Incorporation of active substances in polymeric microparticles (microencapsulation) is an important technological strategy used in the pharmaceutical industry to improve the functionality, quality, safety and/or therapeutic efficiency of pharmaceutical preparations for different routes of administration. The current focus of research in this field is on the encapsulation of small molecules and macromolecules into microparticles based on biocompatible synthetic polymers and biopolymers, such as polypeptides and polysaccharides, in order to achieve preferable drug release kinetics and many other advantages. Diversity in the structure and size of microparticles, choice of polymers, and manufacturing processes, allows for designing a multitude of microcarriers (e.g., monolithic matrix microspheres, hollow microcapsules, water-or oil-core microcapsules, stimulus-sensitive microcapsules), whereby their impact on biopharmaceutical profile of drugs can be manipulated. The results so far indicate that the in vitro drug release kinetics evaluation is one of the key aspects of the microparticle-type carrier characterization, where the application of the mathematical analysis (modeling) of the drug release profiles is an important tool for elucidating drug release mechanisms, as well as for evaluating the influence and optimization of formulation and process parameters in the microencapsulation procedure. The article reviews representative studies in which mathematical modeling of experimentally obtained release data was performed for microencapsulated model drugs with different physicochemical properties, as well as the relevance and potential limitations of this approach.
{"title":"Modeling of in vitro drug release from polymeric microparticle carriers","authors":"Ljiljana Đekić, A. Ćirić","doi":"10.5937/arhfarm72-40229","DOIUrl":"https://doi.org/10.5937/arhfarm72-40229","url":null,"abstract":"Incorporation of active substances in polymeric microparticles (microencapsulation) is an important technological strategy used in the pharmaceutical industry to improve the functionality, quality, safety and/or therapeutic efficiency of pharmaceutical preparations for different routes of administration. The current focus of research in this field is on the encapsulation of small molecules and macromolecules into microparticles based on biocompatible synthetic polymers and biopolymers, such as polypeptides and polysaccharides, in order to achieve preferable drug release kinetics and many other advantages. Diversity in the structure and size of microparticles, choice of polymers, and manufacturing processes, allows for designing a multitude of microcarriers (e.g., monolithic matrix microspheres, hollow microcapsules, water-or oil-core microcapsules, stimulus-sensitive microcapsules), whereby their impact on biopharmaceutical profile of drugs can be manipulated. The results so far indicate that the in vitro drug release kinetics evaluation is one of the key aspects of the microparticle-type carrier characterization, where the application of the mathematical analysis (modeling) of the drug release profiles is an important tool for elucidating drug release mechanisms, as well as for evaluating the influence and optimization of formulation and process parameters in the microencapsulation procedure. The article reviews representative studies in which mathematical modeling of experimentally obtained release data was performed for microencapsulated model drugs with different physicochemical properties, as well as the relevance and potential limitations of this approach.","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":"71199807","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}
D. Michaličková, Öztürk Kübra, Debanjana Das, Bukhari Osama, O. Slanař
Multiple sclerosis (MS) is a highly heterogenous disease regarding radiological, pathological, and clinical characteristics and therapeutic response, including both the efficacy and safety profile of treatments. Accordingly, there is a high demand for biomarkers that sensitively and specifically apprehend the distinctive aspects of the MS heterogeneity, and that can aid in better understanding of the disease diagnosis, prognosis, prediction of the treatment response, and, finally, in the development of new treatments. Currently, clinical characteristics (e.g., relapse rate and disease progression) and magnetic resonance imaging play the most important role in the clinical classification of MS and assessment of its course. Molecular biomarkers (e.g., immunoglobulin G (IgG) oligoclonal bands, IgG index, anti-aquaporin-4 antibodies, neutralizing antibodies against interferon-beta and natalizumab, anti-varicella zoster virus and anti-John Cunningham (JC) virus antibodies) complement these markers excellently. This review provides an overview of exploratory, validated and clinically useful molecular biomarkers in MS which are used for prediction, diagnosis, disease activity and treatment response.
{"title":"Molecular biomarkers in multiple sclerosis","authors":"D. Michaličková, Öztürk Kübra, Debanjana Das, Bukhari Osama, O. Slanař","doi":"10.5937/arhfarm72-36165","DOIUrl":"https://doi.org/10.5937/arhfarm72-36165","url":null,"abstract":"Multiple sclerosis (MS) is a highly heterogenous disease regarding radiological, pathological, and clinical characteristics and therapeutic response, including both the efficacy and safety profile of treatments. Accordingly, there is a high demand for biomarkers that sensitively and specifically apprehend the distinctive aspects of the MS heterogeneity, and that can aid in better understanding of the disease diagnosis, prognosis, prediction of the treatment response, and, finally, in the development of new treatments. Currently, clinical characteristics (e.g., relapse rate and disease progression) and magnetic resonance imaging play the most important role in the clinical classification of MS and assessment of its course. Molecular biomarkers (e.g., immunoglobulin G (IgG) oligoclonal bands, IgG index, anti-aquaporin-4 antibodies, neutralizing antibodies against interferon-beta and natalizumab, anti-varicella zoster virus and anti-John Cunningham (JC) virus antibodies) complement these markers excellently. This review provides an overview of exploratory, validated and clinically useful molecular biomarkers in MS which are used for prediction, diagnosis, disease activity and treatment response.","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":"71199315","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}
Acute upper respiratory tract infections (URIs) are the most common infections in the population, especially in children. URIs are mostly of viral origin and tend to resolve spontaneously in approximately one week. Bacterial URIs are less common, and come mostly as superinfections of acute viral diseases. The therapy is symptomatic and aimed at alleviating cough, maintaining the patency of airways and preventing disease progression. If there are no reasons to see a doctor, parents should be advised to apply general measures and give herbal medicinal products to their children, in an attempt to relieve cough, sore throat and nasal symptoms. In productive cough, herbal expectorants, such as, for example, Hederae helicis folium extracts, are used to facilitate the elimination of mucus. On the other hand, demulcents (Althaeae radix, Plantaginis lanceolatae folium) alleviate dry cough by reducing local irritation. Honey also significantly reduces the frequency and severity of acute cough episodes. Extracts of Sisymbrii officinalis herba and Pelargonii radix are useful for the alleviation of nasal symptoms and sore throat. If the application of the proposed herbal products does not resolve the symptoms within a week, advice of a medical doctor should be sought.
{"title":"Phytotherapy of acute upper respiratory tract infections in children","authors":"T. Kundaković, Z. Maksimović","doi":"10.5937/arhfarm72-37803","DOIUrl":"https://doi.org/10.5937/arhfarm72-37803","url":null,"abstract":"Acute upper respiratory tract infections (URIs) are the most common infections in the population, especially in children. URIs are mostly of viral origin and tend to resolve spontaneously in approximately one week. Bacterial URIs are less common, and come mostly as superinfections of acute viral diseases. The therapy is symptomatic and aimed at alleviating cough, maintaining the patency of airways and preventing disease progression. If there are no reasons to see a doctor, parents should be advised to apply general measures and give herbal medicinal products to their children, in an attempt to relieve cough, sore throat and nasal symptoms. In productive cough, herbal expectorants, such as, for example, Hederae helicis folium extracts, are used to facilitate the elimination of mucus. On the other hand, demulcents (Althaeae radix, Plantaginis lanceolatae folium) alleviate dry cough by reducing local irritation. Honey also significantly reduces the frequency and severity of acute cough episodes. Extracts of Sisymbrii officinalis herba and Pelargonii radix are useful for the alleviation of nasal symptoms and sore throat. If the application of the proposed herbal products does not resolve the symptoms within a week, advice of a medical doctor should be sought.","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":"71198989","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}
Đ. Marić, Vera Bonderović, D. Javorac, K. Baralić, Z. Bulat, Danijela Đukić-Ćosić, S. Mandić-Rajčević, M. Žarković, Aleksandra Buha-Đorđević
Mercury (Hg) is one of the most important environmental pollutants with endocrinedisrupting properties. There is little data from epidemiological studies describing the doseresponse relationship between toxic metal levels and hormone levels. The aim of this study was to use the nearest neighbor matching analysis to determine the difference in Hg concentration in healthy/sick subjects with thyroid disease and to use Benchmark modeling to determine the doseresponse relationship between Hg levels in the blood and thyroid-stimulating hormone (TSH) and thyroid hormones in serum. Blood samples were collected and used for Hg measurement using the ICP-MS method, and separated serum was used for hormone analysis. The study showed the existence of a statistically significant difference in Hg levels measured in healthy and sick subjects and the existence of a dose-response relationship between Hg and all measured hormones, with a narrow interval obtained for the Hg-TSH pair. The results of this research support the use of the Benchmark dose approach for the purpose of analyzing data from human studies, and our further research will be focused on examining the impact of low doses on animal models in order to determine more precise effects of low doses on the organism.
{"title":"Exposure to mercury and thyroid function: Is there a connection?","authors":"Đ. Marić, Vera Bonderović, D. Javorac, K. Baralić, Z. Bulat, Danijela Đukić-Ćosić, S. Mandić-Rajčević, M. Žarković, Aleksandra Buha-Đorđević","doi":"10.5937/arhfarm72-40122","DOIUrl":"https://doi.org/10.5937/arhfarm72-40122","url":null,"abstract":"Mercury (Hg) is one of the most important environmental pollutants with endocrinedisrupting properties. There is little data from epidemiological studies describing the doseresponse relationship between toxic metal levels and hormone levels. The aim of this study was to use the nearest neighbor matching analysis to determine the difference in Hg concentration in healthy/sick subjects with thyroid disease and to use Benchmark modeling to determine the doseresponse relationship between Hg levels in the blood and thyroid-stimulating hormone (TSH) and thyroid hormones in serum. Blood samples were collected and used for Hg measurement using the ICP-MS method, and separated serum was used for hormone analysis. The study showed the existence of a statistically significant difference in Hg levels measured in healthy and sick subjects and the existence of a dose-response relationship between Hg and all measured hormones, with a narrow interval obtained for the Hg-TSH pair. The results of this research support the use of the Benchmark dose approach for the purpose of analyzing data from human studies, and our further research will be focused on examining the impact of low doses on animal models in order to determine more precise effects of low doses on the organism.","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":"71199268","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}
Obesity is a disease of excessive accumulation of adipose tissue due to an increased energy intake which is disproportionate to the energy expenditure in the body. The visceral adipose tissue in the obese accumulated in that way increases the risk of developing a number of metabolic and cardiovascular diseases. Disorders such as diabetes, dyslipidemia, inflammation, endothelial dysfunction and mitochondria can contribute to the development of oxidative stress, which is especially pronounced in the abdominal type of obesity. Obesity can induce systemic oxidative stress through a variety of biochemical mechanisms. Although ROS is generated in a large number of cells, mitochondria play a significant role in their intracellular production through the process of oxidative phosphorylation of the respiratory chain, and in fatty acid oxidation reactions. Oxidative stress is a unique link between the various molecular disorders present in the development of insulin resistance that plays a key role in the pathogenesis and progression of chronic metabolic, proinflammatory diseases. The progression of insulin resistance is also affected by inflammation. Both of these can be the cause and the consequence of obesity. The synthesis of the inflammatory mediators is induced by oxidative stress, thus bringing the inflammation and the oxidative stress into a very significant relation. This review aims to highlight recent findings on the role of oxidative stress in the pathogenesis of obesity, with special reference to the mechanisms that explain its occurrence.
{"title":"Oxidative stress and obesity","authors":"M. Malenica, N. Meseldžić","doi":"10.5937/arhfarm72-36123","DOIUrl":"https://doi.org/10.5937/arhfarm72-36123","url":null,"abstract":"Obesity is a disease of excessive accumulation of adipose tissue due to an increased energy intake which is disproportionate to the energy expenditure in the body. The visceral adipose tissue in the obese accumulated in that way increases the risk of developing a number of metabolic and cardiovascular diseases. Disorders such as diabetes, dyslipidemia, inflammation, endothelial dysfunction and mitochondria can contribute to the development of oxidative stress, which is especially pronounced in the abdominal type of obesity. Obesity can induce systemic oxidative stress through a variety of biochemical mechanisms. Although ROS is generated in a large number of cells, mitochondria play a significant role in their intracellular production through the process of oxidative phosphorylation of the respiratory chain, and in fatty acid oxidation reactions. Oxidative stress is a unique link between the various molecular disorders present in the development of insulin resistance that plays a key role in the pathogenesis and progression of chronic metabolic, proinflammatory diseases. The progression of insulin resistance is also affected by inflammation. Both of these can be the cause and the consequence of obesity. The synthesis of the inflammatory mediators is induced by oxidative stress, thus bringing the inflammation and the oxidative stress into a very significant relation. This review aims to highlight recent findings on the role of oxidative stress in the pathogenesis of obesity, with special reference to the mechanisms that explain its occurrence.","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":"71199288","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}
Optimizing the dosing of medicines for pediatric patients in routine clinical practice and determining the dose for clinical trials is still a challenging task. Children differ from adults in their response to drugs due to inherent differences in pharmacokinetics and/or pharmacodynamics, and responses may also vary among pediatric patients of different ages. However, the greatest disparities compared to adult pharmacokinetic profiles are observed in children below 2 years of age. The maturation of the liver and the kidneys, as well as the variation in body composition, are considered to be the main sources of pharmacokinetic variability. Hence, besides specific pharmacodynamic features, understanding age-related changes in drug absorption, distribution, and elimination is fundamental for optimizing drug efficacy and avoiding toxicity. This paper summarizes the pharmacokinetic changes throughout the childhood, along with the effect of developmental changes on drug dosage calculation. In clinical practice, age and body weight-based dosing regimens are usually used. In spite of dosing recommendations based on age and/or body weight, variabilities in pharmacokinetics and pharmacodynamic response remain, implying a need to monitor patients and optimize the dosing regimen according to physiological characteristics, disease characteristics and therapy.
{"title":"Pediatric pharmacokinetic considerations and implications for drug dosing","authors":"Marija Jovanović, K. Vučićević","doi":"10.5937/arhfarm72-37605","DOIUrl":"https://doi.org/10.5937/arhfarm72-37605","url":null,"abstract":"Optimizing the dosing of medicines for pediatric patients in routine clinical practice and determining the dose for clinical trials is still a challenging task. Children differ from adults in their response to drugs due to inherent differences in pharmacokinetics and/or pharmacodynamics, and responses may also vary among pediatric patients of different ages. However, the greatest disparities compared to adult pharmacokinetic profiles are observed in children below 2 years of age. The maturation of the liver and the kidneys, as well as the variation in body composition, are considered to be the main sources of pharmacokinetic variability. Hence, besides specific pharmacodynamic features, understanding age-related changes in drug absorption, distribution, and elimination is fundamental for optimizing drug efficacy and avoiding toxicity. This paper summarizes the pharmacokinetic changes throughout the childhood, along with the effect of developmental changes on drug dosage calculation. In clinical practice, age and body weight-based dosing regimens are usually used. In spite of dosing recommendations based on age and/or body weight, variabilities in pharmacokinetics and pharmacodynamic response remain, implying a need to monitor patients and optimize the dosing regimen according to physiological characteristics, disease characteristics and therapy.","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":"71198916","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}
Treatment-resistant hypertension is one of the most significant causes of poor blood pressure regulation. Patients with resistant hypertension are at a higher risk of developing comorbidities compared to the general hypertensive population. As a result, these patients have an increased incidence of disability and premature death, as well as increased treatment costs. Due to the above-mentioned, in the last decade, there has been an increase in researchers' interest in elucidating the pathogenesis, diagnosis, and treatment of resistant hypertension. However, recent data indicate that 20% of female and 24% of male patients with arterial hypertension still have uncontrolled blood pressure, despite maximum doses of three antihypertensive drugs (including a diuretic) and appropriate lifestyle measures. New treatment modalities (i.e. devicebased interventions - catheter-based renal denervation and baroreceptor stimulation) offer hope for achieving adequate blood pressure regulation in these patients. In this paper, we have summarized previous knowledge about the mechanisms underlying the pathogenesis of resistant hypertension, as well as optimal diagnostic methods to differentiate true from pseudo-resistant hypertension. We have also given an overview of the current therapeutic approach, including optimal medical therapy and new treatment modalities (i.e. device-based interventions) and their role in the treatment of resistant hypertension.
{"title":"Treatment-resistant hypertension","authors":"Maja Milosevic, P. Otasevic","doi":"10.5937/arhfarm72-34248","DOIUrl":"https://doi.org/10.5937/arhfarm72-34248","url":null,"abstract":"Treatment-resistant hypertension is one of the most significant causes of poor blood pressure regulation. Patients with resistant hypertension are at a higher risk of developing comorbidities compared to the general hypertensive population. As a result, these patients have an increased incidence of disability and premature death, as well as increased treatment costs. Due to the above-mentioned, in the last decade, there has been an increase in researchers' interest in elucidating the pathogenesis, diagnosis, and treatment of resistant hypertension. However, recent data indicate that 20% of female and 24% of male patients with arterial hypertension still have uncontrolled blood pressure, despite maximum doses of three antihypertensive drugs (including a diuretic) and appropriate lifestyle measures. New treatment modalities (i.e. devicebased interventions - catheter-based renal denervation and baroreceptor stimulation) offer hope for achieving adequate blood pressure regulation in these patients. In this paper, we have summarized previous knowledge about the mechanisms underlying the pathogenesis of resistant hypertension, as well as optimal diagnostic methods to differentiate true from pseudo-resistant hypertension. We have also given an overview of the current therapeutic approach, including optimal medical therapy and new treatment modalities (i.e. device-based interventions) and their role in the treatment of resistant hypertension.","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":"71199240","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}
Autoimmune diseases accompanied by the development of hypothyroidism (Hashimoto's thyroiditis) and hyperthyroidism (Graves' disease) are one of the most common disorders of the thyroid gland. Hypothyroidism is a clinical syndrome that occurs as a result of thyroid hormone deficiency. Hyperthyroidism is excessive activity of the thyroid gland accompanied by hypersecretion of thyroid hormones. In simple terms, to achieve a euthyroid state in both clinical syndromes, two drugs are (most commonly) used - levothyroxine (hypothyroidism) and thioamide (hyperthyroidism). While it may seem simple, during the treatment, which is life-long in the case of hypothyroidism, patients should actually be carefully monitored, with the adjustment of the drug dose and the inclusion of other drugs for the treatment of comorbidities.
{"title":"Clinical pharmacology of thyroid and antithyroid drugs","authors":"R. Stepanović-Petrović, M. Tomić","doi":"10.5937/arhfarm72-40086","DOIUrl":"https://doi.org/10.5937/arhfarm72-40086","url":null,"abstract":"Autoimmune diseases accompanied by the development of hypothyroidism (Hashimoto's thyroiditis) and hyperthyroidism (Graves' disease) are one of the most common disorders of the thyroid gland. Hypothyroidism is a clinical syndrome that occurs as a result of thyroid hormone deficiency. Hyperthyroidism is excessive activity of the thyroid gland accompanied by hypersecretion of thyroid hormones. In simple terms, to achieve a euthyroid state in both clinical syndromes, two drugs are (most commonly) used - levothyroxine (hypothyroidism) and thioamide (hyperthyroidism). While it may seem simple, during the treatment, which is life-long in the case of hypothyroidism, patients should actually be carefully monitored, with the adjustment of the drug dose and the inclusion of other drugs for the treatment of comorbidities.","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":"71199260","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. Kovacevic, Aleksandar Kovačević, Tijana Miletić, Jelena Đuriš, S. Ibrić
Understanding the effect of the characteristics of formulation and process parameters on the physicochemical properties of a pharmaceutical product is very significant for the development of solid dosage forms, as the knowledge gained on small scale batches in the early phase of development is used in the later phases of product lifecycle or in the development of other products. One of the approaches for gaining a better understanding of the effects of the formulation and production process on the quality of the finished product is to apply a systematical approach which concerns performing experiments according to a predefined factorial or fractional factorial experimental plan. However, often it is the case that there are available data gathered in a non-systematic way, because experiments were not performed according to a predetermined experimental plan. In such a case, data mining techniques could be used to extract useful data from the historical data set. In this research, the possibility of using several data mining techniques to build models that describe the effect of formulation characteristics on acid resistance and dissolution profile of a model drug from gastro-resistant pellets. The model drug used in the research is duloxetine hydrochloride from the group of antidepressants. It belongs to the BCS 2 class of active pharmaceutical ingredients, and it is therefore necessary for the release profile of duloxetine to be characterized by a higher number of tested time points. The developed models can be used for planning future laboratory trials, or in the development of other products.
{"title":"Data mining techniques applied in the analysis of historical data","authors":"J. Kovacevic, Aleksandar Kovačević, Tijana Miletić, Jelena Đuriš, S. Ibrić","doi":"10.5937/arhfarm72-41368","DOIUrl":"https://doi.org/10.5937/arhfarm72-41368","url":null,"abstract":"Understanding the effect of the characteristics of formulation and process parameters on the physicochemical properties of a pharmaceutical product is very significant for the development of solid dosage forms, as the knowledge gained on small scale batches in the early phase of development is used in the later phases of product lifecycle or in the development of other products. One of the approaches for gaining a better understanding of the effects of the formulation and production process on the quality of the finished product is to apply a systematical approach which concerns performing experiments according to a predefined factorial or fractional factorial experimental plan. However, often it is the case that there are available data gathered in a non-systematic way, because experiments were not performed according to a predetermined experimental plan. In such a case, data mining techniques could be used to extract useful data from the historical data set. In this research, the possibility of using several data mining techniques to build models that describe the effect of formulation characteristics on acid resistance and dissolution profile of a model drug from gastro-resistant pellets. The model drug used in the research is duloxetine hydrochloride from the group of antidepressants. It belongs to the BCS 2 class of active pharmaceutical ingredients, and it is therefore necessary for the release profile of duloxetine to be characterized by a higher number of tested time points. The developed models can be used for planning future laboratory trials, or in the development of other products.","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":"71199496","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}
The treatment of respiratory infections in children requires special attention, since the paediatric population has rather specific characteristics and consists of heterogenous subgroups. In this context, the choice of a suitable drug dosage form is of particular importance, depending on the active substance properties, along with the age and general condition of a paediatric patient. The most commonly used pharmaceutical products for respiratory infections in children include oral, parenteral and inhalation dosage forms, although a large number of drugs are not available in a suitable dosage form and/or strength for paediatric age, leading to the frequent use of unauthorized drugs (i.e., unlicensed use). Other important issues that should be considered when choosing the appropriate paediatric dosage form and/or compounding procedure are related to the careful considerations of the pharmaceutical product composition (safety of excipients) and the choice of administration/dosing device in relation to a child's age. This paper provides an overview of paediatric dosage forms used in the treatment of respiratory infections in children, their benefits and limitations. The review includes examples of various pharmaceutical products, along with the considerations regarding administration/dosing devices. Specific characteristics of paediatric populations affecting the decision on the choice of age-appropriate paediatric formulation are also addressed.
{"title":"How to choose an appropriate drug dosage form for the treatment of respiratory infections in children: Facts and tips","authors":"S. Cvijić, D. Mirković, D. Krajišnik","doi":"10.5937/arhfarm72-37643","DOIUrl":"https://doi.org/10.5937/arhfarm72-37643","url":null,"abstract":"The treatment of respiratory infections in children requires special attention, since the paediatric population has rather specific characteristics and consists of heterogenous subgroups. In this context, the choice of a suitable drug dosage form is of particular importance, depending on the active substance properties, along with the age and general condition of a paediatric patient. The most commonly used pharmaceutical products for respiratory infections in children include oral, parenteral and inhalation dosage forms, although a large number of drugs are not available in a suitable dosage form and/or strength for paediatric age, leading to the frequent use of unauthorized drugs (i.e., unlicensed use). Other important issues that should be considered when choosing the appropriate paediatric dosage form and/or compounding procedure are related to the careful considerations of the pharmaceutical product composition (safety of excipients) and the choice of administration/dosing device in relation to a child's age. This paper provides an overview of paediatric dosage forms used in the treatment of respiratory infections in children, their benefits and limitations. The review includes examples of various pharmaceutical products, along with the considerations regarding administration/dosing devices. Specific characteristics of paediatric populations affecting the decision on the choice of age-appropriate paediatric formulation are also addressed.","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":"71198977","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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