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5 Semi-Solid Extrusion (SSE) in Pharmaceuticals 189
More recently, Goh et al. (2021) produced SSE 3D printed polypills with multiple
release profiles for the delivery of caffeine and vitamin B analogues. The polypill
was developed with two compartments: the inner core for the sustained release of
caffeine and the outer shell containing vitamin B analogues for immediate release.
CraftBlends
™
excipients for 3D printing were chosen to achieve different release
profiles. Craft Blend R30M, containing disintegrants and binders, was the main
component of the outer shell, meant to achieve total vitamin B dissolution in 30 min
in simulated gastric fluid. Meanwhile, Craft Blend R4H excipients, composed of
binders and gel forming agents, were used for the inner core, to achieve a sustained
caffeinedissolutionin4hinbothacidicandbasicpH.
Continuing to explore the oral route, SSE has also been applied to the manufacture of gastro-floating tablets, which have a higher residence time in gastric fluid,
with a sustained drug release and regular plasma concentrations (Li et al.
2018).
These systems can be simply prepared by changing the infill percentage of the
dosage forms (Li et al.
(Falcone et al.
2021) or by designing a core-shell floating systems (Chen et al. 2021).
2018), using a more complex process with a coaxial SSE
Li et al. (2018) demonstrated that a lower infill percentage (30 > 50 > 70%),
generated a higher floating time (12 > 12 > 8 h) using a dipyridamole 3D
printed gastro-floating tablet composed of HPMC K4M (15%), HPMC E15 (15%),
microcrystalline cellulose (MCC) PH101 (30%) and PVP K30 (5%). The floating
phenomena achieved in simulated gastric fluid could be mostly explained by
differences in density and the greater access of air to the inner structure of the printed
material. As an alternative approach, propranolol hydrochloride floating systems
were developed using coaxial SSE. The polymer alginate (outer channel) and a
mixture of the crosslinking agent (Ca
2+
) and the drug (inner channel) were added
in two different syringes to produce a hollow filament as a result of the ionotropic
gelation of the alginate during the printing process. The developed tablets were able
to float for 5 h in an acidic medium containing 0.1 M HCl, and drug release was
complete after 6 h (Falcone et al.
2021).
A different strategy was proposed by Chen et al. (2021) to produce gastric-
floating tablets using multi-nozzle SSE (Fig.
5.4b). They designed a low-density
shell using a blend of HPMC K15M CR, Poloxamer 188 and PVP K30 containing
the drug clarithromycin, and a floating core of ethylcellulose 20, carbomer 934P
and CaCO
interaction of carbomer and CaCO
. The micro airbag structure developed by 3D printing added to the
2
(generating CO2 when in contact with water) in
2
the inner tablet structure, increasing the buoyancy of the dosage form, which showed
a floating time of more than 10 h. Additionally, a high drug loading was achieved
(74.5%),andthetotalreleaseofclarithromycinwasobservedin8hin acetate buffer
medium (pH 5.0).
Another relevant application of SSE in the 3D printing of oral dosage forms
involves the development of paediatric-friendly formulations (Karavasili et al.
2022,Fig. 5.4c. Chewable (Herrada-Manchón et al. 2020; Tagami et al. 2021) and
orodispersible tablets (Díaz-Torres et al.
2021; Suárez-González et al. 2021), among
others, have already been reported in the literature to improve patient compliance.
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Zhu et al. (2022) developed 3D printed gummy chewable tablets with a bear
shape, a pink colour and an orange flavour. The formulation was mainly composed
of gelatin, sodium carboxymethyl starch and carrageenan, and fitted immediate
release specifications using the drug pharmacopoeial dissolution medium, with a
total propranolol hydrochloride release in 15 min. The combination of gelatin and
carrageenan resulted in formulations with good masticatory properties, which were
improved by increasing the gelatin in the formulation. Finally, a taste analysis
experiment was conducted in a randomised crossover, double-blind trial in healthy
humans and the bitterness of the drug was successfully masked by the addition of
bitterness inhibitors (γ-aminobutyric acid) and sucralose in the formulation.
Using the same perspective, Herrada-Manchón et al. (2020) created SSE 3D
printed gummies containing ranitidine hydrochloride and strawberry flavour (Fig.
5.4d). The gummies were printed with four different thermo-reversible inks,
combining gelatin, carrageenan and xanthan gum as the main components, and
varying the presence or absence of corn starch and ranitidine. The inks with starch
in their composition were found to be more appropriate for the SSE 3D printing
technique, providing good extrudability and faster restructuring after printing, and
the 3D printed form was easily removed from the printing bed. Dissolution studies
were performed according to the USP monograph for ranitidine tablets, using
the gummies containing ranitidine with or without corn starch. The presence of
corn starch resulted in a more extended-release of ranitidine, achieving 60% of
drug dissolution in 45 minutes, while almost 100% of the drug was released after
15 minutes in the absence of corn starch, presenting an immediate release-like
profile.
Also focused on the development of paediatric formulations, hydrochlorothiazide
orodispersible printlets with banana flavour were developed using PVP 30 K as
the main polymeric matrix. The authors made modifications to the tablet infill and
concluded that the disintegration specification of the European Pharmacopoeia for
orodispersible tablets (100% in 180 s) could be achieved by reducing the infill
percentage to 70%. Moreover, about 80% of the drug was released within 20 min in
water, meeting FDA requirements for the developed dosage form (Díaz-Torres et al.
2021).
As stated before, the development of dosage forms using SSE 3D printing
goes beyond the oral route. A recent review showed that studies devoted to the
development of topical dosage forms by SSE have been increasing in the last 3 years,
describing the 3D printing of wound dressings, patches, films and scaffolds, for
example (de Oliveira et al.
2021). Recent studies have reported the development of
scaffolds containing a plant extract intended for the treatment of skin wounds (Ilhan
et al.
2020) and the association of mesoporous silica nanoparticles in 3D printed
films for application in oral mucosa lesions (Schmidt et al.
2022).
Satureja cuneifolia extract was incorporated into SSE feedstock to produce
scaffolds for diabetic wound treatment. This plant extract is already known for its
antidiabetic, antioxidant, anticholesterolemic and antimicrobial properties (Jafari et
al.
2016). A polymeric blend of sodium alginate and PEG was used to formulate the
SSE feedstock, mainly due to its biocompatibility, hydrophilic nature, and its ability
5 Semi-Solid Extrusion (SSE) in Pharmaceuticals 191
to provide a favourable environment for local cell proliferation. The porous structure
of the 3D printed scaffold (<200 μm) enabled cell proliferation and provided an
acceleration of the wound closure time. Moreover, the antibacterial activity of
the scaffold against Staphylococcus aureus and Escherichia coli showed the high
antimicrobial effect of the developed dosage form, which was comparable to the
control antibiotic ampicillin (Ilhan et al.
2020).
Continuing with topical applications, hydrophilic films containing triamcinolone
acetonide associated with mesoporous silica particles (SBA-15) were developed for
oral mucosal treatment using SSE (Fig.
5.4e). This was the first study proposing the
development of SSE 3D printed dosage forms containing drug-loaded mesoporous
silica. The film was 3D printed from a CMC feedstock, which demonstrated a
mucoadhesive property in a mucin disc assay that was improved by the presence
of triamcinolone acetonide-loaded SBA-15 particles. This is an important characteristic to increase the residence time of dosage forms in the oral mucosa. In
addition, dissolution studies revealed a 55% drug release in 3 h, using phosphate
buffer solution (pH 7.4) and ethanol (70:30) as the release medium (Schmidt et al.
2022).
The rectal route has also been explored to prepare dosage forms using the SSE
3D printing technique. A recent study reported the incorporation of tacrolimus in a
feedstock of SSE to produce suppositories for the treatment of ulcerative colitis (Fig.
5.4f). Lipid-based formulations (Gelucire ® 44/14 or Gelurice ® 48/16, and coconut
oil) were chosen for the printing ink due to the low water solubility of tacrolimus
and the ability to adjust the melting of the suppositories. These excipients may also
overcome potential rectal irritations related to the use of conventional excipients,
such as PEG, for example. Due to the slightly higher lipophilicity of Gelurice
(hydrophilic-lipophilic balance, HLB = 10.4), a delayed release of tacrolimus was
observed from this formulation in comparison to Gelucire
®
48/16 (HLB = 11.2)
®
44/14
suppositories. However, both suppositories released more than 80% tacrolimus
within 120 min (Seoane-Viaño et al.
2021b).
Looking from another perspective, the SSE technique has also been explored in
the personalisation of veterinary drugs. Pharmacotherapy in veterinary medicine is
prescribed according to the animal’s weight, which is why the number of available
veterinary medicinal products is limited and animals are usually treated off-label
with human medicines. Other aspects need to be considered in the development of
veterinary formulations, such as the safety of the excipients added to the formulation
and the use of flavouring agents to increase adherence to treatment. Only a few
studies have been reported associating the use of SSE and the development of dosage
forms for veterinary use.
As an example of this application, Sjöholm et al. (2022) developed a pet-friendly
chewable tablet containing gabapentin using SSE 3D printing (Fig.
5.4g). The
chosen printing ink was developed with a HPMC-based formulation and mannitol,
and liver powder was added to the formulation to improve palatability and treatment
acceptance. Crospovidone was used to improve the disintegration time. Therapy
with gabapentin is challenging in the veterinary population because of the very
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low doses needed and the limited number of market-approved veterinary dosage
forms. Thus, in this study, it was possible to reach therapeutic doses of between
10 mg and 200 mg gabapentin, changing the size of the chewable tablets. The
disintegration time of the printlets was 202 ± 34 s, and more than 90% of the drug
was released in less than 30 min, which allowed its classification as an immediate
release formulation, according to FDA recommendations.
The SSE technique has been also explored in other areas of healthcare, such
as 3D bioprinting, where structures are produced from biological materials and
living cells. It is well-known that the availability of donors of organs and tissues
for transplantation is limited, so the possibility of using low temperature printing
and semi-solid based raw materials makes SSE a viable choice for printing high
cell density materials that can form living tissues and even organs (Mannoor et al.
2013; Isaacson et al. 2018; Noor et al. 2019). More recently, this technology has
shown its potential in the field of bioelectronics, particularly in the production of
biosensors capable of monitoring physiological parameters of the human body, such
as a glucose biosensor with high sensitivity and selectivity (Tang et al.
2019); and
also in the field of dentistry, where SSE has been used to produce dental implants
such as crowns and bridges (Firth et al.
2018). Joining this field with veterinary
medicine, Lee and colleagues used SSE to developed chewers for the oral hygiene
of dogs and cats, utilising corn starch and glycerin in different proportions as the
printing ink (Lee et al.
2022).
The food industry’s interest in SSE is growing because it is possible to create
edible structures based on chocolate, dough, meat and even mashed potato, for
example. It is also possible to add cellulose or other types of starch to improve
the rheology of the edible material (Lille et al.
2018). The personalisation of food
is important because it allows food to be adapted to the nutritional needs of specific
individuals (Ma and Zhang
2022).
As previously illustrated, SSE has been shown to be a versatile approach among
the available 3D printing techniques as it can be easily applied to diverse fields,
including human and animal health. In addition, the personalised appeal brought by
3D printing technology makes it possible to reduce the environmental impact caused
by the excessive production of pharmaceuticals, which leads to their irrational use
and a high number of disposed medicines. The alliance between human, animal
and environmental health characterises a multidisciplinary approach known as “One
Health”, where 3D printing technology fits perfectly, particularly because of the
possibility of developing dosage forms that can be easily adapted according to their
intended purpose.
5.6 Perspectives
Since the first report on the use of SSE in pharmaceutics in 2014, many studies
have been published highlighting the possibilities given by this technique in the
development of 3D printed dosage forms. As discussed previously, its advantages
include a low working temperature, the easy preparation of feedstocks, the possibil-
5 Semi-Solid Extrusion (SSE) in Pharmaceuticals 193
ity of reaching diverse release profiles, the feasibility of producing polypills and the
relatively easy printer setup needed, among others.
From a technological perspective, it seems that the technique can be explored
much more to improve the printing process and to overcome some drug drawbacks. Recently, cyclodextrins (Conceição et al.
Peltonen
2021; Lopez-Vidal et al. 2022), nanocapsules (de Oliveira et al. 2022)
2019), nanocrystals (Germini and
and mesoporous silica carriers (Schmidt et al. 2022) have been incorporated into
SSE feedstocks, with some interesting outcomes, highlighting the potential of the
alliance of this technique with drug nanocarriers or nanomaterials.
A cyclodextrin-drug complexation showed a positive effect on the facilitation of
the printing process. Nanocrystals displayed the potential to tailor the drug release
from 3D printed formulations, even though increased nanocrystal concentrations
could result in poor ink flowability and nozzle clogging. Nanocapsules remained
intact after printing, without changing the rheological and textural properties of the
feedstock (Fig.
5.4h); and SBA-15 mesoporous silica was shown to be an excellent
carrier to incorporate drugs with poor solubility into SSE feedstocks, as it can be
easily dispersed into water-based formulations (Fig.
5.4e).
From a biological viewpoint, there are still few reports regarding in vivo studies
and preclinical trials of 3D printed products. Goyanes et al. (
2019) were the first
to perform a study in a hospital setting involving the patient acceptability of
SSE 3D printed isoleucine chewable tablets, which were prepared with different
colours and flavours, and tailored the dose according to patient blood levels. Besides
better patient acceptance, the 3D printed dosage forms were able to maintain drug
blood levels within the efficacy window, with a lower variation in isoleucine blood
concentration over time compared with the standard medication. The 3D printed
dosage forms were considered easier to swallow than the commercial isoleucine
capsules, which were usually opened to facilitate drug intake.
In addition, in vivo studies using animal models have recently been described for
SSE 3D printed pharmaceuticals. They showed positive outcomes targeting the rectal and buccal routes, as previously mentioned. Tacrolimus 3D printed suppositories
were developed with a blend of Gelucire
®
44/14 and coconut oil and were evaluated
in vivo for the treatment of inflammatory bowel disease directly to the injured site.
A fast therapeutic response was observed in a rat model by PET/CT imaging and
histological evaluation, showing that the developed suppository presented colitis
remission in rats 4 days earlier than the untreated group (Seoane-Viaño et al.
2020).
In addition, mucoadhesive films containing apigenin were developed to treat oral
leukoplakia using SSE, aiming to tailor the dose and shape according to the need
of the patient. After inducing rat oral carcinogenesis, an effective in vivo prevention
was observed with the apigenin-loaded 3D printed films against the development of
tongue carcinogenesis. While the entire control group exhibited tongue lesions, the
tumour incidence decreased to 50% in the group treated with the developed dosage
form (Takashima et al.
2022).
The positive results cited above could represent the first step towards the implementation of 3D printing of pharmaceuticals by SSE in places where personalised
194 N. L. Funk et al.
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medicines are needed, like hospitals and health services. However, there is a long
road ahead, since SSE 3D printed dosage forms should be further studied regarding their pharmacokinetics, biocompatibility, toxicity and penetration/permeation
across biological membranes, among others, depending on the intended route of
administration.
Moreover, the increased number of studies covering the use of 3D printing
in pharmaceutics also reinforces the need for printers that check all the boxes
relating to pharmaceutical good manufacturing practices. Up to now, printers have
been adapted from fields that do not demand special attention to topics such as
machine cleaning, which is very important between processes, to prevent the cross
contamination of drugs and guarantee the safety of the dosage forms. Concerning
this question, SSE printers seem to be closer to an ideal profile, among the various
3D printing techniques, as disposable syringes filled with appropriate feedstocks
could be available for used in the printing process. However, from an environmental
perspective, an increased accumulation of plastic that cannot be reused after printing
could become an issue. Thus, recycling initiatives or the replacement of plastic
syringes with an eco-friendlier material should be further managed.
5.7 Conclusion
The versatility presented by the SSE technique is unquestionable. Among all 3D
printing techniques, SSE has demonstrated its potential in different fields, including
bioprinting, dentistry and food science. In pharmaceutics, SSE has displayed a major
ascension in the last few years, which can be explained by the various advantages
that enable formulators to design and produce unique personalised medicines. In
this sense, SSE has been proposed as an excellent approach to produce personalised
medicines, supplying a broad range of technological opportunities to attend diverse
patient requirements. On the other hand, additional studies can further explore the
optimisation of the printing process, compliance with good manufacturing practices
requirements, and ensure the safety and efficacy of the SSE 3D printed dosage
forms. In this way, we believe that this chapter illustrates the open path to future
studies on the application of SSE in pharmaceutics, bringing it closer to real-life
implementation.
Acknowledgements We would like to thank the following Brazilian agencies for funding our
research group: CNPq/Brazil; FAPERGS/Brazil and CAPES/Brazil. Furthermore, we kindly thank
Elsevier for the permission to reproduce the following materials: Fig.
published in International Journal of Pharmaceutics, Vol 494, Khaled SA, Burley JC, Alexander
MR, Yang J, Roberts CJ, 3D printing of tablets containing multiple drugs with defined release
profiles, 643–650, Copyright Elsevier (2015); Fig.
Journal of Pharmaceutics, Vol 605, Chen P, Liu J, Zhang K, Huang D, Huang S, Xie Q, Yang F,
Huang J, Fang D, Huang Z, Lu Z, Chen YZ, Preparation of clarithromycin floating core-shell
systems (CSS) using multi-nozzle semi-solid extrusion-based 3D printing, 120837, Copyright
Elsevier (2021); Fig.
Sciences, Vol 147, Karavasili C, Gkaragkounis A, Moschakis T, Ritzoulis C, Fatouros DG,
5.4c. This figure was published in European Journal of Pharmaceutical
5.4b. This figure was published in International
5.4a. This figure was
5 Semi-Solid Extrusion (SSE) in Pharmaceuticals 195
Pediatric-friendly chocolate-based dosage forms for the oral administration of both hydrophilic
and lipophilic drugs fabricated with extrusion-based 3D printing, 105291, Copyright Elsevier
(2020); Fig. 5.4d. This figure was published in International Journal of Pharmaceutics, Vol 587,
Herrada-Manchón
P, García-Montoya E, Aguilar E., 3D printed gummies: Personalised drug dosage in a safe
and appealing way, 119687, Copyright Elsevier (2020); Fig. 5.4e. This figure was published in
International
Funk NL, Petzhold CL, Benvenutti EV, Deon M, Beck RCR, Drug-loaded mesoporous silica
on carboxymethyl cellulose hydrogel: Development of innovative 3D printed hydrophilic films,
121750, Copyright Elsevier (2022); Fig. 5.4f. This figure was published in Asian Journal of
Pharmaceutical
M, Basit AW, Otero-Espinar FJ, Goyanes A., 3D printed tacrolimus suppositories for the treatment
of ulcerative colitis, 110-119, Copyright Elsevier (2021); Fig. 5.4g. This article was published in
European
Wang X, Ojala S, Sandler N., Semi-solid extrusion 3D printing of tailored ChewTs for veterinary
use-A focus on spectrophotometric quantification of gabapentin, 106190, Copyright Elsevier
(2022); Fig. 5.4h. This article was published in International Journal of Pharmaceutics, Vol 624,
de
nanomedicines: An original application of the semi-solid extrusion technique, 122029, Copyright
Elsevier (2022).
Journal
Oli
veira T V., de Oliveira RS, Funk NL, Petzhold CL, Beck RCR, Redispersible 3D printed
H,
Rodríguez-Gonzáleza D, Fernández MA, Suñé-Pouc M, Pérez-Lozanoc
of Pharmaceutics, Vol 620, Schmidt LM, de Oliveira TV, dos Santos J,
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