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Analgesics during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
Etodolac is a COX-2 selective analgesic. No studies of congenital anomalies in offspring exposed to etodolac during the first trimester have been published. Premature closure of the ductus arteriosus is a theoretical risk because of the pharmacologic action of etodolac. Etodolac was found to be safer for the gastrointestinal tract (i.e., fewer bleeding ulcers than naproxen) with chronic therapy (Weideman et al., 2004). The frequency of congenital anomalies was increased among rats or rabbits exposed to etodolac during embryogenesis (Ninomiya et al., 1990a, 1990b). Among 265 infants whose mother took etodolac during the first trimester, the frequency of birth defects was not increased (Daniel et al., 2012).
Drugs Affecting the Musculoskeletal System
Published in Radhwan Nidal Al-Zidan, Drugs in Pregnancy, 2020
Risk Summary: It is better to be avoided during the 1st and 3rd Trimesters because the pregnancy experience in humans suggests a risk of pulmonary hypertension of the newborn, SABs, and congenital malformations linked to the use of Etodolac.
Helicobacter
Published in Dongyou Liu, Laboratory Models for Foodborne Infections, 2017
Tetsuya Tsukamoto, Yuka Kiriyama, Masae Tatematsu
Eradication of H. pylori is most effective in the earlier stages of infection, as evidenced by studies on the prevention of gastric carcinogenesis carried out in both humans and animals. However, eradication may not be efficient for ones with severe chronic atrophic gastritis. A selective cyclooxygenase 2 (COX-2) inhibitor, etodolac, was attempted to prevent H. pylori-infected and MNU-induced gastric carcinogenesis in a Mongolian gerbil model. Etodolac inhibited the development of epithelial cell proliferation, intestinal metaplasia, and gastric cancer in a dose-dependent manner although inflammatory cell infiltration or oxidative DNA damage was not alleviated.79 In humans, Yanaoka et al.80 investigated the preventive effects of etodolac on metachronous cancer development after endoscopic resection of early gastric cancer. Etodolac significantly reduced emergence of gastric cancer even with extensive metaplastic gastritis, which indicated that controlling COX-2 function could be an alternative method (Figure 22.2).
Pharmacokinetic modeling and simulation of etodolac following single oral administration in dogs
Published in Xenobiotica, 2019
Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently used analgesic medications in veterinary as well as human medicine (Lascelles et al., 2005). Etodolac (1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indole-1-acetic acid) is a NSAID with selective cyclooxygenase-2 inhibition that has been approved for treatment of pain and inflammation associated with osteoarthritis in humans and dogs (Jones, 1999; Lascelles et al., 2005)
Etodolac nanosuspension based gel for enhanced dermal delivery: in vitro and in vivo evaluation
Published in Journal of Microencapsulation, 2021
Alptug Karakucuk, Serdar Tort, Sevtap Han, Ayse Nur Oktay, Nevin Celebi
Etodolac (ETD) is Biopharmaceutical Classification System (BCS) Class II, non-steroidal anti-inflammatory drug substance (Jitkar et al. 2016, Madhavi et al. 2019). It is used in the treatment of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis to relieve inflammation, swelling, stiffness, and pain (Goindi et al. 2015). However, ETD is insoluble in water and undergoes first-pass metabolism. Frequent dosing is required because of its low oral bioavailability, which is limited by the dissolution rate (Fayez et al. 2015, Shilakari Asthana et al. 2016). Besides, oral administration of ETD can cause adverse effects on gastrointestinal system, peptic ulcer, and severe gastrointestinal bleedings (Salah et al. 2017). Dermal application of ETD can eliminate these complications and provide high drug concentration at the application side (Tas et al. 2007). For this reason, several studies focussed to develop dermal formulations for ETD. Goindi et al. prepared microemulsions of ETD for dermal application and conducted ex vivo and in vivo studies which show the effectiveness of ETD for inflammation treatment (Goindi et al. 2015). Also, vesicular drug carrier systems were developed, such as niosomal gel (Shilakari Asthana et al. 2016), pharmacosomes (Letha and Viswanad 2017), ethosomes (Chintala and Nadu 2014), transethosomes (Gondkar et al. 2017), and cubosomes (Salah et al. 2017). However, there was no study on etodolac nanosuspension (ETD-NS) for dermal applications. Thus, this study focussed on the development of ETD-NSs based topical gels (ETD-NS-gel) to bring in novel dermal administration alternative of coarse or micronised ETD. ETD-NSs were prepared by wet milling method in a previous study and solubility of ETD enhanced significantly (Karakucuk and Celebi 2020). ETD-NS gels were developed by using different gelling agents and characterised. The rheological properties of gels were investigated. Bioadhesion, in vitro/ex vivo permeation as well as in vivo pharmacodynamic studies were performed.
Design by optimization and comparative evaluation of vesicular gels of etodolac for transdermal delivery
Published in Drug Development and Industrial Pharmacy, 2019
Nimmathota Madhavi, Beeravelli Sudhakar, K. V. N Suresh Reddy, J. Vijaya Ratna
Shumilov et al., developed and characterized ibuprofen loaded ethosomes. They reported that ethosomes by transdermal delivery provides a long plasma concentration of ibuprofen compared to oral administration [16]. Abdul et al., reported that transdermal flux and the anti-inflammatory activity of meloxicam was more from ethosomes compared to rigid liposomes [17]. Chan et al., studied that encapsulation efficiency and transdermal flux of ketoprofen was more from nano-sized ethosomes compared to hydro-alcoholic drug solution. They reported that ethosomes maintained the skin fluidized condition by interaction with hydrophilic portions of lipids in the SC [18]. Shaikh et al., developed ciclopirox-olamine loaded liposomes using phospholipid 90 H and cholesterol for cutaneous delivery. They reported that liposomes for improving skin residence of ciclopirox olamine in cutaneous mycosis. They revealed that cholesterol was found to be primarily responsible for behavior of liposomes [19]. Jianfeng Xing et al., developed Sinomenine hydrochloride loaded ethosomes using lipid, cholesterol and vitamin E by modified ethanol injection method. They reported that the skin irritation study of ethosomes showed desirable skin tolerability. Moreover, ethosomes showed a significant inhibition effect on the ear edema (30.01%) [20]. Nafisi et al., studied that comparative evaluation of fluconazole loaded liposomes and ethosomes for skin delivery. The polysorbate 80 and turpentine was used as the permeation enhancers for the liposomes and ethosomes, respectively. The turpentine contained ethosomes shown higher skin permeation after 24 h compared to liposomes respectively. They reported that formulations containing turpentine showed higher permeation characteristics and can be proposed as promising delivery systems for fluconazole topical delivery [21]. Pathan et al., developed curcumin loaded ethosomes using lecithin, ethanol, and cholesterol by Box Behnken design. They reported that developed ethosomes shown greater drug entrapment efficiency (81.2 ± 3.12%) and smaller vesicle (228.8 nm) with desired flux (10.5 ± 2.6 μg/cm2/hr) through human cadaver skin. The in-vivo study revealed a significant increase in percent inhibition (58.8% for 7 h) of ethosomes compared to oral administration [22]. The objective of the current study was to develop the transdermal dose of etodolac. Etodolac is a BCS class II drug used in the treatment of inflammation at an oral dose of 200 mg twice a day. On oral delivery, it produces severe gastric disturbances [23]. On long term oral delivery, etodolac produces severe gastrointestinal (GIT) bleeding in peptic ulcer patients and it should be contraindicated in patients suffering from cardiovascular disorders and face anemia [24]. To eliminate these side effects, transdermal route can be chosen for administration of etodolac. The organization for economic cooperation and development (OECD), 434 guidelines has given guidelines for dose fixing by dermal toxicity studies [25,26].