- MeSH
- Automation MeSH
- Electronics, Medical MeSH
- Humans MeSH
- Mobile Applications MeSH
- Hospital Information Systems MeSH
- Drug Compounding instrumentation MeSH
- Robotics instrumentation MeSH
- Man-Machine Systems MeSH
- Telemedicine * instrumentation trends MeSH
- Information Storage and Retrieval methods MeSH
- Artificial Intelligence MeSH
- Medical Informatics Applications MeSH
- Computer Security MeSH
- Health Communication methods MeSH
- Check Tag
- Humans MeSH
- Publication type
- Newspaper Article MeSH
- Interview MeSH
An HPLC method with UV and electrospray ionization - mass spectrometry (ESI-MS) detection was developed for the separation and determination of obeticholic acid (OBE) and its related compounds in development process and quality control. OBE and its related compounds were classified into three major group based on the mass spectra profiles: (A) those containing a hydroxyl group at position 3 and 7, (B) those containing a hydroxyl group and/or carbonyl group at position 3, hydrogen, ethyl or ethylidene group at position 6 and a hydroxyl group and/or carbonyl group at position 7, and (C) those containing carbonyl groups at position 3 and 7. ESI-MS ionization of OBE and its related compounds often produced intense adduct ions [M+H+98]+ and/or [M+H+196]+ that were identified as the adduct ions of phosphoric acid ([M+H+H3PO4]+ and [M+H+2H3PO4]+) originating from the mobile phase. The separation on HPLC system was accomplished using stationary phase based on XSelect CSH C18 (3.0×150mm×2.5μm) and a linear gradient elution using acetonitrile and 0.05% of o-phosphoric acid. The condition of chromatographic system was set as follows: flow rate 0.7mL/min, temperature 45°C and UV detection at 192nm. The separation of the 19 compounds was finished in less than 18min (including equilibration time). The HPLC/UV method was partially validated according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines in terms of repeatability, selectivity, linearity and limit of quantification and detection.
- MeSH
- Chemical Fractionation instrumentation methods MeSH
- Chemistry, Pharmaceutical methods MeSH
- Spectrometry, Mass, Electrospray Ionization instrumentation methods MeSH
- Drug Contamination prevention & control MeSH
- Chenodeoxycholic Acid analogs & derivatives analysis chemistry MeSH
- Limit of Detection MeSH
- Drug Compounding instrumentation methods MeSH
- Reproducibility of Results MeSH
- Quality Control * MeSH
- Sensitivity and Specificity MeSH
- Spectrophotometry, Ultraviolet instrumentation methods MeSH
- Chromatography, High Pressure Liquid instrumentation methods MeSH
- Publication type
- Journal Article MeSH
- Validation Study MeSH
Despite the high quantities of tablets produced daily, many tableting processes are still operated at sub-optimal settings and hence lack the necessary flexibility to mitigate for possible process deviations. However, to ensure this flexibility on tableting throughput it is important to select the most robust feed frame design and settings regarding die-filling. In this research study, four paddle designs for a two-compartment forced feeder (equipped with a metering and a feeding paddle wheel) were evaluated at a wide range of process-settings (i.e. tableting speed, paddle speed, overfill level) and feed frame features (i.e. deaeration) for their impact on the die-filling step of a poorly flowing model formulation (i.e. MCC 101) using a quality-by-design approach. No benefit on die-filling was observed when using higher speeds of the metering paddle wheel compared to the feeding paddle wheel, and no convincing arguments were obtained to use the feed frame deaeration opening. Some combinations of paddle design and process-settings significantly increased the risk for inconsistent die-filling (i.e. high tablet weight variability) which can therefore limit the efficiency of the tableting process. The approach used in this study enabled to compare the paddle designs for their die-filling performance in function of varying tableting speeds, eventually resulting in the selection of a feed frame design that is most robust and therefore will provide a uniform die-filling over a wide range of throughputs. Selection of the most robust parameters is an important prerequisite for the ability of using the rotary tablet press as an agile unit-operation.
- MeSH
- Cellulose chemistry MeSH
- Powders MeSH
- Drug Compounding instrumentation MeSH
- Tablets * MeSH
- Hardness MeSH
- Publication type
- Journal Article MeSH
Při léčbě onkologicky nemocných jsou používány látky s rizikem karcinogenity a mutagenity - tzv. cytostatika, která obecně patří k velmi nebezpečným látkám s nízkým terapeutickým indexem, to znamená léčiva s malým rozdílem mezi terapeutickou a toxickou dávkou. Z toho vyplývá, že špatně zvolená dávka může pacienta bezprostředně ohrozit na životě. Jednou z cest, jak minimalizovat možná lidská pochybení, je zajistit maximální kontrolu a zamezit vzniku chyb při přípravě a podání léku. Přesná evidence přípravy a podání cytotoxických léčiv je rovněž vyžadována ze zákona. V Masarykově onkologickém ústavu se od roku 2010 používá v rámci celého procesu přípravy a aplikace chemoterapie tzv. radiofrekvenční identifikace (RFID), která mimo jiné přináší sestrám naprostou jistotu při aplikaci léčiva a okamžitě je upozorní na možné neshody.
- MeSH
- Radio Frequency Identification Device * methods utilization MeSH
- Clinical Pharmacy Information Systems instrumentation MeSH
- Humans MeSH
- Hospital Information Systems MeSH
- Hospital Communication Systems MeSH
- Drug Compounding methods instrumentation MeSH
- Antineoplastic Agents * administration & dosage MeSH
- Medication Systems, Hospital * MeSH
- Check Tag
- Humans MeSH
- MeSH
- Pharmacology, Clinical MeSH
- Clinical Protocols MeSH
- Pharmacy Service, Hospital * methods organization & administration manpower trends utilization supply & distribution MeSH
- Computing Methodologies MeSH
- Pharmacy Residencies MeSH
- Drug Compounding economics methods standards instrumentation MeSH
- Geographicals
- Belgium MeSH
- MeSH
- Pharmaceutical Services organization & administration MeSH
- Clinical Clerkship * MeSH
- Pharmacies * classification organization & administration MeSH
- Humans MeSH
- Drug Compounding standards instrumentation MeSH
- Quality Control MeSH
- Education, Pharmacy, Graduate * MeSH
- Education, Pharmacy MeSH
- Check Tag
- Humans MeSH
- Geographicals
- Japan MeSH
Úvod: V současnosti se pro diagnostická vyšetření připravuje kolem 12 radiofarmak značených techneciem (99mTc) a jedno radiofarmakum OctreoScan značené 111In. Každý jednotlivý kit pro přípravu radiofarmaka má velmi přísné skladovací podmínky, ať již v lednici (2-8 °C) nebo při teplotě místnosti (mezi 15-25 °C). Následující příprava probíhá také pro každé radiofarmakum odlišně. Rozdíly jsou v přidané aktivitě 99mTc, inkubační době, nutnosti temperování, úpravě, době a systému chlazení, úpravě na konečný objem, kontrole radiochemické čistoty a měření aktivity. Metody a kontroly: Od pondělí do středy lze vzhledem k eluci generátorů připravovat radiofarmaka s větším požadavkem na aktivitu, mimo jiné 99mTc-8-MDP (pondělí, úterý) a 99mTc-CARDIO-SPECT (středa). Zbytek týdne je ve znamení několika příprav radiofarmak s požadovanou menší aktivitou. Kontroly kvality se sledují tzv. papírovou chromatografií, případně chromatografií na tenké vrstvě, dvě metody vyžadují kapalinovou extrakci. Závěr: Léčivé přípravky mohou připravovat pouze kvalifikované, zaškolené a trénované osoby. Tento požadavek platí pro radiofarmaka dvojnásob, jelikož tu přistupuje ještě aspekt radiační ochrany. Musí se dodržovat pravidla aseptické přípravy, již zmíněné radiační ochrany, práce musí být velmi rychlá, ale perfektní.
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- MeSH
- Laboratories, Hospital standards supply & distribution MeSH
- Humans MeSH
- Nuclear Medicine methods instrumentation trends MeSH
- Drug Compounding methods standards instrumentation MeSH
- Radiation Protection methods standards MeSH
- Radiopharmaceuticals diagnostic use classification supply & distribution MeSH
- Quality Control MeSH
- Somatostatin diagnostic use supply & distribution MeSH
- Technetium diagnostic use supply & distribution MeSH
- Check Tag
- Humans MeSH
- Publication type
- Review MeSH
The work was aimed at the evaluation of a cleanliness of pharmaceutical equipments after the end of the production and subsequent cleaning process. The influence of a dirty-hold time, a time interval between the end of the production period and the beginning of the cleaning process on its efficiency and the cleanliness of the equipment has been studied. The evaluation was performed for commercial tablet antihypertensive formulation with API losartan potassium. Sampling was carried out by a wet-swabbing method from the equipments and consequently obtained samples were analytically evaluated using HPLC. In the production of the concerned pharmaceutical, it has been found that the cleaning process is properly designed and validated. Despite the concentration of losartan in swabs from the equipment was in all cases within the limits of acceptance criteria, the effect of the dirty-hold time was proved. In the equipments with long hold-time period, the monitored substance was found in substantially higher concentrations.
- MeSH
- Antihypertensive Agents chemistry MeSH
- Time Factors MeSH
- Drug Industry instrumentation standards MeSH
- Equipment Contamination prevention & control MeSH
- Losartan chemistry MeSH
- Drug Compounding instrumentation standards MeSH
- Tablets MeSH
- Chromatography, High Pressure Liquid MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Validation Study MeSH
