Tihhonova Marina, Meos Andres, Airaksinen Sari, Aruväli Jaan, Sandler Topelius Niklas, Heinämäki Jyrki, Paaver Urve
Faculty of Medicine, Institute of Pharmacy, University of Tartu, Nooruse 1, 50411 Tartu, Estonia.
CurifyLabs Oy, Salmisaarenaukio 1, 00180 Helsinki, Finland.
Pharmaceutics. 2024 Nov 29;16(12):1532. doi: 10.3390/pharmaceutics16121532.
: An automated extrusion-based material deposition is a contemporary and rapid method for pharmaceutical dose-dispensing and preparing (printing) individualized solid dosage forms. The aim of this study was to investigate and gain knowledge of the feasibility of automated extrusion-based material deposition technology in preparing customized prednisolone (PRD)-loaded gel tablets for veterinary applications (primarily for dogs and cats). : The PRD loads of the extrusion-based deposited gel tablets were 0.5% and 1.0%, and the target weights of tablets were 0.250 g, 0.500 g, and 1.000 g. The effects of the material deposition processes on the physical solid state, in vitro dissolution, and the physicochemical stability of PRD gel tablets were investigated. : The small-sized gel tablets presented a uniform round shape with an exceptionally smooth outer surface texture. The actual average weight of the tablets (n = 10) was very close to the target weight, showing the precision of the process. We found that PRD was in a pseudopolymorphic sesquihydrate form (instead of an initial PRD crystalline form II) in the gel tablets. In all the immediate-release gel tablets studied, more than 70% of the drug load was released within 30 min. The soft texture and dimensions of gel tablets affected the dissolution behaviour in vitro, suggesting the need for further development and standardization of a dissolution test method for such gel tablets. A short-term storage stability study revealed that the content of PRD did not decrease within 3 months. : Automated extrusion-based material deposition is a feasible method for the rapid preparation of gel tablets intended for veterinary applications. In addition, the present technology and gel tablets could be used in pediatric and personalized medicine where precise dosing is crucial.
基于自动挤压的材料沉积是一种用于药物剂量分配和制备（打印）个性化固体剂型的现代快速方法。本研究的目的是调查并了解基于自动挤压的材料沉积技术在制备用于兽医应用（主要用于犬猫）的定制泼尼松龙（PRD）负载凝胶片方面的可行性。：基于挤压沉积的凝胶片的PRD负载量为0.5%和1.0%，片剂的目标重量为0.250 g、0.500 g和1.000 g。研究了材料沉积过程对PRD凝胶片的物理固态、体外溶出度和物理化学稳定性的影响。：小型凝胶片呈现出均匀的圆形，外表面质地异常光滑。片剂（n = 10）的实际平均重量非常接近目标重量，显示了该过程的精确性。我们发现PRD在凝胶片中呈假多晶型倍半水合物形式（而不是初始的PRD晶型II）。在所有研究的速释凝胶片中，超过70%的药物负载量在30分钟内释放。凝胶片的柔软质地和尺寸影响了体外溶出行为，表明需要进一步开发和标准化此类凝胶片的溶出度测试方法。短期储存稳定性研究表明，PRD的含量在3个月内没有下降。：基于自动挤压的材料沉积是一种快速制备用于兽医应用的凝胶片的可行方法。此外，目前的技术和凝胶片可用于儿科和个性化医学，在这些领域精确给药至关重要。
