scholarly journals Stability of Turoctocog Alfa, a Recombinant Factor VIII Product, during Continuous Infusion In Vitro

TH Open ◽  
2020 ◽  
Vol 04 (04) ◽  
pp. e354-e361
Author(s):  
Masahiro Takeyama ◽  
Anne Mette Nøhr ◽  
Debra Pollard
Keyword(s):  
Factor Viii ◽  
Continuous Infusion ◽  
Chemical Stability ◽  
In Vitro Study ◽  
Recombinant Factor Viii ◽  
Pump Speed ◽  
Acceptance Limits ◽  
The Stability ◽  
Physical And Chemical

Abstract Objective Turoctocog alfa is a recombinant factor VIII (rFVIII) for the prevention and treatment of bleeding in patients with hemophilia A, including those undergoing surgery and invasive medical procedures. This in vitro study evaluated the physical and chemical stability of turoctocog alfa during continuous infusion (CI) over 24 hours at 30°C. Materials and Methods The study was performed at 30°C ( ± 2°C). A CI system with pump speed set at either 0.6 or 1.5 mL/h was used to evaluate the stability of three turoctocog alfa strengths (500, 1,000, and 3,000 IU), equating to doses of 1.1 to 16.1 IU/h per kilogram of body weight. The following parameters were evaluated at selected time points between 0 and 24 hours: appearance of solution, clarity, pH, potency, purity, content, total high molecular weight proteins (HMWPs), and oxidized rFVIII. Results The mean potency of turoctocog alfa was maintained within the predefined acceptance criteria during CI for both pump speeds with all three strengths at 6, 12, or 24 hours (500 IU: ≥484 IU/vial; 1,000 IU: ≥1,014 IU/vial; and 3,000 IU: ≥3,029 IU/vial). Furthermore, the appearance of solution, clarity, pH, purity, content of turoctocog alfa, total HMWP, and oxidized forms were also within the predefined limits, and comparable to the reference samples (time = 0 hours) for the pump speeds and product strengths assessed. Conclusion Physical and chemical stability of turoctocog alfa was maintained during CI over 24 hours. There was only minor degradation or changes in any of the parameters tested. Potency was within the prespecified acceptance limits throughout 24 hours of infusion. These findings confirm the suitability of turoctocog alfa for CI.

Reverse torque values of abutment screws after dynamic loading: The effects of sealant agents and the taper of conical connections

2020 ◽  
Author(s):  
Arda Ozdiler ◽  
suleyman dayan ◽  
Burc Gencel ◽  
Gulbahar Isık-Ozkol
Keyword(s):  
Dynamic Loading ◽  
Antibacterial Agent ◽  
In Vitro Study ◽  
Control Group ◽  
Silicone Sealant ◽  
Reverse Torque ◽  
The Stability ◽  
Torque Values ◽  
Chlorhexidine Gel

This in vitro study evaluated the influence of taper angles on the internal conical connections of implant systems and of the application of chlorhexidine gel as an antibacterial agent or a polyvinyl siloxane (PVS) sealant on the reverse torque values of abutment screws after dynamic loading. The current study tested four implant systems with different taper angles (5.4°, 12°, 45°, and 60°). Specimens were divided into three groups: control (neither chlorhexidine gel filled nor silicone sealed), 2% chlorhexidine gel-filled or silicone-sealed group, and group subjected to a dynamic load of 50 N at 1 Hz for 500,000 cycles prior to reverse torque measurements. Quantitative positive correlation was observed between the taper angle degree and the percentage of tightening torque loss. However, this correlation was significant only for the 60° connection groups except in the group in which a sealant was applied ( p = 0.013 for the control group, p = 0.007 for the chlorhexidine group). Percentages of decrease in the torque values of the specimens with silicone sealant application were significantly higher compared with both the control and chlorhexidine groups ( p = 0.001, p = 0.002, p = 0.001, and p = 0.002, respectively, according to the increasing taper angles); the percentage of decrease in torque values due to chlorhexidine application was statistically insignificant when compared with the control group. The application of gel-form chlorhexidine as an antibacterial agent does not significantly affect the stability of the implant–abutment connection under dynamic loads. PVS sealants may cause screw loosening under functional loads.

scholarly journals Physicochemical Characteristics of Arginine Enriched NaF Varnish: An In Vitro Study

Polymers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 2998
Author(s):  
Mohammed Nadeem Bijle ◽  
Manikandan Ekambaram ◽  
Edward Lo ◽  
Cynthia Yiu
Keyword(s):  
Molecular Dynamics ◽  
Physical Properties ◽  
Artificial Saliva ◽  
Chemical Properties ◽  
In Vitro Study ◽  
Physicochemical Characteristics ◽  
Vitro Study ◽  
Physical And Chemical ◽  
Stable Matrix

The in vitro study objectives were to investigate the effect of arginine (Arg) incorporation in a 5% sodium fluoride (NaF) varnish on its physical and chemical properties including F/Arg release. Six experimental formulations were prepared with L-arginine (L-Arg) and L-arginine monohydrochloride at 2%, 4%, and 8% w/v in a 5% NaF varnish, which served as a control. The varnishes were subjected to assessments for adhesion, viscosity, and NaF extraction. Molecular dynamics were simulated to identify post-dynamics total energy for NaF=Arg/Arg>NaF/Arg<NaF concentrations. The Arg/F varnish release profiles were determined in polyacrylic lactate buffer (pH-4.5; 7 days) and artificial saliva (pH-7; 1 h, 24 h, and 12 weeks). Incorporation of L-Arg in NaF varnish significantly influences physical properties ameliorating retention (p < 0.001). L-Arg in NaF varnish institutes the Arg-F complex. Molecular dynamics suggests that NaF>Arg concentration denotes the stabilized environment compared to NaF<Arg (p < 0.001). The 2% Arg-NaF exhibits periodic perennial Arg/F release and shows significantly higher integrated mean F release than NaF (p < 0.001). Incorporating 2% L-arginine in 5% NaF varnish improves its physical properties and renders a stable matrix with enduring higher F/Arg release than control.

Formulation, Physical and Chemical Stability of Ocimum gratissimum L. Leaf Oil Nanoemulsion

2021 ◽  
Vol 901 ◽  
pp. 117-122
Author(s):  
Netnapa Ontao ◽  
Sirivan Athikomkulchai ◽  
Sarin Tadtong ◽  
Phuriwat Leesawat ◽  
Chuda Chittasupho
Keyword(s):  
Essential Oil ◽  
Zeta Potential ◽  
Chemical Stability ◽  
Polydispersity Index ◽  
Hydrodynamic Diameter ◽  
Potential Value ◽  
Yellow Color ◽  
Leaf Oil ◽  
The Stability ◽  
Physical And Chemical

Ocimum gratissimum L. leaf oil exhibited many pharmacological properties. This study aimed to formulate and evaluate the physical and chemical stability of O.gratissimum leaf oil nanoemulsion. O.gratissimum leaf oil was extracted by hydrodistillation. The major component of the essential oil eugenol, was analyzed by UV-Vis spectrophotometry. Nanoemulsions of O.gratissimum leaf oil were formulated using polysorbate 80, hyaluronic acid, poloxamer 188, and deionized water by phase inversion composition method. The hydrodynamic diameter, polydispersity index, and zeta potential value of O.gratissimum leaf oil nanoemulsion was evaluated by a dynamic light scattering technique. The %remaining of eugenol in the nanoemulsion was analyzed by UV-Vis spectrophotometry. The essential oil extracted from of O. gratissimum leaf oil was a clear, pale yellow color. The %yield of the essential oil was 0.15 ± 0.03% v/w. The size of the nanoemulsion was less than 106 nm. The polydispersity index of the nanoemulsion was ranging from 0.303 - 0.586 and the zeta potential value of the nanoemulsion was closely to zero, depending on the formulation component. O. gratissimum leaf oil at concentrations ranging from 0.002 - 0.012% v/v contained 35 - 41% of eugenol. The size of nanoemulsion was significantly decreased after storage at 4 °C, while significantly increased upon storage at 45 °C. The size of nanoemulsion stored at 30 °C did not significantly change. The %remaining of eugenol in the nanoemulsion was more than 90% after storage at 4 °C and 30 °C for 28 days. The percentage of eugenol remaining in the nanoemulsion stored at 45 °C was more than 85 - 90%, suggesting that the temperature affected the stability of eugenol in the nanoemulsion.

Comparison of bivalirudin, enoxaparin, and unfractionated heparin in preventing cardiac catheter thrombosis

2008 ◽  
Vol 100 (10) ◽  
pp. 693-698 ◽  
Author(s):  
Michael Buerke ◽  
Sebastian Schubert ◽  
Iris Reindl ◽  
Thomas Michel ◽  
Baerbel Hauroeder ◽  
...  
Keyword(s):  
Unfractionated Heparin ◽  
Continuous Infusion ◽  
Treatment Strategies ◽  
In Vitro Study ◽  
Coronary Intervention ◽  
Thrombin Inhibitor ◽  
P Value ◽  
Cardiac Catheter ◽  
Before And After

SummaryBivalirudin, a direct thrombin inhibitor binds specifically and reversibly to both fibrin-bound and unbound thrombin. Bivalirudin is approved for use as an anticoagulant in patients undergoing percutaneous coronary intervention. The OASIS-5 trial presented a significant increase in cardiac catheter thrombosis for the pentasaccharid fondaparinux compared to enoxaparin. Catheter thrombosis has never been reported in any trial using bivalirudin. Our study compared the development of catheter thrombosis for bivalirudin, enoxaparin, and unfractionated heparin in a controlled in-vitro environment. Ten healthy male volunteers were pretreated with aspirin 500 mg 2 hours before venesection of 50 ml of blood. The seven groups of anticoagulant combinations tested were:UFH, UFH + eptifibatide, enoxaparin, enoxaparin + eptifibatide, bivalirudin bolus, bivalirudin + eptifibatide, bivalirudin bolus + continuous infusion. The blood/anticoagulant mix continuously circulated through a cardiac guiding catheter for 60 minutes or until the catheter became blocked with thrombus. Thrombus development was assessed by weighing each catheter before and after the procedure. Electron microscopy was used to quantify the degree of erythrocyte, platelet and fibrin deposition. Following anticoagulation with bolus dose bivalirudin, the catheter was invariably occluded with thrombus after 33 minutes of circulation. However, a continuous infusion of Bivalirudin prevented the development of occlusive catheter thrombosis. In the bolus bivalirudin group the mean thrombus weight was significantly greater than in all other groups (p-value < 0.01 in all analyses). Bivalirudin given as a bolus was not sufficient to prevent cardiac catheter thrombosis in our in-vitro study. However, a continuous infusion of bivalirudin had similar anti-thrombotic efficacy compared to other treatment strategies.

scholarly journals Influence of butt joint connections with long guiding areas on the stability of single crowns and 3-unit bridges - an in-vitro-study

2021 ◽  
Author(s):  
Tobias Graf ◽  
Jan-Frederik Güth ◽  
Daniel Edelhoff ◽  
Gerald Krennmair ◽  
Michael Stimmelmayr
Keyword(s):  
In Vitro Study ◽  
Butt Joint ◽  
Vitro Study ◽  
The Stability ◽  
Single Crowns

AMPHOTERICIN B TOPICAL EXTEMPORANEOUS PREPARATIONS FOR THE TREATMENT OF NON-DERMATOPHYTIC ONYCHOMYCOSIS

2020 ◽  
pp. 135-139
Author(s):  
KOMESMUNEEBORIRAK PHOJANA ◽  
WERAWATGANONE PORNPEN ◽  
MUANGSIRI WALAISIRI
Keyword(s):  
Amphotericin B ◽  
Chemical Stability ◽  
High Performance ◽  
Sodium Lauryl Sulfate ◽  
Physical Stability ◽  
Lauryl Sulfate ◽  
Physical And Chemical ◽  
Injection Product

Objective: At present, the nail preparation to cure onychomycosis, caused by non-dermatophyte molds, is not commercially available in Thailand. The physical and chemical stability of amphotericin B (AmB) extemporaneous preparations in the presence of 30% dimethyl sulfoxide (DMSO) and their in vitro nail permeation was evaluated. Methods: AmB extemporaneous preparations in the presence of 30% DMSO were prepared from a commercial sterile injection product, and cream or hydrophilic ointment. Physical stability was tested at 30°C for 2 months, or using 6 heating-cooling cycles. The chemical stability and in vitro nail permeation of AmB content were analyzed using high-performance liquid chromatography (HPLC). In vitro nail permeation was performed by applying 3.5 mg/mm2 of the tested formulation on nail clippings for 5 consecutive days. Results: The AmB cream and ointment extemporaneous preparations containing 30% DMSO, a permeation enhancer, were homogeneous and pale yellow to yellow cream or ointment. The AmB ointment was stable for up to 60 days. The ointment preparation allows in vitro penetration through nails up to 14.17 μg/cm2. The ointment preparation allows significantly better penetration through than the cream preparation due to the presence of DMSO, sodium lauryl sulfate (SLS), and water in the ointment preparation. Conclusion: The AmB extemporaneous ointment was successfully compounded from a commercial sterile injection product with a beyond-use date of 60 days. The ointment preparation is currently under further investigation for in vivo efficacy.

scholarly journals Extended Half-Life Factor VIII/Factor IX Products: Assay Discrepancies and Implications for Hemophilia Management

2020 ◽  
Vol 40 (S 01) ◽  
pp. S15-S20
Author(s):  
Jens Müller ◽  
Georg Goldmann ◽  
Natascha Marquardt ◽  
Bernd Pötzsch ◽  
Johannes Oldenburg
Keyword(s):  
Factor Viii ◽  
Half Life ◽  
In Vitro Study ◽  
Factor Ix ◽  
University Hospital ◽  
Spiked Plasma ◽  
Structural Differences ◽  
The University ◽  
Life Factor

AbstractDue to structural differences between extended half-life (EHL) factor VIII (FVIII) or FIX products and equivalent plasma wild-type molecules used for assay calibration, reagent-dependent discrepancies during monitoring of FVIII- and FIX-replacement therapies with EHL products have been described. To assess the performance of available one-stage clotting and chromogenic substrate assays on the Siemens Atellica COAG 360 analyzer, an in vitro study using spiked plasma samples was performed. The described results confirm previously described findings and allowed allocation of each EHL product to an appropriate assay. In addition, corresponding EHL product–specific analytes were defined within the order entry system of the University Hospital Bonn. The requirement of product-specific FVIII and FIX assays complicates patient monitoring and demonstrates the need for both continuous education and communication between treating physicians and the coagulation laboratory.

scholarly journals Influence of Orthodontic Anchor Screw Anchorage Method on the Stability of Artificial Bone: An In Vitro Study

Materials ◽  
2020 ◽  
Vol 13 (14) ◽  
pp. 3205 ◽  
Author(s):  
Seen-Young Kang ◽  
Ji-Min Yu ◽  
Hyoung-Sik Kim ◽  
Jun-Seok Lee ◽  
Chan-Mi Yeon ◽  
...  
Keyword(s):  
In Vitro Study ◽  
Automatic Device ◽  
Insertion Torque ◽  
Artificial Bone ◽  
Artificial Bones ◽  
Significant Difference ◽  
The Mean ◽  
The Stability ◽  
Torque Values

This study aims to compare the torque values for various lengths of the titanium-based orthodontic anchor screw (OAS), different anchorage methods and varying artificial bone densities after predrilling. Furthermore, the effects of these parameters on bone stability are evaluated. A total of 144 OASs were prepared with a diameter of 1.6 mm and heights of 6, 8 and 10 mm. Artificial bones were selected according to their density, corresponding to Grades 50, 40 and 30. Torque values for the automatic device and manual anchorage methods exhibited a statistically significant difference for the same-sized OAS, according to the bone density of the artificial bones (p < 0.05). However, when insertion torque was at the maximum rotations, there was no significant difference in the torque values for the Grade 30 artificial bone (p > 0.05). When the torque values of both anchorage methods were statistically compared with the mean difference for each group, the results of the manual anchorage method were significantly higher than those of the automatic device anchorage method (p < 0.05). A statistically significant difference was observed in the bone stability resulting from different OAS anchorage methods and artificial bone lengths. These findings suggest that the automatic anchorage method should be used when fixing the OAS.

Sign in / Sign up

Export Citation Format

Share Document