Archives of Pharmacy

Pharmacovigilance and Adverse Drug Reaction Reporting in Primary, Secondary, and Tertiary Healthcare: A Review of Practices, Challenges, and Recommendations

2025-12-25T12:55:19+01:00

According to the World Health Organization, pharmacovigilance is a science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Since the underreporting of adverse drug reactions (ADRs) remains a significant global issue, reporting ADRs is essential for the success of pharmacovigilance programs. By systematically monitoring and reporting ADRs at the primary, secondary, and tertiary levels of healthcare, pharmacovigilance plays a crucial role in protecting public health. In addition to facilitating the early identification and prevention of negative consequences, reporting also contributes to improving the quality of healthcare services. This article presents a narrative review aimed at synthesizing available literature and regulatory documents related to pharmacovigilance and ADR reporting across various levels of healthcare, with particular emphasis on the national context in Serbia and relevant international comparisons.

The Application of the Extended Thermodynamic Approach to Describe the Effect of Counterions, Both of Chaotropic Agents and Ionic Strength Modifiers, on the Retention Behavior of Protonated Basic Analytes in Chaotropic Chromatography

2025-12-25T12:55:20+01:00

In this study, the extended thermodynamic approach was used to quantitatively explain the effect of counterions, both of chaotropic agents and ionic strength modifiers, in variable (vI) and constant ionic strength (cI) systems on the retention behavior of 23 fully protonated basic analytes. Nine series of experiments (at three pH values for NaPF6, KPF6 and NH4PF6) with vI and nine series of experiments (at three pH values for NaPF6, KPF6 and NH4PF6) with ionic strength kept constant with NaCl, KCl and NH4Cl were performed. The experimentally determined retention factors were modeled using the extended thermodynamic approach and the processes occurring in the stationary phase and in the mobile phase and their influence on retention in the investigated chaotropic chromatography systems were rationalized. In both vI and cI systems, ion pair formation in the stationary phase proved to be dominant over ion pair formation in the mobile phase. In the KPF6_vI systems, these interactions with the stationary phase were even more pronounced than in the other systems. Although both K+ and NH4+ are chaotropic in nature, the formation of ion pairs in the stationary phase was favored by the presence of NH4+ only at its rather high concentrations as in cI systems.

Estimation of Measurement Uncertainty Using Top-Down and Bottom-Up Approaches for Accurate Content Determination of Meloxicam in Injectable Dosage Forms

2025-12-25T12:55:20+01:00

Measurement uncertainty plays a critical role in ensuring the reliability, accuracy, and regulatory compliance of analytical results in pharmaceutical quality control. This study presents a comprehensive comparison of the Top-down and Bottom-up approaches for estimating the uncertainty associated with the quantitative determination of Meloxicam in injectable dosage forms using a validated HPLC method. The Top-down approach, based on method validation data, yielded an expanded uncertainty of ±0.336 mg per injection, while the Bottom-up approach (incorporating uncertainties from volumetric equipment, reference standards, and molar mass) produced a broader value of ±0.646 mg per injection. The results highlight the complementary nature of both approaches and support the integration of their respective strengths to improve the robustness of uncertainty estimation. The proposed methodology is applicable to other methods within pharmaceutical quality control.

Comparative Spectrophotometric Studies of Total Phenolics Content and Antioxidant Capacity Measured by DPPH and ABTS Methods in Green Vegetables

2025-12-25T12:55:20+01:00

Modern trends in nutrition imply the daily intake of fresh fruits and vegetables, with the statement that they are important sources of natural antioxidants that protect the body from oxidative stress and can contribute to the prevention of many chronic diseases. In these recommendations, green vegetables with high total phenolics content (TPC) are especially highlighted. However, one must ask whether the high total phenolics content of green vegetables, such as Brussels sprouts, cabbage, broccoli, parsley, borecole and spinach, is a reliable indicator of antioxidant activity for regulating free radicals in the body. The aim of this work is the spectrophotometric determination of TPC of hydromethanol extracts of selected green vegetables and its correlation with their antioxidant potential. For this purpose, DPPH and ABTS radical scavenging tests of extracts were performed. The obtained results indicate that Brussels sprouts and parsley exhibit the highest antioxidative activities, while cabbage extract shows lower values. The Pearson correlation used to test the correlation between the TPC obtained for green vegetable extracts and the results of the DPPH and ABTS tests shows a moderate correlation between TPC and ABTS values, whereas the correlation for TPC and DPPH is statistically significant.

Ethnopharmacological Survey on Otoglyphis pubescens (Desf.) Pomel in the Northeast of the Algerian Sahara

2025-12-25T12:55:21+01:00

The utilization of phytotherapy is essential in the Algerian Sahara, where endemic plants such as Otoglyphis pubescens are used to address certain health issues. However, discrepancies in knowledge and application of these botanical resources may lead to toxicity and reduced efficacy. A questionnaire was prepared and interviews conducted among herbalists and common population to collect data according to the objectives set. Ethnobotany indices were calculated and comparison was made between the different subgroups of the sampled population. The most commonly used vernacular names for Otoglyphis pubescens are: Gartoufa, Gritfa, and Wazwaza. This plant is endemic and grows wild. The most commonly used parts are the whole aerial parts dried in the shade. This plant is used as herbal tea. The most commonly used preparation methods are maceration and infusion. This plant is used mainly for its therapeutic properties to address issues related to the treatment of digestive, genitourinary, and respiratory problems, and fever. According to the analysed indices, the interviewed populations showed high knowledge of the uses of O. pubescens, with subpopulations such as married individuals, females, persons aged over 60 years, the less educated, and the unemployed noting superior use of the plant. Variations are noted in the answers of the interviewed subjects and differences stood comparing to data reported in the literature, but close responses patterns were noted between the herbalists and the common population.

Formulation and Characterization of Vaginal Capsules and Tablets Providing Fast Release of Live Lactobacillus spp.

2025-12-25T12:55:21+01:00

Live biotherapeutic products (LBPs) are gaining significant medical importance as a new approach in the prevention and treatment of various conditions in the female population. This study investigated the design, development, and evaluation of immediate-release (IR) vaginal dosage forms containing live Lactobacillus spp., with the aim of enabling fast and effective drug delivery in the vaginal environment. Capsule and tablet formulations were developed using different excipients and appropriate manufacturing processes (encapsulation and direct compression) and systematically evaluated for their robustness and performance. The results demonstrated that all capsule formulations exhibited suitable flowability and uniformity of dosage units, with hard gelatine capsules (HGC) providing the most favourable disintegration times compared to hydroxypropyl methylcellulose (HPMC) and pullulan capsules. Tablet formulations based on microcrystalline cellulose (MCC) achieved optimal hardness, friability, and disintegration, especially under lower compression forces, confirming MCC’s multifunctional role as a filler, binder, and disintegrant. Importantly, both dosage forms maintained Lactobacillus viability with only minor losses (~0.5 log), preserved the acidic vaginal environment (pH 4.2), and demonstrated robustness under simulated biorelevant conditions. These findings highlight that IR vaginal capsules and tablets can be effectively tailored to deliver live biotherapeutics with rapid onset of action, thereby advancing microbiome-based strategies for women’s health.

Investigation of Gadobutrol-Induced Sister Chromatid Exchange in G0 Phase and Circulating Human Lymphocytes

2025-12-25T12:55:22+01:00

Gadobutrol (Gadovist®) is a macrocyclic, extracellular gadolinium-based contrast agent widely used in magnetic resonance imaging. This study aims to assess the genotoxic and cytotoxic potential of gadobutrol in human G0 phase lymphocytes and circulating lymphocytes. The Sister Chromatid Exchange (SCE) assay, a fast, sensitive, and reliable method for evaluating genotoxicity, was employed. Genotoxic effects were assessed by measuring SCE frequency, while cytotoxicity was determined using the mitotic index (MI). Peripheral blood samples from two healthy donors were treated in vitro with three different concentrations of gadobutrol for 24 hours in G0 phase lymphocytes and 72 hours in circulating lymphocytes. The results indicated that gadobutrol did not exhibit cytotoxic effects in either cell type. However, at the highest concentration (25 mM), gadobutrol significantly increased the formation of SCE in circulating lymphocytes (p < 0.05), while no significant genotoxic effect was observed in G0 phase lymphocytes (p > 0.05). These findings suggest that gadobutrol, although not cytotoxic, may induce genotoxic effects in a concentration-dependent manner in circulating lymphocytes. Further studies are needed to explore the clinical implications of these findings.

IN MEMORIAM prof. emeritus dr Danica Agbaba (1953–2024)

2025-12-25T12:55:22+01:00