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International Journal of Bioprinting Semi-solid extrusion for pediatric medicine
3. Discussion
3.1. Challenges
Ref. 96 97 99 102 114 115 Based on the literature review on the SSE process for AM
of drugs, it is evident that the SSE process is currently the
most suitable and mature technology for manufacturing
compounded preparations. The SSE process enables the
manufacturing of many different products, allowing
for easy product changeovers. Additionally, it offers
easy-to-use technology with equipment and excipients
adapted to clinical use. Finally, SSE makes it possible
to design a wide range of dosage forms tailored to each
Vacuum oven at 400 mbar pressure technology could significantly benefit patients whose
patient’s needs, mainly for oral administration, with
immediate or modified release kinetics. Therefore, this
medical needs are unmet by existing industrial therapies
or conventional compounding methods. Currently, the
design and production of compounded medicines are
Commentaries subject to various constraints, which can be classified into
three categories: (i) scientific and technical aspects, (ii)
regulatory aspects, and (iii) personnel-related aspects (i.e.,
involved in design and manufacturing).
3.1.1. Scientific and technical aspects 135
According to Pluta, the scientific and technical aspects of
135
compounded medicines encompass several critical factors:
41–114 min post-printing meets the patient’s needs and is stable), (ii) formulation
(i) formulation quality (i.e., ensuring the dosage form
calculations (e.g., renal clearance, the half-life of the API,
stability data, etc.), (iii) operating procedures, and (iv) post-
preparation steps (e.g., control preparation, pharmacopeial
Time Overnight 24 h 2 h 10 min standards, etc.). The SSE process introduces several
technical challenges to these factors. The first challenge is
related to the CAD, which is the model on which printed
medicines are based. In particular, 3D modeling provides
the flexibility to produce different dosages by modifying
parameters, such as size or filling density. However, the
Drying is mentioned but without specific data about the process
resolution of the infill pattern is less precise compared
Temperature 22°C Room temperature 60°C 70°C 70°C to FFF, and the extruded gel tends to be more cohesive.
This can make it difficult to obtain a porous dosage form,
potentially affecting the release kinetics.
As a result, the computational aspects of compounding
become more complex, with mathematical modeling
playing a crucial role in the drug development process.
This complexity highlights the importance of adopting
a Quality by Design (QbD) approach, which integrates
Table 2. Continued Drying method (i) Vacuum oven (ii) Air-dried In-process drying with a heated bed In-process drying with a heated bed In-process drying with a heated bed comprehensive modeling aspects and the use of
experimental designs in drug development. In parallel,
the formulation must not only be compatible with these
numerical aspects but also satisfy rheological constraints.
As highlighted in the technical aspects of SSE, formulations
for drug production can be highly diverse and complex.
In this context, the development of formulations using
Volume 10 Issue 6 (2024) 54 doi: 10.36922/ijb.4063
