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首页> 外文期刊>European journal of pharmaceutics and biopharmaceutics: official journal of Arbeitsgemeinschaft fuer Pharmazeutische Verfahrenstechnik e.V >Does the commonly used pH-stat method with back titration really quantify the enzymatic digestibility of lipid drug delivery systems? A case study on solid lipid nanoparticles (SLN)
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Does the commonly used pH-stat method with back titration really quantify the enzymatic digestibility of lipid drug delivery systems? A case study on solid lipid nanoparticles (SLN)

机译：常用的带有反滴定法的pH值统计方法是否真的可以量化脂质药物输送系统的酶消化率？固体脂质纳米粒（SLN）的案例研究

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摘要

Enzymatic digestion of lipid drug carriers is very important. Commonly, pancreatin induced formation of fatty acids is monitored by the pH-stat method, which provides a fast, but unspecific readout. However, according to the literature, the pKa values of long chain fatty acids are strongly dependent on the local environment and might vary between 4.2 and 10.15. The high pKa values would lead to an incomplete detection of the lipid digestion and false results. In order to investigate these issues in more detail, we produced cetyl palmitate solid lipid nanoparticles (CP-SLN) stabilized with poloxamer 188 or polysorbate 80. The digestion of CP-SLN was investigated by two different and independent readouts. A HPTLC assay was used in addition to the pH-stat method (with or without back titration). An incomplete digestion of CP-SLN was observed with all methods. Partial digestion of polysorbate 80 contributed to the formation of fatty acids. Depending on the investigated system and the experimental conditions (FaSSIF or FeSSIF) the results of both readout methods were comparable or not. For example, in FeSSIF conditions, the values detected by HPTLC were roughly twice as high as the pH-stat results. Our findings on solid lipids agree with data from Helbig et al. on lipid emulsions, where a gas chromatography method detected much higher values than the pH-stat assay (Food Hydrocoll. 28 (2012) 10-19).
机译：脂质药物载体的酶消化非常重要。通常，胰酶诱导的脂肪酸形成是通过pH-stat方法进行监测的，该方法可提供快速但非特异性的读数。但是，根据文献，长链脂肪酸的pKa值强烈依赖于当地环境，可能在4.2和10.15之间变化。高pKa值会导致脂质消化检测不完全和错误结果。为了更详细地研究这些问题，我们生产了用泊洛沙姆188或聚山梨酯80稳定的棕榈酸十六烷基酯固体脂质纳米颗粒（CP-SLN）。通过两个不同且独立的读数研究了CP-SLN的消化。除了pH静态方法（有或没有反滴定法）外，还使用了HPTLC测定法。用所有方法都观察到了CP-SLN的不完全消化。聚山梨酯80的部分消化有助于脂肪酸的形成。根据所研究的系统和实验条件（FaSSIF或FeSSIF），两种读出方法的结果是否可比。例如，在FeSSIF条件下，HPTLC检测到的值大约是pH值结果的两倍。我们对固体脂质的发现与Helbig等人的数据一致。脂质乳剂的检测方法，其中气相色谱法检测到的值比pH值静态检测法高得多（Food Hydrocoll。28（2012）10-19）。

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