Drug Preparation Research Articles

The use of propolis in ointment ingredient for the treatment of dermatophytosis infection

Dermatophytosis in animals is very important since it is zoonotic. Propolis is a promising natural compound against pathogenic fungi since there is an increasing need to discover less expensive, more natural, and more accessible treatments. The purpose of this study was to evaluate propolis as an anti-dermatophyte and topical drug preparation against Trichophyton mentagrophytes. Propolis was tested for its antifungal properties at various concentrations using the diffusion method. The ointment was applied to the rabbit with dermatophytosis after being prepared by combining the ointment base with 10% propolis. The result demonstrated that propolis was able to inhibit the growth of Trichophyton mentagrophytes which was indicated by a clear zone around the disc. Propolis ointment helped lessen inflammation more than Miconazole 2% at severe lesions, according to in vivo trials on rabbits, while the two ointment’s healing times were nearly identical. According to the findings, propolis is a promising ointment ingredient for the treatment of dermatophytosis.

Explanation and prediction for the product of trehalose dihydrate selective dehydration process using mid-frequency Raman difference spectra

Explanation and prediction for the product of trehalose dihydrate dehydration process was realized in this work. β form is the thermodynamic dehydration product of trehalose dihydrate. And α form is the kinetic dehydration product of trehalose dihydrate, which was analyzed by low-frequency Raman spectra, mid-frequency Raman difference spectra and IR difference spectra, and the analysis results confirmed that the crystal structure of trehalose dihydrate and α form are similar. The selective dehydration process from trehalose dihydrate to α form is due to their similar short-range orders. Amorphous trehalose is the uncontrollable dehydration product of trehalose dihydrate due to the collapse of water channels. The dehydration product of trehalose dihydrate by freeze-drying was a mixture of α form and amorphous phase, and the content of amorphous trehalose in the freeze-drying product increases with the decrease of the particle size of dihydrate. Study on the dehydration principle of organic hydrates will guide the preparation, storage and desolvation of drugs and foods.

High throughput preparation and particle size control strategy of nano apigenin by a scale-up microreactor

The particle size and distribution have a significant impact on the bioavailability and stability of insoluble drugs. A scale-up microreactor system based on an ellipsoidal baffle mixer was proposed for the preparation and tuning of insoluble drug. As an important bioactive substance, apigenin was used as a representative of insoluble drugs and was subject to particle size regulation by this system. The effects of surfactant, flow rate ratio, flow rate and solvent concentration on apigenin particle size were studied by solvent/anti-solvent method experiments and the transport process of apigenin molecules in the microreactor was simulated numerically by computational fluid dynamics (CFD). Furthermore, the particle size regulation model of apigenin in the system was built by using the π theorem of fluid mechanics. Finally, under the conditions of optimal parameters, the minimum particle size of nano apigenin (D50) was 116 nm, the recovery was 95.3 % and the purity was increased by 0.88 %. This study demonstrates the feasibility of a highly efficient, high-throughput, particle size controllable preparation of nanomedicine.

A Comparative Analysis of Phytochemicals, Metal Ions, Volatile Metabolites in Heart Wood, Stem Bark and Leaves of Salix alba L. along with in Vitro Antioxidant, Antacid, Antimicrobial Activities for Sake of Environment Conservation by Substitution of Stem Bark With Leaf.

The genus of Salix is used in food, medicine and nutraceuticals, and standardized by using the single marker compound Salicin only. Stem bark is the official part used for the preparation of various drugs, nutraceuticals and food products, which may lead to overexploitation and damage of tree. There is need to search substitution of the stem bark with leaf of Salix alba L. (SA), which is yet not reported. Comparative phytochemicals viz. Salicin, Procyanidin B1 and Catechin were quantified in the various parts of SA viz. heart wood (SA-HW), stem bark (SA-SB) and leaves (SA-L) of Salix alba L.by using newly developed HPLC method. It was observed that SA-HW and SA-L contained far better amount of Salicin, Procyanidin B and Catechin as compared to SA-SB (SA-HW~SA-L≫SA-SB). Essential and toxic metal ions of all three parts were analysed using newly developed ICP-OES method, where SA-L were founded as a rich source of micronutrients and essential metal ions as compared to SA-SB and SA-HW. GC-MS analysis has shown the presence of fatty acids and volatile compounds. The observed TPC and TFC values for all three parts were ranged from 2.69 to 32.30 mg GAE/g of wt. and 37.57 to 220.76 mg QCE/g of wt. respectively. In DPPH assay the IC50 values of SA-SB, SA-HW, and SA-L were 1.09 (±0.02), 5.42 (±0.08), and 8.82 (±0.10) mg/mL, respectively. The order of antibacterial activities against E. coli, S. aureus, P. aeruginosa, and B. subtilis strains was SA-L>SA-HW>SA-SB with strong antibacterial activities against S. aureus, and B. subtilis strains. The antacid activities order was SA-L>SA-SB>SA-HW. The leaves of SA have shown significant source of nutrients, phytochemicals and medicinal properties than SA-HW and SA-SB. The leaves of SA may be considered as substitute of stem bark to save the environment or to avoid over exploitation, but after the complete pharmacological and toxicological studies.

Drying Methods Affecting the Antioxidant Activity of Turmeric Crude Drug

Turmeric is commonly a spice with many benefits in improving health, including antioxidants, anti-inflammatory and antimicrobial properties. The preparation of turmeric crude drug usually uses conventional sun drying. However, the quality of crude drugs is uncontrollable. The alternative using a modern drying process may affect the antioxidant properties of the final crude drug. This research aims to investigate the effect of drying methods (cabinet drying at 30oC and 70oC, infrared (IR), and conventional sun drying) on the antioxidant activity of turmeric crude drugs. The moisture content and its chemical compounds, including Total Phenolic Content (TPC) and Total Flavonoid Content (TFC), were also investigated. Antioxidant activity was measured using DPPH free radical scavenging and Feri Reducing Antioxidant Power (FRAP) method. The results showed that the moisture content of dried turmeric samples from cabinet drying at 70 C and sun drying was less than 10%. TPC of all dried turmeric from modern drying methods was significantly higher than conventional sun drying and the same as TFC results, except for the sample from the IR method. The antioxidant activity of dried curcumin from IR drying was significantly higher than that of another sample in the FRAP method. However, the higher antioxidant of dried turmeric using the DPPH free radical scavenging showed in dried turmeric from cabinet drying at 70 C and sun drying. The results of the antioxidant activity of the dried turmeric crude drug did not correlate with the TPC and TFC data as predicted using Pearson’s Correlation. Thus, it can be concluded that the drying methods influenced the antioxidant activity of turmeric crude drug, and it did not correlate with phenolic and flavonoid content.

Modern methods for identification and quantification of cardiac glycosides

Scientific relevance. Cardiac glycosides have been used in medicine for over two centuries. Current studies suggest that biologically active substances from this group can be used to treat not only heart conditions but also viral infections, cancers, and other diseases. Therefore, quality control methods for cardiac glycosides are becoming increasingly relevant.Aim. Based on a review of Russian and international quality standards, as well as up-to-date scientific data, this study aimed to identify promising methods for the identification and quantification of cardiac glycosides in herbal drugs and herbal medicinal products, as well as to evaluate the possibility of substituting physicochemical methods for biological methods.Discussion. The methods that are currently used to standardise cardiac glycosides are either not selective or require laboratory animals (biological test systems). According to a study of pharmacopoeial methods for the identification of cardiac glycosides in herbal drugs and herbal medicinal products, chemical identification tests and thin-layer chromatography continue to be relevant. Quantitative testing of herbal drugs and extracts uses biological and non-selective (spectrophotometry) methods, whereas chromatography is described only in general and individual monographs for herbal drug preparations containing individual cardiac glycosides and medicinal products containing these preparations. Upon analysing quality standards and scientific publications, the authors identified potentially promising methods for the quantification of cardiac glycosides in herbal drugs, herbal drug preparations, and herbal medicinal products, namely chromatographic methods.Conclusions. Reverse-phase high-performance liquid cjromatography (HPLC) with spectrophotometric detection is the most suitable method for pharmacopoeial analysis. The development of an HPLC-based analytical procedure to determine the cardiac glycoside content will provide an opportunity to advance from biological or non-selective methods to more ethical and selective up-to-date techniques.

A Scoping Review of Australian Literature on People Who Use MDMA and Their Harm Reduction Practices

Background: Discourses around MDMA are often predominantly concerned with identifying risk and characterizing harm. Reluctance from Australian governments to reform drug policy and implement harm reduction services has created a policy and service gap, and it is therefore pertinent to consider how people who use MDMA mediate potential harms, and how this knowledge can inform approaches to drug use and policy reform. This community-led scoping review aimed to identify Australian literature on the practices of harm reduction strategies by people who use MDMA. Methods: Seven topic-specific and multidisciplinary databases were searched in February 2023 in line with conventional scoping review methodology. Eligible articles were published from 2002 onwards, reported on the voices of people who use MDMA as primary evidence within the context of Australia, and included at least one strategy to reduce harm. Data were analyzed by drawing on conventional content analysis and thematic analysis frameworks. Results: Twenty-three peer-reviewed and gray literature sources were included. Five key themes were identified on how people mediate harms and enhance the pleasurable aspects of MDMA use: drug consumption practices, planning and preparation, testing drugs, accessing health services, and community care practices. Conclusion: The results suggest that people who use MDMA take care to identify and reduce unwanted harms. The way people who use MDMA make decisions around drugs is mediated by peer groups and online technologies, as well as broader social and cultural contexts of drug use and drug prohibition. More qualitative, participatory, and action research projects are recommended to accurately reflect the views and needs of people who use MDMA and meaningfully shape service reform.

Systematic Review: Teknologi Needle Free Jet Injection Insulin (NFJI) Efektif Mengontrol Konsentrasi Glukosa Pada Penderita Diabetes Melitus Tipe 2

Needle-free jet injection (NFJI) is a needleless method for insulin delivery in type 2 diabetes mellitus (T2DM) patients. This study evaluates NFJI's effectiveness in controlling blood glucose. In this study, we conducted a systematic review following the PRISMA guidelines, searching six databases (EBSCO Host, ProQuest, PubMed, ScienceDirect, Scopus, and Web of Science). The search yielded a total of 379 articles. We used the following keywords: "Jet injection," "Injection Ject," "Needle-Free Injection," "Insulin," "Diabetes Mellitus Type 2," "Diabetes Type 2," "Type 2 Diabetes," and "Blood Glucose" to identify relevant studies. The aim was to investigate the effectiveness of insulin jet NFJI in controlling blood glucose levels in T2DM patients. We assessed the risk of bias using the Joanna Briggs Institute (JBI) critical appraisal tools checklist. Out of the 379 articles identified, only seven met the inclusion criteria. Among these, six articles employed the Randomized Controlled Trial (RCT) method, while one article used a quasi-experimental design. Respondents in the study consisted of T2DM patients who were divided into two research groups: the intervention group and the control group. The results indicated a significant difference in blood glucose control values between the two groups. NFJI insulin method significantly improves glucose control. It offers advantages like painless, scar-free, low drug preparation, reusability, ease of use, and minimal disease transmission. Recommended for long-term T2DM treatment.

AN UP-TO-DATE REVIEW: MICROSPHERES AS A NEW DRUG DELIVERY SYSTEM

The application of microsphere systems in drug preparations has seen a significant increase in recent years for various purposes. Microsphere systems can be utilized in a range of drug preparations, utilizing polymer types that are appropriate for the intended release target. Microspheres offer numerous benefits and can be used in various applications, including spacer applications, medication administration, and medical diagnostics. Microspheres have minimal negative effects, a more extended therapeutic effect, require fewer doses, and provide more consistent medication absorption. Additionally, they are adaptable, offer effective encapsulation, and are cost-effective. This overview was compiled to provide an up-to-date summary of the latest developments in new drug delivery systems utilizing microsphere dosage forms. Literature from Scopus, ScienceDirect, and PubMed from 2019 to 2022 was searched to provide the latest information. The use of microsphere systems is categorized into various new drug delivery routes, including gastroretentive, colon, nasal and pulmonary, parenteral, ocular, and topical applications.

Cocrystal screening of anticancer drug p-toluenesulfonamide and preparation by supercritical antisolvent process

p-Toluenesulfonamide (PTS) is a new anticancer drug in development. Its poor dissolution behavior complicates the design and development of the formulation process. The present study aimed to improve the dissolution profile of PTS by using a cocrystal engineering approach. Cocrystal screening of PTS with commonly used coformers was investigated, including 4,4′-bipyridine, nicotinamide, isonicotinamide, and sulfacetamide. According to the results of PXRD, FTIR, DSC, and elemental analyzer, a cocrystal of PTS with coformer 4,4′-bipyridine in a stoichiometric ratio of 2:1 was first disclosed. The single crystal of this cocrystal was then prepared, and the crystallographic data were identified and reported. In addition, an intensified crystallization technique, the supercritical antisolvent (SAS) process, was applied to produce this cocrystal using CO2 as the antisolvent. The effect of SAS process parameters was studied, including the operating temperature, operating pressure, solution flow rate, and nozzle diameter. Optimized SAS conditions were proposed for cocrystal preparation, yielding a total powder recovery of approximately 70% and a purity level of up to 90%. Furthermore, according to the results of the dissolution rate study, the dissolution rate of SAS-produced cocrystal was enhanced considerably about 375 times compared to the physical mixture.

Degree of technological implementation in intravenous chemotherapy management in hospitals of the Autonomous Community of Madrid

ObjectiveTo understand the degree of technological implementation in the processes of preparation and administration of cytostatics drugs that is available in those hospitals of the Autonomous Community of Madrid where intravenous chemotherapy is prepared. MethodA descriptive observational study through the completion of a survey targeted to the staff responsible for the preparation of this type of treatments. ResultsThe degree of implementation of assisted electronic prescription is high, there is a medium degree in the case of bar code reading technology, and low in terms of vial re-labelling and gravimetric and voice control for preparation. ConclusionsThere is a large room for improvement regarding traceability in the process of preparation and administration of intravenous chemotherapy.

Comparison of Mini-Tablets and Pellets as Multiparticulate Drug Delivery Systems for Controlled Drug Release

Mini-tablets made into hard capsules or administered using special dosing units, as well as pellets in hard capsules or compressed into tablets, offer the advantages of multiparticulate drug delivery systems and are suitable for controlled drug release using polymer coatings. Four different kinds of solid drug preparations were manufactured and investigated concerning drug release. Inert pellets were coated with the model drug sodium benzoate and, in a second step, with the insoluble polymer ethylcellulose. The coated pellets were compressed into mini-tablets and into normal tablets. Another kind of mini-tablet was compressed from a sodium benzoate compression mixture and finally coated with ethylcellulose. The coating of the tablets was performed using fluidized bed technology. The sodium benzoate release plots of the coated pellets show a lag time and retarded release according first-order kinetics. The mini-tablets and normal tablets compressed from pellets release sodium benzoate according to first-order kinetics as well, but without the lag time due to distinct ethylcellulose layer destruction during tableting. The release is retarded with increasing ethylcellulose layer thickness on directly compressed mini-tablets. The different formulations of coated pellets, mini-tablets, and normal tablets offer a broad choice for variable drug release kinetics depending on the biopharmaceutical and pharmacological requirements.

Development of a carbocysteine 10% + urea 5% cream for the topical treatment of congenital ichthyosis

ObjectiveOptimization of a topical formula of N-acetylcystelne and urea for the topical treatment of ichthyosis. MethodWe reviewed the chemical structure of the N-acetylcysteine molecule and its metabolic processes. A search was conducted of possible alternative molecules with a chemical structure similar to that of N-acetyl- cysteine that could have improved organoleptic properties. The following databases were used: PubChem®, Botplus®, the Drug Information Centre of the Spanish Agency of Medicines and Medical Devices. The molecule selection criteria were as follows: structural similarity, same therapeutic group, same mechanism of action, same authorized indication, absence of unpleasant smell, and being marketed as raw material in Spain. To complete the pharmaceutical development and validation of the compound, several tests and controls were conducted following the emulsion production procedure of the National Formulary. In order to establish the validity period, we followed the recommendations of the “Guide to Good Drug Preparation Practices in Hospital Pharmacy Services”. ResultsN-acetylcysteine has a free sulfhydryl group, which is responsible for its smell, and undergoes deacetylation. Its main metabolites are cystine and cysteamine. The following molecules were assessed: cystine, cyst eamine, carbocisteine, cysteine and methionine. Carbocisteine was selected because it met all the selection criteria. Carbocisteine is practically insoluble in water and soluble in mineral acids and alkaline hydroxides solutions. Unlike N-acetylcysteine, it does not have a fetid smell. It reaches its maximum stability at pH 5.5 to 7.5. The composition of the compound (100 g) was as follows: carbocisteine (10 g), urea (5 g), glycerine (15 g), water (44 mL), sodium hydroxide (1 g), and Neo PCL® Oil/Water (O/W) (25 g). It has an expiration period of 30 days. The organoleptic characteristics, emulsion type, and pH remained stable within the established expiration period. The carbocisteine compound has been incorporated into the group of topical treatments available for the treatment of patients with ichthyosis in our hospital. ConclusionsThe carbocisteine molecule is a good therapeutic alternative that lacks the unpleasant smell of N-acetylcysteine. The carbocisteine compound developed has been included as topical treatment for ichthyosis due to its tolerability, acceptability, and effectiveness in the treatment of patients affected by this genodermatosis.

A method for obtaining aqueous and dry ethanol extracts of grass (a mixture of flowers with leaves) and a stalk of St. John's wort (Hypericum perforatum L.) with inhibitory activity on the replication of the SARS‐CoV‐2 coronavirus in vitro

Aim. In vitro evaluation of the inhibitory activity of aqueous extracts and dry ethanol extracts of St John's wort (Hypericum perforatum L.) on the replication of SARS-CoV-2 according to three experimental schemes – direct inactivation (neutralisation) of the virus as well as "prevention" and "treatment" of cells.Materials and Methods. The laboratory strain SARS-CoV-2/human/RUS/Nsk-FRCFTM-1/2020 was passed on Vero cell culture. Water extracts and dry ethanol extracts of parts of H. perforatum L. collected during the flowering period in the Novosibirsk region were prepared. Dry extracts were dissolved in DMSO. Comparison samples are dry ethanol extracts of chaga, cloves and black tea.Results. It is shown that the aqueous extract of grass (a mixture of flowers with leaves) of H. perforatum L. with direct inactivation of the virus it is active in dilution of 1/4096. For the dry ethanol extract of the herb H. perforatum L., 50 % effective concentrations (EC50) were found equal to 2.44±0.87; 8.79±1.91 and 14.65±1.91 μg/ml respectively with direct inactivation as well as according to the "preventive" scheme and with the "treatment" of cells. Taking into account cytotoxicity, as well as in comparison with control samples, the values of selective indices (SI50) of the studied herbal preparations during direct inactivation were higher than with other experimental schemes and were distributed as follows (in descending order): 204.92; 153.68; 115.27; 32.01 and 21.33 for dry ethanol extracts of black tea from India, cloves, herbs, a mixture of flowers with leaves, of H. perforatum, chaga and the stems of H. perforatum respectively. The HPLC method has shown that the ethanol extract of the herb H. perforatum L. contains a greater amount of flavonoids than the extract of stems. Nevertheless, antiviral activity was also detected for the extract of stems of this plant with EC50 equal to 14.65±1.91; 78.13±20.05 and 117.19±15.31 μg/ml (according to three experimental schemes), respectively.Conclusion. For the preparation of antiviral drugs the whole plant of H. perforatum L., including stems, can be used as raw materials.

Anti-CD4 antibody and dendrimeric peptide based targeted nano-liposomal dual drug formulation for the treatment of HIV infection

AimsDevelopment and characterization of LAM and DTG loaded liposomes conjugated anti-CD4 antibody and peptide dendrimer (PD2) to improve the therapeutic efficacy and to achieve targeted treatment for HIV infection. Main methodsA 2-level full factorial design was used to optimize the preparation of dual drug loaded liposomes. Optimized dual drug loaded ligand conjugated liposomes were assessed for their cytotoxicity and cell internalization on TZM-bl cells. Anti-HIV efficiency of the dual drug loaded liposomes were screened for their inhibitory potential in TZM-bl cells and the activities were confirmed using Peripheral Blood Mononuclear Cells (PBMCs). Key findingsThe particle size of the optimized dual drug-loaded liposomes was 133.7 ± 4.04 nm, and the spherical morphology of the liposomes was confirmed by TEM analysis. The entrapment efficiency was 34 ± 4.9 % and 54 ± 1.8 % for LAM and DTG, respectively, and a slower in vitro release of LAM and DTG was observed when entrapped into liposomes. The cytotoxicity of the dual drug loaded liposomes was similar to the cytotoxicity of free drug solutions. Conjugation of anti-CD4 antibody and PD2 did not significantly influence the cytotoxicity but it enhanced the uptake of liposomes into the cells. Conjugated dual drug loaded liposomes exhibited better HIV inhibition with lower IC50 values (0.0003 ± 0.0002 μg/mL) compared to their free drug solutions (0.002 ± 0.001 μg/mL). The liposomal formulations have shown similar activities in both screening and confirmatory cell-based assays. SignificanceThe results demonstrated the cell targeting ability of dual drug loaded liposomes conjugated with anti-CD4 antibody and peptide dendrimer. Conjugated liposomes also improved anti-HIV efficiency of LAM and DTG.

Comparative phytochemical profiling of different parts of Saraca asoca

Saraca asoca is a plant that is widely used in Ayurveda drug preparations and is most used in Ashokarista. The bark of the plant is used and the removal of the bark from the plant is a destructive mode of material collection and it eventually kills the plant leading to resource scarcity. The present study made an attempt to assess the possibility of using other plant parts of S. asoca in place of bark. Major phytochemicals including alkaloids, carbohydrates, phenols, glycosides, quinones, coumarins, terpenoids, flavonoids, and tannins, were observed to be present in bark, young stem and leaf samples with varying levels. Saponins and anthocyanins were absent in bark and young stem samples, however present in leaf samples. The study showed a completely different GC–MS profile indicating the presence of different volatile molecules in different plant parts. The HPTLC fingerprint of different plant parts of S. asoca represents the characteristic markers of this herb. The study provided the quantitative evaluation of gallic acid present in the bark, young stem and leaves of S. asoca. The leaves of S. asoca are found to have maximum content of gallic acid compared to bark and young stem. The study concludes that the substitution of bark with young stems and leaves may not be a viable option considering their phytochemical constitution. However, the increased level of gallic acid in leaves can be considered as a promising option, wherein the activity of gallic acid is modulating the drug action.

Plant-Derived Vesicles: A New Era for Anti-Cancer Drug Delivery and Cancer Treatment.

Lipid-structured vesicles have been applied for drug delivery system for over 50 years. Based on their origin, lipid-structured vesicles are divided into two main categories, namely synthetic lipid vesicles (SLNVEs) and vesicles of mammalian origin (MDVEs). Although SLNVEs can stably transport anti-cancer drugs, their biocompatibility is poor and degradation of exogenous substances is a potential risk. Unlike SLNVEs, MDVEs have excellent biocompatibility but are limited by a lack of stability and a risk of contamination by dangerous pathogens from donor cells. Since the first discovery of plant-derived vesicles (PDVEs) in carrot cell supernatants in 1967, emerging evidence has shown that PDVEs integrate the advantages of both SLNVEs and MDVEs. Notably, 55 years of dedicated research has indicated that PDVEs are an ideal candidate vesicle for drug preparation, transport, and disease treatment. The current review systematically focuses on the role of PDVEs in cancer therapy and in particular compares the properties of PDVEs with those of conventional lipid vesicles, summarizes the preparation methods and quality control of PDVEs, and discusses the application of PDVEs in delivering anti-cancer drugs and their underlying molecular mechanisms for cancer therapy. Finally, the challenges and future perspectives of PDVEs for the development of novel therapeutic strategies against cancer are discussed.

A comparative study of contamination in three closed systems for the preparation of hazardous drugs through simulations with fluorescein

ObjectiveThe objective of this study was to compare the environmental contamination generated during the preparation of cytostatic agents using three different methods through simulations using fluorescein, and the time required for preparation of each method. MethodA comparative study of the processing of fluorescein mixtures using three types of closed systems was conducted at the centralized unit for hazardous drugs of the Pharmacy Department of a General Teaching Hospital. Environmental contamination was detected in critical points of connection, and in splashes produced at any other points. The main variable was qualitative detection of contamination through ultraviolet light when three methods were compared (method A: ChemoClave®, method B: SmartSite® valve and Texium® connector, method C: PhaSealTM with BD luer extension). A final number of 60 mixtures were prepared to detect differences of at least 5%. ResultsQualitative contamination at the critical points during preparation, was seen in groups A and B for every mixture that was processed. No contamination at all in critical points was seen in any of the mixtures prepared using PhaSealTM. Statistically significant differences were found between arms A and C (p < 0.001) and arms B and C (p < 0.001); no differences were found between arms A and B. ConclusionsThe combination of PhaSealTM system in conjunction with the BD luer extension for administering hazardous drugs from a tree modality system has been shown to be the system with the lowest level of contamination during processing without increasing the time required for preparation of the mixture.

Cost-minimization analysis of individually tailored or fixed-scheduled rituximab maintenance therapy for antineutrophil-cytoplasm antibody associated vasculitides

ObjectivePatients included in MAINRITSAN2 trial received either an individually tailored or a fixed-schedule therapy with rituximab as maintenance treatment of antineutrophil cytoplasm antibody associated vasculitides. The aim of this study was to compare the real-world costs of both arms. MethodWe performed a cost-minimization analysis over an 18-month time period, estimating direct costs –drug acquisition, preparation, administration and monitoring costs- from the health system perspective. We conducted a number of additional sensitivity analyses with different assumptions for unit costs, with further scenarios including the interquartile range of the tailored-infusion group results, different number of monitoring visits for fixed-schedule regimen and different number of reported severe adverse events. A cost-effectiveness analysis was conducted as a sensitivity analysis using the absolute difference in the relapse rate and its confidence interval. ResultsThe individually tailored maintenance therapy with rituximab was shown to be a cost-saving treatment compared to the fixed-schedule therapy (6,049 euros vs. 7,850 euros). Savings resulted primarily from lower drug acquisition costs (2,861 vs. 4,768 euros) and lower preparation and administration costs (892 vs. 1,486 euros), due to the lower number of infusions per patient in the tailored-infusion regimen. The tailored-infusion regimen presented higher monitoring costs (2,296 vs. 1,596 euros). This result was replicated in all assumptions considered in the sensitivity analysis of cost-minimization approach. ConclusionsFrom the perspective of the health system, the tailored-therapy regimen seems to be the preferable option in terms of direct costs. Further studies assessing all the effects and costs associated to vasculitides maintenance treatment with rituximab are needed to support clinical management and healthcare planning.

Evaluating the Potency of Selected Antibiotic Medications Dispensed in Community Pharmacies in Gwale, Kano, Nigeria.

The worsening of antibiotic resistance is a multifactorial process. One aspect of this is the counterfeiting of antibiotic medications. This is supposed to be particularly high in developing countries, including Nigeria. Therefore, the potency of some antibiotic drugs dispensed in community pharmacies in Gwale, Kano, Nigeria, was investigated in this case study. Three products, each from different manufacturers, with the active ingredients of ceftriaxone, gentamicin, ciprofloxacin, and metronidazole, respectively, were included in this study. By means of a disc-diffusion assay, the effect against the typed strains Staphylococcus aureus (ATCC 25923) and Escherichia coli (ATCC 25922) as well as Clostridium tetani isolated from soil was tested. Clinical isolates of S. aureus and E. coli were also used. While antibiotics, with the exception of ciprofloxacin-containing preparations against C. tetani, showed acceptable efficacy against the typed strains by comparison with the clinical science laboratory references, a predominant failure was observed with the clinical isolates. Thus, the investigated drug preparations can be considered of acceptable quality for the treatment of susceptible bacterial infections. This excludes counterfeits in the sampled preparations. However, the insufficient efficacy against clinical isolates further documents the severity of nosocomial bacteria.