Papers by Jasmina Ribarska
International Journal of Pharmaceutics, 2016
oral solution of lorazepam 1 mg/mL containing a minimal amount of propylene glycol. Given the kno... more oral solution of lorazepam 1 mg/mL containing a minimal amount of propylene glycol. Given the known temperature-dependent degradation of lorazepam, an extensive in-use stability study was performed. Purpose: We performed shelf-life and in-use stability studies to assess the influence of temperature on the paediatric lorazepam formulation. Method: The lorazepam solutionconsisted of propylene glycol (3%, v/v), polyethylene glycol 400 (10%, v/v) and glycerol 85% (q.s.) and was packaged in dark brown, PET-bottles. Shelf-life studies were performed under refrigerated conditions and at ambient temperature (20-25 • C). In-use tests werebased on a four-times daily dosing schedule. The containers were removed from the refrigerator and exposed to air, light and ambient temperature for 15 min at every dosing simulation. Lorazepam concentrations were determined using a validated HPLC-assay. The limits for related substances were derived from the United States Pharmacopoeia monograph for lorazepam oral concentrate and set at 4.0% for impurity C and 2.0% for the remainder. Results: Lorazepam solution stored between 2 • C and 8 • C, resulted in at least 12 months physical and chemical stability with a lorazepam recovery of ≥96% and ≤1.5% total related substances. Lorazepam solution kept at room temperature resulted in significant degradation after one month, with a recovery of 92.1% and 6.7% total related substances. In-use stability was confirmed for up to one month with a lorazepam recovery of ≥97.9% and 0.5% total related substances. Conclusions: The paediatricoral lorazepam solution showed physical and chemical stability at 2-8 • C for 12 months and was stable under in-use conditions for at least one month.
The International Organization of Scientific Research, Sep 1, 2021
Journal of Pharmaceutical Research International, 2021
Aim: The aim of this study was to determine the terpenoid profile in dried cannabis flowers obtai... more Aim: The aim of this study was to determine the terpenoid profile in dried cannabis flowers obtained from different varieties of cannabis plant and in cannabis extracts in order to investigate quantity of terpenes lost during extraction and purification process. Methods: GC/MS method for determination of terpenes was verified. The concentration of terpenes was determined in dry flowers as raw material and in decarboxylated and distillated cannabis extracts, using the same GC/MS analytical method. The extraction was performed using 96% ethanol as a solvent. Results: The obtained results indicate that dry cannabis flowers from different cannabis plant can be distinguished only by their terpenoid profile. The use of standardized cannabis-based extracts can be confirmed by determination of terpenoid profile. The purification process of the cannabis extracts removes terpenes. The percentage of major terpen beta-Myrcene decreased from 68% in dry flower to 15% in decarboxylated and, 1.9% i...
Macedonian Pharmaceutical Bulletin, 2021
The present study investigates the Health-related quality of life of teen/adults patients with cy... more The present study investigates the Health-related quality of life of teen/adults patients with cystic fibrosis in the Republic of N. Macedonia for the first time. The main objective was to describe the health-related quality of life status of these patients with cystic fibrosis and the second objective was to investigate the connection of the current medical treatment with the analysed parameters. The survey was conducted on 31 patients by using the Cystic Fibrosis Questionnaire Revised for Health-related quality of live measurement and questions for current medical treatment. All patients scored their digestive condition with the highest score, while the lower score was reported for social activity. The gender, the nationality and the educational level of the patients with Cystic Fibrosis had no significant impact on their perception of Health-Related Quality of Live. The highest score for digestive condition was in positive correlation with the fact that all patients continuously ...
Macedonian Pharmaceutical Bulletin, 2020
The association of C3435T single-nucleotide polymorphism, Pgp-glycoprotein gene expression levels... more The association of C3435T single-nucleotide polymorphism, Pgp-glycoprotein gene expression levels and carbamazepine maintenance dose in patients with epilepsy
Atypical antipsychotic risperidone is widely used first-line monotherapy in schizophrenia and com... more Atypical antipsychotic risperidone is widely used first-line monotherapy in schizophrenia and combined therapy in bipolar disorders. Therapeutic plasma concentrations of risperidone and its active moiety are directly influenced by genetic variations in metabolic CYP450 enzymes (CYP2D6 and CYP3A4/5) and transporter (ABCB1) protein and additional environmental factors. Since active metabolite 9-OH risperidone has a greater percentage of the pharmacologically active fraction and is equipotent to the parent drug risperidone, it is assumed that it contributes significantly to therapeutic and adverse effects. Unpredictable dose/concentration ratio, narrow therapeutic index, number of interactions, along with serious adverse reactions (ADR), raises the need for individualization of risperidone treatment and establishing of good therapeutic regime using TDM. A simple and reliable validated bioanalytical liquide-liquide extraction HPLC/UV method was applied for the simultaneous determination...
Macedonian Pharmaceutical Bulletin, 2020
The Good Distribution Practice (GDP) represents a collection of standardized, routine methods of ... more The Good Distribution Practice (GDP) represents a collection of standardized, routine methods of work, which ensure that the characteristics defining the quality, safety and efficacy of the pharmaceutical products remain intact from the beginning to the end of their stay in the pharmaceutical supply chain, (European Commission, 2013). According to these practices, the pharmaceutical products should be stored according to the prescribed storage conditions, especially during the process of transportation. Since the manufacturers of the pharmaceutical products that also distribute their assortment are inspected and authorized in the Good Manufacturing Practice (GMP), they are exempted from the obligation of acquiring separate authorization for distribution. Every other legal entity has to be authorized to do so. The principles laid in the GDP expand outside of the pharmaceutical products’ distribution and include the procurement, storage and transport of active substances and other ing...
A computational study of structural and vibrational spectroscopic properties of hydrophilic drug ... more A computational study of structural and vibrational spectroscopic properties of hydrophilic drug irinotecane was carried out. Both static and dynamical approaches to the problem have been implemented. In the static ones, vibrational spectra of the title system were computed within the double harmonic approximation, diagonalizing the mass-weighted Hessian matrices. These were calculated for the minima on AM1, PM3, PM6 and B3LYP/6-31G(d,p) potential energy surfaces. Within the dynamical approach, atom-centered density matrix propagation scheme was implemented at AM1 level of theory. From the computed molecular dynamics trajectories at series of temperatures (ranging from 10 to 300 K), velocity-velocity autocorrelation function was calculated and the vibrational density of states was sequentially obtained by Fourier transformation. Comparison with the experimental data revealed that the employed density functional level of theory exhibited remarkable performances. Of all semiempirical ...
Frontiers in Medicine, 2021
Aim: The aim of this study was to investigate whether the cannabis extract obtained from cannabis... more Aim: The aim of this study was to investigate whether the cannabis extract obtained from cannabis flowers that contain the maximum allowed level of mycotoxins affects human safety and health. For that purpose, a novel liquid chromatography with tandem mass spectrometry (LC/MS/MS) method was developed and validated for the determination of aflatoxins and ochratoxin A (OchA) in cannabis extracts to demonstrate that this analytical method is suitable for the intended experimental design.Methods: Experimental design was done by adding maximum allowed concentration of aflatoxins (B1, B2, G1, G2) and OchA according to the European Pharmacopeia related to cannabis flowers. The concentration of aflatoxins and OchA was determined using the same LC/MS/MS analytical method in the starting material (dry flower) before preparing the spiked sample and after obtaining decarboxylated extract with ethanol 96%.Results: The results obtained indicate that aflatoxins and OchA, primarily added to the can...
Macedonian Pharmaceutical Bulletin, 2018
The aim of this work was to develop a single, generally applicable high performance liquid chroma... more The aim of this work was to develop a single, generally applicable high performance liquid chromatography/diode array detector (HPLC/DAD) method for simultaneous determination of the most frequently used cough and cold active substances and their impurities that would be applicable for a number of possible formulation compositions of cough and cold medicines. The compounds that are separated by the method include eleven active substances: paracetamol, phenylephrine HCl, caffeine, ibuprofen, ascorbic acid, propiphenazone, pheniramine maleate, chlorphenamine maleate, pseudoephedrine HCl, dextromethorphan HBr and cetylpyridinium Cl; five of their impurities: 4-aminophenol, 4-nitrophenol, 4`-chloroacetanilide, chlorphenamine impurity C and ephedrine HCl; and two preservatives: sodium benzoate and propyl parahydroxybenzoate. All 18 compounds were successfully separated on a reversed phase (RP)-HPLC column with superficially porous particles using gradient elution with a very simple mobil...
Arhiv za farmaciju, 2020
The fast growth of counterfeiting medicines in the last two decades has created one of the bigges... more The fast growth of counterfeiting medicines in the last two decades has created one of the biggest problems facing the pharmaceutical industry on the global level, resulting in loss of income, product withdrawal, loss of brand value, etc. But this is not only the problem of the intellectual property rights of the pharmaceutical industry, it is also the problem of the healthcare regulatory authorities, whose most significant concern is the risk to the public health. Pharmaceutical manufacturers, together with the wholesalers and retailers, have an essential role in the fight against counterfeit medicines by the implementation of different anti-counterfeit technologies for securing the supply-chain of medicines. The protection of drug packaging has a specific role in the drug development process, as well as in the fight against counterfeit medicine. The authenticity of the medicine and the forensic elements for protection on the packaging may be confirmed using different technologies....
Macedonian Pharmaceutical Bulletin, 2016
Counterfeiting and piracy are one of the biggest issues of the global economy in the last two dec... more Counterfeiting and piracy are one of the biggest issues of the global economy in the last two decades, facing all industrial sectors, including pharmaceutical industry. Counterfeiting of medicines is a growing phenomenon affecting all type of medicines including both innovative and generic and represents a serious public health problem and a problem of the trade competition as an intellectual property right infringement. In order to combat this problem, anti-counterfeit regulatory activities are undertaken on a global level through establishment of legislation, strengthening the regulatory activities, development of mechanisms for effective collaboration between the stakeholders on national and international level and communication for raising public awareness regarding the risk of using counterfeited medicines. The role of the pharmaceutical manufacturers, wholesalers and retailers in the fight against counterfeited medicines is essential for securing the supply chain and providing...
Folia Medica, 2019
Background: : Health-related quality of life (HRQoL) is a parameter that is examined in the area ... more Background: : Health-related quality of life (HRQoL) is a parameter that is examined in the area of clinical effectiveness. Like other chronic health conditions, paediatric cystic fibrosis (CF) impacts not only children but also their families. Aim: The present study investigates for the first time the HRQoL of children and parents in the Republic of North Macedonia. Materials and methods: The survey included 22 children (6 to 13 years of age) and their parents and 7 parents of children under 6 years of age by using the CFQ Revised and questions for current medical treatment. Results: Children (6-13 years) reported the highest score for the digestive condition (84.85), while the lowest score was given for social activity (59.74). The highest score for digestive condition was also obtained from the parents of children from 6-13 years and under age of 6. The parents of children (6-13 years) reported the lowest score (60.56) for treatment burden activity, while the lowest score (50.0) ...
Macedonian Pharmaceutical Bulletin, 2015
Core-shell silica particles were developed as a new material for chromatographic stationary phase... more Core-shell silica particles were developed as a new material for chromatographic stationary phases in order to provide fast and high efficiency separations of small and large molecules and complex samples, at pressures compatible with conventional HPLC equipment. The aim of our work was to show the applicability of the HPLC columns based on a core-shell technology for determination of related substances in diclofenac sodium and in metamizole sodium using the methods described in the corresponding monographs of the European pharmacopoeia. The obtained results have shown that the proposed methods can be successfully transferred on core shell column, with suitable adjustment of injection volume and flow rate. The advantage of using core-shell column is fast and highly efficient separation on conventional HPLC equipment with increased sensitivity of the method and high throughput of the analysis, providing enhanced lab productivity and reduced costs.
Macedonian Pharmaceutical Bulletin, 2014
The selection of an adequate regression model is the basis for obtaining accurate and reproducibl... more The selection of an adequate regression model is the basis for obtaining accurate and reproducible results during the bionalytical method validation. Given the wide concentration range, frequently present in bioanalytical assays, heteroscedasticity of the data may be expected. Several weighted linear and quadratic regression models were evaluated during the selection of the adequate curve fit using nonparametric statistical tests: One sample rank test and Wilcoxon signed rank test for two independent groups of samples. The results obtained with One sample rank test could not give statistical justification for the selection of linear vs. quadratic regression models because slight differences between the error (presented through the relative residuals) were obtained. Estimation of the significance of the differences in the RR was achieved using Wilcoxon signed rank test, where linear and quadratic regression models were treated as two independent groups. The application of this simple...
Macedonian Pharmaceutical Bulletin, 2013
The importance of medical devices in everyday users/patients lives is imensse. This is the reason... more The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses
Macedonian Pharmaceutical Bulletin, 2005
Recombinant DNA technology has led to a significant increase in the number of peptide and protein... more Recombinant DNA technology has led to a significant increase in the number of peptide and protein based pharmaceuticals, giving a new approach to combat poorly controlled diseases. This particular development has been reached in the last two decades. However, proteins are highly susceptible of physical and chemical degradation resulting in a decrease or complete loss of biological activities. Reasons for their physical and chemical instabilities and the methods for their examination, become a challenge for the pharmaceutical scientists for successful development of stabile protein - based pharmaceuticals. The stability of protein - based pharmaceuticals is significant in terms of their pharmaceutical quality and biological activity. In addition, a right choice of suitable analytical methods is needed in order to detect an early formation of degradation products or modified forms.
PRILOZI, 2018
Atypical antipsychotic risperidone is widely used first-line monotherapy in schizophrenia and com... more Atypical antipsychotic risperidone is widely used first-line monotherapy in schizophrenia and combined therapy in bipolar disorders. Therapeutic plasma concentrations of risperidone and its active moiety are directly influenced by genetic variations in metabolic CYP450 enzymes (CYP2D6 and CYP3A4/5) and transporter (ABCB1) protein and additional environmental factors. Since active metabolite 9-OH risperidone has a greater percentage of the pharmacologically active fraction and is equipotent to the parent drug risperidone, it is assumed that it contributes significantly to therapeutic and adverse effects. Unpredictable dose/concentration ratio, narrow therapeutic index, number of interactions, along with serious adverse reactions (ADR), raises the need for individualization of risperidone treatment and establishing of good therapeutic regime using TDM. A simple and reliable validated bioanalytical liquide-liquide extraction HPLC/UV method was applied for the simultaneous determination...
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Papers by Jasmina Ribarska