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Three-dimensional aspects of formulation excipients in drug discovery:a critical assessment on orphan excipients,matrix effects and Drug interactions

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Journal of Pharmaceutical Analysis 2020年第6期10卷 522-531页

作者： Vijayabhaskar Veeravalli Hanumanth Srikanth Cheruvu Pratima Srivastava Lakshmi Mohan Vamsi Madgula Syngene International Limited Biocon ParkSEZBommasandra Industrial Area-Phase-IV Bommasandra-Jigani Link RoadBangalore560099India GVK BIO Pvt Ltd NacharamHyderabadTelangana500076India

Formulation/pharmaceutical excipients play a major role in formulating drug candidates,with the objectives of ease of administration,targeted delivery and complete availability.Many excipients used in pharmaceutical formulations are orphanized in preclinical drug discovery.These orphan excipients could enhance formulatability of highly lipophilic compounds.Additionally,they are safe in preclinical species when used below the LD50 values.However,when the excipients are used in formulating compounds with diverse physico-chemical properties,they pose challenges by modulating study results through their bioanalytical matrix effects.Excipients invariably present in study samples and not in the calibration curve standards cause over-/under-estimation of exposures.Thus,the mechanism by which excipients cause matrix effects and strategies to nullify these effects needs to be revisited.Furthermore,formulation excipients cause Drug interactions by moderating the pathways of drug metabolizing enzymes and drug transport proteins.Although it is not possible to get rid of excipient driven interactions,it is always advised to be aware of these interactions and apply the knowledge to draw meaningful conclusions from study results.In this review,we will comprehensively discuss a)orphan excipients that have wider applications in preclinical formulations,b)bioanalytical matrix effects and possible approaches to mitigating these effects,and c)excipient driven Drug interactions and strategies to alleviate the impacts of Drug interactions.

关键词： Formulation excipients Preclinical drug discovery Matrix effects Drug interactions Bioanalysis Pharmacokinetics Formulation development

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HIV/HCV Antiviral Drug interactions in the Era of Direct-acting Antivirals

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Journal of Clinical and Translational Hepatology 2016年第3期4卷 234-240页

作者： Donald P.Rice Jr. John J.Faragon Sarah Banks Lisa M.Chirch Division of Infectious Diseases Department of Medicine University of Connecticut School of Medicine Farmington CT USA Division of HIV Medicine Albany Medical Center Albany NY USA Department of Medicine The Hospital of Central ConnecticutUniversity of Connecticut School of Medicine Farmington CT USA

Therapy for human immunodeficiency virus (HIV) and chronic hepatitis C has evolved over the past decade,resulting in better control of infection and clinical outcomes;however,drug-Drug interactions remain a significant hazard.Joint recommendations from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America regarding drug-Drug interactions between HIV antiretroviral agents and direct-acting antiviral agents for treatment of hepatitis C virus (HCV) infection are reviewed here.This review is oriented to facilitate appropriate selection of an antiviral therapy regimen for HCV infection based on the choice of antiretroviral therapy being administered and,if necessary,switching antiretroviral regimens.

关键词： HIV Hepatitis C Direct-acting antivirals Drug interactions Pharmacokinetics Antiretroviral therapy

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Review of Clinically Relevant Drug interactions with Next Generation Hepatitis C Direct-acting Antiviral Agents

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Journal of Clinical and Translational Hepatology 2020年第3期8卷 322-335页

作者： Jenny Hong Robert C.Wright Nilu Partovi Eric M.Yoshida Trana Hussaini Pharmaceutical Sciences Vancouver General HospitalVancouverBCCanada Faculty of Pharmaceutical Sciences University of British ColumbiaVancouverBCCanada Liver Transplant Program Vancouver General HospitalVancouverBCCanada Division of Gastroenterology Faculty of MedicineUniversity of British ColumbiaVancouverBCCanada

In this review,we examine the pharmacokinetics and clinically relevant Drug interactions of the newer generation direct-acting antivirals(DAAs)for the treatment of chronic hepatitis C,specifically sofosbuvir/velpatasvir(Epclusa®),sofosbuvir/velpatasvir/voxilaprevir(Vosevi®),glecaprevir/pibrentasvir(Maviret®),and elbasvir/grazoprevir(Zepatier®).We searched MEDLINE(1948-January 2020),Embase(1964-January 2020),Google,and GoogleScholar using the terms pharmacokinetics,drug interaction,drug metabolism,sofosbuvir,velpatasvir,Epclusa,voxilaprevir,Vosevi,glecaprevir,pibrentasvir,Maviret,elbasvir,grazoprevir,and Zepatier,from inception to January 13,2020.The search was limited to randomized controlled trials,in vitro studies,prospective and retrospective human studies,drug monographs,abstracts,and conference proceedings.All relevant published literature on pharmacokinetic and pharmacodynamic interactions involving DAAs were reviewed and the data extracted.Numerous clinically relevant drug-Drug interactions(DDIs)were identified with the newer generation DAAs and commonly prescribed drugs.NS3/4A protease inhibitors are more likely to be involved in DDIs,followed by NS5A inhibitors and NS5B polymerase inhibitor.The majority of clinically relevant DDIs are predictable,according to known pharmacokinetic,pharmacodynamics,and physicochemical properties of DAAs;however,in select cases,unpredictable DDIs do occur.As expected,many Drug interactions exist between newer generation DAAs and commonly prescribed medications.While the majority of clinically relevant interactions are predictable,many require therapeutic dose adjustment or careful selection of non-interacting drugs.In select cases,severe and unpredictable Drug interactions can occur.Clinicians should consult hepatitis C virus pharmacotherapy experts and tertiary drug interaction resources when initiating DAA therapy in patients taking other medications.

关键词： Hepatitis C Drug interactions Pharmacokinetics Direct-acting antiviral agents

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To “tell or not to tell”——Exploring disclosure about medicine use by people living with sleep disorders

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Journal of Integrative Medicine 2022年第4期20卷 338-347页

作者： Vibha Malhotra Joanna Harnett Erica McIntyre Amie Steel Keith Wong Bandana Saini School of Pharmacy Faculty of Medicine and Healththe University of SydneySydneyNew South Wales 2006Australia The Australian Research Centre in Complementary and Integrative Medicine School of Public Healththe University of TechnologySydneyNew South Wales 2007Australia Institute for Sustainable Futures the University of TechnologySydneyNew South Wales 2007Australia The Woolcock Institute of Medical Research the University of SydneySydneyNew South Wales 2037Australia Sydney Medical School Faculty of Medicine and Healththe University of SydneySydneyNew South Wales 2006Australia Department of Respiratory&Sleep Medicine Royal Prince Alfred HospitalCamperdownNew South Wales 2050Australia

Objective: To explore the difference in rates and reasons for disclosure of either conventional or complementary medicine(CM) to healthcare practitioners between people living with sleep disorders(SDs) and those without SDs.Methods: A cross-sectional survey(N = 2019 adults) that measured sociodemographic characteristics,health status, health service utilisation, health literacy and health communication(medicine disclosure)of a representative sample of Australians was conducted. Data from participants reporting an SD(n = 265)were compared to those not reporting an SD to assess measures of health communication and disclosure about medicine use.Results: Overall, rates of medicine disclosure to both conventional and CM practitioners were high, in respondents with(70%) and without an SD(57%). Those reporting an SD had higher expectations of their conventional health practitioner’s knowledge of CM, associated clinical decision-making skills, and approval of CM use, and held a higher degree of concern about Drug interactions(P Drug interactions with the CMs used.”Conclusion: The high rate of medicine use disclosure by people with SDs is driven by an intention to inform their healthcare practitioner about their health status and concerns about potential medicine interactions. Therefore, research about the expectations that people with an SD have of their conventional healthcare practitioners’ knowledge of CM and CM-Drug interactions requires further examination.Likewise, further examination of CM practitioner’s conventional medicine knowledge is encouraged.

关键词： Medicine disclosure Complementary medicine Drug interactions Sleep disorder Patient safety Cross-sectional survey

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Impact of Proton-pump Inhibitors on the Pharmacodynamic Effect and Clinical Outcomes in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary Intervention： A Propensity Score Analysis

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Chinese Medical Journal 2017年第24期130卷 2899-2905页

作者： Pei Zhu Zhan Gao Xiao-Fang Tang Jing-Jing Xu Yin Zhang Li-Jian Gao Jue Chen Shu-Bin Qiao Yue-Jin Yang Run-Lin Gao Bo Xu Jin-Qing Yuan Department of Cardiology Fuwai Hospital National Center for Cardiovascular Diseases Chinese Academy of Medical Science and Peking Union Medical College Beijing 100037 China

Background：Prior studies have reported controversial conclusions regarding the risk of adverse cardiovascular events in patients using proton-pump inhibitors （PPIs） combined with clopidogrel therapy,causing much uncertainty in clinical practice.We sought to evaluate the safety of PPIs use among high-risk cardiovascular patients who underwent percutaneous coronary intervention （PCI） in a long-term follow-up study.Methods：A total of 7868 consecutive patients who had undergone PCI and received dual antiplatelet therapy （DAPT） at a single center from January 2013 to December 2013 were enrolled.Adenosine diphosphate （ADP）-induced platelet aggregation inhibition was measured by modified thromboelastography （mTEG） in 5042 patients.Propensity score matching （PSM） was applied to control differing baseline factors.Cox proportional hazards regression was used to evaluate the 2-year major adverse cardiovascular and cerebrovascular events （MACCEs）,as well as individual events,including all-cause death,myocardial infarction,unplanned target vessel revascularization,stent thrombosis,and stroke.Results：Among the whole cohort,27.2% were prescribed PPIs.The ADP-induced platelet aggregation inhibition by mTEG was significantly lower in PPI users than that in non-PPI users （42.0 ± 30.9% vs.46.4 ± 31.4%,t =4.435,P 〈 0.001）.Concomitant PPI use was not associated with increased MACCE through 2-year follow-up （12.7% vs.12.5%,x2 =0.086,P =0.769）.Other endpoints showed no significant differences after multivariate adjustment,regardless of PSM.Conclusion：In this large cohort of real-world patients,the combination of PPIs with DAPT was not associated with increased risk of MACCE in patients who underwent PCI at up to 2 years of follow-up.

关键词： Clopidogrel Drug interactions Percutaneous Coronary Intervention Proton-pump lnhibitors

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Pretreatment of Shaoyao Gancao Decoction(芍药甘草汤)Alters Pharmacokinetics of Intravenous Paclitaxel in Rats

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Chinese Journal of Integrative Medicine 2017年第1期23卷 70-75页

作者： WANG Yang HUANG Xi ZHONG Mei-zuo LU Ruo-huang XIA Zi-an FAN Rong LIU Bo HUANG Wei GAN Ping-ping Laboratory of Ethnopharmacology Institute of Integrated Traditional Medicine and Western MedicineXiangya HospitalCentral South UniversityChangsha 410008China Department of Oncology Xiangya HospitalCentral South UniversityChangsha 410008China Department of Stomatology the Third Xiangya HospitalCentral South UniversityChangsha 410008China Department of geriatrics Xiangya Hosoital.Central South UniversityChanqsha 410008China

Objective：To investigate the effect of Shaoyao Gancao Decoction（芍药甘草汤,SGD）on the pharmacokinetics of intravenously administered paclitaxel in rats.Methods：Paclitaxel was intravenously administered to rats（3 mg/kg）with or without the concomitant administration of SGD（752 mg/kg,a single day or 14 consecutive days pretreatment）.The paclitaxel in the serum was quantified using a simple and rapid ultra performance liquid chromatography（UPLC）method for the pharmacokinetic study.The pharmacokinetic parameters were calculated via a non-compartment model using the computer program DAS 2.0.Results：The pharmacokinetic parameters of paclitaxel were significantly altered in response to 14 consecutive days of pretreatment with SGD.The area under the curve（AUC0-t,from 4 820±197 to 4 205±186 ng·m L-1·h-1）and AUC0-∞（from 5 237±280 to 4 514±210 ng·m L-1·h-1）significantly decreased in response to the 14-day pretreatment with SGD.The values of V dss（L/kg）were 10.74±1.08 and 9.35±0.49,those of CL（L/kg）were0.67±0.03 and 0.57±0.03 and the t1/2（h）values were 11.17±0.84 and 11.32±0.93,respectively,for the14-day SGD pretreatment and intravenous paclitaxel alone.The AUC0-t and AUC0-∞values decreased by13%and 14%（P〈0.01）,respectively.The area under the curve decreased significantly（P〈0.01）,and the total clearance increased by 1.2-fold（P〈0.01）,after 14 consecutive days of pretreatment with SGD.A single-day pretreatment with SGD did not significantly affect the pharmacokinetic parameters of paclitaxel.Conclusions：SGD administration for 14 consecutive days increased the metabolism of paclitaxel,while a 1-day pretreatment had little effect.The results would contribute important information to the study on interaction between Chinese medicines and chemotherapy and also help to utilize SGD better in the adjunctive therapy of cancer patients.

关键词： paclitaxel Shaoyao Gancao Decoction pharmacokinetic Drug interactions

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Prevalence and risk factors for acquired long QT syndrome in the emergency department:a retrospective observational study

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World Journal of Emergency Medicine 2023年第6期14卷 454-461页

作者： Diogo de Almeida Fernandes Guilherme de Freitas Camoes Diana Ferreira Carolina Queijo Carlos Fontes-Ribeiro Lino Gongalves Rui Pina Natalia Antonio Department of Cardiology Coimbra Hospital and University Centre(CHUC)Coimbra 3000-075Portugal Department of Internal Medicine Coimbra Hospital and University Centre(CHUC)Coimbra 3000-075Portugal Faculty of Medicine University of CoimbraCoimbra 3000-370Portugal Institute for Clinical and Biomedical Research Faculty of MedicineUniversity of CoimbraCoimbra 3000-548Portugal

BACKGROUND: Long QT syndrome(LQTS) is a heterogeneous syndrome that may be congenital or, more frequently, acquired. The real-world prevalence of acquired LQTS(aLQTS) in the emergency department(ED) remains to be determined. The aim of this study was to determine prevalence of aLQTS and its impact on symptoms on ED admissions.METHODS: Electrocardiograms(ECG) of 5,056 consecutively patients admitted in the ED of a tertiary hospital between January 28th and March 17th of 2020 were reviewed. All patients with aLQTS were included. Clinical data with a focus on QT prolonging drugs and clinical factors were recorded. Statistical comparison was made between the groups with and without corrected QT(QTc) interval greater than 500 ms(value that is considered severely increased).RESULTS: A total of 383 ECGs with prolonged QTc were recognized, corresponding to a prevalence of aLQTS at admission of 7.82%. Patients with aLQTS were more commonly men(53.3%) with an age of(73.49±14.79) years old and QTc interval of(505.3±32.4) ms. Only 20.4% of these patients with aLQTS were symptomatic. No ventricular arrhythmias were recorded. Patients with QT interval greater than 500 ms were more frequently female(59.5%;Pdrugs(77.3%;P=0.025). Main contributing factor was intake of antibiotics(odds ratio [OR] 4.680) followed by female gender(OR 2.473) and intake of antipsychotics(OR 1.925).CONCLUSION: aLQTS is particularly prevalent in the ED. Female patients on antibiotics and antipsychotics are at particularly high risk. Efforts must be made to avoid, detect and treat aLQTS as early as possible.

关键词： Long QT syndrome Epidemiology Drug interactions Emergency department

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Assessment of the potential interactions between favipiravir and radiocontrast agents

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World Journal of Radiology 2024年第5期16卷 128-135页

作者： Sonay Aydin Ozlem Celik Aydin Mesut Furkan Yazar Huseyin Aydemir Mecit Kantarci Sureyya Barun Department of Radiology Erzincan Binali Yıldırım UniversityFaculty of MedicineErzincan 24100Türkiye Department of Pharmacology Gazi UniversityFaculty of MedicineErzincan 24100Türkiye Department of Radiology Bilecik Education and Reseach HospitalBilecik 11230Türkiye Department of Radiology Atatürk UniversityFaculty of MedicineErzurum 25030Türkiye

BACKGROUND In cases of coronavirus disease 2019(COVID-19),favipiravir is commonly included to the therapy regimen.Drug interactions between favipiravir and other COVID-19 therapy drugs are frequently researched.However,no research on possible Drug interactions between Favipiravir and radiocontrast agents,which have become almost crucial in diagnostic processes while not being part of the treatment,has been found.AIM To determine potential medication interactions between Favipiravir and radiocontrast agents.METHODS The study comprised patients who were taking Favipiravir for COVID-19 therapy and underwent a contrast-enhanced computed tomography(CT)or magnetic resonance imaging(MRI)test while taking the medicine.The computerized patient files of the cases included in the study,as well as the pharmacovigilance forms in the designated hospital,were evaluated for this purpose.RESULTS The study included the evaluation of data from 1046 patients.The study sample's mean age was 47.23±9.48 years.The mean age of cases with Drug interactions was statistically significant greater than that of cases with no Drug interactions(P=0.003).When evaluated with logistic regression analysis,a 1-year raises in age increases the risk of developing Drug interactions by 1.63 times(P=0.023).There was no statistically significant difference in the occurrence of medication interactions between the sexes(P=0.090).Possible medication interactions were discovered in 42 cases(4%).CONCLUSION The findings of this study revealed that the most notable findings as a result of the combined use of contrast agents and favipiravir were increased creatinine and transaminase values,as well as an increase in the frequency of nausea and vomiting.The majority of Drug interactions discovered were modest enough that they were not reflected in the clinic.Drug interactions become more common as people get older.

关键词： Favipiravir Iohexol Gadoxetic acid Meglumine gadoterate Drug interactions

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Safety of direct acting antiviral treatment for hepatitis C in oncologic setting:A clinical experience and a literature review

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World Journal of Hepatology 2022年第3期14卷 525-534页

作者： Anna Maria Spera Infectious Disease Unit Universitary Hospital OO RR San Giovanni di Dio e Ruggi d'AragonaSalerno 84131Italy

With a globally estimated 58 million people affected by,chronic hepatitis C virus(HCV)infection still represents a hard challenge for scientific community.A chronic course can occur among patients with a weak innate ad adaptive response with cirrhosis and malignancies as main consequences.Oncologic patients undergoing chemotherapy represent a special immunocompromised population predisposed to HCV reactivation(HCVr)with undesirable changes in cancer treatment and outcome.Aim of the study highlight the possibility of HCVr in oncologic population eligible to chemotherapy and its threatening consequences on cancer treatment;underline the importance of HCV screening before oncologic therapy and the utility of direct aging antivirals(DAAs).A comprehensive overview of scientific literature has been made.Terms searched in PubMed were:“HCV reactivation in oncologic setting”“HCV screening”,“second generation DAAs”.Pharmacokinetic and Pharmacodynamics characteristics of DAAs are reported,along with drug-Drug interactions among chemotherapeutic drug classes regimens and DAAs.Clinical trials conducted among oncologic adults with HCV infection eligible to both chemotherapy and DAAs were analyzed.Viral eradication with DAAs in oncologic patients affected by HCV infection is safe and helps liver recovery,allowing the initiation of cancer treatment no compromising its course and success.

关键词： Hepatitis C Virus Direct aging antivirals Drug interactions Pharmacodynamic Pharmacokinetic Pre-emptive therapy

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Interaction between antitumor drug and silver nanoparticles: combined fluorscence and surface enhanced Raman scattering study

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Chinese Optics Letters 2009年第10期7卷 894-897页

作者：杨晶王宏王元谈学斌宋春元张若虎李锦崔一平 Advanced Photonics Center Southeast University Clinical Laboratory Center of the First Affliated Hospital of Nanjing Medical University

Optical methods and MTT method are used to characterize the antiproliferation effect of antitumor drug 9-aminoacridine （9AA） with and without silver nanoparticles. Intracellular surface enhanced Raman scattering （SERS） spectra and fluorescent spectra of 9AA indicate the form of 9AA adsorbed on the surface of silver nanoparticles. Although both silver nanoparticles and antitumor drug can inhibit the growth of Hela cells, silver nanoparticles can slow down the antiproliferation effect on Hela cells at low concentration of antitumor drugs. Our experimental results suggest that silver nanoparticles may serve as slow-release drug carriers, which is important in antitumor drug delivery.

关键词： drug delivery Drug interactions Nanoparticles Raman scattering

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