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Drug Approvals Research

18:18 EST 11th December 2019 | BioPortfolio

Motives for Illicit Drug Use Among Individuals With Body Dysmorphic Disorder.

Drug use disorders (DUDs) are highly prevalent in body dysmorphic disorder (BDD), but motives for illicit drug use in BDD have not yet been explored. This study examined motives for drug use and clinical correlates of drug use motives in a sample of individuals with BDD and lifetime drug use, using the Drug Use Motives Questionnaire and 3 additional body image-specific drug use motives. As predict...

Catatonia Due to Tacrolimus Toxicity 16 Years After Renal Transplantation: Case Report and Literature Review.

Tacrolimus, a potent posttransplant immunosuppressant, has been associated with major neuropsychiatric complications, including catatonia and psychosis. We report a novel case of tacrolimus-induced encephalopathy that developed 16 years after renal transplantation while the drug was at a therapeutic level. Discontinuation of tacrolimus and switching to an alternative immunosuppressant resulted in ...

Optimization of peptide-drug conjugates for targeted tumor therapy.

In case of cancers with high mortality rate and lacking efficient medication there is a huge need of new, innovative treatments. Targeted tumor therapy, a real breakthrough in this field, is based on the concept that the antitumor agent is linked to a targeting molecule (e.g. peptide) specifically recognizing receptors or antigens that are tumor specific or overexpressed by tumor cells. The effici...

How can we better manage drug-resistant OAB/DO? ICI-RS 2018.

Botulinum toxin A (BTX-A), sacral nerve stimulation (SNM), and posterior tibial nerve stimulation (PTNS) are established treatments for idiopathic overactive bladder (OAB) refractory to oral drug therapy. At the ICI-RS meeting in Bristol in 2018 a think tank was convened to address the question of how to better manage drug-resistant OAB/DO (detrusor overactivity).

Correlates of alcohol and illicit drug use before commercial sex among transgender women with a history of sex work in China.

Research on substance use among transgender female sex workers in China is scarce. The aims of this study were to examine: (1) the prevalence of alcohol or illicit drug use before commercial sex among this population; and (2) correlates of alcohol and illicit drug use. Complete survey data were analysed from 397 transgender female sex workers recruited from three of the largest cities in China: S...

The improved cargo loading and physical stability of ibuprofen orodispersible film: molecular mechanism of ion-pair complexes on drug-polymer miscibility.

High drug cargo loading in polymer and physical stability was essential for the development of orodispersible film (ODFs) due to the small amount of excipients used in a thin film. The present study aimed to investigate the mechanism of ion-pair strategy in improving drug cargo loading and physical stability of drug in ODFs. The results showed that the ion-pair, especially IBU-ethanolamine, improv...

Preparation, characterization and evaluation of antibacterial properties of epirubicin loaded PHB and PHBV nanoparticles.

Poly-3-hydroxybutyrate (PHB) and poly-3-hydroxybutyrate-co-3-hydroxyvalerate (PHBV) are considered as ideal drug carriers due to their non-toxic, biodegradable and biocompatible nature. In this study, the epirubicin (EPI) was used as a model drug. The blank (PHB, PHBV) and drug loaded (EPI-PHB-PEG, EPI-PHBV-PEG) nanoparticles were prepared by nanoprecipitation method. The average particle size, po...

Development of photo-magnetic drug delivery system by facile-designed dual stimuli-responsive modified biopolymeric chitosan capped nano-vesicle to improve efficiency in the anesthetic effect and its biological investigations.

Though anesthetic drug delivery system and drug vehicles is generally applied for pain relief, there are have many difficulties and issues due to its short duration carrier and low biocompatibility, effectiveness at the conditions of inflammation at acidic pH. To resolve this issue, we have designed and developed the dual (pH and temperature) responsive bio-nanomaterial to improve the efficiency a...

Prevalence of drug-drug interaction in atrial fibrillation patients based on a large claims data.

This study aimed to compare and determine the prevalence of drug-drug interaction (DDI) and bleeding rate in atrial fibrillation (AF) patients receiving anticoagulants in a clinical setting. We used large claims data of AF patients obtained from the Japan Medical Data Center. The prevalence of DDIs and cases leading to bleeding events were surveyed clinically relevant DDIs extracted from 1) report...

Poly (glycerol adipate) (PGA): From a functionalized nano-carrier to a polymeric-prodrug matrix to create amorphous solid dispersions.

Amorphous Solid Dispersions (ASDs) are a promising strategy to overcome poor-solubility and stability limitations, reducing the crystallinity of the drug through incorporation within a polymer matrix. However, in order to achieve an effective ASD, the polymer and drug must be compatible, otherwise the drug can undergo recrystallisation. In this work, we investigated the potential of the enzymatica...

Drug delivery to macrophages: A review of targeting drugs and drug carriers to macrophages for inflammatory diseases.

Macrophages play a key role in defending against foreign pathogens, healing wounds, and regulating tissue homeostasis. Driving this versatility is their phenotypic plasticity, which enables macrophages to respond to subtle cues in tightly coordinated ways. However, when this coordination is disrupted, macrophages can aid the progression of numerous diseases, including cancer, cardiovascular diseas...

Green synthesis, formulation and biological evaluation of a novel ZnO nanocarrier loaded with paclitaxel as drug delivery system on MCF-7 cell line.

In this study we design green synthesis of a novel ZnO nanocarrier loaded with paclitaxel as a drug delivery system with high cytotoxicity against breast cancer cell line (MCF-7) and low side effects on the normal cell line (fibroblast). Paclitaxel is formulated in high concentration in Cremophor EL because of its low solubility. Zinc oxide nanoparticles (ZnO NPs) were prepared by the ethanolic ex...

Transmural and rate-dependent profiling of drug-induced arrhythmogenic risks through in silico simulations of multichannel pharmacology.

In vitro human ether-à-go-go related gene (hERG) inhibition assay alone might provide insufficient information to discriminate "safe" from "dangerous" drugs. Here, effects of multichannel inhibition on cardiac electrophysiology were investigated using a family of cardiac cell models (Purkinje (P), endocardial (Endo), mid-myocardial (M) and epicardial (Epi)). We found that: (1) QT prolongation alo...

Third Consensus Development Conference on the Safety of Intravenous Drug Delivery Systems-2018.

The Third Consensus Conference on the Safety of Intravenous Drug Delivery Systems was convened to evaluate the benefits and risks of available systems and assess ongoing threats to the safety of intravenous drug delivery.

A role for leptin and ghrelin in the augmentation of heroin seeking induced by chronic food restriction.

Caloric restriction increases the risk of relapse in abstinent drug users. Hormones involved in the regulation of energy balance and food intake, such as leptin and ghrelin, are implicated in drug-related behaviors.

Drug-Induced Pulmonary Arterial Hypertension: Mechanisms and Clinical Management.

Pulmonary arterial hypertension is a rare disease, with drug-induced causes even more uncommon, accounting for only 10% of cases in large registry series. Predisposing factors for drug-induced PAH have not been completely defined. This review summarizes drugs with definite, possible, or likely association to pulmonary hypertension and possible mechanisms involved in the occurrence of pulmonary hyp...

Immunotherapy in pediatric acute lymphoblastic leukemia.

The 5-year survival rate for children and adolescents with acute lymphoblastic leukemia (ALL) has improved to more than 90% in high-income countries. However, further increases in the intensity of conventional chemotherapy would be associated with significant adverse effects; therefore, novel approaches are necessary. The last decade has seen significant advances in targeted therapy with immunothe...

Clarifications regarding the authority and role of FDA in drug approval.

With great concern, we read the editorial entitled, "FDA jeopardizes the lives of lung transplant recipients and in the process severely increases the cost to develop new immunosuppression" by Drs. Klintmalm, Kaplan, and Kirk. The editorial reflects a misunderstanding of FDA's role and authority, as well as of the feasibility of randomized controlled clinical trials (RCTs) in lung transplantation.

Safety implications of combined antiretroviral and anti-tuberculosis drugs.

: Antiretroviral and anti-tuberculosis (TB) drugs are often co-administered in people living with HIV (PLWH). Early initiation of antiretroviral therapy (ART) during TB treatment improves survival in patients with advanced HIV disease. However, safety concerns related to clinically significant changes in drug exposure resulting from drug-drug interactions, development of overlapping toxicities and...

Testing Unconventional Matrices to Monitor for Prenatal Exposure to Heroin, Cocaine, Amphetamines, Synthetic Cathinones, and Synthetic Opioids.

The prevalence of drug use during pregnancy continues to increase despite the associated serious adverse obstetrical outcomes, including increased risk of miscarriage, fetal growth restriction, brain development impairment, neonatal abstinence syndrome (NAS), preterm delivery, and stillbirths. Monitoring drug use during pregnancy is crucial to limit prenatal exposure and provide suitable obstetric...

TDM-guided Crushed Sofosbuvir-velpatasvir Treatment: A case study.

Herein, the authors report the case of a patient diagnosed with hepatitis C virus who was treated with sofosbuvir-velpatasvir (400/100 mg). As the patient was unable to swallow whole tablets, therapeutic drug monitoring was performed to evaluate the effect of crushing sofosbuvir-velpatasvir tablets on drug absorption and global exposure.

Photolichenoid dermatitis: a presenting sign of human immunodeficiency virus.

Photolichenoid dermatitis is an uncommon eruptive dermatitis that often occurs in association with a photosensitizing drug. Photodermatitis, in general, is an uncommon clinical manifestation of human immunodeficiency virus (HIV), most often affecting patients of African and Native American descent. Photolichenoid dermatitis has infrequently been reported in patients with HIV who have not been expo...

Low-abundance drug-resistant HIV-1 variants in antiretroviral drug-naïve individuals: A systematic review of detection methods, prevalence, and clinical impact.

The presence of high-abundance drug-resistant HIV-1 jeopardizes the success of antiretroviral therapy (ART). Despite numerous investigations, the clinical impact of low-abundance drug-resistant HIV-1 variants (LA-DRVs) present at levels

Kinetic stability of amorphous dipyridamole: A fast scanning calorimetry investigation.

One of the main tasks of modern pharmaceutics is enhancing the solubility of drugs. The approaches for solving this problem include producing active pharmaceutical ingredients in the amorphous state. However, the use of amorphous drugs requires the determination of their kinetic stability. The latter is often assessed using isothermal techniques, which are time-consuming. Alternatively, non-isothe...

A combination drug delivery system employing thermosensitive liposomes for enhanced cell penetration and improved in vitro efficacy.

Drug-loaded thermosensitive liposomes are investigated as drug delivery systems in combination with local mild hyperthermia therapy due to their capacity to release their cargo at a specific temperature range (40-42 °C). Additional benefit can be achieved by the development of such systems that combine two different anticancer drugs, have cell penetration properties and, when heated, release thei...

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