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Pickering emulsions: Development of an all-in-one dermocosmetic formulation 皮克林乳液:一种一体化皮肤化妆品配方的开发
Pub Date : 2023-09-01 DOI: 10.33320/maced.pharm.bull.2023.69.03.147
Ayşe Sila Turan, Gulin Amasya, Ozge Inal, Ulya Badilli
Classical emulsions have been recognized as the most widely used vehicle for topical drug delivery as well as cosmetic purposes. In general, an emulsion can be defined as a mixture of two or more immiscible liquids, one of which is finely and uniformly dispersed as globules throughout the second phase. However, since emulsions are thermodynamically unstable systems, a third component, surfactants should be used to stabilize the system by forming a thin film around the globules of the dispersed phase. On the other hand, Pickering emulsion is a relatively new concept and is a type of surfactant-free emulsion stabilized only by fine solid organic or inorganic particles (Albert et al., 2019). Pickering emulsions are a promising alternative as they eliminate surfactant-induced toxicity, improve formulation appearance, provide good viscosity, and promote long-term stability. With these features, Pickering emulsions appear as a satisfactory solution for daily cosmetic/dermocosmetic products as well as for drug delivery to the skin. Depending on the consistency, Pickering emulsions can range from liquid formulations such as lotions to semi-solid formulations such as creams. So, they are promising formulations for the treatment of skin disorders such as atopic dermatitis or eczema as well as skin care product such as anti-aging, moisturizer, or sunscreen (de Carvalho-Guimarães et al., 2022). For the formation of Pickering emulsion, the solid particles adsorbed at the oil-water interface must be fractionally wetted by two phases and the emulsion type (O/W or W/O) can be determined by the wettability of the particles. Hence, organic or inorganic solid particles such as silica, clay minerals, chitin/chitosan, hydroxyapatite, cyclodextrins, cellulose, starch, or minerals like titanium dioxide and zinc oxide, as well as metallic, polymeric, or lipidic nanoparticles can be utilized for creating stable Pickering emulsions. However, the type and morphology of the solid particles can modulate the properties of Pickering emulsions. Hence, choosing the right kind of solid is the essential parameter for the stability of the emulsion. Herein, it is aimed to effectively improve the changes such as fine lines and wrinkles, dryness, and loss of elasticity which are the main signs of skin aging with a single dermocosmetic product. Therefore, in this study, Pickering emulsion formulations were developed by combining different components known to be effective for skin appearance and in vitro characterizations of the formulations were studied.
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引用次数: 0
Determination of betamethasone residues on manufacturing equipment surfaces and PDE calculation in cleaning validation processes 生产设备表面倍他米松残留量的测定及清洁验证过程中PDE的计算
Pub Date : 2023-09-01 DOI: 10.33320/maced.pharm.bull.2023.69.03.116
Katerina Kochova, Irena Slaveska Spirevska, Elena Petrovska, Kristina Grncharoska, Milena Prculovska, Marijana Nikoloska, Hristina Shavrevska Dujovska, Vesna Tegova
Determination of Permitted Daily Exposure (PDE) implies reviewing all relevant data available, identification of the pharmacological and toxicological effects and the therapeutic dose that can cause specific and serious adverse effect and understanding and applying several adjustment factors to account for various uncertainties (Bagade and Krishna, 2014; EMA, 2014; Geremia, 2019; LeBlanc, 2000). Topical formulations are generally considered to be safe and less potent than oral or parenteral formulations (Aung and Aung, 2021; FDA, 2008). The minimum and maximum daily dose of topical formulations can be calculated based on the criteria of finger-tip unit (FTU) set by Long and Finely (1991) (Ovais and Lian, 2008). The resorption of Betamethasone during topical administration is low and it is unreliable to result in toxicological systemic side effects (Aung and Aung, 2021; EMA, 1999; FDA, 2008; Mahalingam et al., 2008). There are no evident long-term studied to assess the potential carcinogenicity and mutagenicity of topical corticosteroids (FDA, 2008). However, the literature data proved some teratogenic effects in animal studies after systemic administration (EMA, 1999; FDA, 2008). According to data obtained from animal studies on rabbits the minimal obtained PDE value, extrapolated on topical administration, is 33 μg/day and the calculated MACO value is 0.82 ppm, or 80.67 mg carryover in subsequent product (EMA, 1999; FDA, 2008). Betamethasone dipropionate is the 17,21dipropionate ester of Betamethasone, a synthetic corticosteroid with dominant glucocorticoid effect (EMA, 1999; Manassra et al., 2010). Betamethasone is extensively used for topical application in the treatment of various skin disorders and is available in several semisolid pharmaceutical dosage forms with strength of 0.05% (Aung and Aung, 2021; Manassra et al., 2010; Sweetman, 2011). The aim of this study was to develop and validate sensitive reversed-phase high performance liquid chromatography (RP-HPLC) method for quantification of Betamethasone residues from manufacturing equipment surface in cleaning validation processes.
{"title":"Determination of betamethasone residues on manufacturing equipment surfaces and PDE calculation in cleaning validation processes","authors":"Katerina Kochova, Irena Slaveska Spirevska, Elena Petrovska, Kristina Grncharoska, Milena Prculovska, Marijana Nikoloska, Hristina Shavrevska Dujovska, Vesna Tegova","doi":"10.33320/maced.pharm.bull.2023.69.03.116","DOIUrl":"https://doi.org/10.33320/maced.pharm.bull.2023.69.03.116","url":null,"abstract":"Determination of Permitted Daily Exposure (PDE) implies reviewing all relevant data available, identification of the pharmacological and toxicological effects and the therapeutic dose that can cause specific and serious adverse effect and understanding and applying several adjustment factors to account for various uncertainties (Bagade and Krishna, 2014; EMA, 2014; Geremia, 2019; LeBlanc, 2000). Topical formulations are generally considered to be safe and less potent than oral or parenteral formulations (Aung and Aung, 2021; FDA, 2008). The minimum and maximum daily dose of topical formulations can be calculated based on the criteria of finger-tip unit (FTU) set by Long and Finely (1991) (Ovais and Lian, 2008). The resorption of Betamethasone during topical administration is low and it is unreliable to result in toxicological systemic side effects (Aung and Aung, 2021; EMA, 1999; FDA, 2008; Mahalingam et al., 2008). There are no evident long-term studied to assess the potential carcinogenicity and mutagenicity of topical corticosteroids (FDA, 2008). However, the literature data proved some teratogenic effects in animal studies after systemic administration (EMA, 1999; FDA, 2008). According to data obtained from animal studies on rabbits the minimal obtained PDE value, extrapolated on topical administration, is 33 μg/day and the calculated MACO value is 0.82 ppm, or 80.67 mg carryover in subsequent product (EMA, 1999; FDA, 2008). Betamethasone dipropionate is the 17,21dipropionate ester of Betamethasone, a synthetic corticosteroid with dominant glucocorticoid effect (EMA, 1999; Manassra et al., 2010). Betamethasone is extensively used for topical application in the treatment of various skin disorders and is available in several semisolid pharmaceutical dosage forms with strength of 0.05% (Aung and Aung, 2021; Manassra et al., 2010; Sweetman, 2011). The aim of this study was to develop and validate sensitive reversed-phase high performance liquid chromatography (RP-HPLC) method for quantification of Betamethasone residues from manufacturing equipment surface in cleaning validation processes.","PeriodicalId":30550,"journal":{"name":"Makedonsko Farmacevtski Bilten","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135200757","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}
引用次数: 0
Development and validation of a RP-HPLC method for simultaneous determination of Ciprofloxacin and Ornidazole in a solid dosage formulation 建立反相高效液相色谱法同时测定固体剂型中环丙沙星和奥硝唑的含量
Pub Date : 2023-09-01 DOI: 10.33320/maced.pharm.bull.2023.69.03.114
Irena Slaveska Spirevska, Marjan Piponski, Tanja Bakovska Stoimenova, Kristina Grncharoska, Martina Miloshevska, Marijana Nikoloska, Maksim Osman Nikolov, Mimoza Sokleva Ivanova
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引用次数: 0
Risk reduction measures for counterfeit medicines in the supply chain 供应链中降低假药风险的措施
Pub Date : 2023-09-01 DOI: 10.33320/maced.pharm.bull.2023.69.03.115
Ana Grozdanoska Zdravevski, Nikola Simonovski, Nada Popstefanova
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引用次数: 0
Digital light processing 3D printing of Hydrochlorothiazide with modified release 改性氢氯噻嗪的数字光处理3D打印
Pub Date : 2023-09-01 DOI: 10.33320/maced.pharm.bull.2023.69.03.136
Teodora Tasevska, Ivana Adamov, Nikola Geskovski, Maja Simonoska Crcarevska, Katerina Goracinova, Svetlana Ibrić
Additive manufacturing also known as 3D printing gains more attention in scientific research due to its great advantages in simple and fast producing custom-designed products. 3D models created with computer-aided design (CAD) are presented to the printers and with different techniques, printing layer-by-layer desired products are made. Most used techniques in additive manufacturing are fused deposition modeling (FDM), material and ink jetting, sintering and vat polymerization techniques. Stereolithography (SLA) and digital light processing (DLP) are the most frequently used techniques in vat polymerization due to their advantages. In DLP technique, a digital micromirror is used for gradually exposing and solidifying a layer of liquid photopolymer solution following a layer-by-layer mechanism (Adamov et al., 2022; Zhu et al., 2020). Nowadays additive manufacturing finds its place in medicine by producing medical devices, implants, prostheses and medical equipment. 3D printing has enormous potential in personalized medicine as a result of different possibilities in production of dosage forms with desired shapes that contain one or more active compounds that can have different release profiles. 3D printing helps in overcoming the problem with permeability and solubility of some drugs and enables using drugs from different BCS classes. On that hand the aim of this study was to manufacture 3D printed tablets (printlets) with hydrochlorothiazide (HHT) as active pharmaceutical ingredient. HHT is commonly used in the treatment of high blood pressure and has low solubility, low permeability, exhibiting poor oral absorption (BCS Class IV) which makes it suitable as a model drug for 3D printlets.
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引用次数: 0
Design and optimization of a chitosan coated nanostructured lipid carriers of paliperidone 壳聚糖包被纳米结构脂质载体帕立酮的设计与优化
Pub Date : 2023-09-01 DOI: 10.33320/maced.pharm.bull.2023.69.03.137
Omer Yedikaya, Ulya Badilli, Gulin Amasya, Nurten Ozdemir
Schizophrenia is a chronic, severe psychiatric disease characterized by delusions and hallucinations, disorganized speech and behavior, social withdrawal, affective flattening and amotivation, and cognitive dysfunction (Lewis and Lieberman, 2000). Paliperidone (9-hydroxyrisperidone) (PAL), which is the main active metabolite of risperidone, belongs to the class of secondgeneration antipsychotics as a benzisoxazole derivative. In 2006, it was approved by the U.S. Food and Drug Administration for the acute and maintenance treatment of schizophrenia. Like other atypical antipsychotics, paliperidone acts by inhibiting serotonergic type 2 receptors (5-HT2A) and dopamine type 2 (D2) receptors in the brain (Chue and Chue, 2012). The brain, which is the most vital organ in our body, is protected by the Blood-Brain Barrier (BBB), a highly sophisticated brain support system. The BBB acts as a barrier that prevents the entry of unwanted substances from the bloodstream into the brain (Dong, 2018). As the BBB is also the primary obstacle to drug delivery to the brain, various approaches have been attempted to overcome this barrier (Bourganis et al., 2018). Intranasal administration, which is among the non-invasive strategies, offers a safe means of drug targeting to the brain, allowing direct passage to the central nervous system (CNS) without encountering the BBB and hepatic first-pass effect associated with oral administration (Keller et al., 2022). Numerous approaches have been investigated for nose-to-brain delivery of nanostructured lipid carriers (NLCs) which are composed of a mixture of solid and liquid lipids to form a matrix and stabilized with surfactants. The major disadvantage of intranasal administration is the mucociliary clearance, which reduces the residence time and consequently the drug absorption in the nasal cavity. This condition can be resolved through the surface modification of lipid nanoparticles using a cationic polymer such as chitosan (CH). Recent studies have reported that CH has mucoadhesive, penetrationenhancing properties across epithelial mucus and increases the duration of nasal retention (Bruinsmann et al., 2019). In light of above discussion, it was proposed to develop and evaluate CH-coated PAL loaded NLCs for brain delivery after intranasal administration to overcome the limitations. In this context, in vitro characterization studies were carried out by coating PAL-loaded NLC formulations with low molecular weight CH. The effect of different surfactants on CH coating was investigated.
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引用次数: 0
Cytotoxic potential of nanoliposomes on hCMEC/D3 and SH-SY5Y cell lines 纳米脂质体对hCMEC/D3和SH-SY5Y细胞系的细胞毒潜能
Pub Date : 2023-09-01 DOI: 10.33320/maced.pharm.bull.2023.69.03.135
Dushko Shalabalija, Ljubica Mihailova, Nikola Geskovski, Andreas Zimmer, Marija Glavas Dodov
It is well known that nanoliposomes (NLs) are considered as pharmacologically inactive vesicles, exhibiting minimal toxicity. Despite their biocompatibility and cell membrane structure similarity, it is important to highlight that their potential cytotoxicity is tightly related to the cell culture model, exposure time and dose as well as NLs physicochemical and surface properties including lipid composition, size, surface charge, PEGylation and others (Inglut et al., 2020; Syama et al., 2022). Therefore, the aim of this study was to investigate the cytotoxic potential of different formulations of NLs on two different cell culture lines
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引用次数: 0
PCA based screening for melamine adulteration in supplements for sport nutrition using vibrational spectroscopy tools 基于PCA的运动营养补充剂中三聚氰胺掺假的振动光谱筛选
Pub Date : 2023-09-01 DOI: 10.33320/maced.pharm.bull.2023.69.03.120
Kristina Shutevska, Ana Marija Bajatovska, Zoran Zivikj, Liljana Anastasova, Tanja Petreska Ivanovska, Nikola Geskovski
University Ss Cyril and Methodius, Faculty of Pharmacy, Institute of Applied Biochemistry, Mother Theresa 47, 1000 Skopje, Republic of North Macedonia University Ss Cyril and Methodius, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis, Mother Theresa 47, 1000 Skopje, Republic of North Macedonia University Ss Cyril and Methodius, Faculty of Pharmacy, Institute of Pharmaceutical Technology, Mother Theresa 47, 1000 Skopje, Republic of North Macedonia
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引用次数: 0
Air abrasion or silicatization – optimal conditioning method for zirconium dioxide prosthetic restorations due to the bonding of ceramic orthodontic brackets 空气磨损或硅化-二氧化锆修复体修复的最佳调理方法,由于陶瓷正畸托架的结合
Pub Date : 2023-01-01 DOI: 10.33320/maced.pharm.bull.2023.69.01.002
Stefan Kuzmanovski, Emilija Valjakova – Bajraktarova
According to the results obtained from the survey of the American Orthodontic Society conducted in 2015, the number of adult patients that requested orthodontic treatment was increased from 14% to 27% between 2010 and 2014. Because of the increased age of the patients, fixed orthodontic treatment is expected to be performed on restored teeth as well. The aim of the present study was to evaluate the bond strength of the ceramic brackets bonded to the zirconium dioxide ceramic surfaces after air abrasion or silicatization as a single method of mechanical conditioning and their combination with the use of a universal primer. In this research, zirconium dioxide CAD CAM blocks were used for the experimental phase. The following conditioning treatments were performed: group 1 - direct bonding of the ceramic brackets, group 2 – air abrasion with 29 μm aluminum oxide (Al 2 O 3 ), group 3 – silicatizaion with 30 μm aluminium oxide coated with silicium dioxide (Al 2 O 3 x SiO 2 ), group 4 - air abrasion combined with universal primer, group 5 – silicatization combined with universal primer. It was observed that the treatment from group 5 achieved the highest average value of shear bond strength SBS (MPa): 30 µm Al 2 O 3 x SiO 2 + universal primer - 9.32±1.29 (95%CI 8.3-10.3) MPa with min/max values of 7.6/11.1 MPa. In group 1, the lowest average value of SBS was established by 0.51±0.12 (95%CI 0.4-0.6) MPa with min/max values of 0.4/0.8 MPa. After evaluation of the obtained results, it was concluded that air abrasion followed by the application of a universal primer can be considered as an adequate method for conditioning the zirconium dioxide ceramic bonding surfaces.
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Makedonsko Farmacevtski Bilten
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