Fabrication of three dimensional printed tablets in flexible doses: A comprehensive study from design to evaluation

Gultekin H. E., TORT S., ACARTÜRK F.

JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY, cilt.74, 2022 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 74
  • Basım Tarihi: 2022
  • Doi Numarası: 10.1016/j.jddst.2022.103538
  • Dergi Adı: JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Biotechnology Research Abstracts, EMBASE
  • Anahtar Kelimeler: Personalized treatment, 3D printing, Fused deposition modeling, Design of experiment, Pramipexole, EXTENDED-RELEASE, DRUG-RELEASE, DOSAGE FORMS, 3D, IMMEDIATE, EXTRUSION, POLYMERS, PHARMACOKINETICS, FORMULATION, DELIVERY
  • Gazi Üniversitesi Adresli: Evet

Özet

Three-dimensional (3D) printing provides an advantage, especially in neurodegenerative diseases such as Parkinson's disease, where personalized treatment is important. Pramipexole is used in various doses according to patients' requirements. Using different polymers it is possible to prepare dosage forms with variable release properties by fused deposition modeling based 3D printing. In the present work, a comprehensive polymer screening study was carried out to obtain a solid dosage form with immediate release properties. 3D-printed tablet formulations were manufactured with commercially available (0.25 and 1 mg) and intermediate (0.375, 0.5, and 0.75 mg) doses of pramipexole. 3D-printed tablets containing Eudragit EPO and POLYOX N80 polymers were chosen as the optimum formulation and the obtained design of experiment (DoE) results confirmed the effect of formulation parameters such as polymer ratio, 3D-printed tablet thickness, and infill% on drug release. 3D-printed tablets exhibited reproducible physico-mechanical and in vitro drug release properties for all doses of pramipexole. The f2 values of different dose 3D-printed tablets were found to be > 50 for all doses, compared to the highest dose (1 mg) 3D-printed tablet. The optimum 3D-printed tablet formulation was found to be stable for 12 months at 25 degrees C/60% relative humidity (RH) and 6 months at 40 degrees C/75% RH conditions and the stability results were comparable with the stability of conventional tablets. The obtained results from all the preformulation and formulation studies showed that 3D-printed tablets can be manufactured in personalized doses successfully and by the changement of formulation parameters, the desired drug release profile can be achieved.