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Current Neuropharmacology 2022Poloxamer 188 (P188) is an FDA-approved biocompatible block copolymer composed of repeating units of Poly(Ethylene Oxide) (PEO) and poly(propylene oxide) (PPO). Due to...
Poloxamer 188 (P188) is an FDA-approved biocompatible block copolymer composed of repeating units of Poly(Ethylene Oxide) (PEO) and poly(propylene oxide) (PPO). Due to its amphiphilic nature and high Hydrophile-Lipophile Balance (HLB) value of 29, P188 is used as a stabilizer/emulsifier in many cosmetics and pharmaceutical preparations. While the applications of P188 as an excipient are widely explored, the data on the pharmacological activity of P188 are scarce. Notably, the neuroprotective potential of P188 has gained a lot of interest. Therefore, this systematic review is aimed at summarizing evidence of neuroprotective potential of P188 in CNS disorders. The PRISMA model was used, and five databases (Google Scholar, Scopus, Wiley Online Library, ScienceDirect, and PubMed) were searched with relevant keywords. The search resulted in 11 articles, which met the inclusion criteria. These articles described the protective effects of P188 on traumatic brain injury or mechanical injury in cells, neurotoxicity, Parkinson's disease, Amyotrophic lateral sclerosis (ALS), and ischemia/ reperfusion injury from stroke. All the articles were original research in experimental or pre-clinical stages using animal models or in vitro systems. The reported activities demonstrated the potential of P188 as a neuroprotective agent in improving CNS conditions such as neurodegeneration.
Topics: Animals; Central Nervous System Diseases; Humans; Neuroprotective Agents; Poloxamer; Reperfusion Injury
PubMed: 34077349
DOI: 10.2174/1570159X19666210528155801 -
The efficacy of dexketoprofen for migraine attack: A meta-analysis of randomized controlled studies.Medicine Nov 2019The efficacy of dexketoprofen for migraine attack remains controversial. We conduct a systematic review and meta-analysis to explore the influence of dexketoprofen... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The efficacy of dexketoprofen for migraine attack remains controversial. We conduct a systematic review and meta-analysis to explore the influence of dexketoprofen supplementation versus placebo on pain control in migraine attack patients.
METHODS
We search PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through March 2019 for randomized controlled trials (RCTs) assessing the effect of dexketoprofen supplementation versus placebo on pain control for migraine attack patients. This meta-analysis is performed using the random-effect model.
RESULTS
Five RCTs involving 794 patients are included in the meta-analysis. Overall, compared with control group for migraine attack, dexketoprofen supplementation is associated with substantially increased pain free at 2 hours (RR = 1.90; 95% CI = 1.43-2.53; P < .0001), pain free at 48 hours (RR = 1.63; 95% CI = 1.07-2.49; P = .02), good or excellent treatment (RR = 1.48; 95% CI = 1.24-1.78; P < .0001) and pain relief at 2 hours (RR = 1.80; 95% CI = 1.17-2.77; P = .007), as well as reduced need for rescue drug (RR = 0.64; 95% CI = 0.43-0.94; P = .02), with no significant increase in adverse events (RR = 1.51; 95% CI = 0.87-2.62; P = .14).
CONCLUSION
Dexketoprofen supplementation benefits to improve pain control at 48 hours and reduce the need for rescue drug in migraine attack patients.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Drug Therapy, Combination; Female; Humans; Ketoprofen; Male; Middle Aged; Migraine Disorders; Pain Management; Randomized Controlled Trials as Topic; Treatment Outcome; Tromethamine
PubMed: 31725614
DOI: 10.1097/MD.0000000000017734 -
MAbs 2023Three critical aspects that define high concentration antibody products (HCAPs) are as follows: 1) formulation composition, 2) dosage form, and 3) primary packaging...
A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations.
Three critical aspects that define high concentration antibody products (HCAPs) are as follows: 1) formulation composition, 2) dosage form, and 3) primary packaging configuration. HCAPs have become successful in the therapeutic sector due to their unique advantage of allowing subcutaneous self-administration. Technical challenges, such as physical and chemical instability, viscosity, delivery volume limitations, and product immunogenicity, can hinder successful development and commercialization of HCAPs. Such challenges can be overcome by robust formulation and process development strategies, as well as rational selection of excipients and packaging components. We compiled and analyzed data from US Food and Drug Administration-approved and marketed HCAPs that are ≥100 mg/mL to identify trends in formulation composition and quality target product profile. This review presents our findings and discusses novel formulation and processing technologies that enable the development of improved HCAPs at ≥200 mg/mL. The observed trends can be used as a guide for further advancements in the development of HCAPs as more complex antibody-based modalities enter biologics product development.
Topics: Pharmaceutical Preparations; Drug Packaging; Excipients; Viscosity
PubMed: 37243580
DOI: 10.1080/19420862.2023.2205540 -
Pharmacotherapy Apr 2021Cannabidiol (CBD), a non-psychotropic phytocannabinoid from the Cannabis plant, is increasingly being pursued as a treatment for differing ailments. The bioavailability...
Cannabidiol (CBD), a non-psychotropic phytocannabinoid from the Cannabis plant, is increasingly being pursued as a treatment for differing ailments. The bioavailability and pharmacokinetics of CBD are not well understood, and proper dosing schemes have not been adequately developed for its clinical use. CBD is a lipophilic molecule and exhibits low water solubility, so its formulation expectedly impacts its gastrointestinal absorption and subsequent blood plasma concentrations. In this review article, the food effects on CBD pharmacokinetics were analyzed. Clinical trials focusing on the performance of Epidiolex, the FDA-approved CBD formulation, were found in several databases and systematically analyzed in terms of administration method, dosing schedules, and patient characteristics. 44 data sets from clinical trials were found to be useful in the quantitative analysis. Following the normalization of all the pharmacokinetic data sets by dose and patient weight, CBD exhibited a much greater bioavailability in fed patients. For Epidiolex, administration in the fed state led to lower interindividual variability and more predictable pharmacokinetics. Considering all the different oral formulations of CBD, further analysis points to the main excipient of oral CBD formulations (refined sesame seed oil) as a major contributor to the dose-dependent variations in CBD pharmacokinetics, especially affecting the fasted state. We discuss the implications of these results on the downstream pharmacodynamics of endocannabinoid receptor modulation and its broad physiological implications.
Topics: Biological Availability; Cannabidiol; Clinical Trials as Topic; Food; Humans
PubMed: 33583102
DOI: 10.1002/phar.2512 -
Influenza and Other Respiratory Viruses Nov 2021Standard-dose seasonal influenza vaccines often produce modest immunogenic responses in adults ≥65 years old. MF59 is intended to elicit a greater magnitude and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Standard-dose seasonal influenza vaccines often produce modest immunogenic responses in adults ≥65 years old. MF59 is intended to elicit a greater magnitude and increased breadth of immune response.
OBJECTIVE
To determine the effectiveness of seasonal MF59-adjuvanted trivalent/quadrivalent influenza vaccine (aTIV/aQIV) relative to no vaccination or vaccination with standard or high-dose egg-based influenza vaccines among people ≥65 years old.
METHODS
Cochrane methodological standards and PRISMA-P guidelines were followed. Real-world evidence from non-interventional studies published in peer-reviewed journals and gray literature from 1997 through to July 15, 2020, including cluster-randomized trials, were eligible. Two reviewers independently extracted data; risk of bias was assessed using the ROBINS-I tool.
RESULTS
Twenty-one studies conducted during the 2006/07-2019/20 influenza seasons were included in the qualitative review; 16 in the meta-analyses. Meta-analysis of test-negative studies found that aTIV reduced medical encounters due to lab-confirmed influenza with pooled estimates of 40.7% (95% CI: 21.9, 54.9; I = 0%) for non-emergency outpatient visits and 58.5% (40.7, 70.9; I = 52.9%) for hospitalized patients. The pooled estimate of VE from case-control studies was 51.3% (39.1, 61.1; I = 0%) against influenza- or pneumonia-related hospitalization. The pooled estimates for the relative VE of aTIV for the prevention of influenza-related medical encounters were 13.9% (4.2, 23.5; I = 95.9%) compared with TIV, 13.7% (3.1, 24.2; I = 98.8%) compared with QIV, and 2.8% (-2.9, 8.5; I = 94.5%) compared with HD-TIV.
CONCLUSIONS
Among adults ≥65 years, aTIV demonstrated significant absolute VE, improved relative VE compared to non-adjuvanted standard-dose TIV/QIV, and comparable relative VE to high-dose TIV.
Topics: Adjuvants, Immunologic; Adult; Aged; Humans; Influenza Vaccines; Influenza, Human; Polysorbates; Seasons; Squalene
PubMed: 34081398
DOI: 10.1111/irv.12871 -
Journal of Oleo Science 2024Medium-chain triacylglycerol (MCT) is a type of triacylglycerol that has six or seven to twelve carbon chains. It consists of three molecules of fatty acids attached to...
Medium-chain triacylglycerol (MCT) is a type of triacylglycerol that has six or seven to twelve carbon chains. It consists of three molecules of fatty acids attached to one molecule of glycerol. Drug delivery system (DDS) is defined as a formulation to distribute drugs into the human body. The unique properties of MCTs have garnered interest in using them as excipients in DDS. Even though there are many significant effects attributed to the use of MCTs, especially in modulating the rate of drug delivery in various DDS, they are all limited and intermittent. This warrants a detailed summary of the previous studies on the use of MCTs in various DDS. Therefore, this review focuses on presenting a systematic review of previous studies on the use of MCTs in the last six years and explores the types and effects of MCTs on DDS that employ various types of delivery routes. A systematic search through PubMed, Science Direct and Scopus was performed. Keywords like "medium-chain triglycerides", "medium-chain fatty acids", "medium-chain triglycerides and their fractions", "medium-chain fatty acids and their fractions", "MCTs", "MCFA", "in drug delivery", "in drug delivery system" and their combinations were used. The synonyms of the words were also used to extend the search. A total of 17 articles that met the inclusion criteria were identified. Findings from this review have identified the several MCTs and their fractions used in DDS that employed the oral/enteral, topical, transdermal, parenteral, and pulmonary routes of drug delivery. The review also highlights that the usage of MCTs in DDS results in a better transportation of drugs into the human body.
Topics: Humans; Drug Delivery Systems; Carbon; Excipients; Fatty Acids; Triglycerides
PubMed: 38432994
DOI: 10.5650/jos.ess23204 -
Human Vaccines & Immunotherapeutics 2019Seasonal influenza is a very common disease. Yearly vaccination of at-risk population groups is a well-recognized cost-effective/cost-saving preventive measure. It is,...
Seasonal influenza is a very common disease. Yearly vaccination of at-risk population groups is a well-recognized cost-effective/cost-saving preventive measure. It is, however, unclear which available alternative has the most favorable economic profile. Some available options are: trivalent (TIV) and quadrivalent (QIV) inactivated vaccines, adjuvanted TIV (aTIV). Because of immunosenescence, aTIV has been specifically developed for elderly. The present study aimed at assessing the available evidence of aTIV use in elderly from the economic perspective. A systematic literature review targeting aTIV economic evaluations in adults aged ≥65 years was performed using Medline via Ovid, Embase, DARE and NHS/EED. Of a total of 3,654 papers screened, 18 studies (13 full papers, 5 conference abstracts) were included. It emerged that compared with both non-vaccination or non-adjuvanted vaccines, aTIV was cost-effective or cost-saving. The vaccinations strategies incorporating aTIV based on age and/or risk profile are associated with the most favorable economic outcomes.
Topics: Adjuvants, Immunologic; Age Factors; Aged; Aged, 80 and over; Antibodies, Viral; Cost-Benefit Analysis; Humans; Influenza Vaccines; Influenza, Human; Polysorbates; Risk Factors; Squalene; Vaccination
PubMed: 30735465
DOI: 10.1080/21645515.2019.1578597 -
Lung India : Official Organ of Indian... Jan 2012Because of limitations associated with the conventional treatment of various chronic diseases a growing attention has been given to the development of targeted drug...
Because of limitations associated with the conventional treatment of various chronic diseases a growing attention has been given to the development of targeted drug delivery systems. Pulmonary route of drug delivery gaining much importance in the present day research field as it enables to target the drug delivery directly to lung both for local and systemic treatment. Over the last 2 decades, the systemic absorption of a broad range of therapeutics after pulmonary application has been demonstrated in animals as well as in humans. This review was prepared with an aim to discuss the technical, physiological, and efficacy aspects of the novel pulmonary route of drug targeting. The review also focuses on the mechanisms of pulmonary drug administration along with compatibility of the excipients employed, devices used, and techniques of particulate dosage production. This review was prepared based on the method of extensive literature survey on the topics covering all the aspects discussed in the present subject. Hence, the better understanding of complexes and challenges facing the development of pulmonary drug delivery system offer an opportunity to the pharmaceutical scientist in minimizing the clinical and technical gaps.
PubMed: 22345913
DOI: 10.4103/0970-2113.92361