-loaded GFD in HCl buffer (pH 1.2) exhibited that all formulations float for more than 24 h. This is because the inner structure design of 3D-printed tablets presented an air chamber inside for floating properties. The buoyancy characteristic of GFD was maintaining an upright orientation with an upper air chamber of GFD, and the propranolol gel was immersed in the medium solution over floating time. This agrees with the previous article, which found that the gastro-floating 3D printed device from PLA filament could float more than 24 h with the in vitro floating ability (pH 1.2). In addition, the in vivo floating ability of the PLA 3D-printed device in beagle dogs showed that the device presented in the small intestine at 24 h and disappeared at 48 h after oral administration (Shin et al. 2019). Besides, Fu et al. (2018) evaluated another floating PLA 3D-printed device design. The result of in vivo floating ability depicted that the device was observed in the rabbit’s stomach for more than three days (Fu et al. 2018). However, PLA is a biodegradable, biocompatible, environmentally friendly polymer, and PLA polymer can be hydrolyzed to alfa-hydroxy acid and then be eliminated from the body (Makhija and Vavia 2003). Thus, the PLA-printed device could lose its floating ability over time due to the degradation of PLA, which directly causes leakage of the air chamber, leading to elimination from the body by the peristalsis movement of the gastrointestinal tract.

In-vitro dissolutions of propranolol-loaded GFD

The in-vitro drug release of propranolol HCl commercial tablets and propranolol-loaded GFD was evaluated using dissolution apparatus II. The results are presented in Fig. 3. The propranolol commercial tablets exhibited an immediate release profile, and the cumulative release of the drug was achieved 100% at 1 h. The outcome was consistent with earlier research, which stated that the commercial propranolol tablets had a release characteristic of about 80% within 30 minutes (Shuma et al. 2021). Moreover, Rodriguez-Saavedra et al. (2024) reported that the release of propranolol commercial tablets was similar to the mentioned article (Rodriguez-Saavedra et al. 2024).

Figure 3. 

The drug release profile of propranolol tablets (lilac circle) and propranolol-loaded GFD with 2 (blue square), 3 (brown x-shape), 4 (yellow triangle), and 5 (purple diamond) channels. * Statistically significant (p <0.05) compared with 5 channels of GFD.

The dissolution results of propranolol-loaded GFD showed sustained release profiles. The difference in the number of channels is important to the drug release rate. The results found that the 2 and 3 channels of GFD exhibited a slow-release rate that achieved more than 90% accumulative release after 8 h. In comparison, the 4 and 5 channels of printed tablets showed a fast release profile of approximately 90% accumulative release at 6 h. These results were consistent with the previous article, which designed the drug release channel for various sizes. The result showed that when the interface between the drug and medium solution was decreased, the rate of drug release was decreased (Zhao et al. 2022).

In addition, the type of filament used to print GFD is important to the dissolution rate of the drug. PLA is a hydrophobic polymer that can maintain the surface area of the drug in contact with a medium (Tagami et al. 2018). On the other hand, the PVA 3D-printed device exhibits a faster release rate because a PVA is a hydrophilic polymer that could dissolve in a medium solution and could not maintain a channel diameter while the drug was released. Although the PVA affected the release profile by uncontrollably increasing the channel diameter, Xu et al. (2019) fabricated a PVA 3D-printed device containing paracetamol gel in a spherical shape to overcome this limitation (Xu et al. 2019). However, using PVA was inappropriate for printing the floatable device. Moreover, in the previous article, commercial propranolol immediate-release tablets were incorporated into the PVA GRFDs. The results showed that propranolol-incorporated PVA GRFD had a short total floating time and was rapidly released, with the accumulated release of propranolol being more than 90% within 2 h. Because the PVA was quickly soluble in a medium solution, resulting in air chamber leakage (Alqahtani et al. 2023). Thus, the was obtained. Besides, the PLA GRFDs showed a sustained release profile of propranolol up to 10 h. However, a lag time of 30–60 min was found from the PLA GRFDs because the device has an opening channel at the base side center of the device (Alqahtani et al. 2023). In this study, these limitations were addressed by designing an opening channel on the side wall of the GFD to prevent the release lag time, and the propranolol-loaded GFD with 2 channels could provide satisfied sustained release properties for 8 h.

Drug release kinetics

The release kinetics of the propranolol from GFD with 4 and 5 channels were evaluated from 0 to 6 h because propranolol was completely released in 6 h. On the other hand, the propranolol-loaded GFD with 2 and 3 channels was completely released at 8 h. Thus, the time interval of 0–8 h was used to analyze the release kinetics. The release kinetics, including zero-order (Varelas et al. 1995), first-order (Savaşer et al. 2005), and Higuchi model (Siepmann and Peppas 2011), were calculated and shown in Table 2. The results indicated that the various designs of GFD were the best fit with the zero-order kinetics model with R2 > 0.95. According to the previous literature, the finding explained that the zero-order kinetics model exhibited a continuously released profile of the drug from the device until the device was emptied (Yoshida et al. 1991). Moreover, Zhao et al. (2022) developed an intragastric floating and sustained-release drug delivery system using PLA polymer for fabricating the 3D-printed tablets, in which the drug release fit the zero-order kinetic model (Zhao et al. 2022). Furthermore, Charoenying et al. (2023) used PLA to print the tablet-shaped floating 3D-printed device with zero-order kinetics (Charoenying et al. 2023). These results were based on the Noyes-Whitney equation because the interface between the propranolol gel and medium was fixed by the channel diameter (Goyanes et al. 2015). Therefore, PLA was the suitable material for 3D-printed device fabrication to obtain the zero-order kinetic of drug release. On the other hand, the PVA 3D-printed device mostly fits with the first-order or Higuchi model because the hole size changed and could not be maintained during the drug release. Thus, it could be indicated that the GFD with 2 channels exhibited a great controlled release with zero-order kinetic for 8 h and floating properties.

Table 2.
Download as
CSV
XLSX

Drug release kinetics of 3D-printed tablets loaded with propranolol gel.

Number of channels Zero-order (R2) First-order (R2) Higuchi (R2)
2 0.9974* 0.7276 0.9092
3 0.9909* 0.8986 0.8371
4 0.9986* 0.9248 0.9260
5 0.9895* 0.9041 0.9395

* The value of R2 > 0.95

Conclusion

The novel-designed GFDs were successfully fabricated with an FDM 3D printer using PLA, and the propranolol gel could be loaded into GFDs using a syringe. The present study showed that the drug’s potency in gel formulation was easily varied for personalization. Moreover, the GFDs exhibited floating ability via the air chamber. Propranolol-loaded GFPs provided sustained release properties without the lag time, which sustained times depending on the number of channels, which were 6 and 8 h for 4–5 channels and 2–3 channels, respectively. The GFD with 2 channels was fit for the zero-order kinetics release model with the highest R2 value. Therefore, GFDs might be a promising strategy to apply to other drugs for personalized gastro-retentive drug delivery systems.

Acknowledgments

We would like to thank the Faculty of Pharmacy, Silpakorn University, and undergraduate students, including Natchrintorn Tranitapiwit and Pornwachira Jumpangern, for processing assistance.

Additional information

Conflict of interest

The authors have declared that no competing interests exist.

Ethical statements

The authors declared that no clinical trials were used in the present study.

The authors declared that no experiments on humans or human tissues were performed for the present study.

The authors declared that no informed consent was obtained from the humans, donors or donors’ representatives participating in the study.

The authors declared that no experiments on animals were performed for the present study.

The authors declared that no commercially available immortalised human and animal cell lines were used in the present study.

Funding

This research project is funded by the National Research Council of Thailand (NRCT) (Contact No. N41A661139 and N42A660847).

Author contributions

Dareena Jaiseri: Data curation, Methodology, Investigation, Writing – Original draft preparation, Funding acquisition. Supusson Pengnam: Writing – review & editing Investigation. Praneet Opanasopit: Methodology, Visualization, Funding acquisition, Formal Analysis. Prasopchai Patrojanasophon: Formal Analysis. Tanasait Ngawhirunpat: Formal Analysis. Theerasak Rojanarata: Formal Analysis. Teeratas Kansom: Revised the manuscript. Thapakorn Charoenying: Conceptualization, Methodology, Validation, Visualization, Writing – review & editing, Supervision, Project administration, Funding acquisition.

Author ORCIDs

Dareena Jaiseri https://orcid.org/0009-0005-3866-8879

Supusson Pengnam https://orcid.org/0000-0003-4664-0276

Praneet Opanasopit https://orcid.org/0000-0002-4878-2529

Tanasait Ngawhirunpat https://orcid.org/0000-0003-4260-6097

Theerasak Rojanarata https://orcid.org/0000-0002-5309-1896

Prasopchai Patrojanasophon https://orcid.org/0000-0002-4974-4532

Teeratas Kansom https://orcid.org/0000-0002-3014-6807

Thapakorn Charoenying https://orcid.org/0000-0003-2419-1676

Data availability

All of the data that support the findings of this study are available in the main text.

References

  • Alqahtani AA, Mohammed AA, Fatima F, Ahmed MM (2023) Fused deposition modelling 3D-printed gastro-retentive floating device for propranolol Hcl tablets. Polymers (Basel) 15(17): 3554–3570. https://doi.org/10.3390/polym15173554
  • Alsoufi MS, Elsayed AE (2018) Surface roughness quality and dimensional accuracy – a comprehensive analysis of 100% infill printed parts fabricated by a personal/desktop cost-effective FDM 3D printer. Materials Sciences and Applications 9: 11–40. https://doi.org/10.4236/msa.2018.91002
  • Araújo MR, Sa-Barreto LL, Gratieri T, Gelfuso GM, Cunha-Filho M (2019) The digital pharmacies era: How 3D printing technology using fused deposition modeling can become a reality. Pharmaceutics 11(3): 128–142. https://doi.org/10.3390/pharmaceutics11030128
  • Cader HK, Rance GA, Alexander MR, Gonçalves AD, Roberts CJ, Tuck CJ, Wildman RD (2019) Water-based 3D inkjet printing of an oral pharmaceutical dosage form. International journal of pharmaceutics 564: 359–368. https://doi.org/10.1016/j.ijpharm.2019.04.026
  • Cailleaux S, Sanchez-Ballester NM, Gueche YA, Bataille B, Soulairol I (2021) Fused Deposition Modeling (FDM), the new asset for the production of tailored medicines. Journal of Controlled Release 330: 821–841. https://doi.org/10.1016/j.jconrel.2020.10.056
  • Charoenying T, Opanasopit P, Ngawhirunpat T, Rojanarata T, Akkaramongkolporn P, Patrojanasophon P (2023) Development of a novel tablet-shaped floating 3D-printed device with adjustable floating time as floating drug delivery systems provided zero-order release kinetics. Journal of Drug Delivery Science and Technology 84: 104506. https://doi.org/10.1016/j.jddst.2023.104506
  • Chaturvedi K, Umadevi S, Vaghani S (2010) Floating matrix dosage form for propranolol hydrochloride based on gas formation technique: development and in vitro evaluation. Scientia pharmaceutica 78(4): 927–940. https://doi.org/10.3797/scipharm.0909-02
  • Cohen A, Laviv A, Berman P, Nashef R, Abu-Tair J (2009) Mandibular reconstruction using stereolithographic 3-dimensional printing modeling technology. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology 108(5): 661–666. https://doi.org/10.1016/j.tripleo.2009.05.023
  • Fu J, Yin H, Yu X, Xie C, Jiang H, Jin Y, Sheng F (2018) Combination of 3D printing technologies and compressed tablets for preparation of riboflavin floating tablet-in-device (TiD) systems. International Journal of Pharmaceutics 549(1–2): 370–379. https://doi.org/10.1016/j.ijpharm.2018.08.011
  • Giri BR, Song ES, Kwon J, Lee J-H, Park J-B, Kim DW (2020) Fabrication of intragastric floating, controlled release 3D printed theophylline tablets using hot-melt extrusion and fused deposition modeling. Pharmaceutics 12(1): 77. https://doi.org/10.3390/pharmaceutics12010077
  • Goyanes A, Martinez PR, Buanz A, Basit AW, Gaisford S (2015) Effect of geometry on drug release from 3D printed tablets. International Journal of Pharmaceutics 494(2): 657–663. https://doi.org/10.1016/j.ijpharm.2015.04.069
  • Huang S, O’Donnell KP, de Vaux SMD, O’Brien J, Stutzman J, Williams III RO (2017) Processing thermally labile drugs by hot-melt extrusion: The lesson with gliclazide. European Journal of Pharmaceutics and Biopharmaceutics 119: 56–67. https://doi.org/10.1016/j.ejpb.2017.05.014
  • Jagdale SC, Agavekar AJ, Pandya SV, Kuchekar BS, Chabukswar AR (2009) Formulation and evaluation of gastroretentive drug delivery system of propranolol hydrochloride. Aaps Pharmscitech 10: 1071–1079. https://doi.org/10.1208%2Fs12249-009-9300-8
  • Józó M, Simon N, Yi L, Móczó J, Pukánszky B (2021) Improved release of a drug with poor water solubility by using electrospun water-soluble polymers as carriers. Pharmaceutics 14(1): 34. https://doi.org/10.3390/pharmaceutics14010034
  • Makhija SN, Vavia PR (2003) Controlled porosity osmotic pump-based controlled release systems of pseudoephedrine: I. Cellulose acetate as a semipermeable membrane. Journal of controlled release 89(1): 5–18. https://doi.org/10.1016/S0168-3659(02)00482-0
  • Maroni A, Melocchi A, Parietti F, Foppoli A, Zema L, Gazzaniga A (2017) 3D printed multi-compartment capsular devices for two-pulse oral drug delivery. Journal of controlled release 268: 10–18. https://doi.org/10.1016/j.jconrel.2017.10.008
  • Mwema FM, Akinlabi ET, Mwema FM, Akinlabi ET (2020) Basics of fused deposition modelling (FDM). In: Fused Deposition Modeling: Strategies for Quality Enhancement. Springer, Cham, 1–15. https://doi.org/10.1007/978-3-030-48259-6_1
  • Rodriguez-Saavedra LR, Alva-Plasencia PM, Curo-Vallejos YF, Saavedra-Suárez SF, Chávez-Abanto LA, Caballero-Aquiño OE, Gutiérrez-Ramos ME, Sánchez-Bautista JF (2024) Dissolution kinetics of propranolol hydrochloride 40 mg tablets under biowaiver conditions. Journal of Pharmacy & Pharmacognosy Research 12(5): 814–821. https://doi.org/10.56499/jppres23.1853_12.5.814
  • Shin S, Kim TH, Jeong SW, Chung SE, Lee DY, Kim D-H, Shin BS (2019) Development of a gastroretentive delivery system for acyclovir by 3D printing technology and its in vivo pharmacokinetic evaluation in Beagle dogs. PloS One 14(5): e0216875. https://doi.org/10.1371%2Fjournal.pone.0216875
  • Shuma ML, Biswas BK, Raihan SZ, Halder S (2021) In vitro comparative dissolution studies of different propranolol generic tablets available in Bangladesh. Journal of Drug Delivery and Therapeutics 11(6-S): 86–91. https://doi.org/10.22270/jddt.v11i6-S.5225
  • Tagami T, Fukushige K, Ogawa E, Hayashi N, Ozeki T (2017) 3D printing factors important for the fabrication of polyvinylalcohol filament-based tablets. Biological and Pharmaceutical Bulletin 40(3): 357–364. https://doi.org/10.1248/bpb.b16-00878
  • Tagami T, Nagata N, Hayashi N, Ogawa E, Fukushige K, Sakai N, Ozeki T (2018) Defined drug release from 3D-printed composite tablets consisting of drug-loaded polyvinylalcohol and a water-soluble or water-insoluble polymer filler. International Journal of Pharmaceutics 543(1–2): 361–367. https://doi.org/10.1016/j.ijpharm.2018.03.057
  • Trenfield SJ, Awad A, Goyanes A, Gaisford S, Basit AW (2018a) 3D printing pharmaceuticals: drug development to frontline care. Trends in pharmacological sciences 39(5): 440–451. https://doi.org/10.1016/j.tips.2018.02.006
  • Trenfield SJ, Madla CM, Basit AW, Gaisford S (2018b) Binder jet printing in pharmaceutical manufacturing. In: Basit A, Gaisford S (Eds) 3D Printing of Pharmaceuticals. AAPS Advances in the Pharmaceutical Sciences Series, vol 31. Springer, Cham, 41–54. https://doi.org/10.1007/978-3-319-90755-0_3
  • Yoshida R, Sakai K, Okano T, Sakurai Y (1991) A new model for zero-order drug release I. Hydrophobic drug release from hydrophilic polymeric matrices. Polymer Journal 23(9): 1111–1121. https://doi.org/10.1295/polymj.23.1111
  • Zhao X, Wei W, Niu R, Li Q, Hu C, Jiang S (2022) 3D printed intragastric floating and sustained-release tablets with air chambers. Journal of Pharmaceutical Sciences 111(1): 116–123. https://doi.org/10.1016/j.xphs.2021.07.010
login to comment