Teodora Dragan, L. Rus, A. Muntean, A. L. Vonica-Țincu, I. Tomuțǎ
{"title":"Quantitative characterisation of extended-release tablets with quetiapine using NIR-chemometric methods","authors":"Teodora Dragan, L. Rus, A. Muntean, A. L. Vonica-Țincu, I. Tomuțǎ","doi":"10.37897/rjphp.2021.2.4","DOIUrl":"https://doi.org/10.37897/rjphp.2021.2.4","url":null,"abstract":"This study aims to develop and validate NIR-chemometric methods for quantifying the API (quetiapine) and two excipients in extended-release tablets without sample preparation. The calibration samples were prepared following an experimental design with three variables (quetiapine, HPMC and microcrystalline cellulose) and five levels (concentration 80-90-100-110-120% of API). The validation set included three concentration levels (90-100-110%). The best calibration algorithms have used the same pre-treatment method (SNV), and different factors: 7 PLS factors (R² -0,966 and RMSEP-6,84) for quetiapine, 8 PLS factors (R²-0,927 and RMSEP 6,84) for HPMC and 3 PLS factors (R²-0,983 and RMSEP-7,26) for microcrystalline cellulose. The methods were fully validated according to the ICH guidance using these calibration models. Regarding the trueness of the methods, the recovery was between 98.51 and 99.43 for quetiapine, between 98.61 and 100.85 for HPMC, and between 100.61 and 101.78 for microcrystalline cellulose. According to data obtained, the accuracy profile was ± 5 for quetiapine and HPMC, and ± 6 for microcrystalline cellulose. Linearity profile was also in establish intervals at accuracy and the R2 value was 0.983 for quetiapine, 0.948 for HPMC and 0.997 for microcrystalline cellulose. In conclusion, the developed NIR-chemometric methods have suitable reproducibility, accuracy, linearity and can be used for quantitative characterisation of extended-release tablets with quetiapine, with any sample preparation.","PeriodicalId":124207,"journal":{"name":"Romania Journal of Pharmaceutical Practice","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115800706","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}
{"title":"The cannabinoids – important therapeutic approach in the field of oncology","authors":"N. Blebea, L. Bucur, S. Negreș","doi":"10.37897/rjphp.2021.2.1","DOIUrl":"https://doi.org/10.37897/rjphp.2021.2.1","url":null,"abstract":"Oncological diseases are the most common cause of death worldwide, it is estimated that 25% of the population will face the diagnosis of cancer during life. Phytochemicals such as cannabinoids (CBs) have been used in various branches of medicine for their properties, and the discovery of the anti-tumor, anti-emetic and anti-inflammatory effects of some of these substances has encouraged their use in oncology. Phytocannabinoids, cannabidiol (CBD) and Δ-9-tetra-hydrocannabinol (THC), have numerous anti-emetic, analgesic, orexigenic, anti-inflammatory / immunosuppressive pharmacodynamic effects. In recent years, studies have been aimed at evaluating their efficacy as antineoplastic agents. Much in vivo and in vitro research has demonstrated the efficacy of CBs on certain tumor cell lines, highlighting their potential role in the complementary treatment of cancer. This paper suggests that exploring the molecular mechanisms induced by CBs in cancer cells may contribute to the development of effective treatments in oncological diseases.","PeriodicalId":124207,"journal":{"name":"Romania Journal of Pharmaceutical Practice","volume":"70 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126372180","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}
{"title":"Phytochemical analysis of herbal teas containing caffeic acid","authors":"Mihai Todoran, L. Hanga, D. Benedec","doi":"10.37897/rjphp.2021.2.3","DOIUrl":"https://doi.org/10.37897/rjphp.2021.2.3","url":null,"abstract":"Objectives. The present analysis was to investigate the content of caffeic acid derivatives, antioxidant activity, and the presence of caffeic acid in alcoholic extracts obtained from 16 simple teas from the following medicinal plants: Vaccinium mуrtilluѕ, Camеllia ѕinеnѕiѕ, Coffea arabica, Mеlіssa οffіcіnalіs, Οcіmum basіlіcum, Rοsmarіnus οffіcіnalіs, Salvіa οffіcіnalіs, Ηyssοрus οffіcіnalіs, Αrtеmіsіa absіntһіum, Cynara scοlymus, Calendula officinalis, Cοrіandrum satіvum, Fοеnіculum vulgarе, Carum carvі, Rοsa canіna, Crataеgus mοnοgyna. Materials and methods. The presence of caffeic acid was evaluated using the thin layer chromatography method (TLC). The total content of phenylpropanoids from the medicinal herbs alcoholic extracts was determined using a spectrophotometric method. Outcomes. Results were in the range of 0.046-2.426% caffeic acid derivatives (CAE%). The antioxidant properties were measured using the DPPH radical scavenging mechanism. The results were found to be in the range of 63.93% and 0.38% inhibition level (I%). The greatest antioxidant activity was measured for Camellia sinensis (I = 45.54%), followed by Vaccinium myrtillus (I = 50.289%). Conclusions. In this paper it was shown that these medicinal plants are rich in caffeic acid derivatives with antioxidant action capitalized in the prevention of serious diseases.","PeriodicalId":124207,"journal":{"name":"Romania Journal of Pharmaceutical Practice","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133913463","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}
C. Lungu, C. Mihai, G. Vochița, Daniela Gherghel, S. Miron, A. C. Aprotosoaie, A. Miron
{"title":"Cytotoxic activity of Pinus cembra L. needle extract: A preliminary study on HeLa cell line","authors":"C. Lungu, C. Mihai, G. Vochița, Daniela Gherghel, S. Miron, A. C. Aprotosoaie, A. Miron","doi":"10.37897/rjphp.2021.2.5","DOIUrl":"https://doi.org/10.37897/rjphp.2021.2.5","url":null,"abstract":"The aim of this study was to investigate the cytotoxic effects of a hydromethanolic extract obtained from cembran pine needles in HeLa cell line. In this respect, the effects of needle extract on protein synthesis, viability, proliferation and cell cycle in HeLa cells were evaluated after 48 h treatment. Cembran pine needle extract dose-dependently decreased protein synthesis in HeLa cells causing 44.26% reduction in protein synthesis at 100µg/ml. At 25, 50 and 100µg/ml, it increased cell death in comparison with the control (20.99%, 21.49% and 23.63%, respectively vs. 9.83%). In addition, at 100µg/ml, cembran pine needle extract showed a remarkable antiproliferative effect whereas at 25 and 50µg/ml, it induced sub-G1 phase cells accumulation (11.68 ± 0.81% and 14.69 ± 0.56%, respectively in comparison with control, 6.03 ± 0.55%), an indicator of proapoptotic effects. Taken together, these results indicate that cembran pine needles are a source of compounds with antitumor potential which needs to be further investigated and exploited.","PeriodicalId":124207,"journal":{"name":"Romania Journal of Pharmaceutical Practice","volume":"124 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134072187","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. Muntean, Alina Porfire, C. Alecu, Sonia Iurian, T. Casian, Alexandru Gâvan, I. Tomuțǎ
{"title":"A non-destructive NIR spectroscopic method combined with chemometry for simultaneous assay of paracetamol and caffeine in tablets","authors":"D. Muntean, Alina Porfire, C. Alecu, Sonia Iurian, T. Casian, Alexandru Gâvan, I. Tomuțǎ","doi":"10.37897/rjphp.2021.2.2","DOIUrl":"https://doi.org/10.37897/rjphp.2021.2.2","url":null,"abstract":"The use of near infrared (NIR) spectroscopy to predict the concentration of two active pharmaceutical ingredients (APIs), paracetamol and caffeine, in intact tablets, has been evaluated in this study. A partial least squares (PLS) regression model was developed using spectral data obtained on a calibration set consisting of 28 formulations containing 80, 90, 100, 110 and 120% of each API. Regression models were developed for each API, both using un-processed spectral data as well as after applying various spectra pre-processing methods. Cross-validation was used to select best calibration model. The selected model was validated in terms of precision, trueness, accuracy and linearity in a concentration ranging from 90 to 110% of the targeted APIs concentration. The applicability of the method was tested on tablets containing 300 mg paracetamol and 30 mg caffeine as targeted composition, and the API content predicted by the proposed NIR-chemometric method was not statistically different from the one obtained by HPLC method, used as a reference method. Thus, the method presented in the current paper is a step forward towards the implementation NIR as useful tool for monitoring the manufacturing process of fixed-dose combination tablets with paracetamol and caffeine.","PeriodicalId":124207,"journal":{"name":"Romania Journal of Pharmaceutical Practice","volume":"57 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117063489","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}
{"title":"A brief analysis of parenteral medicines delivered in community pharmacies for off-label use in pediatric","authors":"E. Dinte, D. Matei, Teodora Zehan","doi":"10.37897/rjphp.2021.2.6","DOIUrl":"https://doi.org/10.37897/rjphp.2021.2.6","url":null,"abstract":"Objectives. The current paper aims to obtain an overview regarding the use of parenteral medicines recommended for the pediatric sector and delivered in Romanian community pharmacies. Materials and methods. A retrospective observational study was developed, based on a questionnaire which was distributed in community pharmacies in Romania. Results. The parenteral medicines were delivered in 100 community pharmacies which partake in the study, and which are distributed in 22 counties in Romania. The total number of parenteral medicines considered in the study were aimed for pediatric use and they represented approximately 5% of the total number of medicines prescribed for children delivered in the respective pharmacies. Of these, most of them are medicines authorized for adults, delivered for off-label use, by other routes of administration, in their original form or reformulated in the form of other pharmaceutical preparations, during the compounding activity in the pharmacy. Conclusions. The parenteral medications most prescribed for pediatric use and delivered in community pharmacies are injectable solutions and powders for parenteral use. They are used as off-label medication in children, by other routes of administration, both to capitalize the therapeutic action of the active principle, and also as a vehicle for other medications with oral route or external route of administration.","PeriodicalId":124207,"journal":{"name":"Romania Journal of Pharmaceutical Practice","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130446336","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}