Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.179-180
Bálint Basa, G. Jakab, E. Balogh, Bence Borbás, I. Antal
the interest toward additive manufacturing is growing considering the formulation of personalized medicines [1]. 3D printing is commonly an additive process, which results in various layer-bylayer built objects. A vast number of methods are available beyond 3D Printing but there are only few of them which can be employed for tailored pharmaceutical manufacturing (e.g. Photopolymerization, Selective Laser Sintering (SLS) and Fused Deposition Modelling (FDM)) [2]. During these methods the number of unit operations is minimalized, and the opportunity to fabricate every single printlet shaped according to the individuals’ profile with only minimal human intervention can be the cause of the increased research activity in this field [3]. The additional benefit of this type of manufacturing is the capability of producing customized ways of medication for pediatrics, geriatrics and patients suffering from organ dsyfunctions, avoiding the slightest chance of reaching toxic doses in their body. Several types of dosage forms were previously microfabricated including floating systems, pulsatile drug release tablets and zero-order release forms [4]. The first 3D printed orodispersible tablet was approved by the FDA in 2015.[5] The objective of our study was to design and print biodegradable drug delivery systems. Commercially available filament materials were screened as well as the print settings were optimized. In addition, the influence of design parameters including wall thickness, morphology, number and size of pores on the drug delivery in case of model drugs was investigated. Moreover, the applicability of matrix polymers and gelling agents in the process of 3D printing was studied. There were some formulations aiming the study of dose proportionality, in order to expand the opportunities of personalized medication. 2. Materials and methods
{"title":"The Application of 3D Printing in the Formulation of Personalized Drug Delivery Systems","authors":"Bálint Basa, G. Jakab, E. Balogh, Bence Borbás, I. Antal","doi":"10.33892/aph.2021.91.179-180","DOIUrl":"https://doi.org/10.33892/aph.2021.91.179-180","url":null,"abstract":"the interest toward additive manufacturing is growing considering the formulation of personalized medicines [1]. 3D printing is commonly an additive process, which results in various layer-bylayer built objects. A vast number of methods are available beyond 3D Printing but there are only few of them which can be employed for tailored pharmaceutical manufacturing (e.g. Photopolymerization, Selective Laser Sintering (SLS) and Fused Deposition Modelling (FDM)) [2]. During these methods the number of unit operations is minimalized, and the opportunity to fabricate every single printlet shaped according to the individuals’ profile with only minimal human intervention can be the cause of the increased research activity in this field [3]. The additional benefit of this type of manufacturing is the capability of producing customized ways of medication for pediatrics, geriatrics and patients suffering from organ dsyfunctions, avoiding the slightest chance of reaching toxic doses in their body. Several types of dosage forms were previously microfabricated including floating systems, pulsatile drug release tablets and zero-order release forms [4]. The first 3D printed orodispersible tablet was approved by the FDA in 2015.[5] The objective of our study was to design and print biodegradable drug delivery systems. Commercially available filament materials were screened as well as the print settings were optimized. In addition, the influence of design parameters including wall thickness, morphology, number and size of pores on the drug delivery in case of model drugs was investigated. Moreover, the applicability of matrix polymers and gelling agents in the process of 3D printing was studied. There were some formulations aiming the study of dose proportionality, in order to expand the opportunities of personalized medication. 2. Materials and methods","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"567 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83353972","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}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.124-125
I. Toth, M. Skwarczynski
The development of an effective vaccine for group A streptococci (GAS) has been challenged by the induced autoimmunity of epitopes derived from the C-repeat regions. Additionally, there are B-cell epitopes that have been shown to react with human heart tissue. Shorter safe B-cell epitopes, show little or no immunogenicity unless bound to a delivery platform including the conjugation to an inbuilt adjuvant. Self-adjuvanting lipid core peptide (LCP) systems where the antigen(s), carrier and adjuvant were within the same molecular entity has been developed. The LCP amphiphilic construct was incorporated into liposomes to produce particles with the desired size. The construct alone elicited high-levels of antibody titers comparable to that of the positive control (J8 + Complete Freund’s adjuvant). The developed strategy to produce nanoparticles, consisting of a peripheral antigenic epitope layer conjugated to a dendrimer core, which is both self-adjuvanting and produces a strong immune response to the GAS M-protein, offers an attractive alternative to conventional vaccine approaches. The greatest advantage of this system being the generation of protective immune response after oral administration. Our dendrimer-nanoparticles vaccine approach should be readily acquiescent to other pathogenic organisms in addition to GAS, and may prove particularly useful for the design of vaccines against infection deceases know to stimulate autoimmune response in a host.
{"title":"Lipopeptide Nanoparticulate Vaccine Candidates for the Induction of Protective Immune Responses","authors":"I. Toth, M. Skwarczynski","doi":"10.33892/aph.2021.91.124-125","DOIUrl":"https://doi.org/10.33892/aph.2021.91.124-125","url":null,"abstract":"The development of an effective vaccine for group A streptococci (GAS) has been challenged by the induced autoimmunity of epitopes derived from the C-repeat regions. Additionally, there are B-cell epitopes that have been shown to react with human heart tissue. Shorter safe B-cell epitopes, show little or no immunogenicity unless bound to a delivery platform including the conjugation to an inbuilt adjuvant. Self-adjuvanting lipid core peptide (LCP) systems where the antigen(s), carrier and adjuvant were within the same molecular entity has been developed. The LCP amphiphilic construct was incorporated into liposomes to produce particles with the desired size. The construct alone elicited high-levels of antibody titers comparable to that of the positive control (J8 + Complete Freund’s adjuvant). The developed strategy to produce nanoparticles, consisting of a peripheral antigenic epitope layer conjugated to a dendrimer core, which is both self-adjuvanting and produces a strong immune response to the GAS M-protein, offers an attractive alternative to conventional vaccine approaches. The greatest advantage of this system being the generation of protective immune response after oral administration. Our dendrimer-nanoparticles vaccine approach should be readily acquiescent to other pathogenic organisms in addition to GAS, and may prove particularly useful for the design of vaccines against infection deceases know to stimulate autoimmune response in a host.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90797487","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}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.204-205
D. Farkas, Nikolett Kállai-Szabó, I. Antal
For almost half a century foams have been present in the pharmaceutical markets worldwide. Generally, they can be defined as thin liquid or solid film separated gas bubble agglomerations, but the pharmacopoeial monograph of medicated foams recognizes only the aforementioned 1,2. Pharmaceutical foams offer an outstanding alternative to conventional dosage forms in topical treatment. Apart from the satisfactory drug delivery ability, the ease and convenience of application contributes to the high acceptance and excellent patient compliance of this dosage form. Despite the growing interest for foams, the current pharmacopoeial examinations are not sufficient for the description of their unique nature and virtue. Although image analysis can not provide an exhaustive overview on foams, it offers a great complementary method for their assessment 3,4. This research aims to demonstrate the extensive applicability of image analysis in the evaluation process of pharmaceutical foams. It also aims to make assumptions on important foam characteristics based on the composition and the microand macroscopic properties of foams.
{"title":"Image Analysis: A Novel Method in the Assessment of Pharmaceutical Foams","authors":"D. Farkas, Nikolett Kállai-Szabó, I. Antal","doi":"10.33892/aph.2021.91.204-205","DOIUrl":"https://doi.org/10.33892/aph.2021.91.204-205","url":null,"abstract":"For almost half a century foams have been present in the pharmaceutical markets worldwide. Generally, they can be defined as thin liquid or solid film separated gas bubble agglomerations, but the pharmacopoeial monograph of medicated foams recognizes only the aforementioned 1,2. Pharmaceutical foams offer an outstanding alternative to conventional dosage forms in topical treatment. Apart from the satisfactory drug delivery ability, the ease and convenience of application contributes to the high acceptance and excellent patient compliance of this dosage form. Despite the growing interest for foams, the current pharmacopoeial examinations are not sufficient for the description of their unique nature and virtue. Although image analysis can not provide an exhaustive overview on foams, it offers a great complementary method for their assessment 3,4. This research aims to demonstrate the extensive applicability of image analysis in the evaluation process of pharmaceutical foams. It also aims to make assumptions on important foam characteristics based on the composition and the microand macroscopic properties of foams.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91070820","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}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.328-329
Zsófia Vilimi, M. Hajdú, Nikolett Kállai-Szabó, I. Antal
{"title":"Study on Drug Release from Oleogel Carriers","authors":"Zsófia Vilimi, M. Hajdú, Nikolett Kállai-Szabó, I. Antal","doi":"10.33892/aph.2021.91.328-329","DOIUrl":"https://doi.org/10.33892/aph.2021.91.328-329","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"31 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91070909","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}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.106-107
K. Fodor
ATMPs - a new era A boy from Hungary, Zente, was one and a half years old when the crowd-funding campaign to finance his life-saving medicine Zolgensma concluded with a happy end. He was the third European patient that received the new gene therapy, which replaces the function of the missing or nonworking survival motor neuron 1 (SMN1) gene with a new, working copy of a human SMN gene that helps motor neuron cells work properly and survive. From a European perspective, it has been almost 15 years by now since regulatory framework for advanced therapy medicinal products (ATMPs) had been established to ensure the free movement of these medicines within the European Union, to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical companies in the field. Zolgensma has been approved in the EU in May 2020. The FDA expects it will be reviewing and approving up to 20 cell and gene therapies each year until 2025. Rapid development of technology and better understanding of the manufacturing challenges are not the only prerequisites of the growth. Assessment of products like Zolgensma requires very specific knowledge and often an adaptive approach from regulators. They have to gain enough experience and need to be able to summarize knowledge in guidelines that would help developers of products that are substantially different from traditional medicines. FDA issued seven new guidelines in January 2020, in which, for example, they highlight the importance of long-term follow-up for gene therapies that offer one-time fix for inherited diseases and where pre-market studies may have limited value. 2. Regulatory tools These examples may already show that rapid change in technology leads to new kinds of medicines that require a properly adapted regulatory system. Patients would expect state-of-the-art medicines within the shortest possible time frame, however, authorities are traditionally more cautious. Still, there are several various initiatives from the EMA and the FDA to foster early access to medicines. Some of these have been available for a longer time. EMA's accelerated assessment reduces the timeframe for review of innovative applications of medicines with major public health interest. Conditional marketing authorisation grants authorization before a complete dataset is available, and compassionate use allows the use of an unauthorized medicine for patients with an unmet medical need. A more recent regulatory tool of EMA is the priority medicines scheme (PRIME) that aims to enhance support for the development of medicines that are expected to make a real difference to patients. Early dialogue between EMA and the developers is a crucial part of the tool, together with accelerated assessment and continuous scientific advice and protocol assistance. Up to now, 282 applications for PRIME eligibility have been assessed by the CHMP of which 95 have received a green light. Most of the applicants are small and medi
{"title":"Regulatory Science Challenges : Encouraging Innovation Through an Adaptive Regulatory System","authors":"K. Fodor","doi":"10.33892/aph.2021.91.106-107","DOIUrl":"https://doi.org/10.33892/aph.2021.91.106-107","url":null,"abstract":"ATMPs - a new era A boy from Hungary, Zente, was one and a half years old when the crowd-funding campaign to finance his life-saving medicine Zolgensma concluded with a happy end. He was the third European patient that received the new gene therapy, which replaces the function of the missing or nonworking survival motor neuron 1 (SMN1) gene with a new, working copy of a human SMN gene that helps motor neuron cells work properly and survive. From a European perspective, it has been almost 15 years by now since regulatory framework for advanced therapy medicinal products (ATMPs) had been established to ensure the free movement of these medicines within the European Union, to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical companies in the field. Zolgensma has been approved in the EU in May 2020. The FDA expects it will be reviewing and approving up to 20 cell and gene therapies each year until 2025. Rapid development of technology and better understanding of the manufacturing challenges are not the only prerequisites of the growth. Assessment of products like Zolgensma requires very specific knowledge and often an adaptive approach from regulators. They have to gain enough experience and need to be able to summarize knowledge in guidelines that would help developers of products that are substantially different from traditional medicines. FDA issued seven new guidelines in January 2020, in which, for example, they highlight the importance of long-term follow-up for gene therapies that offer one-time fix for inherited diseases and where pre-market studies may have limited value. 2. Regulatory tools These examples may already show that rapid change in technology leads to new kinds of medicines that require a properly adapted regulatory system. Patients would expect state-of-the-art medicines within the shortest possible time frame, however, authorities are traditionally more cautious. Still, there are several various initiatives from the EMA and the FDA to foster early access to medicines. Some of these have been available for a longer time. EMA's accelerated assessment reduces the timeframe for review of innovative applications of medicines with major public health interest. Conditional marketing authorisation grants authorization before a complete dataset is available, and compassionate use allows the use of an unauthorized medicine for patients with an unmet medical need. A more recent regulatory tool of EMA is the priority medicines scheme (PRIME) that aims to enhance support for the development of medicines that are expected to make a real difference to patients. Early dialogue between EMA and the developers is a crucial part of the tool, together with accelerated assessment and continuous scientific advice and protocol assistance. Up to now, 282 applications for PRIME eligibility have been assessed by the CHMP of which 95 have received a green light. Most of the applicants are small and medi","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73460152","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}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.276-277
Á. Móricz, D. Krüzselyi, Maryam Jamshidi-Aidji, P. Ott, G. Morlock
In the last decade, effect-directed analysis (EDA) gave new impetus for the discovery of new potential drug compounds from natural sources. Highperformance thin-layer chromatography (HPTLC) was established as a high-throughput and reliable separation technique that is frequently utilized for screening of highly complex samples, such as crude plant extracts. HPTLC combined with biological and biochemical assays and high-resolution mass spectrometry (HRMS) followed by bioassay-guided isolation and NMR was demonstrated as a straightforward strategy for bioanalysis of natural products [1,2]. Diabetes and Alzheimer’s disease (AD) represent two of the global health issues. Type 2 diabetic patients, the majority of the people with diabetes, suffer from the hyperglycemia. The salivary and pancreatic α-amylases and αand β-glucosidases are involved in the degradation and digestion of polyand oligosaccharides to glucose, hence, glucosidase and amylase inhibitors are of therapeutic interest in type 2 diabetes as well as overweight and obesity [3,4]. AD is associated with the loss of cholinergic neurons in the brain and decrease in the neurotransmitter acetylcholine. Acetylcholinesterase (AChE) and butyrylcholinesterase (BChE) are crucially involved in the hydrolysis of the acetylcholine into choline. Hence, AChE-selective and dual AChE/BChE inhibitors represented the first generation of medicines for the decrease of the AD progression rate [5]. The fight against infectious diseases, a major global public hazard, is also a challenge due to the increase in the emergence of the (multi)drug-resistant microorganisms [6]. In this study (HP)TLC combined with direct αand β-glucosidase, α-amylase and antimicrobial assays will be demonstrated for the comparison of the bio-profiles (the enzyme inhibitory and antibacterial potentials) of invasive goldenrod species.
{"title":"High-Throughput Screening for Bioactive Natural Compounds from Plant Extracts by HPTLC Hyphenations","authors":"Á. Móricz, D. Krüzselyi, Maryam Jamshidi-Aidji, P. Ott, G. Morlock","doi":"10.33892/aph.2021.91.276-277","DOIUrl":"https://doi.org/10.33892/aph.2021.91.276-277","url":null,"abstract":"In the last decade, effect-directed analysis (EDA) gave new impetus for the discovery of new potential drug compounds from natural sources. Highperformance thin-layer chromatography (HPTLC) was established as a high-throughput and reliable separation technique that is frequently utilized for screening of highly complex samples, such as crude plant extracts. HPTLC combined with biological and biochemical assays and high-resolution mass spectrometry (HRMS) followed by bioassay-guided isolation and NMR was demonstrated as a straightforward strategy for bioanalysis of natural products [1,2]. Diabetes and Alzheimer’s disease (AD) represent two of the global health issues. Type 2 diabetic patients, the majority of the people with diabetes, suffer from the hyperglycemia. The salivary and pancreatic α-amylases and αand β-glucosidases are involved in the degradation and digestion of polyand oligosaccharides to glucose, hence, glucosidase and amylase inhibitors are of therapeutic interest in type 2 diabetes as well as overweight and obesity [3,4]. AD is associated with the loss of cholinergic neurons in the brain and decrease in the neurotransmitter acetylcholine. Acetylcholinesterase (AChE) and butyrylcholinesterase (BChE) are crucially involved in the hydrolysis of the acetylcholine into choline. Hence, AChE-selective and dual AChE/BChE inhibitors represented the first generation of medicines for the decrease of the AD progression rate [5]. The fight against infectious diseases, a major global public hazard, is also a challenge due to the increase in the emergence of the (multi)drug-resistant microorganisms [6]. In this study (HP)TLC combined with direct αand β-glucosidase, α-amylase and antimicrobial assays will be demonstrated for the comparison of the bio-profiles (the enzyme inhibitory and antibacterial potentials) of invasive goldenrod species.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77562632","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}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.278-279
Z. Mucsi, Gergely Szalay, G. Katona, B. Rózsa
{"title":"Revolutionary Application of 3D-Two-Photon Microscopes for Human Therapy and Drug Research","authors":"Z. Mucsi, Gergely Szalay, G. Katona, B. Rózsa","doi":"10.33892/aph.2021.91.278-279","DOIUrl":"https://doi.org/10.33892/aph.2021.91.278-279","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"48 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78489905","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}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.290-292
Musaab Saada, Y. Özalp, Nailla Jiwa, J. T. Chunu, Emre Kara, D. Taşkent, Zeynep Atabay Taşkent
density values. True density was measured using helium pycnometer
密度值。用氦浓度计测定真密度
{"title":"Evaluation of Different Pre-Processed Directly Compressible Paracetamol","authors":"Musaab Saada, Y. Özalp, Nailla Jiwa, J. T. Chunu, Emre Kara, D. Taşkent, Zeynep Atabay Taşkent","doi":"10.33892/aph.2021.91.290-292","DOIUrl":"https://doi.org/10.33892/aph.2021.91.290-292","url":null,"abstract":"density values. True density was measured using helium pycnometer","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"32 3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80357898","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}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.128-129
I. Antal
microcapsules are compo-nents of multiparticulate drug carriers structural patient-centered Depending on the mode of be into solid (capsules, tablets, semi-solid (gels, creams, pastes) or liquid (solutions, suspen-sions, or parenteral) dosage forms
{"title":"Advanced Drug Delivery Systems: From Nano- and Microparticles to Smart Pills","authors":"I. Antal","doi":"10.33892/aph.2021.91.128-129","DOIUrl":"https://doi.org/10.33892/aph.2021.91.128-129","url":null,"abstract":"microcapsules are compo-nents of multiparticulate drug carriers structural patient-centered Depending on the mode of be into solid (capsules, tablets, semi-solid (gels, creams, pastes) or liquid (solutions, suspen-sions, or parenteral) dosage forms","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"46 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88831325","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}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.112-113
P. Rocco, P. Minghetti
Complex drugs may be either biological, if the active ingredients are derived from a biological source, or non-biological, if obtained by chemical synthesis. In both cases, their quality depends considerably on the manufacturing process. For Non Biological Complex Drugs (NBCDs), in particular, complexity may arise either from the active substance, as in the case of glatiramer acetate (GA), or from other sources, such as the formulation, as in the case of liposomes (Figure 1) (1). GA is approved, in the US and the EU, as a diseasemodifying treatment for patients with relapsing forms of Multiple Sclerosis. It is a heterogeneous mixture of not fully characterized synthetic polypeptides, containing L-alanine, L-lysine, L-glutamic acid, L-tyrosine in the constant molar ratio 0.43:0.34:0.14:0.09, with and average molecular weight from 5 to 9 kDa and distribution range from 2.5 to 20 kDa (2). The amino acid sequences are not completely random, being the result of both the physicochemical properties of the starting materials and the fundamental reaction scheme. However, they are not completely conserved from batch to batch, even when the process is tightly controlled. Indeed along with conserved characteristics such as amino acid molar ratio other characteristics such as the specific amino acid sequences will show batch-to-batch variability (1). To address this complexity, for the marketing of GA copies, US and EU regulatory agencies have chosen a generic approach integrated with additional data. However, the implementation is different in the two jurisdictions (Figure 1).
{"title":"Same Product Different Regulatory Approach Around the World: Glatiramer Acetate","authors":"P. Rocco, P. Minghetti","doi":"10.33892/aph.2021.91.112-113","DOIUrl":"https://doi.org/10.33892/aph.2021.91.112-113","url":null,"abstract":"Complex drugs may be either biological, if the active ingredients are derived from a biological source, or non-biological, if obtained by chemical synthesis. In both cases, their quality depends considerably on the manufacturing process. For Non Biological Complex Drugs (NBCDs), in particular, complexity may arise either from the active substance, as in the case of glatiramer acetate (GA), or from other sources, such as the formulation, as in the case of liposomes (Figure 1) (1). GA is approved, in the US and the EU, as a diseasemodifying treatment for patients with relapsing forms of Multiple Sclerosis. It is a heterogeneous mixture of not fully characterized synthetic polypeptides, containing L-alanine, L-lysine, L-glutamic acid, L-tyrosine in the constant molar ratio 0.43:0.34:0.14:0.09, with and average molecular weight from 5 to 9 kDa and distribution range from 2.5 to 20 kDa (2). The amino acid sequences are not completely random, being the result of both the physicochemical properties of the starting materials and the fundamental reaction scheme. However, they are not completely conserved from batch to batch, even when the process is tightly controlled. Indeed along with conserved characteristics such as amino acid molar ratio other characteristics such as the specific amino acid sequences will show batch-to-batch variability (1). To address this complexity, for the marketing of GA copies, US and EU regulatory agencies have chosen a generic approach integrated with additional data. However, the implementation is different in the two jurisdictions (Figure 1).","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"69 6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83677605","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：