Gueche Yanis A, Sanchez-Ballester Noelia M, Bataille Bernard, Aubert Adrien, Leclercq Laurent, Rossi Jean-Christophe, Soulairol Ian
ICGM, University Montpellier, CNRS, ENSCM, 34000 Montpellier, France.
IBMM, University Montpellier, CNRS, ENSCM, 34000 Montpellier, France.
Pharmaceutics. 2021 Jan 26;13(2):160. doi: 10.3390/pharmaceutics13020160.
Material suitability needs to be considered for the 3D printing of solid oral dosage forms (SODFs). This work aims to assess the suitability of a CO laser (λ = 10.6 μm) for selective laser sintering of SODFs containing copovidone and paracetamol. First, physicochemical characterization of powders (two grades of copovidone, two grades of paracetamol and their mixtures at various proportions) was conducted: particle size distribution, morphology, infrared absorbance, flowability, and compactness. Then, printing was launched, and printability of the powders was linked to their physicochemical characteristics. The properties of the sintered SODFs were evaluated (solid state, general aspect, porosity, hardness, drug content and release). Hence, it was found that as copovidone absorbs at the laser's wavelength, sintering was feasible without using an absorbance enhancer. Also, flowability, which mainly depends on the particle size, represents the first control line for "sinterability" as a fair flow is at least required. Low compactness of copovidone and mixtures reduces the mechanical properties of the SODFs but also increases porosity, which can modulate drug release. Moreover, the drug did not undergo degradation and demonstrated a plasticizer effect by lowering the heating temperature. In conclusion, this work proves the applicability of CO laser SLS printer to produce SODFs.
对于固体口服剂型（SODF）的3D打印，需要考虑材料的适用性。本研究旨在评估CO激光（λ = 10.6 μm）对含共聚维酮和对乙酰氨基酚的SODF进行选择性激光烧结的适用性。首先，对粉末（两种等级的共聚维酮、两种等级的对乙酰氨基酚及其不同比例的混合物）进行了物理化学表征：粒度分布、形态、红外吸收率、流动性和紧实度。然后，进行打印，并将粉末的可打印性与其物理化学特性联系起来。对烧结后的SODF的性能进行了评估（固态、外观、孔隙率、硬度、药物含量和释放）。因此，发现由于共聚维酮在激光波长处有吸收，在不使用吸收增强剂的情况下烧结是可行的。此外，流动性主要取决于颗粒大小，是“可烧结性”的第一道控制线，因为至少需要良好的流动性。共聚维酮及其混合物的低紧实度会降低SODF的机械性能，但也会增加孔隙率，从而可以调节药物释放。此外，药物没有发生降解，并且通过降低加热温度表现出增塑作用。总之，这项工作证明了CO激光SLS打印机在生产SODF方面的适用性。
