Acute respiratory infections are the most common group of infective diseases in the pediatric population. Although the improvement of health care and vaccination program has led to a significant reduction in the incidence of certain respiratory infections, the combination of a high prevalence in vulnerable pediatric categories and uncritical prescription of antibiotics, due to the inability to adequately distinguish between viruses and bacterial etiology, still represents a significant challenge for the public health system. In order to promote rational antibiotic therapy with an overall improvement of both diagnostic and therapeutic principles, acute respiratory diseases have been the subject of consideration in numerous publications and national guidelines. Nonspecific clinical manifestations with pathogen heterogeneity and both anatomical and physiological characteristics of the child's respiratory system during growth and development have created the need for individualized therapy. Since the guidelines emphasize the undoubtful and crucial benefits of symptomatic therapy (e.g. analgesics in acute otitis media, supplemental oxygen in lower respiratory tract infections with hypoxemia), the use of antibiotics and corticosteroids is indicated in selected cases with a severe clinical picture. The choice of antibiotic depends on the clinical condition, presumed causative agent, and local epidemiologic circumstances. Respiratory support (oxygen therapy and/or artificial ventilation) is reserved for inpatient treatment of cases with a particularly severe clinical picture and associated complications.
{"title":"Treatment of the most common respiratory infections in children","authors":"M. Baša, A. Sovtić","doi":"10.5937/arhfarm72-37857","DOIUrl":"https://doi.org/10.5937/arhfarm72-37857","url":null,"abstract":"Acute respiratory infections are the most common group of infective diseases in the pediatric population. Although the improvement of health care and vaccination program has led to a significant reduction in the incidence of certain respiratory infections, the combination of a high prevalence in vulnerable pediatric categories and uncritical prescription of antibiotics, due to the inability to adequately distinguish between viruses and bacterial etiology, still represents a significant challenge for the public health system. In order to promote rational antibiotic therapy with an overall improvement of both diagnostic and therapeutic principles, acute respiratory diseases have been the subject of consideration in numerous publications and national guidelines. Nonspecific clinical manifestations with pathogen heterogeneity and both anatomical and physiological characteristics of the child's respiratory system during growth and development have created the need for individualized therapy. Since the guidelines emphasize the undoubtful and crucial benefits of symptomatic therapy (e.g. analgesics in acute otitis media, supplemental oxygen in lower respiratory tract infections with hypoxemia), the use of antibiotics and corticosteroids is indicated in selected cases with a severe clinical picture. The choice of antibiotic depends on the clinical condition, presumed causative agent, and local epidemiologic circumstances. Respiratory support (oxygen therapy and/or artificial ventilation) is reserved for inpatient treatment of cases with a particularly severe clinical picture and associated complications.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71199026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Functional thyroid disorders (hypothyroidism and hyperthyroidism) are amongst the most common endocrine disorders pharmacists encounter on a daily basis. They are highly prevalent in iodine-replete areas, and affect women about 10 times more often than man. Hypothyroidism (thyroid hormone deficiency) is usually caused by Hashimoto's thyroiditis, an autoimmune disorder that leads to gradual thyroid destruction. The drug-of-choice for treating hypothyroidism is levothyroxine, a synthetic form of thyroxine. Key points which need to be discussed with patients who are prescribed levothyroxine for the first time are when/how to administer this drug, how its effects are monitored, what drugs may affect its efficacy, and the importance of properly treating hypothyroidism during pregnancy. Hyperthyroidism (increased production of thyroid hormones) is most often caused by Graves' disease, another thyroid autoimmune disorder in which stimulatory autoantibodies against the TSH receptor lead to increased thyroid function. Graves' disease is most commonly treated with thionamide drugs (thiamazole, carbimazole or propylthiouracil) and patients using these drugs should be advised on the monitoring requirements, duration of treatment, and how to recognize possible serious adverse effects (agranulocytosis and hepatotoxicity), and informed that these drugs must be used during pregnancy in order to reduce the risk of adverse outcomes for the mother and baby.
{"title":"Functional thyroid disorders in the pharmacy setting: How can we help our patients?","authors":"Uroš Pecikoza","doi":"10.5937/arhfarm72-39858","DOIUrl":"https://doi.org/10.5937/arhfarm72-39858","url":null,"abstract":"Functional thyroid disorders (hypothyroidism and hyperthyroidism) are amongst the most common endocrine disorders pharmacists encounter on a daily basis. They are highly prevalent in iodine-replete areas, and affect women about 10 times more often than man. Hypothyroidism (thyroid hormone deficiency) is usually caused by Hashimoto's thyroiditis, an autoimmune disorder that leads to gradual thyroid destruction. The drug-of-choice for treating hypothyroidism is levothyroxine, a synthetic form of thyroxine. Key points which need to be discussed with patients who are prescribed levothyroxine for the first time are when/how to administer this drug, how its effects are monitored, what drugs may affect its efficacy, and the importance of properly treating hypothyroidism during pregnancy. Hyperthyroidism (increased production of thyroid hormones) is most often caused by Graves' disease, another thyroid autoimmune disorder in which stimulatory autoantibodies against the TSH receptor lead to increased thyroid function. Graves' disease is most commonly treated with thionamide drugs (thiamazole, carbimazole or propylthiouracil) and patients using these drugs should be advised on the monitoring requirements, duration of treatment, and how to recognize possible serious adverse effects (agranulocytosis and hepatotoxicity), and informed that these drugs must be used during pregnancy in order to reduce the risk of adverse outcomes for the mother and baby.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71199171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Homšek, M. Roganović, Milena Kovačević, Marija Jovanović
Thyroid dysfunction is one of the most prevalent endocrine disorders, especially common in female patients. If patients are not diagnosed in time or adequately treated, the patients' quality of life can be significantly impaired and additional health problems may occur, considering the key roles of thyroid hormones in the body. Therefore, it is necessary to raise awareness about the importance of recognition of symptoms that may indicate a potential problem with the thyroid gland and help to identify possible causes. For patients who are already being treated with levothyroxine (hypothyroidism), or thiamazole, carbimazole or propylthiouracil (hyperthyroidism), it is necessary to point out the necessity of proper, regular use of the drugs and implementation of accompanying nonpharmacological measures, as well as the potential for the occurrence of adverse reactions and interactions with other drugs or food. A significant role in the mentioned activities should be played by the pharmacist, as the most accessible member of the health team, who can, if necessary, refer the patient to a doctor for diagnosis, monitor the effectiveness and safety of the therapy, and provide appropriate patient counseling.
{"title":"Role of pharmacists in management of patients with thyroid disorders","authors":"A. Homšek, M. Roganović, Milena Kovačević, Marija Jovanović","doi":"10.5937/arhfarm72-39948","DOIUrl":"https://doi.org/10.5937/arhfarm72-39948","url":null,"abstract":"Thyroid dysfunction is one of the most prevalent endocrine disorders, especially common in female patients. If patients are not diagnosed in time or adequately treated, the patients' quality of life can be significantly impaired and additional health problems may occur, considering the key roles of thyroid hormones in the body. Therefore, it is necessary to raise awareness about the importance of recognition of symptoms that may indicate a potential problem with the thyroid gland and help to identify possible causes. For patients who are already being treated with levothyroxine (hypothyroidism), or thiamazole, carbimazole or propylthiouracil (hyperthyroidism), it is necessary to point out the necessity of proper, regular use of the drugs and implementation of accompanying nonpharmacological measures, as well as the potential for the occurrence of adverse reactions and interactions with other drugs or food. A significant role in the mentioned activities should be played by the pharmacist, as the most accessible member of the health team, who can, if necessary, refer the patient to a doctor for diagnosis, monitor the effectiveness and safety of the therapy, and provide appropriate patient counseling.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71199181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
N. Milinković, M. Sarić-Matutinović, Gordana Dmitrašinović, S. Ignjatović
Previous research suggests that point-of-care (POCT) determination of glycated hemoglobin (HbA1c) is a diagnostic test that can be an adequate alternative to measuring HbA1c in the laboratory. The main goal of this study was to examine the analytical characteristics of the novel INCLIX POCT method for HbA1c determination in order to test its performance before introducing this method into routine use. HbA1c is measured in a duplicate in 44 EDTA blood samples parallel on INCLIX POCT device (Sugitech, Inc.) and using automated turbidimetric immunoinhibition test on Olympus AU400 (Beckman Coulter). The within run imprecision was 7.58%, between runs imprecision was 6.63% and 6.22%, and day-to-day imprecision was 8.80% and 7.51%. Total laboratory imprecision was in agreement with those stated by the manufacturer. A statistically significant Pearson correlation coefficient was calculated (r = 0.871, P < 0.01; linear R2 = 0.757). Using Deming regression analysis, the following equation was obtained: y = - 1.80 + 1.304x. Our results indicate statistically significant correlation, linear relationship, and a significant degree of compatibility between the two analyzed methods. However, the negative bias of the HbA1c values determined on the POCT analyzer compared to the Olympus AU400 was confirmed, highlighting the need to standardize the INCLIX method.
{"title":"Compliance of the POCT method with the fully automated method for HbA1c determination","authors":"N. Milinković, M. Sarić-Matutinović, Gordana Dmitrašinović, S. Ignjatović","doi":"10.5937/arhfarm72-35905","DOIUrl":"https://doi.org/10.5937/arhfarm72-35905","url":null,"abstract":"Previous research suggests that point-of-care (POCT) determination of glycated hemoglobin (HbA1c) is a diagnostic test that can be an adequate alternative to measuring HbA1c in the laboratory. The main goal of this study was to examine the analytical characteristics of the novel INCLIX POCT method for HbA1c determination in order to test its performance before introducing this method into routine use. HbA1c is measured in a duplicate in 44 EDTA blood samples parallel on INCLIX POCT device (Sugitech, Inc.) and using automated turbidimetric immunoinhibition test on Olympus AU400 (Beckman Coulter). The within run imprecision was 7.58%, between runs imprecision was 6.63% and 6.22%, and day-to-day imprecision was 8.80% and 7.51%. Total laboratory imprecision was in agreement with those stated by the manufacturer. A statistically significant Pearson correlation coefficient was calculated (r = 0.871, P < 0.01; linear R2 = 0.757). Using Deming regression analysis, the following equation was obtained: y = - 1.80 + 1.304x. Our results indicate statistically significant correlation, linear relationship, and a significant degree of compatibility between the two analyzed methods. However, the negative bias of the HbA1c values determined on the POCT analyzer compared to the Olympus AU400 was confirmed, highlighting the need to standardize the INCLIX method.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71199275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J. Čanji-Panić, N. Todorović, Ana Stjepanović, M. Lalic-Popovic
In recent years, the interest in 3D printing of medicines has increased due to many advantages of this technology, such as flexibility of the dose and dosage form of the printed product. Fused deposition modeling (FDM) is one of the most popular 3D printing technologies in the pharmaceutical field, due to its low cost and simplicity. The subject of this review is the potential use of natural products as biodegradable and biocompatible materials with good safety profiles in FDM 3D printing of pharmaceuticals. Natural products such as alginate, chitosan and starch have already been employed as excipients in FDM 3D printed pharmaceutical dosage forms, while others like shellac and zein show the potential, but haven't yet been part of 3D printed pharmaceutical formulations. These excipients have different roles in the formulation of filaments for FDM 3D printing, for example as fillers, matrix carriers or drug-release modifiers. In addition, the possibility of incorporating active pharmaceutical ingredients of natural origin in filaments for FDM 3D printing was reviewed. High printing temperatures limit the use of natural products in FDM 3D printing. However, adequate selection of thermoplastic material and printing parameters can widen the use of natural products in FDM 3D printing of pharmaceutical dosage forms.
{"title":"The potential of natural products use in fused deposition modeling 3D printing of pharmaceutical dosage forms","authors":"J. Čanji-Panić, N. Todorović, Ana Stjepanović, M. Lalic-Popovic","doi":"10.5937/arhfarm72-40155","DOIUrl":"https://doi.org/10.5937/arhfarm72-40155","url":null,"abstract":"In recent years, the interest in 3D printing of medicines has increased due to many advantages of this technology, such as flexibility of the dose and dosage form of the printed product. Fused deposition modeling (FDM) is one of the most popular 3D printing technologies in the pharmaceutical field, due to its low cost and simplicity. The subject of this review is the potential use of natural products as biodegradable and biocompatible materials with good safety profiles in FDM 3D printing of pharmaceuticals. Natural products such as alginate, chitosan and starch have already been employed as excipients in FDM 3D printed pharmaceutical dosage forms, while others like shellac and zein show the potential, but haven't yet been part of 3D printed pharmaceutical formulations. These excipients have different roles in the formulation of filaments for FDM 3D printing, for example as fillers, matrix carriers or drug-release modifiers. In addition, the possibility of incorporating active pharmaceutical ingredients of natural origin in filaments for FDM 3D printing was reviewed. High printing temperatures limit the use of natural products in FDM 3D printing. However, adequate selection of thermoplastic material and printing parameters can widen the use of natural products in FDM 3D printing of pharmaceutical dosage forms.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71199392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nenad Nikolić, Tijana Miletić, J. Kovacevic, Đorđe Medarević, S. Ibrić
Compaction simulators are designed as machines which can provide an in-depth analysis of the powder compaction process. Characterization of the powder compression and compaction process, as well as material characterization, play an important role in the formulation and manufacturing process design and development, as well as in creating a strong knowledge basis for the scale-up of the tablet compression and troubleshooting in further stages of the product lifecycle. Although compaction simulators are designed to simulate the compression process on high-speed tablet-presses, with the advantages of a small quantity of material needed and highly sophisticated instrumentation, there are certain limitations in the extrapolation of the process parameters from these machines to high-speed rotary tablet presses. However, the advantage of the use of compaction simulators for studying basic compression and compaction mechanisms, identification of critical material attributes and critical process parameters ranges, and their relations with tablet characteristics and critical quality attributes of pharmaceutical products is clear, compared to the use of small excentre tablet presses, and complementary to the use of small rotary tablet presses. This scientific paper provides an overview and examples of the different advantages provided by the instrumentation of compaction simulators, including certain limitations in their exploitation.
{"title":"Usage of compaction simulators for the powder compression characterization: Advantages and limitations","authors":"Nenad Nikolić, Tijana Miletić, J. Kovacevic, Đorđe Medarević, S. Ibrić","doi":"10.5937/arhfarm72-41301","DOIUrl":"https://doi.org/10.5937/arhfarm72-41301","url":null,"abstract":"Compaction simulators are designed as machines which can provide an in-depth analysis of the powder compaction process. Characterization of the powder compression and compaction process, as well as material characterization, play an important role in the formulation and manufacturing process design and development, as well as in creating a strong knowledge basis for the scale-up of the tablet compression and troubleshooting in further stages of the product lifecycle. Although compaction simulators are designed to simulate the compression process on high-speed tablet-presses, with the advantages of a small quantity of material needed and highly sophisticated instrumentation, there are certain limitations in the extrapolation of the process parameters from these machines to high-speed rotary tablet presses. However, the advantage of the use of compaction simulators for studying basic compression and compaction mechanisms, identification of critical material attributes and critical process parameters ranges, and their relations with tablet characteristics and critical quality attributes of pharmaceutical products is clear, compared to the use of small excentre tablet presses, and complementary to the use of small rotary tablet presses. This scientific paper provides an overview and examples of the different advantages provided by the instrumentation of compaction simulators, including certain limitations in their exploitation.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71199483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Jovanović, M. Petrović, D. Stojanović, S. Ibrić, P. Uskoković
In this work, a blend of gelatin A (GA) and polyvinylpyrrolidone (PVP K30) was used for semi-solid 3D printing of bone scaffold for ibuprofen (IBU) delivery. The cross-linking of the obtained scaffold was performed with a 1% glutaraldehyde (GTA) solution, followed by lyophilization. The thermal and mechanical properties, as well as drug release profiles, and drug kinetics of prepared scaffolds were investigated. The cross-linked and lyophilized scaffold has shown good thermal stability, mechanical properties, and prolonged release of IBU following the Fickian diffusion process.
{"title":"Preparation and characterization of 3D printed bone scaffold for ibuprofen delivery","authors":"M. Jovanović, M. Petrović, D. Stojanović, S. Ibrić, P. Uskoković","doi":"10.5937/arhfarm72-40262","DOIUrl":"https://doi.org/10.5937/arhfarm72-40262","url":null,"abstract":"In this work, a blend of gelatin A (GA) and polyvinylpyrrolidone (PVP K30) was used for semi-solid 3D printing of bone scaffold for ibuprofen (IBU) delivery. The cross-linking of the obtained scaffold was performed with a 1% glutaraldehyde (GTA) solution, followed by lyophilization. The thermal and mechanical properties, as well as drug release profiles, and drug kinetics of prepared scaffolds were investigated. The cross-linked and lyophilized scaffold has shown good thermal stability, mechanical properties, and prolonged release of IBU following the Fickian diffusion process.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71199817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Population aging is progressing at the highest rate historically, leading to an increased morbidity. Therefore, higher levels of collaborative pharmaceutical practice (CPP) and interprofessional collaboration (IPC) are expected to provide the necessary improvement to the healthcare system performance. For a strong body of literature to be built in the area of CPP and IPC, methodologically sound research studies must be completed, using questionnaires with well-developed psychometric properties. Therefore, the objective was to develop a questionnaire aimed at researching the attitudes of the elderly (65+) towards IPC and CPP. A structured questionnaire was developed using the Delphi method by a team of experts (n=8) within four rounds of meetings. Reliability, question correlation and factor analysis were used for questionnaire validation. Questionnaire validation (n=40) determined the Cronbach's Alpha to be at the high value of 0.774, and reliability analysis of questionnaire's scales on the total sample (n=185) in the five Geriatric Centers confirmed a relatively high value of 0.736. Interclass correlation coefficient values were highly significant (ICC=0.749; p<0.01), which confirmed questionnaire compactness regarding CPP. An exploratory factor analysis highlighted 2 significant factors explaining 53% of the entire model variability. Both questionnaire validation (n=40) and total sample analysis (n=185) confirmed the appropriateness of the developed questionnaire.
{"title":"Attitudes of the elderly towards interprofessional cooperation and collaborative pharmacy practices: Questionnaire development","authors":"Velibor Ilić, L. Tasić, V. Marinković","doi":"10.5937/arhfarm71-32284","DOIUrl":"https://doi.org/10.5937/arhfarm71-32284","url":null,"abstract":"Population aging is progressing at the highest rate historically, leading to an increased morbidity. Therefore, higher levels of collaborative pharmaceutical practice (CPP) and interprofessional collaboration (IPC) are expected to provide the necessary improvement to the healthcare system performance. For a strong body of literature to be built in the area of CPP and IPC, methodologically sound research studies must be completed, using questionnaires with well-developed psychometric properties. Therefore, the objective was to develop a questionnaire aimed at researching the attitudes of the elderly (65+) towards IPC and CPP. A structured questionnaire was developed using the Delphi method by a team of experts (n=8) within four rounds of meetings. Reliability, question correlation and factor analysis were used for questionnaire validation. Questionnaire validation (n=40) determined the Cronbach's Alpha to be at the high value of 0.774, and reliability analysis of questionnaire's scales on the total sample (n=185) in the five Geriatric Centers confirmed a relatively high value of 0.736. Interclass correlation coefficient values were highly significant (ICC=0.749; p<0.01), which confirmed questionnaire compactness regarding CPP. An exploratory factor analysis highlighted 2 significant factors explaining 53% of the entire model variability. Both questionnaire validation (n=40) and total sample analysis (n=185) confirmed the appropriateness of the developed questionnaire.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71198527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Milena Rmandić, Milan Rađenović, J. Stanković, A. Protić, Biljana Otašević, A. Malenović
In this research, Analytical Quality by Design (AQbD) methodology was used to develop the HILIC-PDA-CAD method for the determination of magnesium, pyridoxine and thiamine content in a dietary supplement. Experiments were conducted on the Dionex Ulitimate 3000 HPLC system with PDA and CAD detectors. Separations were performed on the ZIC-HILIC PEEK column (100 × 4.6 mm, 5 mm) with a mixture of acetonitrile, acetone and ammonium acetate/ammonium formate aqueous solution (48:12:40, v/v/v) as the mobile phase. The detection was performed at 220 nm. The optimal settings of CAD were defined with the one-factor-at-a-time approach: evaporation temperature 50°C, filter constant 10 s, pressure gas 60 psi. The influence of qualitative (salt type) and quantitative factors (pH and salt concentration) on the magnesium retention factor, k Mg and the selectivity factor between pyridoxine and chloride anion, a B6/Cl-, was tested using the I-optimal design. The design space was defined by Monte Carlo simulations and model coefficients' errors were propagated with the aim of identifying the conditions that meet the following criteria: k Mg <4 and a B6/Cl->3.5, with the probability p=95%. From the derived 2D-Design Space graph, 95 mM of ammonium formate pH 4.4 was selected as the optimal composition of the aqueous phase. The method was validated and its reliability in routine application was confirmed.
{"title":"PDA-CAD method for the determination of magnesium, pyridoxine and thiamine in a dietary supplement supported by analytical quality by design methodology","authors":"Milena Rmandić, Milan Rađenović, J. Stanković, A. Protić, Biljana Otašević, A. Malenović","doi":"10.5937/arhfarm71-32093","DOIUrl":"https://doi.org/10.5937/arhfarm71-32093","url":null,"abstract":"In this research, Analytical Quality by Design (AQbD) methodology was used to develop the HILIC-PDA-CAD method for the determination of magnesium, pyridoxine and thiamine content in a dietary supplement. Experiments were conducted on the Dionex Ulitimate 3000 HPLC system with PDA and CAD detectors. Separations were performed on the ZIC-HILIC PEEK column (100 × 4.6 mm, 5 mm) with a mixture of acetonitrile, acetone and ammonium acetate/ammonium formate aqueous solution (48:12:40, v/v/v) as the mobile phase. The detection was performed at 220 nm. The optimal settings of CAD were defined with the one-factor-at-a-time approach: evaporation temperature 50°C, filter constant 10 s, pressure gas 60 psi. The influence of qualitative (salt type) and quantitative factors (pH and salt concentration) on the magnesium retention factor, k Mg and the selectivity factor between pyridoxine and chloride anion, a B6/Cl-, was tested using the I-optimal design. The design space was defined by Monte Carlo simulations and model coefficients' errors were propagated with the aim of identifying the conditions that meet the following criteria: k Mg <4 and a B6/Cl->3.5, with the probability p=95%. From the derived 2D-Design Space graph, 95 mM of ammonium formate pH 4.4 was selected as the optimal composition of the aqueous phase. The method was validated and its reliability in routine application was confirmed.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71198518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jevrem Stojanović, Jovana Krmar, A. Protić, B. Svrkota, Nevena Đajić, Biljana Otašević
Design of Experiments (DoE) is an indispensable tool in contemporary drug analysis as it simultaneously balances a number of chromatographic parameters to ensure optimal separation in High Pressure Liquid Chromatography (HPLC). This manuscript briefly outlines the theoretical background of the DOE and provides step-by-step instruction for its implementation in HPLC pharmaceutical practice. It particularly discusses the classification of various design types and their possibilities to rationalize the different stages of HPLC method development workflow, such as the selection of the most influential factors, factors optimization and assessment of the method robustness. Additionally, the application of the DOE-based Analytical Quality by Design (AQbD) concept in the LC method development has been summarized. Recent achievements in the use of DOE in the development of stability-indicating LC and hyphenated LC-MS methods have also been briefly reported. Performing of Quantitative structure retention relationship (QSRR) study enhanced with DOE-based data collection was recomended as a future perspective in description of retention in HPLC system.
{"title":"Experimental design in HPLC separation of pharmaceuticals","authors":"Jevrem Stojanović, Jovana Krmar, A. Protić, B. Svrkota, Nevena Đajić, Biljana Otašević","doi":"10.5937/arhfarm71-32480","DOIUrl":"https://doi.org/10.5937/arhfarm71-32480","url":null,"abstract":"Design of Experiments (DoE) is an indispensable tool in contemporary drug analysis as it simultaneously balances a number of chromatographic parameters to ensure optimal separation in High Pressure Liquid Chromatography (HPLC). This manuscript briefly outlines the theoretical background of the DOE and provides step-by-step instruction for its implementation in HPLC pharmaceutical practice. It particularly discusses the classification of various design types and their possibilities to rationalize the different stages of HPLC method development workflow, such as the selection of the most influential factors, factors optimization and assessment of the method robustness. Additionally, the application of the DOE-based Analytical Quality by Design (AQbD) concept in the LC method development has been summarized. Recent achievements in the use of DOE in the development of stability-indicating LC and hyphenated LC-MS methods have also been briefly reported. Performing of Quantitative structure retention relationship (QSRR) study enhanced with DOE-based data collection was recomended as a future perspective in description of retention in HPLC system.","PeriodicalId":39173,"journal":{"name":"Arhiv za Farmaciju","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71198599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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