Hydrophobic ion pair loaded self-emulsifying drug delivery system (SEDDS): A novel oral drug delivery approach of cromolyn sodium for management of bronchial asthma

Asfour, Marwa Hasanein; Kassem, Ahmed Alaa; Salama, Abeer; El-Alim, Sameh Hosam Abd

doi:10.1016/j.ijpharm.2020.119494

Cited by 21 publications

(6 citation statements)

References 91 publications

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“…TGF-β1 is one of airway remodeling mediators which has a vital role in asthma and associated with vascular endothelial cell proliferation and angiogenesis (Asfour et al, 2020 ). In the current work, OVA induced airway structural changes evidenced by an elevation of TGF-β1 levels while hesperidin could decrease TGF-β1 levels and protected from these changes modulating airway remodeling.…”

Section: Discussionmentioning

confidence: 99%

Immunoregulatory role of hesperidin against ovalbumin (OVA)-induced bronchial asthma and depression in rats

Salama,

Gouida,

Yassen

et al. 2023

Naunyn-Schmiedeberg's Arch Pharmacol

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Links between bronchial asthma and depression have recently become a great subject of interest. The present study was carried out to assess the protective role of hesperidin against ovalbumin (OVA)-induced bronchial asthma that is associated with depression in rats, for this purpose, four groups. Rats were sensitized with intraperitoneal administration of 200 μg OVA/10 mg aluminum hydroxide (Al (OH) 3 for 3 consecutive days then at day 11 followed by intranasal challenge with OVA (1.5 mg/kg) at days 19, 20, and 21. Rats were pretreated with hesperidin (100 & 200 mg/kg) 1h before OVA challenge. At the end of the study, behavioral tests, biochemical indices, and histopathological architectures of lung and brain tissues were evaluated. Our findings showed that hesperidin significantly ameliorated the reduction in motor activity, motor coordination, forced swimming, CD4, CD25 and foxp3, interleukin-10 (IL-10), dopamine, serotonin, and neurotrophin-3 (NT3) as well as alleviated the elevation in transforming growth factor-beta (TGF-β), tumor necrosis factor-alpha (TNF-α), iL-5, and immunoglobulin E (IgE). In addition, hesperidin reduced cellular infiltration, alveolar sacs damage, the bronchioles wall disruption, and nuclei pyknosis in neuron cells. Finally, hesperidin may provide protection against OVA-induced asthma and depression. This impact could be mediated in part by its anti-inflammatory and immunoregulatory properties. Graphical abstract

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Section: Discussionmentioning

confidence: 99%

Immunoregulatory role of hesperidin against ovalbumin (OVA)-induced bronchial asthma and depression in rats

Salama,

Gouida,

Yassen

et al. 2023

Naunyn-Schmiedeberg's Arch Pharmacol

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“…Ex Vivo Mice Non-everted Gut Sac Study. The mice non-everted gut sac study was carried out as described previously, 37,38 with some modifications. The mice were fasted but allowed water ad libitum for 12 h prior to the experiment.…”

Section: ■ Experimental Sectionmentioning

confidence: 99%

Effect of Pharmaceutical Excipients on Intestinal Absorption of Metformin via Organic Cation-Selective Transporters

Ruan

et al. 2021

Mol. Pharmaceutics

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Growing evidence has shown that some pharmaceutical excipients can act on drug transporters. The present study was aimed at investigating the effects of 13 commonly used excipients on the intestinal absorption of metformin (MTF) and the underlying mechanisms using Caco-2 cells and an ex vivo mouse non-everted gut sac model. First, the uptake of MTF in Caco-2 cells was markedly inhibited by nonionic excipients including Solutol HS 15, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, and crospovidone. Second, transport profile studies showed that MTF was taken up via multiple cation-selective transporters, among which a novel pyrilaminesensitive proton-coupled organic cation (H + /OC + ) antiporter played a key role. Third, Solutol HS 15, polysorbate 40, and polysorbate 60 showed cis-inhibitory effects on the uptake of either pyrilamine (prototypical substrate of the pyrilamine-sensitive H + /OC + antiporter) or 1-methyl-4phenylpyridinium (substrate of traditional cation-selective transporters including OCTs, MATEs, PMAT, SERT, and THTR-2), indicating that their suppression on MTF uptake is due to the synergistic inhibition toward multiple influx transporters. Finally, the pH-dependent mouse intestinal absorption of MTF was significantly decreased by Solutol HS 15, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, and pyrilamine. In conclusion, this study revealed that a novel transport process mediated by the pyrilamine-sensitive H + /OC + antiporter contributes to the intestinal absorption of MTF in conjunction with the traditional cationselective transporters. Mechanistic understanding of the interaction of excipients with cation-selective transporters can improve the formulation design and clinical application of cationic drugs.

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“…Incorporating HIPs in SEDDSs appears to be a potential strategy for significantly increasing the oral bioavailability of hydrophilic drugs, such as matrine [ 16 ] and morine [ 17 ], and charged hydrophilic drugs, such as enoxaparin [ 18 ], atazanavir [ 19 ], vancomycin [ 20 ], cromolyn sodium [ 21 ], polymyxin B [ 22 ], etc. More crucially, promising in vivo results of SEDDSs containing ion-paired biopharmaceuticals were obtained [ 23 , 24 , 25 ].…”

Section: Introductionmentioning

confidence: 99%

Quality by Design-Based Development of Solid Self-Emulsifying Drug Delivery System (SEDDS) as a Potential Carrier for Oral Delivery of Lysozyme

et al. 2023

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For many years, researchers have been making efforts to find a manufacturing technique, as well as a drug delivery system, that will allow for oral delivery of biopharmaceuticals to their target site of action without impairing their biological activity. Due to the positive in vivo outcomes of this formulation strategy, self-emulsifying drug delivery systems (SEDDSs) have been intensively studied in the last few years as a way of overcoming the different challenges associated with the oral delivery of macromolecules. The purpose of the present study was to examine the possibility of developing solid SEDDSs as potential carriers for the oral delivery of lysozyme (LYS) using the Quality by Design (QbD) concept. LYS was successfully ion paired with anionic surfactant, sodium dodecyl sulphate (SDS), and this complex was incorporated into a previously developed and optimized liquid SEDDS formulation comprising medium-chain triglycerides, polysorbate 80, and PEG 400. The final formulation of a liquid SEDDS carrying the LYS:SDS complex showed satisfactory in vitro characteristics as well as self-emulsifying properties (droplet size: 13.02 nm, PDI: 0.245, and zeta potential: −4.85 mV). The obtained nanoemulsions were robust to dilution in the different media and highly stable after 7 days, with a minor increase in droplet size (13.84 nm) and constant negative zeta potential (−0.49 mV). An optimized liquid SEDDS loaded with the LYS:SDS complex was further solidified into powders by adsorption onto a chosen solid carrier, followed by direct compression into self-emulsifying tablets. Solid SEDDS formulations also exhibited acceptable in vitro characteristics, while LYS preserved its therapeutic activity in all phases of the development process. On the basis of the results gathered, loading the hydrophobic ion pairs of therapeutic proteins and peptides to solid SEDDS may serve as a potential method for delivering biopharmaceuticals orally.

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Hydrophobic ion pair loaded self-emulsifying drug delivery system (SEDDS): A novel oral drug delivery approach of cromolyn sodium for management of bronchial asthma

Cited by 21 publications

References 91 publications

Immunoregulatory role of hesperidin against ovalbumin (OVA)-induced bronchial asthma and depression in rats

Immunoregulatory role of hesperidin against ovalbumin (OVA)-induced bronchial asthma and depression in rats

Effect of Pharmaceutical Excipients on Intestinal Absorption of Metformin via Organic Cation-Selective Transporters

Quality by Design-Based Development of Solid Self-Emulsifying Drug Delivery System (SEDDS) as a Potential Carrier for Oral Delivery of Lysozyme

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