ABSTRACT
The worldwide epidemic of Coronavirus disease 2019 (COVID-19), caused by a new virus known as severe acute respiratory syndrome (SARS) coronavirus 2, has posed a growing threat to public health (SARS-CoV-2). The only antiviral drug authorized by the FDA for treating adult and pediatric patients hospitalized with a severe disease is remdesivir, which is given intravenously (IV). Although only a few methods for estimating remdesivir in pharmaceutical formulations using high-pressure liquid chromatography (HPLC) have been described, its determination still requires an accurate, precise, quick, and easy analytical methodology. The main goal of this study was to develop and validate a reliable and accurate HPLC method for quantitative estimation of remdesivir in its intravenous dosage formulation. The separation was performed on a C18 (4.6 mm x 150 mm, 5.0 microm) column with a flow rate of 0.7 mL/min and a total run duration of 6 minutes using a simple isocratic mobile phase of acetonitrile and 0.1 percent formic acid. The method was validated for the system suitability, linearity, precision, accuracy, robustness, and others as per the International Council for Harmonization (ICH) Q2 (R1) guideline. The results show that the method for measuring remdesivir using HPLC is simple, quick, sensitive, accurate, precise and robust. The described approach was successfully used to quantify remdesivir in a commercially available pharmaceutical formulation.Copyright All © 2023 are reserved by International Journal of Pharmaceutical Sciences and Research.
ABSTRACT
EudraVigilance, as a system for managing and analysing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area, is always improving and changing to comply with the latest trends as well as applicable regulatory guidelines. In recent years, the system faced multiple challenges: continuous implementation of E2B(R3) standards for reporting;introduction of EVDAS access for Marketing Authorization Holders and of course the COVID-19 pandemic, which resulted in an enormous surge in reports coming into the system, as well as increased demand of public access to data via the ADR reports portal. Since the access to EVDAS has been granted to MAHs, there was a limit of five users per organization. Due to the stabilization of the system, this has now been increased to 10. Another new rule is the implementation of European Directorate for the Quality of Medicines & HealthCare (EDQM) codes for pharmaceutical dose forms and route of administration while reporting ICSRs. This poses a certain challenge for organizations, as they need to download and implement the terms onto their databases on a periodic basis. Changes to Article 57 Database (XEVMPD), another component of EudraVigilance, are also worth mentioning. While the information about medicinal products is preparing for transition to ISO IDMP standards, MAHs and Sponsors still have the obligation to send information about authorized and development medicinal products to XEVMPD. The platform runs on an older version of the Internet Explorer browser, which Microsoft stopped providing support for in June 2022. The European Medicines Agency provided a workaround using Microsoft Edge or by downloading extensions for other browsers that emulate the Internet Explorer mode. Not only EudraVigilance is being updated and modernized, internal EMA tools such as Service Desk are also keeping up with the pace and are being transferred from their current JIRA platform to ServiceNow (SNOW). We also cannot forget the changes post Brexit. MAHs are using the ICSR Submission Portal for transmission of ICSRs to MHRA, and since the beginning of October 2022, SUSARs from Clinical Trials are also submitted via this portal.
ABSTRACT
Background: An outbreak of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection or COVID 19 has caused serious threats to all around the world. Until an effective and safe vaccine for novel coronavirus is developed by scientists, current drug therapy should be optimized for the control and treatment of COVID 19. Objective(s): In this manuscript, we present a perspective on possible benefits of reformulating antiviral drug dosage form with nanoemulsion system against novel coronavirus infection. Method(s): Literature review has been done on COVID 19, treatment strategies, novel drug delivery sys-tems and the role of pulmonary surfactant in lung protection. Result(s): Nanoemulsion system and its components have certain biophysical properties which could in-crease the efficacy of drug therapy. Antiviral drugs, delivered through a nanoemulsion system contain-ing P-gp inhibitor (surfactant and co-solvent), can minimize the cellular resistance to drugs and would potentiate the antiviral action of drugs. Pulmonary Surfactant (PS) assisted antiviral drug delivery by nanoemulsion system could be another effective approach for the treatment of COVID 19. The use of functional excipients like Pulmonary Surfactant (PS) and Surfactant Proteins (SPs) in the formulation of the antiviral drug-loaded nanoemulsion system can improve the treatment of coronavirus infection. Conclusion(s): In our opinion, for synergizing antiviral action, lipid and protein portion of PS and their commercial analogs should be explored by pharmaceutical scientists to use them as a functional excipi-ent in the formulation of antiviral drug-loaded nanoemulsion system.Copyright © 2021 Bentham Science Publishers.
ABSTRACT
Background/Aims Effective symptom management may require the use of medications. Medication adherence may be hindered by formulation aspects, such as poor taste. Paediatric studies indicate, that despite concerns of swallowing solid dose forms, children prefer these to liquid forms. They find the solid dose forms more palatable. However, swallowing numerous solid dose forms, may present a significant 'pill' burden to patients and their care-givers. Filling empty gelatine capsules with requisite medications is seen and used as a way to address palatability, decrease pill burden and thereby increase compliance. Yet there is little evidence on the impact this practise may have on the effectiveness of over-encapsulated medicines. This study explored the effect of over-encapsulation on in vitro disintegration and dissolution, of some commonly used medicines in paediatric palliative care. Method Immediate release (Cyclizine Hydrochloride, Gabapentin, Paracetamol) and modified release preparations (Omeprazole, Diclofenac sodium) were over-encapsulated in size 00 gelatin and HPMC capsules (n=6). Dissolution and disintegration were tested according to Pharmacopeia standards. Statistical analyses, using Student's T-test and f1 and f2 tests (respectively) were applied to determine similarities or differences in disintegration or dissolution. Results Disintegration and dissolution was prolonged for all over-encapsulated immediate release preparations, especially when using HPMC capsules. However, percentage of drug dissolved met the acceptance criteria for immediate-release solid oral dosage. Over-encapsulation of modified release preparations did not lead to significant dissolution or disintegration changes. Conclusion Over-encapsulation, may delay medication release, especially for immediate release medicines however, medicine effectiveness may not be. Further studies are required before we can safely recommend use of over-encapsulation as an administration compliance aid.
ABSTRACT
Favipiravir is an anti-viral agent used for the treatment of a large number of RNA viruses including influenza and was considered for the treatment of COVID-19. A new stability indicating RP-HPLC has been developed for the estimation of Favipiravir and the method was validated. Hypersil BDS C18 column was used for the chromatographic study with a flow rate 1ml/min (Detection wavelength 230nm). The LOD and LOQ were found to be 0.2918mug/mL and 0.9207mug/mL respectively. Linearity was observed over the concentration 1-300mug/mL with linear regression equation, y = 28444x + 21853 (R2 = 09998) and the method is precise, accurate and robust. Stress degradation studies were performed and the method was found to be selective and specific. Copyright © RJPT All right reserved u.
ABSTRACT
Favipiravir is a pyrazine carboxamide derivative discovered by Toyama chemical of Japan to act against many RNA viruses (potent broad spectrum inhibitor of Influenza & other RNA viruses). The present study gives the development of the RP HPLC method by using Quality by Design followed by validation of developed method for estimation co Favipiravir in bulk and tablet dosage form. The central composite method was applied on organic Phase concentration & buffer PH for initial Screening studies. The selection of optimum chromatographic condition was carried out by design space numerical, graphical optimization on retention time, Peak asymmetry & Theoretical Plates. Optimized analytical method consisted Acetonitrile: water (80:20%v/v) as mobile phase, pH 5, flow rate 1ml/min, a wavelength 323 nm. Favipiravir was eluted with retention time 2.7 min & peak area 51248, Favipiravir showed good linear relationship in range of 10-90 microg/ml with a correlation coefficient of 0.9985. The % RSD for intraday, inter day precision & Repeatability was found to be 0.88, 0.65 & 0.97 respectively. Limit of detection & quantification was found to be 104.44 microg/ml &. 316.5 microg/ml. The method validation parameters were in the prescribed limit as per ICH guidelines. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.
ABSTRACT
Coronavirus disease COVID-19 is causing havoc globally, infecting millions of people and has led to the deaths of people in thousands. COVID-19 attacks persons with low immune sys-tems, especially neonates and geriatrics. Hence, boosting immunity may be one of the best options during this pandemic. There is a need to explore the possible herbal drugs to boost the immunity of people as a result of the rising cases of deaths due to COVID-19. However, the rationale for the use of herbal drugs is that each herb has the possibility of treating many health conditions. A single herb could have antiviral, antibacterial, and anti-inflammatory properties. Herbs may be one possible source of a true cure for COVID-19. Herbal drugs are from renewable sources and pose less danger of possible adverse effects compared to synthetic drugs. Because COVID-19 has no true cure pres-ently, man should resort to herbal drugs given by nature. Herbal drugs are highly potent and effica-cious;hence, the early men treated their ailments with herbs. However, their use has been limited by poor pharmaceutical design into dosage forms that would be acceptable to people. Herbal drugs could be formulated as teas, decoctions, infusions, and, more recently, tablets, capsules, microparti-cles, nanoparticles, and phytosomes, amongst others. Different herbal plants with possible immune booster effects will be discussed in this work, and how they can be formulated into stable and acceptable dosage forms will be explored. Copyright © 2023 Bentham Science Publishers.
ABSTRACT
Remdesivir is a prodrug that works by imitating the nucleoside adenosine. It is an antiviral medication that has been used to treat the coronavirus. Given the severity of the condition, the medicine is critical to the therapy and accompanying research. Remdesivir is extremely important as a medicinal dose form. Remdesivir has been used with other medications in the following combinations: Remdesivir and Dexamethasone, Remdesivir and Tocilizumab, and Remdesivir and Ivermectin. To aid future study, the paper also gives a simultaneous and comparative review of the analytical investigations published in the literature for a pharmacological estimate. The extensive literature searches turned up a plethora of study publications. A complete explanation of common, hyphenated, and unique ways of analysis is given. Remdesivir analytical quantification is provided using HPLC, LCMS, UV-Visible spectroscopy, and fluorescence. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.
ABSTRACT
Background and importance Pharmaceutical validation of inpatient treatments is a fundamental activity in the clinical practice of the hospital pharmacist. Thanks to this, many prescription errors are detected, promoting patient safety. Aim and objectives To describe the interventions performed by a hospital pharmacy resident in the area of pharmaceutical validation, supervised by consultant pharmacists, and to evaluate their degree of acceptance. Material and methods Prospective interventional study conducted during September 2021. Adult inpatients, whose hospital treatment was reviewed, were included. Demographic (sex and age), clinical (clinical judgement (CJ) and inpatient clinical service) and pharmacotherapeutic (number of chronic medicines and polymedication (≥6 drugs)) variables were collected. Interventions were reported to the clinician via electronic prescribing software. They were classified as: Activity (reconciliation on admission/information to the clinician), Adequacy (detection of prescribing error/therapy reconciliation error), Change (therapeutic exchange), Initiation (usual treatment not prescribed/need for additional treatment), Modification Dosage Form (DF) or Posology, Suspension (duplicity/unnecessary medication/allergy). Patient lists and data were collected through medical records and electronic prescribing software, and processed using Excel 2020. Results Interventions were performed in 56 patients. 63.2% male;median age 73 years (IQR 61-80). The most frequent CJ were: heart failure (10.7%), COVID-19 (7.1%), liver dysfunction (7.1%). Services with most interventions: Internal Medicine (25.8%), General/Vascular Surgery (19.4%), Digestive (11.3%). Median number of chronic medicines: 8 (IQR 5-12). Polymedication in 71.4%. 62 interventions were performed (12.9% were 'not evaluable', reasons: discharge/death). Of the evaluable interventions, 77.8% were accepted. The percentages were: duplicity (30.9%), modification DF/posology (23.8%), usual treatment not prescribed (7.1%), therapeutic exchange (7.1%), discontinue medication due to allergy (7.1%), therapy reconciliation error (4.8%), reconciliation on admission (4.8%), information (4.8%), additional treatment (4.8%), prescribing error (2.4%), unnecessary medication (2.4%). Of the accepted interventions, 11.9% were related to high-risk medicines according to the Institute for the Safe Use of Medicines1- 2 (nonsteroidal anti-inflammatory drugs (NSAIDs), betablockers, heparin, immunosuppressants). Of the not-accepted interventions, 50.0% corresponded to errors in home treatment reconciliation. Conclusion and relevance The data obtained demonstrate that clinical interventions performed by the hospital pharmacy resident have a high degree of acceptance, increasing the quality and safety of healthcare and avoiding medication errors.
ABSTRACT
Excipients are critically important in converting active pharmaceutical ingredients (API) into drug products that have optimal stability, bioavailability, manufacturability, duration of action, and therapeutic benefits. They will play even greater roles in the future to enable drug targeting, delivery of biotech products and vaccines, gene therapy, continuous manufacturing, 3D printing, and so forth. This commentary describes the author’s experience in teaching a graduate course on excipients at St. John’s University to train students on optimal selection and appropriate use of excipients in formulating dosage forms and development of drug delivery systems. The course is offered in 15 two-hour sessions over a semester, and the course materials are divided into 13 modules on chemistry of different classes of polymeric and non-polymeric excipients and their application in dosage form development, including the use as solubilizing agents, lyophilizing agents, cryoprotectants, buffers, biodegradable materials, and carriers for amorphous solid dispersions and 3D printing. The development of coprocessed excipients, the need for new excipients, and the regulatory aspects of excipients are also covered. The course includes presentations by guest speakers from the industry, and the students also watch virtual presentations from experts that are publicly available from the internet. It is a popular course at St. John’s University taken by all graduate students in the pharmaceutics program. It is recommended that such courses are introduced in other pharmacy schools and academic institutions. The course may be adapted to meet specific needs of different academic programs. Professional associations, such as AAPS and CRS, industry groups like IPEC, and the pharmaceutical industry may be able to help in introducing such courses by providing lecture materials and guest lecturers.
ABSTRACT
INTRODUCTION: The importance of critical care pharmacists has been well demonstrated in the literature and their inclusion on the multidisciplinary team is a best practice. During the COVID-19 Pandemic, resource allocation and surging intensive care unit (ICU) census generated staffing constraints around the world. At our 12 hospital midwestern health system, this became a new normal. In an effort to “keep care close to home”, ICUs were created at institutions that historically had not had a clinical pharmacist presence. This was quickly identified as an area of opportunity and a critical care pharmacist was deployed to remotely monitor patients 7 days a week from 0900-2030. The goal was to provide high quality critical care pharmacist coverage across the enterprise and establish a presence at institutions without an established clinical pharmacist position. METHODS: We describe a retrospective review of a twomonth dedicated pilot of critical care trained pharmacists remotely covering 7 hospital ICUs within the health system. We defined a critical care trained pharmacist as having board certification in critical care pharmacy and/or PGY2 Critical Care residency completion per health system guidance. Intervention data was obtained from the electronic medical record for the time period of November 30, 2020 to January 31, 2021. This data was subsequently compared to on-site critical care pharmacist intervention data from the largest institution to assess efficiency and efficacy of remote staffing. RESULTS: Over the course of 60-day pilot period, a total of 684 pharmacist interventions and 1984 routine monitoring completions were documented. The most frequently occurring pharmacist interventions were admission medication reconciliation, dosage form change, therapeutic monitoring, and dose change. When compared to standard critical care pharmacist staffing at the largest institution, the remote critical care pharmacist provided 11.4 documented interventions per day, compared to 4.3 per day by the on-site pharmacist. For routine monitoring documentation, the remote pharmacist completed 33 per day compared to 12 per day on-site. CONCLUSIONS: Our review suggests that a remote critical care pharmacist can provide efficient and appropriate patient care to ICU patients at multiple care sites.