Stano Pasquale, Bufali Simone, Pisano Claudio, Bucci Federica, Barbarino Marcella, Santaniello Mosè, Carminati Paolo, Luisi Pier Luigi
Institute of Polymers, ETH-Zentrum, Universitätstrasse 6, Zürich, Switzerland.
J Liposome Res. 2004;14(1-2):87-109. doi: 10.1081/lpr-120039794.
Small-sized liposomes have several advantages as drug delivery systems, and the ethanol injection method is a suitable technique to obtain the spontaneous formation of liposomes having a small average radius. In this paper, we show that liposomal drug formulations can be prepared in situ, by simply injecting a drug-containing lipid(s) organic solution into an aqueous solution. Several parameters should be optimized in order to obtain a final suitable formulation, and this paper is devoted to such an investigation. Firstly, we study the liposome size distributions determined by dynamic light scattering (DLS), as function of the lipid concentration and composition, as well as the organic and aqueous phases content. This was carried out, firstly, by focusing on POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine) then on the novel L-carnitine derivative PUCE (palmitoyl-(R)-carnitine undecyl ester chloride), showing that it is possible to obtain monomodal size distributions of rather small vesicles. In particular, depending on the conditions, it was possible to achieve a population of liposomes with a mean size of 100 nm, when a 50 mM POPC ethanol solution was injected in pure water; in the case of 50 mM PUCE the mean size was around 30 nm, when injected in saline (0.9% NaCl). The novel anticancer drug Gimatecan, a camptothecin derivative, was used as an example of lipophilic drug loading by the injection method. Conditions could be found, under which the resultant liposome size distributions were not affected by the presence of Gimatecan, in the case of POPC as well as in the case of PUCE. To increase the overall camptothecin concentration in the final liposomal dispersion, the novel technique of "multiple injection method" was used, and up to a final 5 times larger amount of liposomal drug could be reached by maintaining approximately the same size distribution. Once prepared, the physical and chemical stability of the liposome formulations was satisfactory within 24, as judged by DLS analysis and HPLC quantitation of lipids and drug. The Gimatecan-containing liposomes formulations were also tested for in vitro and in vivo activity, against the human nonsmall cell lung carcinoma NCI-H460 and a murine Lewis lung carcinoma 3 LL cell lines. In the in vitro tests, we did not observe any improvement or reduction of the Gimatecan pharmacological effect by the liposomal delivery system. More interestingly, in the in vivo Lewis lung carcinoma model, the intravenously administration of liposomal Gimatecan formulation showed a mild but significant increase of Tumor Volume Inhibition with respect to the oral no-liposomal formulation (92% vs. 86 %, respectively; p < 0.05). Finally, our study showed that the liposomal formulation was able to realize a delivery system of a water-insoluble drug, providing a Gimatecan formulation for intravenous administration with a preserved antitumoral activity.
小型脂质体作为药物递送系统具有多个优点,而乙醇注入法是一种获得平均半径较小的脂质体自发形成的合适技术。在本文中,我们表明脂质体药物制剂可以通过简单地将含药物的脂质有机溶液注入水溶液中来原位制备。为了获得最终合适的制剂,需要优化几个参数,本文致力于此类研究。首先,我们研究了通过动态光散射(DLS)测定的脂质体大小分布,作为脂质浓度和组成以及有机相和水相含量的函数。这首先通过关注1-棕榈酰-2-油酰-sn-甘油-3-磷酸胆碱(POPC),然后关注新型L-肉碱衍生物棕榈酰-(R)-肉碱十一烷基酯氯化物(PUCE)来进行,结果表明可以获得相当小的囊泡的单峰大小分布。特别地,根据条件,当将50 mM的POPC乙醇溶液注入纯水中时,有可能获得平均大小为100 nm的脂质体群体;在50 mM的PUCE的情况下,当注入盐水(0.9% NaCl)时,平均大小约为30 nm。新型抗癌药物吉马替尼,一种喜树碱衍生物,被用作通过注入法负载亲脂性药物的例子。在POPC以及PUCE的情况下,都可以找到这样的条件,即所得脂质体大小分布不受吉马替尼存在的影响。为了提高最终脂质体分散体中喜树碱的总体浓度,使用了“多次注入法”这一新技术,通过保持大致相同的大小分布,可以使脂质体药物的最终量增加到原来的5倍。一旦制备完成,通过DLS分析以及脂质和药物的HPLC定量判断,脂质体制剂在24小时内的物理和化学稳定性令人满意。还对含吉马替尼的脂质体制剂针对人非小细胞肺癌NCI-H460和小鼠Lewis肺癌3LL细胞系进行了体外和体内活性测试。在体外测试中,我们没有观察到脂质体递送系统对吉马替尼药理作用有任何改善或降低。更有趣的是,在体内Lewis肺癌模型中,脂质体吉马替尼制剂静脉给药相对于口服非脂质体制剂显示出肿瘤体积抑制有轻微但显著的增加(分别为92%对86%;p < 0.05)。最后,我们的研究表明脂质体制剂能够实现一种水不溶性药物的递送系统,提供一种具有保留抗肿瘤活性的用于静脉给药的吉马替尼制剂。