Akademik Veri Yönetim Sistemi
Mesut B. (Yürütücü), Erginer Y., Awad A.
Türkiye Sağlık Enstitüleri Başkanlığı (TÜSEB) Araştırma Projesi, 2023 - 2025
With the industrial revolution that started in the
second half of the 18th century, there have been many developments in the
pharmaceutical industry and pharmaceutical production technologies. One of
these developments is 3D printing technology. This technology enables the design
created with a computer software to be developed in virtual environments with
the additive manufacturing approach and materialized with a 3D application,
without the need for a separate equipment or process step. Thus, both digitalization
and mechanization are used in an integrated manner (Awad vd., 2018a). Printing
technologies of 3D printers; Ink printing is based on different systems such as
nozzle-based or laser printing (Azizoğlu vd., 2020). Fused deposition modeling
(FDM) is one of the nozzle-based systems, and it allows printing by making use
of the thermoplastic properties of the material used, and thanks to this
advantage it allows the use of very different materials (Awad vd., 2018b).
Solid dosage forms are the most preferred
pharmaceutical forms due to many advantages like patient compliance (Helliwell
vd., 1993). During the design of the formulation, the specifications should be
well studied. The ICH Q8 pharmaceutical development and ICH Q9 Quality risk
management guidelines, which are new guidelines, enable systematic and
scientifically-based drug development during drug development and state that
everything about the drug should be evaluated during its design; supports
statistical-based, scientific formulation development (Mesut vd., 2015). ICH Q8
recommends the statistical approach in drug development and the use of
statistical tools in analysis. Today, the use of artificial intelligence (AI)
has become popular with the introduction of these guidelines in order to
facilitate analysis in complex mathematical processes in drug development (Doughman,
2019).
In addition to using AI in optimization studies of the
developed formulations, there are different algorithms and programs developed
for in vivo predictions. These predictions are called in silico (IS) modeling
and predict the in vivo behavior of a pre-developed formulation based on inputs
without in vivo trials. Thus, it allows predictions about the situations that
will be encountered in vivo conditions.
Cold and flu are among the most common diseases in the
world, especially in winter. In their treatment, painkillers and antihistamines
can be given alone or in combination. It is thought that the market for
painkillers will grow by about 30%, increasing from 4 billion dollars in 2011
to 5.8 billion dollars in 2023 in the USA alone (Data Bridge Market Research,
2022). Likewise, it is estimated that the antihistamine market will reach
476.08 million dollars with a growth of approximately 10% from 2022 to 2029,
depending on the need in the world (Kuczyńska vd., 2022). Dexketoprofen (DEX)
is one of the commonly used pain relievers and gives more successful results
than paracetamol (Koçum vd., 2014). Among the antihistamines on the market,
Bilastine (BLS) is the only antihistamine that does not cause sedation and does
not require dose adjustment for special patient groups (Ridolo vd,. 2015).
Considering the current advantages, the combined use
of DEX and BLS compared to other combinations will be very advantageous in terms
of less side effects. In our study, a 3-layer tablet formulation with DEX and
BLS combined, which will increase patient compliance by providing only one drug
intake per day, will be developed with a 3D printer with a Quality by Design
approach, optimized with AI, and possible in vivo behaviors will be evaluated
with IS methods. Thus, a drug formulation that is not commercially available in
the market yet but has a high commercialization potential will be developed, as
well as a production process optimization in which contemporary digital
technologies are adapted in an integrated manner (3D, AI, IS). In addition to
the original scientific and academic outputs to be obtained within the scope of
the project, it is anticipated that it will contribute to the development of
our country with its potential to be transferred to the digitalized industry in
the future.