Plastic hypodermic needles are a potential solution to the problem of disease spread through needle reuse. Plastics could be used to potentially reduce needle reuse as they are easier to destroy than steel. A key issue in their acceptance is the force required to penetrate a patient; a smaller force is associated with less pain. The effect that needle parameters have on the penetration force is studied in an effort to better understand how to reduce penetration forces and increase the success of penetrations for plastic needles. These parameters - geometry, tip radius, diameter, material, and lubricant - are studied through penetration, buckling, and coefficient of friction testing. The tests are conducted on steel needles, which serve as a control group, as well as two varieties of plastic needles. The outcome is a quantitative understanding of the effect that the various parameters have on penetration force, which is used to inform plastic needle design.

Purpose:Omeprazole is a proton pump inhibitor (PPI) used in the treatment of gastrointestinal conditions, such as gastrointestinal esophageal reflux disease (GERD). Omeprazole is often prepared as an oral suspension to accommodate certain patients. Historically, oral suspensions of omeprazole were prepared using pharmaceutical compounding with sodium bicarbonate, but a kit for preparation of omeprazole oral suspension is available, FIRST® - Omeprazole. The purpose of this project is to compare the stability of the active pharmaceutical ingredient (API), omeprazole, in the FIRST® kit product to a traditionally compounded omeprazole suspension, when stored in refrigerated unit-dosed syringes. Methods: Five 100-mL batches of compounded omeprazole oral suspension (2 mg/mL) and five 300-mL kits of FIRST® - Omeprazole were prepared by a licensed pharmacist, and aliquoted into 5-mL doses in clear luer-lock plastic oral syringes, and stored at refrigerated temperature (2-8oC). Omeprazole concentration was assessed in each batch/kit on the day of preparation. Triplicate syringes from each batch/kit (n = 15 per test group per day) were removed after 7 days, 14 days, 21 days, and 30 days of refrigerated storage. Samples were diluted to assay concentration (1 mg/mL) in ion-free water and filtered using a 0.22-micron microcentrifuge filter tube. Samples were analyzed for omeprazole recovery using a validated high-performance liquid chromatography with ultraviolet detection (HPLC-UV) method. Recovery was quantitatively assessed by comparing sample peak area to a freshly prepared calibration curve (1 – 0.125 mg/mL) using United States Pharmacopoeia (USP) reference standard on each day of sampling. Refrigerator temperatures were recorded daily using a digital thermometer. Results:Stability was defined as recovery of 90 - 110% of initial concentration of API. For the FIRST® - Omeprazole samples, the chemical potency remained within this window for the entire study period of 30 days. The compounded omeprazole suspension demonstrated a less than 90% average recovery at the day 21 sample. Furthermore, a statistically significant difference in the initial concentration was detected on the day of compounding (p = 0.0244), with the compounded omeprazole starting at 1.89 ± 0.10 mg/mL and the FIRST® - Omeprazole at 1.98 ± 0.04 mg/mL. After 30 days, the compounded omeprazole suspension had an 89.13% average API recovery (standard deviation; ± 5.17%) and the FIRST® - Omeprazole 97.20% API recovery (± 3.59%). Conclusion:Both traditionally compounded omeprazole suspension (2mg/mL) and FIRST® - Omeprazole suspension (2mg/mL) may be stored in clear luer-lock oral syringes under refrigeration for 14 days, and retain potency between 90 to 110% based on initial concentration. Furthermore, the FIRST® - Omeprazole suspension can be stored for the duration of the product’s beyond-use date of 30 days and retain potency between 90 to 110% of initial concentration or label claim. Finally, the data suggest that API concentration in FIRST® - Omeprazole suspension is more consistent from batch to batch than traditionally compounded omeprazole suspension.

No description available.

Background: Omeprazole is a proton pump inhibitor used to manage gastrointestinal disorders. Special populations may require omeprazole to be given as an oral suspension. Objective: The purpose of this project was to compare the stability of omeprazole in the FIRST kit product to a traditionally compounded omeprazole suspension, when stored in refrigerated unit-dosed syringes. NG tube delivery of the 2 products was also investigated. Methods: Five batches of compounded omeprazole oral suspension and 5 kits of FIRST-Omeprazole were prepared to an initial concentration of 2 mg/mL. Suspensions were aliquoted into 5-mL doses in clear plastic oral syringes, and stored at 2-8 °C. Syringes from each batch were analyzed at baseline and after 7, 14, 21, and 30 days for omeprazole potency using HPLC. To assess suitability for NG tube administration, 20 mL of each suspension were administered through NG tubes (8Fr, 10Fr, and 18Fr), and percent omeprazole recovery assessed. Results: The chemical potency remained within 90-110% for 14 days and 30 days for compounded samples and FIRST-Omeprazole samples, respectively. There was a statistically significant difference in initial concentration; 1.89 mg/mL versus 1.98 mg/mL for compounded and FIRST-Omeprazole, respectively. After 30 days, FIRST-Omeprazole demonstrated 97.20% API recovery. Neither suspension experienced statistically significant loss of potency following NG tube passage. Conclusion: FIRST-Omeprazole suspension may be stored in refrigerated clear luer-lock oral syringes for 30 days. Traditionally compounded omeprazole suspension should be used within 14 days. Both suspensions are suitable for NG tube administration.

Pre-filled syringes: Examination of the needs for ready-to-administer parenteral drugs at Uppsala University hospital  Background: Many parenteral drugs delivered to hospital wards are not ready-to-administer drugs. These drugs are delivered as concentrates or lyophilizates (dry powders) and need preparation by responsible healthcare professionals/nurses before they can be administered. Today, however, there is a shortage of nurses that forces the hospital management to find new ways to free nursing time and open more hospital beds. Aim: The purpose of this study was to examine the consumption of parenteral drugs at the Uppsala University Hospital that could potentially be provided by the extemporaneous manufacturing unit, CBE, as prefilled syringes. Methods: Quantitative data from the Concise Database hosted by the Swedish eHealth Agency was used to derive data on parenteral medications used in Region Uppsala year 2021. Information regarding common drug’s dilutions and shelf life was obtained from the information systems/databases MedMark, MetaVison, and Micromedex. In addition to the collected data, a small sub-study with two nurses was conducted regarding their thoughts on parenteral drug preparation and pre-filled syringes. Results: Quantitative data showed the top 40 most used non-ready to administer drugs for Region Uppsala, year 2021.The most common drugs that need precreation is antibiotics. According to drug stability and shelf-life data, longer shelf life could be obtained using extemporaneous compounding. This cross-sectional study also indicate freed nursing time between 6-11 full-time nursing estimates. Based on the unstructured interviews, positive attitudes are seen towards the provision of parenteral drugs in pre-filled syringes.  Conclusion: It can be concluded that ready-to-administer drugs for parenteral use could possibly be provided by CBE, using extemporaneous compounding. This can thereby increase the safety and quality of parenteral drugs used in the clinical environment, and potentially free nursing time.

Thesis (MBA)--Stellenbosch University, 2001. / ENGLISH ABSTRACT: Daily more than 300 000 health care workers in South Africa are to a lesser or greater extent exposed to the risk of deadly viruses which can be transferred through neediestick injuries. It is estimated that currently 9,8 million people in South Africa are HIV positive. This high incidence of HIV has a great impact on the danger of infection from neediestick injuries. It is estimated that 44 000 neediestick injuries takes place annually in South Africa. Despite such a high risk there are currently few safety regulations or official efforts to prevent or determine the true impact and incidence of needlesticks in South Africa. This study project investigated the number of neediestick injuries that could potentially be prevented by the use of needles with safety features and estimated the ranges of benefits and costs of using such safety devices. With the financial constraints that are imposed on South African hospitals, infection control through the use of safety syringes makes economic sense. Prevention of infections is clearly far cheaper than cure. / AFRIKAANSE OPSOMMING: Daagliks word meer as 300 000 gesondheids personeel in Suid Afrika in 'n mindere of meerdere mate blootgestel aan die risiko van lewens gevaarlike viruse wat deur middel van naaldprik ongelukke oorgedra kan word. Hierdie risiko word spesifiek in Suid Afrika verhoog deur die hoë insidensie van HIV. Dit word beraam dat daar tans 9,8 miljoen mense in Suid Afrika is wat HIV positief is. Daar word beraam dat daar tans 44 000 naaldprik ongelukke per jaar in Suid Afrika plaasvind. Ten spyte van die hierdie hoë risko is daar tans min veiligheids regulasies of amptelike pogings om die omvang en voorkoming van naaldprik insidente te bepaal nie. Hierdie studie het die getal naaldprikke wat voorkom kan word deur die gebruik van veiligheids inspuitnaalde ondersoek en het die voordele en kostes van sulke veiligheidsmaatreëls beraam. Gegewe die finasiële druk wat ons tans in Suid Afrikaanse hospitale ondervind, is bewys dat die gebruik van veiligheids inspuitnaalde ekonomiese sin maak. Voorkoming op hierdie manier is bewys as 'n ver goedkoper opsie as nasorg.

The purpose of this study was to evaluate the stability of vitamin K1 oral liquids in Sterile Water for Injection when stored in amber glass bottles and amber plastic syringes under refrigerated conditions. Four 100-mL batches of vitamin K1 in Sterile Water for Injection were prepared in amber glass bottles to protect from light. One of the batches was divided into 1-mL aliquots, using amber plastic oral syringes, and capped. The prepared bottles and syringes were stored in a laboratory refrigerator. On each day of sampling, 1-mL aliquots were removed from each bottle and mixed with an equal volume of ethanol. Likewise, the contents of sample syringes were mixed with ethanol to achieve an assay concentration of 0.5 mg/mL. Recovery of vitamin K1 in the compounded samples was quantified against a United States Pharmacopeia reference standard. Quantification was achieved using a stability-indicating high-performance liquid chromatography with ultraviolent light detection method. Product stability is defined as 90% to 110% of the initial concentration. The percent recovery in the Sterile Water for Injection preparations in glass bottles remained above 90% for the 105-day duration of the study, but some samples stored in amber plastic syringes fell below 90% on day 21. Furthermore, a statistically significant difference (2-way ANOVA, P < 0.0001) emerged between syringes at day 0 and day 30, and this trend continued through the day 60, 90, and 105 samples. The only statistically significant difference found within the bottle-stored samples occurred on day 105 (versus zero, P = 0.0465), but the recovery on day 105 still exceeded 90%. Vitamin K1 in Sterile Water for Injection, stored in a refrigerated amber glass bottle, is stable for 105 days. This preparation can also be stored in amber plastic syringes, but this decreases the beyond-use date to 14 days.

The purpose of this study was to evaluate the stability of two preparations of vancomycin oral solution in two different storage containers, capped amber oral-dosing syringes and heat-sealed oral-dosing cups, stored under refrigerated conditions. Commercially available grape-flavored vancomycin oral preparation and compounded vancomycin for intravenous use in cherry syrup oral preparation were divided into 5-mL aliquots into heat-sealed plastic dosing cups and capped oral-dosing syringes. All samples were stored under refrigeration (2°C to 8°C) and evaluated at days 0, 3, 7, 14, 30, 60, and 90. For each evaluation, samples were visually inspected and analyzed for potency using a stability-indicating high-performance liquid chromatographic method with ultraviolet detection. Over the study period, at least 90% of the initial concentrations for the preparation and the product in both storage containers were retained at 60 days. The commercially available oral vancomycin further demonstrated stability within 90% out to 90 days in the syringe and the unit-dose cups. Visual inspection revealed no changes in the grape-flavored vancomycin oral preparation, but a detectable red-dye precipitate could be seen in the crevices of the dosing cups from the vancomycin in cherry syrup oral preparation after 60 days. Commercially available grape-flavored vancomycin oral preparation was stable up to 90 days, and com- pounded vancomycin for intravenous use in cherry syrup oral preparation maintained stability for 60 days when dispensed in capped amber polypropylene oral-dosing syringes and heat-sealed plastic dosing cups when stored at refrigerated conditions.

4AbstractA pre-filled syringe consists of a number of different components and materials e.g. glass, polymer and silicone oil, which will, in various degrees, interact with the pharmaceutical protein and excipients contained within. In addition to soluble protein loss due to adsorption to silicone droplets, silicone oil (SO) have also been reported to form complexes with pharmaceutical proteins that potentially provoke early and late-stage immune responses. The objective of this project was to investigate the impact of 10 different syringe barrel and plunger combination on the quality on pharmaceutical X and the performance of the syringe (syringeability). This is an explorative study and the purpose of this study was to investigate what options there were rather than to make firm recommendations. pH measurements indicated all chosen combinations were within acceptance criteria. Similarly, subvisible particle with reference standards and USP &lt;788&gt; tests indicated that all chosen combinations were within acceptance criteria. Analysis of visible particles without reference standards indicated that all combinations except 1B and 1C were within acceptance criteria. In terms of syringeability, functional testing revealed that combination 8A was a very poor choice and combination 1B a very good choice. In all of the tests, the currently used combination 1A was within the acceptance criteria. With respect to both the pharmaceutical quality and syringeability, it was considered to be equally preferred as many other combinations. Therefore, there is no real urgency to exchange the currently used syringe. Further investigation of plunger B, and possible other plunger combinations is recommended as they might play a bigger role than the syringe barrel with regard to the syringeability. Additionally, placebo suspension can only be used as a representative alternative for testing pH. / En förfylld spruta består av många olika komponenter och material så som glas, polymer, silikon olja, vilka, till olika grad, kommer reagera med proteiner och hjälpämnen i läkemedlet. Utöver förlust av protein (som följd av adsorption till silikon droppar), har det även rapporterats att silikon olja (SO) bildar komplex med proteinerna i läkemedlet vilka kan framkalla en immunologisk reaktion. Syftet med detta projekt var att undersöka effekten av 10 olika kombinationer av sprut-höljen samt kolvar på kvalitén på läkemedel X samt sprutans prestationsförmåga. Detta är en explorativ studie och syftet var att undersöka vilka alternativ som finns samt få en indikation för hur de uppför sig snarare än att ge tydliga rekommendationer. pH mätningar indikerade att alla valda kombinationer var inom acceptanskriterier. Liknande, både mätning av synliga och mikroskopiska partiklar med hjälp av referenslösningar samt metod USP 788 indikerade att alla valda kombinationer var inom acceptanskriterier. Mätning av synliga och mikroskopiska partiklar utan referenslösningar indikerade att alla kombinationer utom 1B och 1C var inom acceptanskriterier. Gällande sprutkombinationernas funktionalitet (prestationsförmåga) visade det sig att kombination 8A var ett dåligt val och kombination 1B ett attraktivt val. I alla tester, den nuvarande använda kombinationen (1A) var inom acceptanskriterier. Med avseende på både läkemedlets kvalité samt funktionalitet visade sig 1A vara ett likvärdigt alternativ till de andra kombinationerna. Detta innebär att det i dagsläget inte finns ett akut behov av att byta ut det nuvarande sprutkombinationen. Fortsatt utredning av kolv B, samt andra kolvar, är att rekommendera då de kan ha större påverkan funktionaliteten än höljet. Vidare kan placebolösning enbart användas som ett representativt alternativ för att testa pH.

The thesis deals with the issue of care of drug addicts in the in the Czech Republic, particularly the Harm Reduction. The theoretical part of the thesis describes the above-mentioned working procedures with clients, the legislative framework of the services and the current situation on the drug scene in the Czech Republic. The practical part uses a qualitative form of research. The information was collected by means of structured interviews with open questions. The respondents were eleven workers of contact centres in the Central Bohemian region which has five such facilities. I cooperated with four of them for the purposes of the thesis. The objective of the thesis was to demonstrate that the Harm Reduction services are important and beneficial from the viewpoint of workers of contact centres and to find out whether the contact workers have any suggestions about how to improve the Harm Reduction services in the Czech Republic.