Envisioning New Concepts for 3D Printing and Solubility Enhancement: Tablet Manufacturing of Loaded Parteck SLC ® Through Z-Form Binder Jetting Technology

This poster was presented at the AAPS 2024 by APRECIA and Millipore Sigma

Many new drug substances are poorly soluble, making traditional drug development slow and costly.

This study explores improving solubility using mesoporous silica, which stabilizes drugs within nanosized pores. It also showcases the benefits of 3D printing binder jetting technology, particularly the Z-Form Flex system, to streamline drug development.

Binder jetting technology enables rapid, scalable production by layering powder into pre-formed blister cavities, creating dosage forms directly within their primary packaging.

PURPOSE

Majority of drug substances in development are poorly soluble: Solubility enhancement through mesoporous silica: Encapsulation and stabilization in the nanosized silica pores

Traditional drug product development is often time-consuming and costly → 3D printing binder jetting (BJ) provides the benefits of rapid manufacturing and scalable production (1)

The BJ technology Z-Form Flex deposits powder into preformed blister cavities and forms the dosage forms layer-by-layer directly in their primary packaging

OBJECTIVE(S)

Combine the use the mesoporous silica Parteck® SLC loaded with a poorly soluble drug (carbamazepine, CBZ) with binder jetting technology Z-Form Flex to accelerate development and improve drug delivery

RESULT(S)

Tablet properties and SEM-EDS

• Tablets showed a consistent appearance upon removal from the blisters (Fig. 1a)
• Average mass of 806.2 mg (RSD 5.6%) CBZ was evenly distributed in the tablet being visualized through SEMEDS (Figure 1b)

Solid state characterization

• CBZ was amorphous as no diffraction peaks related to CBZ were visible (Fig. 2).
• The peaks observed in the diffractogram were associated with the excipients in the tablet, as demonstrated by the comparison with a placebo tablet

Content and dissolution
• Tablets showed a uniform drug content of 5.0% (RSD 1.6%)
• The 3D printed tablets exhibited a rapid release with over 85% of CBZ being dissolved within 5 min

METHOD(S)

Silica loading

In-blister printing (Z-Form)

Analytics

XRPD: Miniflex (Rigaku, Japan), D/teX Ultra 2 detector, copper anode at 40 kV and 15 mA, step size 0.02° and 0.8°/min, range 3 – 50°

SEM-EDS: Tescan VEGA3 XMU (TESCAN, Germany), wolfram cathode, acceleration voltage 0.2 kV to 30 kV;
EDS: Quantax (Bruker, USA)

Content: Tablets were dissolved in 250 mL of methanol. HPLC (Agilent 1260 Infinity, USA), Ascentis Express ESCyano column (10 cm x 4.6 mm I.D., 2.7 μm), 30 °C, flow 1.4 mL

Dissolution: AT7 (Sotax Switzerland) with paddles in 500 mL of water, 75 rpm. Absorption measured at 288 nm

CONCLUSION(S)

•  Parteck® SLC loaded with CBZ can be successfully used in BJ technology Z-Form Flex
•  Suitable tablet properties: Amorphous API, uniform drug content, rapid dissolution profile
• Combining both technologies could expedite the development of poorly soluble drugs

Discover more in the full scientific poster on “Envisioning New Concepts for 3D Printing and Solubility Enhancement” here

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Source: Merck technical poster “Envisioning New Concepts for 3D Printing and Solubility Enhancement”

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