3D extrusion printing of high drug loading immediate release paracetamol tablets

Abstract

The manufacture of immediate release high drug loading paracetamol oral tablets was achieved using an extrusion based 3D printer from a premixed water based paste formulation. The 3D printed tablets demonstrate that a very high drug (paracetamol) loading formulation (80% w/w) can be printed as an acceptable tablet using a method suitable for personalisation and distributed manufacture. Paracetamol is an example of a drug whose physical form can present challenges to traditional powder compression tableting. Printing avoids these issues and facilitates the relatively high drug loading. The 3D printed tablets were evaluated for physical and mechanical properties including weight variation, friability, breaking force, disintegration time, and dimensions and were within acceptable range as defined by the international standards stated in the United States Pharmacopoeia (USP). X-ray Powder Diffraction (XRPD) was used to identify the physical form of the active. Additionally, XRPD, Attenuated Total Reflectance Fourier Transform Infrared spectroscopy (ATR-FTIR) and differential scanning calorimetry (DSC) were used to assess possible drug-excipient interactions. The 3D printed tablets were evaluated for drug release using a USP dissolution testing type I apparatus. The tablets showed a profile characteristic of the immediate release profile as intended based upon the active/excipient ratio used with disintegration in less than 60 s and release of most of the drug within 5 min. The results demonstrate the capability of 3D extrusion based printing to produce acceptable high-drug loading tablets from approved materials that comply with current USP standards.

Fabrication of Muco-Adhesive Oral Films by the 3D Printing of Hydroxypropyl Methylcellulose-Based Catechin-Loaded Formulations

“…7, various designs and shapes of AD and FD films were designed and prepared. Aphthous stomatitis is typically char-acterized by small, round or ovoid ulcers 38) whereas the shapes of mouth ulcers formed by cheek bites differ depending on the strength of the bite. The shape of oral mucositis induced by Formulations D′-AD and D′-FD, described in Table 2, were used as the film samples.…”

“…3D printed manufacturing of personalized pharmaceuticals was previously proposed. 39) An electronic prescription is sent from a hospital department to a 3D printer, and raw materials in the printer ink are used to manufacture formulations (tablets) using a 3D printer under quality control via process analysis technology. Film formulations are likely also applicable to this concept, since 3D bioprinters can handle several types of drug formulations.…”

3D Printed Tablets (Printlets) with Braille and Moon Patterns for Visually Impaired Patients

“…In this regard, three-dimensional (3D) printing may offer an elegant and practical solution to the problem. 3D printing is an additive manufacturing technique in which an object is built up in a layer-by-layer manner [10][11][12][13][14], based on a 3D model designed using computer-aided design (CAD) software [15][16][17][18][19]. At present, 3D printing is often used to produce engineering prototypes due to its fast production speed and cost-effectiveness [20][21][22][23].…”

Pharmaceutical applications of 3D printing technology: current understanding and future perspectives

“…For example, a thermoplastic polyurethane-based dosage form loaded with 60% drug was successfully developed via the FDM method (Verstraete et al 2018). Similarly, an IR tablet loaded with a very high dose of 80% paracetamol was prepared using an extrusion-based 3D printer (Khaled et al 2018). In addition to IR tablets, 3DP is applicable to produce extended release (ER) tablets.…”