Pilot-scale binder jet 3D printing of sustained release solid dosage forms.

Autor: Tan M; Department of Chemical and Biomolecular Engineering, University of Connecticut, Storrs, CT 06269, USA; Polymer Program, Institute of Materials Science, University of Connecticut, Storrs, CT 06269, USA., Dharani D; Department of Chemical and Biomolecular Engineering, University of Connecticut, Storrs, CT 06269, USA., Dong X; Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA., Maiorana C; Department of Chemical and Biomolecular Engineering, University of Connecticut, Storrs, CT 06269, USA; Polymer Program, Institute of Materials Science, University of Connecticut, Storrs, CT 06269, USA., Chaudhuri B; Department of Chemical and Biomolecular Engineering, University of Connecticut, Storrs, CT 06269, USA; Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA., Nagapudi K; Genentech, 465 East Grand Avenue, South San Francisco, CA 94080, USA., Chang SY; Department of Chemical and Biomolecular Engineering, University of Connecticut, Storrs, CT 06269, USA; Polymer Program, Institute of Materials Science, University of Connecticut, Storrs, CT 06269, USA., Ma AWK; Department of Chemical and Biomolecular Engineering, University of Connecticut, Storrs, CT 06269, USA; Polymer Program, Institute of Materials Science, University of Connecticut, Storrs, CT 06269, USA. Electronic address: anson.ma@uconn.edu.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2023 Jan 25; Vol. 631, pp. 122540. Date of Electronic Publication: 2022 Dec 23.
DOI: 10.1016/j.ijpharm.2022.122540
Abstrakt: The additive nature and versatility of 3D printing show great promise in the rapid prototyping of solid dosage forms for clinical trials and mass customization for personalized medicine applications. This paper reports the formulation and process development of sustained release solid dosage forms, termed "printlets", using a pilot-scale binder jetting (BJT) 3D printer and acetaminophen (APAP) as the model drug. With the inclusion of hydroxypropyl methylcellulose (HPMC) as a release retardant polymer in the print powder, the drug release time of APAP increased considerably from minutes to hours. However, given the swelling propensity of HPMC, a thicker layer of powder must be laid down during printing to avoid any shape distortion of the printlets. For a fixed print volume, the level of binder saturation (i.e., ratio between the liquid binder and powder in the as-printed sample) is inversely proportional to the thickness of the spread powder layer. An increase in the spread powder layer inadvertently resulted in a lower level of binder saturation and consequently weaker printlets. By increasing the level of binder saturation with jetting from more print heads, the mechanical strength of printlets containing 18% HPMC was successfully restored. The resultant printlets have a drug release time of 3.5 h and a breaking force of 12.5 kgf that is comparable to the fast-disintegrating printlets containing no HPMC and surpasses manually pressed tablets with the same HPMC content.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Anson Ma reports financial support was provided by Genentech. Anson Ma reports equipment, drugs, or supplies was provided by Kerry Inc. Anson Ma reports equipment, drugs, or supplies was provided by BASF Corp. Anson Ma reports equipment, drugs, or supplies was provided by Ashland Inc. Anson Ma reports equipment, drugs, or supplies was provided by Anton Paar USA Inc. Anson Ma reports a relationship with A.D.A.M. that includes: board membership.
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Databáze: MEDLINE