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Yi Chuan = Hereditas Oct 2022Diabetes mellitus is a kind of metabolic disease characterized by hyperglycemia resulting from insulin insufficiency and insulin resistance. It has become one of the...
Diabetes mellitus is a kind of metabolic disease characterized by hyperglycemia resulting from insulin insufficiency and insulin resistance. It has become one of the major diseases threatening human health. In this paper, we analyze the current R&D status of diabetes from the aspects of papers, patents, drugs and industrial development. The results show that scientific outcomes are increasing steadily and the hot topics are diabetic complications and epidemiological research. In terms of technology development, large pharmaceutical companies, such as Janssen Pharmaceutical, Lilly pharmaceutical, Boehringer Ingelheim, are actively engaged in diagnosis, treatment and management of diabetes. By March 23 2022, 207 drugs have been launched and a large number of candidate drugs are in the pre-clinical and clinical stage. In terms of industrial development, the potential diabetes market is huge and the digital management of diabetes is developing rapidly. China has certain strength in diabetes research and development. In the future, measures should be taken to strengthen the transformation of research outcomes, and promote product development to meet China's huge needs of diabetes cares.
Topics: Humans; Diabetes Mellitus; Insulin Resistance; Research; Pharmaceutical Preparations; China
PubMed: 36384721
DOI: 10.16288/j.yczz.22-272 -
Journal of Pharmacy Practice Feb 2023Timely medication administration is integral to patient care, and operational delays can challenge timely administration. Within an inpatient pharmacy of an academic...
BACKGROUND
Timely medication administration is integral to patient care, and operational delays can challenge timely administration. Within an inpatient pharmacy of an academic medical center, intravenous medications were historically compounded on a patient-specific basis. In 2020, the pharmacy began batching frequently-utilized medications. This analysis explored the impact of compounded sterile batching on pharmacy and nursing services.
METHODS
This pre- and post-interventional study compared data from February through March 2020 with a seasonally matched period from 2019. The primary endpoint was difference in time to administration of urgent (STAT) medications. Secondary endpoints included timeframes for a pharmacy technician to prepare, a pharmacist to check, and a nurse to administer the medications, as well as reprinted labels and estimated waste.
RESULTS
On average, it took one hour and 43 minutes to administer a STAT medication in 2019 and one hour and 57 minutes in 2020 ( = 0.122). It took about four hours to administer routine medications in 2019 and 2020 ( = 0.488). The number of labels reprinted decreased from 616 in 2019 to 549 in 2020 ( = 0.195), relating to decreased missing doses. The mean time to check and send a medication decreased from 2019 to 2020 for STAT orders ( < 0.001), and there was no difference in wasted medications looking at all orders in this time.
CONCLUSION
Anticipatory batching decreased time to prepare, check, and send medications, though there was no effect on waste or on time to administration. Future studies can examine the correlation between pharmacy operations and medication administration.
Topics: Humans; Pharmaceutical Preparations; Pharmaceutical Services; Pharmacists; Pharmacies; Pharmacy
PubMed: 34165027
DOI: 10.1177/08971900211027134 -
Advanced Drug Delivery Reviews Mar 2024Ultrasound-responsive agents have shown great potential as targeted drug delivery agents, effectively augmenting cell permeability and facilitating drug absorption. This... (Review)
Review
Ultrasound-responsive agents have shown great potential as targeted drug delivery agents, effectively augmenting cell permeability and facilitating drug absorption. This review focuses on two specific agents, microbubbles and nanodroplets, and provides a sequential overview of their drug delivery process. Particular emphasis is given to the mechanical response of the agents under ultrasound, and the subsequent physical and biological effects on the cells. Finally, the state-of-the-art in their pre-clinical and clinical implementation are discussed. Throughout the review, major challenges that need to be overcome in order to accelerate their clinical translation are highlighted.
Topics: Humans; Microbubbles; Ultrasonography; Drug Delivery Systems; Pharmaceutical Preparations; Permeability
PubMed: 38199257
DOI: 10.1016/j.addr.2023.115178 -
Advances in Experimental Medicine and... 2023Advanced Therapy Medicinal Products (ATMPs) are a new class of medicinal products that fall under the Drug Act. B.E.2510. The Medicines Regulation Division, a regulatory... (Review)
Review
Advanced Therapy Medicinal Products (ATMPs) are a new class of medicinal products that fall under the Drug Act. B.E.2510. The Medicines Regulation Division, a regulatory unit under the Thai Food and Drug Administration, takes responsibility for the regulation of ATMPs. This includes importing or manufacturing of ATMPs for clinical trials, GMP inspection, and marketing authorization. In Thailand, ATMPs have been classified into four groups: cell therapy medicinal products, gene therapy medicinal products, tissue-engineered products, and combined ATMPs. At present, the guidelines for biological products are applied to ATMP in clinical trials and marketing authorization applications. At the same time, the specific guidelines for ATMPs are under development. This chapter provides an overview of the Thai FDA regulatory oversight of ATMPs, which covers investigational ATMPs, GMP certification, and marketing authorization.
Topics: Cell- and Tissue-Based Therapy; Drugs, Investigational; Pharmaceutical Preparations; Thailand; Tissue Engineering
PubMed: 37526851
DOI: 10.1007/978-3-031-34567-8_13 -
Paediatric Drugs Sep 2022Medication errors can happen at any phase of the medication process at health care settings. The objective of this study is to identify the characteristics of severe...
OBJECTIVES
Medication errors can happen at any phase of the medication process at health care settings. The objective of this study is to identify the characteristics of severe prescribing errors at a pediatric hospital in the inpatient setting and to provide recommendations to improve medication safety and rational drug use.
METHODS
This descriptive retrospective study was conducted at a tertiary pediatric hospital using data collected from Jan. 1st, 2019 to Dec. 31st, 2020. During this period, the Prescription Pre-audit Intelligent Decision System was implemented. Medication orders with potential severe errors would trigger a Level 7 alert and would be intercepted before it reached the pharmacy. Trained pharmacists maintained the system and facilitated decision making when necessary. For each order intercepted by the system the following patient details were recorded and analyzed: patient age, patient's department, drug classification, dosage forms, route of administration, and the type of error.
RESULTS
A total of 2176 Level 7 medication orders were intercepted. The most common errors were associated with drug dosage, administration route, and dose frequency, accounting for 35.2%, 32.8% and 13.2%, respectively. Of all the intercepted oerrors. 53.6% occurred in infants aged < 1 year. Administration routes involved were mainly intravenous, oral and external use drugs. Most alerts came from the neonatology department and constituted 40.5% of the total alerts, followed by the nephrology department 15.9% and pediatric intensive care unit (PICU) 11.3%. As to dosage forms, injections accounted for 50.4% of alerts, with 21.3% attributable to topical solutions, 9.1% to tablets, and 5.7% to inhalation. Anti-infective agents were the most common therapeutic drugs prescribed with errors.
CONCLUSIONS
The Prescription Pre-audit Intelligent Decision System, with the supervision of trained pharmacists can validate prescriptions, increase prescription accuracy, and improve drug safety for hospitalized children. It is a medical service model worthy of consideration.
Topics: Child; Drug Prescriptions; Humans; Infant; Medication Errors; Pharmaceutical Preparations; Pharmacists; Retrospective Studies
PubMed: 35906499
DOI: 10.1007/s40272-022-00521-2 -
Social Science & Medicine (1982) Jan 2022As part of their populist performances during disease outbreaks, public officials and politicians tend to offer 'miracle cures' or 'wonder drugs' that can supposedly...
As part of their populist performances during disease outbreaks, public officials and politicians tend to offer 'miracle cures' or 'wonder drugs' that can supposedly treat or prevent the disease in question. This article analyzes contemporary instances of what we call 'pharmaceutical messianism' and proposes four characteristics for this phenomenon, namely, that it: (1) emerges during times of extraordinary health crisis; (2) builds on pre-existing knowledge, practices, and sentiments; (3) borrows from medical, often heterodox, authority; and (4) involves accessible, affordable, and/or familiar substances. Demonstrating the analytic value of our framework, we present three case studies, constructed using academic and journalistic sources, during the COVID-19 pandemic: hydroxychloroquine in France, ivermectin in the Philippines, and Covid-Organics in Madagascar. We conclude by identifying some implications of our findings on public health and avenues for future research.
Topics: COVID-19; Humans; Hydroxychloroquine; Pandemics; Pharmaceutical Preparations; SARS-CoV-2
PubMed: 34794852
DOI: 10.1016/j.socscimed.2021.114567 -
Acta Biomaterialia Apr 2021Biotherapeutics have achieved global economic success due to their high specificity towards their drug targets, providing exceptional safety and efficiency. The ongoing...
Biotherapeutics have achieved global economic success due to their high specificity towards their drug targets, providing exceptional safety and efficiency. The ongoing shift away from small molecule drugs towards biotherapeutics heightens the need to further improve the pharmacokinetics of these biological drugs. Three pervasive obstacles that limit the therapeutic capacity of biotherapeutics are proteolytic degradation, circulating half-life, and the development of anti-drug antibodies. These challenges can culminate in limited efficiency and consequently warrant the need for higher drug doses and more frequent administration. We have explored the coupling of biotherapeutics to long-lived and biocompatible red blood cells (RBCs) to address limited pharmacokinetics. Butyrylcholinesterase (BChE), for example, provides prophylactic protection against organophosphate nerve agents (OPNAs), yet the short circulation life of the drug requires extraordinary doses. Herein, we report the rapid and tunable chemical engineering of BChE to RBC membranes to create a cell-based delivery system that retains the enzyme activity and enhances stability. In a three-step process that first pre-modifies BChE with a cell-reactive polymer chain, primes the cells for engineering, and then grafts the conjugates to the cells, we attached over 2 million BChE molecules to the surface of each RBC without diminishing the bioscavenging capacity of the enzyme. Critically, this membrane-engineering approach was cell-tolerated with minimal hemolysis observed. These results provide strong evidence for the ability of engineered RBCs to serve as an enhanced biotherapeutic delivery vehicle. STATEMENT OF SIGNIFICANCE: Organophosphate nerve agents (OPNAs) are one of the most lethal forms of chemical warfare. After exposure to OPNAs, a patient is given life-saving therapeutics, such as atropine and oxime. However, these drugs are limited, and the patient can still suffer from irreparable injuries. Given the toxicity of OPNAs, access to a prophylactic is vital. We have created an enhanced delivery system for prophylactic butyrylcholinesterase (BChE) by engineering this biotherapeutic to the red blood cell (RBC) surface. In three simple steps that first pre-modifies BChE with a cell-reactive polymer, primes the cells for engineering, and then grafts the conjugates to the cells, we attached over 2 million BChE molecules to a single RBC while retaining the enzyme's activity and enhancing its stability.
Topics: Butyrylcholinesterase; Erythrocytes; Humans; Organophosphates; Oximes; Pharmaceutical Preparations
PubMed: 33529769
DOI: 10.1016/j.actbio.2021.01.043 -
AAPS PharmSciTech Mar 2021Intravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal... (Review)
Review
Intravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.
Topics: Drug Delivery Systems; Drug Packaging; Humans; Intravitreal Injections; Needles; Pharmaceutical Preparations; Sterilization; Syringes
PubMed: 33709236
DOI: 10.1208/s12249-021-01949-4 -
International Journal of Clinical... Feb 2021Background Drug-related problems after discharge are common among older adults with polypharmacy. Medication review during hospitalization has been proposed as one...
Background Drug-related problems after discharge are common among older adults with polypharmacy. Medication review during hospitalization has been proposed as one solution. Inpatient medication review is often based on clinical records only. An obstacle is the lack of insight into the outpatient history. Therefore, a geriatric stewardship was designed and involved an inpatient medication review by a hospital pharmacist and geriatrician based on (I) clinical records to draft initial recommendations, (II) consultations with primary care providers (general practitioner and community pharmacist) to discuss the hospital-based recommendations, (III) patient interviews to assess their needs, and (IV) a multidisciplinary evaluation of all previous steps to draft final recommendations. Objective To assess the effect of the geriatric stewardship on drug-related problems reported by patients after discharge. Setting General teaching hospital. Methods An implementation study (pre-post design) was performed. Orthopaedic and surgical patients (≥ 65 years) with polypharmacy and a frailty risk factor were included. The pre-group received usual care, the post-group received the geriatric stewardship intervention. Two weeks post-discharge, patient-reported drug-related problems were assessed using a validated questionnaire. Drug-related problems were classified into drug-related complaints, practical problems, and questions about medication. Outcomes The outcomes were the number and type of drug-related problems per patient (primary) and the number of initial recommendations that were altered due to primary care provider and patient input (secondary). Results In total, 127 patients were analysed (usual care n = 74, intervention n = 53). Intervention patients reported fewer drug-related problems compared to usual care: 2.8 versus 3.3 per patient (Adjusted relative risk 0.83, 95% confidence interval 0.66-1.05). This difference resulted from a halving in drug-related complaints (p < 0.05), for example pain, drowsiness, nausea or constipation. Nearly 30% of the initial recommendations based on the clinical records were discarded or modified after primary care provider consultations and patient interviews. Conclusion The geriatric stewardship did not significantly reduce drug-related problems, but it significantly halved drug-related complaints. One-in-three initial recommendations were altered due to primary care provider and patient input. Inpatient medication reviews should not be based on clinical records only; they require transmural collaboration and patient participation to ensure continuity of patient care.
Topics: Aftercare; Aged; Hospitals, General; Humans; Inpatients; Patient Discharge; Pharmaceutical Preparations; Pharmacists
PubMed: 32909222
DOI: 10.1007/s11096-020-01133-x -
International Journal of Pharmaceutics Feb 2021Therapeutic monoclonal antibodies and related products have steadily grown to become the dominant product class within the biopharmaceutical market. Production of... (Review)
Review
Therapeutic monoclonal antibodies and related products have steadily grown to become the dominant product class within the biopharmaceutical market. Production of antibodies requires special precautions to ensure safety and efficacy of the product. In particular, minimizing antibody product heterogeneity is crucial as drug substance variants may impair the activity, efficacy, safety, and pharmacokinetic properties of an antibody, consequently resulting in the failure of a product in pre-clinical and clinical development. This review will cover the manufacturing and formulation challenges and advances of therapeutic monoclonal antibodies, focusing on improved processes to minimize variants and ensure batch-to-batch consistency. Processes put in place by regulatory agencies, such as Quality-by-Design (QbD) and current Good Manufacturing Practices (cGMP), and how their implementation has aided drug development in pharmaceutical companies will be reviewed. Advances in formulation and considerations on the intended use of a therapeutic antibody, including the route of administration and patient compliance, will be discussed.
Topics: Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Cell Line; Humans; Pharmaceutical Preparations
PubMed: 33309833
DOI: 10.1016/j.ijpharm.2020.120164