Peculiarities of the filtration process of liposomal emulsion for the production of eye drops based on a peptide complex

Ye. M. Kruglov, G. I. Borshchevskiy
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Abstract

Liposomes are increasingly being studied and implemented as drug delivery systems in the form of eye drops. An important stage in the production of a liposomal preparation in the form of eye drops is the stage of sterilization filtration before filling the medicinal product into a container for final dosage. It is assumed that liposome components interact with the membrane and clog it due to their unique physicochemical properties. Therefore, a deeper understanding of the sterilization filtration of liposomes is needed to make appropriate decisions regarding the choice of filters for sterilization.Resistance and permeability values calculated from the Darcy equation are well suited for comparing different filter membranes or process parameters. Aim. To substantiate the choice of optimal brands of filter membranes and parameters of the liposomal emulsion filtration process for the production of eye drops based on a peptide complex. Materials and methods. The study object was a liposomal emulsion for the production of eye drops based on a peptide complex. A prepared liposomal emulsion of eye drops based on a peptide complex and membrane filters of various brands were used for filtration. Filtration tests were performed on a Zero-T scaling unit manufactured by Sartorius, Germany. For all measurements, the filtrate weight was controlled using a balance. Filtration experiments were evaluated using Zero-T 2.0 software from Sartorius Stedim Biotech, Germany. At the first stage, the recorded data of the results was saved to a file. Based on the data obtained using the Excel table processor, the filtration flow J°, the initial resistance of the membrane R°zag and the throughput Ṽ were calculated according to the calculated measurement time: the beginning of T10 % and the end of T80 %. Results and discussion. According to the results obtained, the optimal brands of sterilizing membranes were determined; it was shown that by increasing the pressure drop, the volumetric throughput was significantly improved by more than 18 times (from 0.7 to 4.1 bar), and in another experiment – by more than 10 times (from 0.3 to 2.1 bar). In addition, the benefit of using a higher pressure drop to filter liposomes through various sterilizing membranes was shown. Conclusions. The obtained values of the initial resistance of the membrane showed that the geometrical aspects and properties of the material of the Supor® (Pall) and Sartopore 2® (Sartorius) membrane brands have a lower ability to block the membrane during filtration and provide the filtration resource due to greater throughput. It has been also shown that the use of a higher pressure drop increases the productivity of the process.
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以肽复合物为基础的滴眼液用脂质体乳剂过滤过程的特点
脂质体以滴眼液的形式被越来越多地研究和实施作为药物输送系统。在生产滴眼液形式的脂质体制剂的一个重要阶段是在将药品填充到最终剂量的容器之前的灭菌过滤阶段。据推测,脂质体成分与膜相互作用,并堵塞它由于其独特的物理化学性质。因此,需要更深入地了解脂质体的灭菌过滤,以便在选择灭菌过滤器时做出适当的决定。由达西方程计算出的电阻和渗透率值非常适合于比较不同的过滤膜或工艺参数。为了确定最佳滤膜品牌的选择和基于肽复合物的滴眼液的脂质体乳化过滤工艺参数。材料和方法。研究对象是一种以肽复合物为基础的用于生产滴眼液的脂质体乳液。以多肽复合物为基础制备滴眼液脂质体乳液,并用不同品牌的膜过滤器进行过滤。过滤试验在德国Sartorius公司生产的Zero-T标度装置上进行。对于所有测量,滤液重量使用天平控制。过滤实验采用德国Sartorius Stedim Biotech公司的Zero-T 2.0软件进行评价。在第一阶段,将记录的结果数据保存到文件中。根据Excel表格处理器获得的数据,根据计算出的测量时间:t10%开始和t80%结束,计算出过滤流量J°、膜的初始阻力R°zag和吞吐量Ṽ。结果和讨论。根据所得结果,确定了灭菌膜的最佳品牌;结果表明,通过增加压降,体积吞吐量显着提高了18倍以上(从0.7到4.1 bar),在另一项实验中-提高了10倍以上(从0.3到2.1 bar)。此外,还显示了用较高的压降过滤脂质体通过各种灭菌膜的好处。所获得的膜的初始阻力值表明,Supor®(Pall)和Sartopore 2®(Sartorius)膜品牌的材料的几何方面和性能在过滤过程中阻塞膜的能力较低,并且由于更高的吞吐量而提供过滤资源。还表明,使用较高的压降可以提高工艺的生产率。
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The theoretical and experimental substantiation of the composition of a mouthwash Substantiation of the composition and technology for obtaining combined sustained-release tablets for the treatment of hypertension Development of conditions for sertraline isolation from biological fluids Determination of the physical and mechanical indicators of the polymer base and the optimal method of introducing active pharmaceutical ingredients into the base composition Peculiarities of the filtration process of liposomal emulsion for the production of eye drops based on a peptide complex
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