Acta Pharmaceutica最新文献_第3页

Efficacy of sorafenib plus transcatheter arterial chemoembolization in treating hepatocellular carcinoma with portal vein tumor thrombosis: A meta-analysis. 索拉非尼联合经导管动脉化疗栓塞治疗伴门静脉肿瘤血栓形成的肝癌的疗效：荟萃分析

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-09-14 Print Date: 2024-09-01 DOI: 10.2478/acph-2024-0019

Li Xu, Shanshan Chen, Haijun Cao, Zemin Feng, Chao Yang

{"title":"Efficacy of sorafenib plus transcatheter arterial chemoembolization in treating hepatocellular carcinoma with portal vein tumor thrombosis: A meta-analysis.","authors":"Li Xu, Shanshan Chen, Haijun Cao, Zemin Feng, Chao Yang","doi":"10.2478/acph-2024-0019","DOIUrl":"10.2478/acph-2024-0019","url":null,"abstract":"This meta-analysis aimed to evaluate the efficacy of sorafenib plus transcatheter arterial chemoembolization (TACE) in treating hepato-cellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT). Twelve randomized controlled trials published until 28th Sep 2022 were finally included. Of the total 1746 patients, of whom 458 received sorafenib and TACE treatment (Group S+TACE), and 1288 only underwent TACE (Group TACE), were enrolled. Outcomes including time to progression (TTP), objective response rate (ORR), disease control rate (DCR), overall survival (OS), survival rate (SR), and adverse reactions, were extracted. The OS (HR: 0.596, 95 %CI: 0.507-0.685, p < 0.001; I2 = 0.0 %) and TTP (HR: 0.379, 95 %CI: 0.205-0.553, p < 0.001; I2 = 4.5 %) in the S+TACE group were longer than those in the TACE group. The ORR (RR: 2.101, 95 %CI: 1.555-2.839, p < 0.001; I2 = 0.0 %), DCR (RR: 1.547, 95 %CI: 1.126-2.126, p = 0.007; I2 = 79.6 %) and SR (RR: 1.416, 95 %CI: 1.183-1.694, p < 0.001; I2 = 83.8 %) in the S+TACE group were higher than those in the TACE group. Compared with the TCAE group, the higher odds of HFSR, oral ulcer, and diarrhea among patients with HCC complicated by PVTT were discovered in the S+TACE group. The marginal significance was found in ascites and gastrointestinal bleeding between the two groups. Sorafenib plus TACE has good efficacy and mild adverse reactions, which may be worthy of clinical promotion.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 3","pages":"405-422"},"PeriodicalIF":2.1,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142278652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Enhanced biomedical potential of polyurethane/hydroxyapatite composites through chemical modification: A comprehensive study on structure, morphology, and cytocompatibility for tissue regeneration. 通过化学修饰增强聚氨酯/羟基磷灰石复合材料的生物医学潜力：用于组织再生的结构、形态和细胞相容性综合研究。

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-09-14 Print Date: 2024-09-01 DOI: 10.2478/acph-2024-0021

Misbah Sultan, Shaista Parveen, Mohammad N Uddin, Farhat Jubeen, Mohsin Kazi

{"title":"Enhanced biomedical potential of polyurethane/hydroxyapatite composites through chemical modification: A comprehensive study on structure, morphology, and cytocompatibility for tissue regeneration.","authors":"Misbah Sultan, Shaista Parveen, Mohammad N Uddin, Farhat Jubeen, Mohsin Kazi","doi":"10.2478/acph-2024-0021","DOIUrl":"https://doi.org/10.2478/acph-2024-0021","url":null,"abstract":"Polyurethane/hydroxyapatite (PU/HA) composites are well-known for various biomedical applications. This study reports a chemical approach to improve the interaction between HA and PU matrix. HA was surface-modified with 1,6-hexamethylene diisocyanate (HMDI). First, an isocyanate-modified HA (IHA) was synthesized by hydro-thermal method. Second, IHA was incorporated into a separately synthesized thermoplastic PU by a solvent casting technique. A series of PU/IHA composites was prepared by varying PU᾿s soft and hard segments. The IHA was added to PU (5 and 10 %). The FTIR spectra exhibited characteristic bands of urethane and HA, confirming the synthesis of the composites. XRD study showed the crystallite size of IHA (20 Å) with hexagonal geometry and an amorphous to semicrystalline nature of composites. SEM showed that composites displayed porous and granular morphology. The TGA thermograms of the composites revealed the thermal stability up to 400 °C. The IHA addition considerably improved hydrophilicity and degradation of the composites in simulated body fluid (SBF). MTT assay revealed improved cytocompatibility (> 80 %) of the composites. These results demonstrated an appreciable improvement in structure, morphology, hydrophilicity, degradation, and cytocompatibility of PU/IHA composites by chemical modification of HA. Hence, these composites possess remarkable potential for biomedical applications such as tissue regeneration.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 3","pages":"525-537"},"PeriodicalIF":2.1,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142278653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of doxorubicin and fullerenol in rat serum by micellar electrokinetic capillary chromatography. 利用胶束电动毛细管色谱法分析大鼠血清中的多柔比星和富勒烯醇。

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-09-14 Print Date: 2024-09-01 DOI: 10.2478/acph-2024-0026

Rade Injac, Miranda Sertić, Nina Kočevar Glavač

{"title":"Analysis of doxorubicin and fullerenol in rat serum by micellar electrokinetic capillary chromatography.","authors":"Rade Injac, Miranda Sertić, Nina Kočevar Glavač","doi":"10.2478/acph-2024-0026","DOIUrl":"https://doi.org/10.2478/acph-2024-0026","url":null,"abstract":"A new micellar electrokinetic capillary chromatographic (MEKC) method has been developed and optimized for simultaneous quantitation of doxorubicin (Dox) and fullerenol (Frl) in rat serum. The separation was carried out in a capillary (48.5-40 cm to the detector - 50 µm id fused-silica capillary with bubble cell, 150 µm) at an applied voltage of 25 kV and temperature of 25 °C. For the background electrolyte 10 mmol L- 1 borate buffer pH 9.3 plus 15 mmol L-1 phosphate buffer pH 7.0 (with the final pH of the mixture adjusted to 7.0 with HCl), with added 10 % (V/V) methanol, and 15 mmol L-1 sodium dodecyl sulfate as a surfactant, were used. The hydrodynamic injection was carried out at 5.0 kPa during the period of 100 s. Linear calibration curves were established over the concentration range 0.5-500.0 mg L- 1 for Dox and 10.0-500.0 mg L- 1 for Frl (at 234 nm). The proposed MEKC procedure was fully validated and applied for the deter mination of Dox and Frl in Wistar rats after intra pe ritoneal administration of both molecules.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 3","pages":"495-509"},"PeriodicalIF":2.1,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142278651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Exploring novel pharmacological trends: Natural compounds in dry eye disease management. 探索新型药理学趋势：天然化合物在干眼症治疗中的应用。

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-09-14 Print Date: 2024-09-01 DOI: 10.2478/acph-2024-0028

Tibor Rák, Adrienne Csutak

{"title":"Exploring novel pharmacological trends: Natural compounds in dry eye disease management.","authors":"Tibor Rák, Adrienne Csutak","doi":"10.2478/acph-2024-0028","DOIUrl":"https://doi.org/10.2478/acph-2024-0028","url":null,"abstract":"Dry eye disease (DED) is an ocular condition characterized by altered tear film homeostasis, resulting in symptoms like tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities. It affects visual acuity and quality of life and is influenced by age, gender, and environmental factors. The first line of treatment consists of dynamically developing artificial tears, gels, and eyelid sprays, which can be supplemented with natural ingredients for enhanced efficacy. Other therapeutic steps include auto-logous serum tears, anti-inflammatory and immunosuppressive eyedrops, or oral tablets. Management also targets Meibomian gland dysfunction and the ocular surface micro-biome. This article explores various therapeutic approaches, including natural compounds and complementary strategies. Natural compounds, such as vitamins, and herbal substances (e.g., trehalose), offer promising benefits in enhancing tear film stability and ocular surface protection. Apitherapeutic products like manuka honey and propolis exhibit antibacterial and anti-inflammatory properties. Additionally, human tissue-derived solutions, such as auto-logous serum tears and amniotic membrane extracts, hold the potential for ocular surface regeneration. Other strategies, including polyherbal eye drops, liposomal eyelid sprays, and microbiome-supporting solutions offer alternative therapeutic avenues. Moreover, patient education, lifestyle modifications, and interdisciplinary collaboration play crucial roles in DED management, emphasizing the importance of holistic care approaches.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 3","pages":"383-404"},"PeriodicalIF":2.1,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142278654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Population pharmacokinetics of ramipril in patients with chronic heart failure: A real-world longitudinal study. 慢性心力衰竭患者体内雷米普利的群体药代动力学：真实世界纵向研究。

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-05-30 Print Date: 2024-06-01 DOI: 10.2478/acph-2024-0018

Katja Čvan Trobec, Iztok Grabnar, Jurij Trontelj, Mitja Lainščak, Mojca Kerec Kos

{"title":"Population pharmacokinetics of ramipril in patients with chronic heart failure: A real-world longitudinal study.","authors":"Katja Čvan Trobec, Iztok Grabnar, Jurij Trontelj, Mitja Lainščak, Mojca Kerec Kos","doi":"10.2478/acph-2024-0018","DOIUrl":"10.2478/acph-2024-0018","url":null,"abstract":"In patients with chronic heart failure (CHF), the use of angiotensin-converting enzyme inhibitors, including ramipril, is recommended to reduce the risk of heart failure worsening, hospitalisation, and death. Our aim was to investigate the influence of body composition on the pharmacokinetics of ramipril and its active metabolite ramiprilat and to evaluate the changes in pharmacokinetics after prolonged therapy. Twenty-three patients with CHF who were on regular therapy with ramipril participated at the first study visit ( median age 77 years, 65 % male, and 70 % New York Heart Association Class II); 19 patients attended the second study visit and the median time between the two visits was 8 months. Pharmacokinetics were assessed using a nonlinear mixed-effects parent-metabolite model comprising two compartments for ramipril and one compartment for ramiprilat. The influence of body size and composition was best described by an allometric relationship with fat-free mass. In addition, ramipril clearance was related to patient age and daily ramipril dose, while clearance of ramiprilat was influenced by glome rular filtration rate and daily ramipril dose. There were no clinically relevant changes in the pharmacokinetics of ramipril and ramiprilat between the study visits. Due to the relatively stable pharmacokinetics of ramipril, regular outpatient visits at 6-month intervals seem appropriate to evaluate ramipril therapy.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 2","pages":"315-328"},"PeriodicalIF":2.1,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Sedative load and anticholinergic burden among older adults in Slovenia over a decade: Potential for optimization of pharmacotherapy. 斯洛文尼亚老年人十年来的镇静剂负荷和抗胆碱能药物负担：优化药物治疗的潜力。

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-05-30 Print Date: 2024-06-01 DOI: 10.2478/acph-2024-0017

Janja Jazbar, Igor Locatelli, Mitja Kos

{"title":"Sedative load and anticholinergic burden among older adults in Slovenia over a decade: Potential for optimization of pharmacotherapy.","authors":"Janja Jazbar, Igor Locatelli, Mitja Kos","doi":"10.2478/acph-2024-0017","DOIUrl":"10.2478/acph-2024-0017","url":null,"abstract":"This study investigates the 10-year trend in the sedative and anticholinergic burden among older adults in Slovenia, with the aim of identifying opportunities to optimize pharmacotherapy in this population. A retrospective drug utilization analysis was conducted based on a national anonymized database of dispensed prescriptions from 2009 to 2019. The study employed the sedative load model and the anticholinergic cognitive burden scale to assess the sedative and anti cholinergic burden, respectively. The findings indicate that in 2019, 45.6 % and 40.8 % of older adults (≥ 65 years) used sedative and anticholinergic medications, respectively. A high sedative load and a clinically significant anticholinergic burden were observed in a considerable proportion of older adults (13.2 % and 11.2 %, respectively, in 2019). The age-standardized prevalence of sedative load and anti-cholinergic burden significantly decreased over the 10-year study period by 5.6 % and 1.7 %, respectively (absolute difference), while the prevalence of clinically significant anticholinergic burden remained stable. Notably, the age groups 85-89 years and above 90 years had an increase in the proportion of individuals with a clinically significant anticholinergic burden over the years. These results emphasize the need for targeted interventions, particularly in the oldest age groups, to promote safe and effective medication use among older adults.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 2","pages":"329-341"},"PeriodicalIF":2.1,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Forecasting the effect of water gastric emptying patterns on model drug release in an in vitro glass-bead flow-through system. 预测水胃排空模式对体外玻璃珠流动系统中模型药物释放的影响

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-05-30 Print Date: 2024-06-01 DOI: 10.2478/acph-2024-0016

Tjaša Felicijan, Marija Bogataj

{"title":"Forecasting the effect of water gastric emptying patterns on model drug release in an in vitro glass-bead flow-through system.","authors":"Tjaša Felicijan, Marija Bogataj","doi":"10.2478/acph-2024-0016","DOIUrl":"10.2478/acph-2024-0016","url":null,"abstract":"Oral solid dosage forms are most frequently administered with a glass of water which empties from the stomach relatively fast, but with a certain variability in its emptying kinetics. The purpose of this study was thus to simulate different individual water gastric emptying (GE) patterns in an in vitro glass-bead flow-through dissolution system. Further, the effect of GE on the dissolution of model drugs from immediate-release tablets was assessed by determining the amount of dissolved drug in the samples pumped out of the stomach compartment. Additionally, different HCl solutions were used as dissolution media to assess the effect of the variability of pH of the gastric fluid on the dissolution of three model drugs: paracetamol, diclofenac sodium, and dipyridamole. The difference in fast and slow GE kinetics resulted in different dissolution profiles of paracetamol in all studied media. For diclofenac sodium and dipyridamole tablets, the effect of GE kinetics was well observed only in media, where the solubility was not a limiting factor. Therefore, GE kinetics of co-ingested water influences the drug release from immediate-release tablets, however, in certain cases, other parameters influencing drug dissolution can partly or fully hinder the expression of this effect.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 2","pages":"269-287"},"PeriodicalIF":2.1,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Taste-masking methods in multiparticulate dosage forms with a focus on poorly soluble drugs. 多颗粒剂型中的掩味方法，重点关注溶解性差的药物。

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-05-30 Print Date: 2024-06-01 DOI: 10.2478/acph-2024-0015

Tilen Simšič, Odon Planinšek, Ana Baumgartner

{"title":"Taste-masking methods in multiparticulate dosage forms with a focus on poorly soluble drugs.","authors":"Tilen Simšič, Odon Planinšek, Ana Baumgartner","doi":"10.2478/acph-2024-0015","DOIUrl":"10.2478/acph-2024-0015","url":null,"abstract":"In the past, the administration of medicines for children mainly involved changes to adult dosage forms, such as crushing tablets or opening capsules. However, these methods often led to inconsistent dosing, resulting in under- or overdosing. To address this problem and promote adherence, numerous initiatives, and regulatory frameworks have been developed to develop more child-friendly dosage forms. In recent years, multiparticulate dosage forms such as mini-tablets, pellets, and granules have gained popularity. However, a major challenge that persists is effectively masking the bitter taste of drugs in such formulations. This review therefore provides a brief overview of the current state of the art in taste masking techniques, with a particular focus on taste masking by film coating. Methods for evaluating the effectiveness of taste masking are also discussed and commented on. Another important issue that arises frequently in this area is achieving sufficient dissolution of poorly water-soluble drugs. Since the simultaneous combination of sufficient dissolution and taste masking is particularly challenging, the second objective of this review is to provide a critical summary of studies dealing with multiparticulate formulations that are tackling both of these issues.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 2","pages":"177-199"},"PeriodicalIF":2.1,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The potential of three-dimensional printing for pediatric oral solid dosage forms. 三维打印在儿科口服固体制剂方面的潜力。

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-05-30 Print Date: 2024-06-01 DOI: 10.2478/acph-2024-0012

Klemen Kreft, Marina Fanous, Volker Möckel

{"title":"The potential of three-dimensional printing for pediatric oral solid dosage forms.","authors":"Klemen Kreft, Marina Fanous, Volker Möckel","doi":"10.2478/acph-2024-0012","DOIUrl":"10.2478/acph-2024-0012","url":null,"abstract":"Pediatric patients often require individualized dosing of medicine due to their unique pharmacokinetic and developmental characteristics. Current methods for tailoring the dose of pediatric medications, such as tablet splitting or compounding liquid formulations, have limitations in terms of dosing accuracy and palatability. This paper explores the potential of 3D printing as a solution to address the challenges and provide tailored doses of medication for each pediatric patient. The technological overview of 3D printing is discussed, highlighting various 3D printing technologies and their suitability for pharmaceutical applications. Several individualization options with the potential to improve adherence are discussed, such as individualized dosage, custom release kinetics, tablet shape, and palatability. To integrate the preparation of 3D printed medication at the point of care, a decentralized manufacturing model is proposed. In this setup, pharmaceutical companies would routinely provide materials and instructions for 3D printing, while specialized compounding centers or hospital pharmacies perform the printing of medication. In addition, clinical opportunities of 3D printing for dose-finding trials are emphasized. On the other hand, current challenges in adequate dosing, regulatory compliance, adherence to quality standards, and maintenance of intellectual property need to be addressed for 3D printing to close the gap in personalized oral medication.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 2","pages":"229-248"},"PeriodicalIF":2.1,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Lyophilised protein formulations as a patient-centric dosage form: A contribution toward sustainability paradigm. 冻干蛋白质制剂是一种以病人为中心的剂型：对可持续发展模式的贡献。

IF 2.1 4区医学

Acta Pharmaceutica Pub Date : 2024-05-30 Print Date: 2024-06-01 DOI: 10.2478/acph-2024-0013

Maja Bjelošević Žiberna, Pegi Ahlin Grabnar, Mirjana Gašperlin, Mirjam Gosenca Matjaž

{"title":"Lyophilised protein formulations as a patient-centric dosage form: A contribution toward sustainability paradigm.","authors":"Maja Bjelošević Žiberna, Pegi Ahlin Grabnar, Mirjana Gašperlin, Mirjam Gosenca Matjaž","doi":"10.2478/acph-2024-0013","DOIUrl":"10.2478/acph-2024-0013","url":null,"abstract":"At present, society has embraced the fact apropos population aging and climate changes, that demand, amongst others, innovative pharmaceutical technologies, emphasising the development of patient-specific delivery systems and thus the provision of efficient and sustainable drugs. Protein drugs for subcutaneous administration, by allowing less frequent application, represent one of the most important parts of the pharmaceutical field, but their development is inevitably faced with obstacles in providing protein stability and suitable formulation viscosity. To gain further knowledge and fill the gaps in the already constructed data platform for the development of monoclonal antibody formulations, we designed a study that examines small model proteins, i.e., bovine serum albumin. The main aim of the presented work is to evaluate the effect of protein concentrations on critical quality attributes of both, pre-lyophilised liquid formulations, and lyophilised products. Through the study, the hypothesis that increasing protein concentration leads to higher viscosity and higher reconstitution time without affecting the stability of the protein was confirmed. The most important finding is that sucrose plays a key role in the lyophilisation of investigated protein, nevertheless, it can be predicted that, to ensure the beneficial effect of mannitol, its amount has to prevail over the amount of sucrose.","PeriodicalId":7034,"journal":{"name":"Acta Pharmaceutica","volume":"74 2","pages":"289-300"},"PeriodicalIF":2.1,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0