Journal of Pharmacy & Pharmaceutical Sciences : a Publication of the Canadian Society for Pharmaceutical Sciences

Purpose: An efficient, cost-effective and non-invasive test is required to overcome the challenges faced in the process of bioequivalence (BE) studies of various orally inhaled drug formulations. Two different types of pressurized meter dose inhalers (MDI-1 and MDI-2) were used in this study to test the practical applicability of a previously proposed hypothesis on the BE of inhaled salbutamol formulations. Methods: Salbutamol concentration profiles of the exhaled breath condensate (EBC) samples collected from volunteers receiving two inhaled formulations were compared employing BE criteria...

Purpose: An intraocular hemorrhage is an adverse event that can lead to visual acuity impairment. Antithrombotic therapy with antiplatelet agents and anticoagulants may increase intraocular hemorrhage. However, since their frequency is low, studies on the risk of intraocular hemorrhage with these drugs, especially under combination therapy, are limited. This study aimed to investigate the occurrence of intraocular hemorrhages under monotherapy and combination therapy with antiplatelets and anticoagulants by analyzing a large pharmacovigilance database...

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Background: Tools to grade risk of complaint to a regulatory board have been developed for physicians but not for other health practitioner groups, including pharmacists. We aimed to develop a score that classified pharmacists into low, medium and high risk categories. Methods: Registration and complaint data were sourced from Ontario College of Pharmacists for January 2009 to December 2019. We undertook recurrent event survival analysis to predict lodgement of a complaint. We identified those variables that were associated with a complaint and included these in a risk score which we called PRONE-Pharm (Predicted Risk of New Event for Pharmacists)...

Purpose: To investigate the value-to-value relationships, relationship between values and patient background, continuation rate of treatment after shared decision-making (SDM), and disease status in order to clarify the values involved in drug therapy decisions for patients with rheumatic disease. Methods: We investigated patient values (efficacy of drug therapy [effectiveness], safety, economics, daily life, and other) and the continuance rate and disease status of treatment after 6 months in 94 patients with rheumatic disease aged ≥18 years who made decisions with pharmacists and physicians in the pharmacy outpatient clinic between September 2019 and April 2021...

Purpose: To investigate whether interindividual variability in the CYP2C9 (*2 and *3 alleles) and VKORC1 (rs9923231) genes is associated with increased risk of upper gastrointestinal bleeding (UGIB) in users of non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: A full case-control study including 200 cases of patients diagnosed with UGIB and 706 controls was conducted in a Brazilian hospital complex. To perform an analysis of NSAIDs dose-effect, the defined daily dose (DDD) for NSAIDs was calculated in the 7-day etiologic window preceding the data index...

Purpose: Our previous study has demonstrated that tetracycline exerts excellent bactericidal activity against Staphylococcus aureus strains isolated from patients with atopic dermatitis (AD) while simultaneously inhibiting the development of T helper (Th) type 2 (Th2) cells. The present study was designed to evaluate the effectiveness of dual therapy with betamethasone and tetracycline for AD. Methods: Betametasone (0.1%) and tetracycline (3%) were topically administered to NC/Nga mice with AD-like skin lesions...

Purpose: Gastrointestinal perforation (GIP) is a fatal adverse event (AE). The AE of GIP induced by novel antineoplastic agents has attracted attention recently. We aimed to explore the AE signals of GIP related to novel antineoplastic agents comprehensively based on the FDA Adverse Event Reporting System (FAERS). Methods: The FAERS database containing 71 quarters of records was used for analysis. Reporting odds ratio (ROR), information component (IC), and empirical Bayesian geometric mean (EBGM) were utilized to evaluate the signals of GIP associated with novel antineoplastic drugs...

Background: Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder affecting women. Chinese herbs have been considered as an alternative treatment for PCOS, and Yi-mu-cao ( Leonuri Herba ) is one of the most commonly used herbs to treat PCOS, which can relieve symptoms of PCOS patients. But the mechanism of its treatment remains unclear. Method: The main active ingredients and potential targets of Leonuri Herba were obtained by TCMSP and Swiss Target Forecast, and the related targets of PCOS were obtained by searching DrugBank, GeneCard and DisGeNet databases...

Purpose: Remdesivir use in COVID-19 is associated with cardiac conduction abnormalities from unclear mechanisms. A proposed mechanism is the bioaccumulation of the intermediate metabolite GS-441524 resulting in exogenous activation of cardiac adenosine A1 due to the structural similarity between adenosine and GS-441524. The prolonged half-life of GS-441524 can result in sustained activation of adenosine A1 receptors. In this study, we used molecular modeling of adenosine, GS-441524 and the adenosine A1 receptor to assess the potential mechanistic association of the proposed mechanism...

Inflammation is a culprit in many conditions affecting millions of people worldwide. A plethora of studies has revealed that inflammation and inflammatory mediators such as cytokines and chemokines are associated with altered expression and activity of various proteins such as those involved in drug metabolism, specifically cytochrome P450 enzymes (CYPs). Emphasis of most available reports is on the inflammation-induced downregulation of CYPs, subsequently an increase in their substrate concentrations, and the link between the condition and the inflammatory mediators such as interleukin-6 and tumor necrosis factor alpha...

PURPOSE: To describe patient characteristics, treatment patterns, and the burden of illness among adult migraine patients in Canada prescribed migraine prophylactics. Little is known about the relative persistence of treatments in the real-world setting and the impact of migraine prophylactic therapy on patients. As a result, migraine care in Canada continues to inadequately serve patients suffering from frequent headache days, reflecting a large unmet need. METHODS: This retrospective study used Reformulary Group's longitudinal prescription claims database...

PURPOSE: Obstructive sleep apnea (OSA) is a common serious sleep disorder. Melatonin-based drugs such as agomelatine may have beneficial effects on patients with sleep disorders. This study aimed to evaluate agomelatine effects on polysomnography parameters in patients with OSA. METHODS: In this randomized, parallel, and single-blind study, seventy patients 18 years of age or older with obstructive sleep apnea who were referred to the sleep clinic were evaluated...

The exhaled breath condensate (EBC) presents a simple and non-invasive alternative approach for bioequivalence assessments and therapeutic drug monitoring of inhaled drugs. EBC better represents the drug at the site of action and eliminates the possibility of the contribution of a swallowed portion of the dose when systemic bioavailability is used for assessment. This review summarizes the recently reported analytical methods for the quantification of drugs in EBC. It also discusses the difficulties in the bioequivalence evaluation criteria of generic orally inhaled drug products suggested by various regulatory agencies that may be eliminated using the EBC analysis approach...

PURPOSE: Vemurafenib received approval for treatment of BRAF V600 variation metastatic melanoma in August 2011. This study analyzed Vemurafenib-related adverse events (AEs) to detect and characterize relevant safety signals using the real-word-data through the Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: Disproportionality analyses, including the reporting odds ratio (ROR), the healthcare products regulatory agency (MHRA), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) algorithms, were applied to quantify the signals of vemurafenib-related AEs...

PURPOSE: Osteoporosis is an adverse event of prednisolone. This study aimed to assess prednisolone-induced osteoporosis (PIO) profiles and patient backgrounds by analyzing data from the Japanese Adverse Drug Event Report (JADER) database. METHODS: The current study focused only on orally administered prednisolone. PIO was defined using preferred terms from the Medical Dictionary for Regulatory Activities. Reporting odds ratio (ROR) at 95% confidence interval (CI) and the time-to-onset profile of PIO were used to evaluate adverse events...

PURPOSE: In 2007, electronic cigarettes (e-cigarette) were introduced as a smoking cessation device. Since then, its sale and marketing has been expanded annually. Concomitantly, there is an increase in the electronic cigarette (e-cigarette) and liquid nicotine exposure cases reported to the United States (US) poison control centers. The purpose of this review is to assess the exposure cases reported to US poison control centers to characterize the adverse health effects of e-cigarette and liquid nicotine use...

Diethylene glycol monoethyl ether (DEGME) is a hydroalcoholic solvent that gained tremendous attention in the cosmetics, food, nanoformulations, and pharmaceutical industries. Due to its physicochemical features, it has been widely used as a penetration enhancer, surfactant, and solubilizer. Among numerous tradenames defined for DEGME -- Carbitol® (by Dow Chemical Co., USA), and Transcutol® HP, CG, and P. (by Gattefossé Co., France) -- are known to be employed in pharmaceutical industries. Transcutol® CG is utilized only in cosmetics; however, Transcutol® P and Carbitol® are both used in various pharmaceutical topical dosage forms such as creams, gels, etc...

The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is no longer available as a comparator product, a survey conducted within the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Programme (IPRP) indicated that the criteria for selecting an alternative comparator product varies. For most members of the BEWGG, an existing marketed generic that was approved based on a comparison with the locally registered innovator product can be used, contingent on criteria that ranges from allowing any generic to be used, to allowing only specific criteria-defined generics to be used...

The World Health Organization, has declared the recent multiregional outbreak of monkeypox, a global public health emergency. Monkeypox is a zoonotic viral infection endemic to the west and central Africa. It belongs to the Poxviridae family, the Chordopoxvirinae subfamily, and the Orthopoxvirus genus. The Poxviridae family generally consists of complex, large, enveloped, and linear double-stranded DNA viruses. The initial clinical symptoms of monkeypox are often fever, severe headache, lymphadenopathy, myalgia, and fatigue...