Comparison Of Different Formulations Research Articles

Botulinum toxin-A in the treatment of upper facial wrinkles: efficacy comparison of different formulations

Objective: It is suggested that different formulations of botulinum toxin-A (BoNT-A) used for the same indication might be a factor affecting patient satisfaction. This study aimed to assess patient satisfaction levels in treating upper facial wrinkles (UFW) using various BoNT-A formulations and their association with age and gender. Materials and Methods: This retrospective study included 600 UFW patients treated with different formulations of BoNT-A. The BoNT-A formulations included three different groups: onaBoNT-A (ONA, n:200), aboBoNT-A (ABO, n:200), and praBoNT-A (PRA, n:200).In the patient files or records, satisfaction levels from the BoNT-A application were scored as follows: 1: not satisfied, 2: slightly satisfied, 3: satisfied, 4: very satisfied, 5: completely satisfied. Results: The mean patient satisfaction scores were similar in the ONA and ABO groups, but higher in the PRA group (4.4±0.5 vs. 4.3±0.6 vs. 4.0±0.9, P <0.001, respectively). The mean satisfaction score of the patients aged 18-30 and those aged >60 were lower than the other age groups. Among all patients in the 41-50 age range, the patient satisfaction score was higher in the ONA group than the ABO and PRA group. In all female patients, the mean satisfaction score was lower in the PRA group compared to the ONA and ABO groups (P <0.001), Conclusions: While various BoNT-A formulations are generally associated with high patient satisfaction in the treatment of UFW, this can vary depending on age ranges and gender. Evaluating patient-related factors such as age and gender can contribute to the treatment planning for UFW and enhancing treatment adherence.

Dopaminergic Therapy for Motor Symptoms in Early Parkinson Disease Practice Guideline Summary: A Report of the AAN Guideline Subcommittee.

To review the current evidence on the options available for initiating dopaminergic treatment of motor symptoms in early-stage Parkinson disease and provide recommendations to clinicians. A multidisciplinary panel developed practice recommendations, integrating findings from a systematic review and following an Institute of Medicine-compliant process to ensure transparency and patient engagement. Recommendations were supported by structured rationales, integrating evidence from the systematic review, related evidence, principles of care, and inferences from evidence. Initial treatment with levodopa provides superior motor benefit compared to treatment with dopamine agonists, whereas levodopa is more likely than dopamine agonists to cause dyskinesia. The comparison of different formulations of dopamine agonists yielded little evidence that any one formulation or method of administration is superior. Long-acting forms of levodopa and levodopa with entacapone do not appear to differ in efficacy from immediate-release levodopa for motor symptoms in early disease. There is a higher risk of impulse control disorders associated with the use of dopamine agonists than levodopa. Recommendations on initial therapy for motor symptoms are provided to assist the clinician and patient in choosing between treatment options and to guide counseling, prescribing, and monitoring of efficacy and safety.

An in-depth study on the agar gel effectiveness for built heritage cleaning

The cleaning effectiveness of agar gels for copper stain removal from marble is mainly related to the gel morphology and to the possibility of copper coordination. • Different agar gel formulations were tested for copper stain removal from marble. • Hydrogel lyophilisation allowed to systematically compare gel formulations. • The relationship between gel morphology and effectiveness was assessed. • AgarArt 1% with TAC was the most effective gel for copper removal from marble. • EDTA in gels leads to a broader pore size distribution and to a lower gel strength. The effectiveness of Agar gels for copper stain removal from marble surfaces was systematically studied. Gels with different agar concentrations (1, 3, 5%) and different chelating agents used as additives (ethylenediaminetetraacetic acid, EDTA, and ammonium citrate tribasic, TAC) were tested on laboratory marble specimens for different contact times (30 and 60 min). For better characterization, hydrogels were lyophilised and cryogels were obtained. Systematic comparison of different formulations was feasible on cryogels and performed in terms of: (i) the morphological properties, by field-emission scanning electron microscopy (FE-SEM); (ii) the type of Cu(II)-complexes formed and their quantitative comparison by electron paramagnetic resonance (EPR) spectroscopy; (iii) the total amount of copper removed from marble surfaces, by Inductively Coupled Plasma–Optical Emission Spectrometry (ICP-OES). AgarArt 1% with TAC exhibited the highest effectiveness for copper stain removal after 60 min contact (431 μg/cm 2 ). Such a good cleaning effectiveness can be ascribed to the co-presence of the following properties: efficient metal coordination, which is related to the additive presence, and favourable gel morphology, related both to the gel concentration and to the additive type. In fact, it was observed that both the low gel concentration and the presence of TAC are related to a narrow pore size distribution in gels, besides the possibility of copper coordination. The presence of EDTA results in a broader pore size distribution and in a lower gel strength, with respect to gels with TAC. Thus, a new procedure for studying gels was proposed, which allows to optimize the conditions for metal stain removal from built heritage.

Computational comparisons of different formulations for the Stackelberg minimum spanning tree game

AbstractLet be a given graph whose edge set is partitioned into a set R of red edges and a set B of blue edges, and assume that red edges are weighted and contain a spanning tree of G. Then, the Stackelberg minimum spanning tree game (StackMST) is that of pricing (i.e., weighting) the blue edges in such a way that the total weight of the blue edges selected in a minimum spanning tree of the resulting graph is maximized. In this paper, we present different new mathematical programming formulations for the StackMST based on the properties of the minimum spanning tree problem and the bilevel optimization. We establish a theoretical and empirical comparison between these new formulations that are able to solve random instances of 20–70 nodes. We also test our models on instances in the literature, outperforming previous results.

A study of crown development mechanisms using a shoot-based tree model and segmented terrestrial laser scanning data.

Functional-structural plant models (FSPMs) allow simulation of tree crown development as the sum of modular (e.g. shoot-level) responses triggered by the local environmental conditions. The actual process of space filling by the crowns can be studied. Although the FSPM simulations are at organ scale, the data for their validation have usually been at more aggregated levels (whole-crown or whole-tree). Measurements made by terrestrial laser scanning (TLS) that have been segmented into elementary units (internodes) offer a phenotyping tool to validate the FSPM predictions at levels comparable with their detail. We demonstrate the testing of different formulations of crown development of Scots pine trees in the LIGNUM model using segmented TLS data. We made TLS measurements from four sample trees growing in a forest on a relatively poor soil from sapling size to mature stage. The TLS data were segmented into internodes. The segmentation also produced information on whether needles were present in the internode. We applied different formulations of crown development (flushing of buds and length of growth of new internodes) in LIGNUM. We optimized the parameter values of each formulation using genetic algorithms to observe the best fit of LIGNUM simulations to the measured trees. The fitness function in the estimation combined both tree-level characteristics (e.g. tree height and crown length) and measures of crown shape (e.g. spatial distribution of needle area). Comparison of different formulations against the data indicates that the Extended Borchert-Honda model for shoot elongation works best within LIGNUM. Control of growth by local density in the crown was important for all shoot elongation formulations. Modifying the number of lateral buds as a function of local density in the crown was the best way to accomplish density control. It was demonstrated how segmented TLS data can be used in the context of a shoot-based model to select model components.

Reformulations of well-known active ingredients in the topical treatment of psoriasis vulgaris can improve clinical outcomes for patients.

Although the majority of patients with psoriasis vulgaris are treated exclusively with topical therapies, research to develop more effective topical therapies that are associated with higher patient satisfaction has lagged behind the development of systemic agents. The aim of this literature review was to determine whether there is documented evidence that applying an innovative approach to improving the formulation of active ingredients commonly used in the topical treatment of psoriasis can have a positive effect on clinical outcomes and patient-reported outcomes (PROs). The Embase and PubMed databases were searched for articles published between 2001 and 2016 that made direct head-to-head comparisons of different formulations of an active pharmaceutical ingredient (API), focusing on clinical outcomes and PROs. In total, 22 publications on APIs or API combinations met the eligibility criteria (19 head-to-head clinical trials, one pooled analysis, one health-economic modelling study and one systematic review). Significant clinical benefit associated with the use of a reformulated API over an older formulation was reported in three trials of clobetasol propionate, one trial of calcipotriol, three trials of betamethasone and five trials/pooled analyses of calcipotriol/calcipotriene + betamethasone dipropionate (Cal/BD) formulations. Significantly improved PROs associated with the use of a reformulated API over an older formulation were reported in three trials of clobetasol propionate, one trial of betamethasone valerate and two trials of Cal/BD formulations. These results demonstrate that the innovative reformulation of APIs used in the treatment of psoriasis can produce therapies that attain significantly improved clinical outcomes and PROs. This suggests that improvement in topical therapy for psoriasis need not only to be achieved by the identification of new targets and the development of new APIs, but that improvement in the vehicle used to deliver existing APIs has the potential to result in significant clinical and patient benefits.

Protein comparability assessments and potential applicability of high throughput biophysical methods and data visualization tools to compare physical stability profiles

In this review, some of the challenges and opportunities encountered during protein comparability assessments are summarized with an emphasis on developing new analytical approaches to better monitor higher-order protein structures. Several case studies are presented using high throughput biophysical methods to collect protein physical stability data as function of temperature, agitation, ionic strength and/or solution pH. These large data sets were then used to construct empirical phase diagrams (EPDs), radar charts, and comparative signature diagrams (CSDs) for data visualization and structural comparisons between the different proteins. Protein samples with different sizes, post-translational modifications, and inherent stability are presented: acidic fibroblast growth factor (FGF-1) mutants, different glycoforms of an IgG1 mAb prepared by deglycosylation, as well as comparisons of different formulations of an IgG1 mAb and granulocyte colony stimulating factor (GCSF). Using this approach, differences in structural integrity and conformational stability profiles were detected under stress conditions that could not be resolved by using the same techniques under ambient conditions (i.e., no stress). Thus, an evaluation of conformational stability differences may serve as an effective surrogate to monitor differences in higher-order structure between protein samples. These case studies are discussed in the context of potential utility in protein comparability studies.

Management of parenteral nutrition in intensive care units in Spain

some relevant aspects related to parenteral nutrition in the Spanish ICUs are still unclear. These aspects include: caloric and protein intake, total volume, glycemic control, the type of lipid emulsion used or the comparison of different formulations. Our objective is to know the clinical practice patterns of artificial nutrition therapeutics, particularly of parenteral nutrition in the Spanish ICUs. twelve representative ICU's participated in a nutrition survey from January to March 2012. The survey was divided in two sections: A) Management of artificial nutritional support in critically ill patients and B) Assessment of a new parenteral nutrition formulation adapted to critically ill patients. The following information was collected: percentage of patients receiving artificial nutrition; availability of enteral formulations; types of lipid emulsions; calories, amino acids and lipids supplied; addition of glutamine, vitamins and trace elements; management of volume and hyperglycemia; and comparative data between patients receiving the new formulation vs. standard formulations: glycemic control, assessment of hepatic function and infectious complications as well as the intake of total calories, proteins, volume and insulin supplied. The average number of hospital beds and ICU beds is 780 and 25 respectively; the average number of patients admitted in the ICU is 950 per year. 49% were medical patients, 31% surgical patients and 20% trauma patients. 59.75% of patients required artificial nutrition (AN), of which, 58.7% required enteral nutrition (EN), 16% total parenteral nutrition (TPN); and 25.3% suplementary parenteral nutrition (SPN). When EN was contraindicated, 83.3% of patients were started on early TPN (24 hours) and if EN was not sufficient, 66.7% were started on SPN within 48 hours. Regarding prescribers usual practice, 50% tried to reduce volume of PN and 100% of them had an insulin infusion protocol. 39% of prescribers recommended high-protein, low-volume and low-glucose TPN; 42% prescribe TPN with SMOF (soybean, MCT, olive and fish oil); and 33% with OOBE (olive oil based emulsion) as lipid emulsion. 92% added glutamine. 60% considered that the new formulation may be indicated for sepsis, trauma, burn patients and MOF (multiple organ failure) and the 30% would use it as a routine therapy at the time of admission. 40% considered that insulin requirements were reduced; 50% claimed better volume management and 60% highlighted the protein/volume ratio. Attending to patient outcome, patients receiving the specific formulation have less affected hepatic function, higher protein intake and lower volume infusion but no significant differences were observed and they required less insulin dosage (p = 0.07). In the twelve ICUs included in the survey, the clinical practice patterns related to parenteral nutrition management are adapted to the guidelines of scientific societies such as the Spanish Society of Intensive Care Medicine and Coronary Units (SEMICYUC), the Spanish Society of Parenteral and Enteral Nutrition (SENPE) and the European Society for Clinical Nutrition and Metabolism (ESPEN). The new formulations designed for critically ill patients may be indicated for these conditions.

CLSM Method for the Dynamic Observation of pH Change within Polymer Matrices for Oral Delivery

If acid-sensitive drugs or cells are administered orally, there is often a reduction in efficacy associated with gastric passage. Formulation into a polymer matrix is a potential method to improve their stability. The visualization of pH within these materials may help better understand the action of these polymer systems and allow comparison of different formulations. We herein describe the development of a novel confocal laser-scanning microscopy (CLSM) method for visualizing pH changes within polymer matrices and demonstrate its applicability to an enteric formulation based on chitosan-coated alginate gels. The system in question is first shown to protect an acid-sensitive bacterial strain to low pH, before being studied by our technique. Prior to this study, it has been claimed that protection by these materials is a result of buffering, but this has not been demonstrated. The visualization of pH within these matrices during exposure to a pH 2.0 simulated gastric solution showed an encroachment of acid from the periphery of the capsule, and a persistence of pHs above 2.0 within the matrix. This implies that the protective effect of the alginate-chitosan matrices is most likely due to a combination of buffering of acid as it enters the polymer matrix and the slowing of acid penetration.

An evaluation of models of bare soil evaporation formulated with different land surface boundary conditions and assumptions

Bare soil evaporation is a key process for water exchange between the land and the atmosphere and an important component of the water balance. However, there is no agreement on the best modeling methodology to determine evaporation under different atmospheric boundary conditions. Also, there is a lack of directly measured soil evaporation data for model validation to compare these methods to establish the validity of their mathematical formulations. Thus, a need exists to systematically compare evaporation estimates using existing methods to experimental observations. The goal of this work is to test different conceptual and mathematical formulations that are used to estimate evaporation from bare soils to critically investigate various formulations and surface boundary conditions. Such a comparison required the development of a numerical model that has the ability to incorporate these boundary conditions. For this model, we modified a previously developed theory that allows nonequilibrium liquid/gas phase change with gas phase vapor diffusion to better account for dry soil conditions. Precision data under well‐controlled transient heat and wind boundary conditions were generated, and results from numerical simulations were compared with experimental data. Results demonstrate that the approaches based on different boundary conditions varied in their ability to capture different stages of evaporation. All approaches have benefits and limitations, and no one approach can be deemed most appropriate for every scenario. Comparisons of different formulations of the surface boundary condition validate the need for further research on heat and vapor transport processes in soil for better modeling accuracy.

Excipient exchange in the comparison of preparations of the same biologic made by different manufacturing processes: An exploratory study with recombinant human growth hormone (rhGH)

Demonstrations of bio-similarity between subsequent entry (follow-on) biologics and innovator’s formulated drug products may depend upon methods that either remove excipients completely or allow the exchange of excipients to give equivalent formulations. Excipient exchange through dialysis is perhaps the simplest of such methods but its use has been hotly debated. This debate, in the absence of published data, has relied largely on theoretical considerations. This study presents data that indicate that excipient exchange can allow comparisons of different formulations of the same therapeutic protein. The use of excipient exchange to and from one concentration of mannitol to another or to a mixture of glycine and mannitol was reproducibly demonstrated for recombinant human growth hormone (rhGH). We show that marketed rhGH products from several different manufacturers exhibit differences in conformational stability when compared directly. These differences, however, are shown to be the result of differences in formulation rather than in the drug substance itself and were removed through excipient exchange. The data presented, therefore, also indicate that failure to assure a common excipient background can lead to erroneous conclusions about the similarities and differences in the physico-chemical properties of two preparations of the same therapeutic protein made by different manufacturing processes.

A Systematic Review on the Efficacy of Interferon Beta in Relapsing Remitting Multiple Sclerosis; Comparison of Different Formulations

A Systematic Review on the Efficacy of Interferon Beta in Relapsing Remitting Multiple Sclerosis; Comparison of Different Formulations

Comparison of Different Formulations for the Numerical Calculation of Unsteady Incompressible Viscoelastic Fluid Flow

In this paper we compare different methods currently used in the sta- bilization of numerical simulations of time-dependent viscoelastic fluid flows de- scribed with the Oldroyd-B and related models. The methods under consideration, based on the separation of newtonian-like components from the stress tensor, are applied to a finite volume analysis of two simple benchmark problems (the plane Poiseuille startup and pulsated flows), for which analytical solutions are known. The relative performances of each method are evaluated regarding stability, accu- racy and efficiency.

Hedonic prices for cars: an application to the Spanish car market, 1981–2005

In this article we provide a comparison of different formulations for hedonic regression analysis in order to construct a quality adjusted price index for the Spanish car market over the period 1981 to 2005. Specifically, we address the issue of instability of coefficients over time, and propose two alternative estimation procedures based, firstly, on a moving sample of observations and, secondly, on a moving average of estimated coefficients in single period equations. The statistical tests applied support the proposed methodologies. On empirical grounds two conclusions can be emphasized. Firstly, our study concludes that, taking quality changes into account, car prices in Spain deflated by consumer price index (CPI) declined by 40% between 1981 and 2005. This result is robust to the alternative estimation procedures employed in the study. Secondly, an analysis of σ-convergence shows that for quality adjusted prices a clear trend in σ-convergence emerges between 1986 and 1992, whereas such a trend does not exists for observed prices. This result has to be related to Spain's integration into the European Community (EC).

Comparison of different formulations of 2D beam elements based on Bond Graph technique

Bond Graphs are well suited for modelling multibody systems. In this paper modelling of planar flexible beams undergoing large overall motions are studied based on finite element (FE) technique. Two well-known approaches are used – the co-rotational (CR) and absolute nodal coordinate (ANC) formulation. Two ANC formulations are analyzed – one in which elastic forces is described using classical beam theory in a local coordinate frame, and another based on a global continuum mechanics approach. Starting from these classical formulations velocity formulations are developed and used to develop Bond Graph FE components. The effect of gravity has been considered as well. These components can be put in libraries and used for systematic Bond Graph flexible body model development. It is shown that Bond Graph technique is capable of dealing with different flexible body formulations and can be used as a general approach in parallel to other modelling approaches. Models are developed and simulations are performed using the object oriented environment of BondSim. Owing to the object oriented approach, transformation from one to the other model is relatively simply. The results are illustrated by suitable examples and they confirm accuracy of the developed models. It was shown that the CR approach offers much better performance than the both ANC formulations.

Study of the Geometric Stiffening Effect: Comparison of Different Formulations

This paper reviews different formulations to account for the stressstiffening or geometric stiffening effect arising from deflections largeenough to cause significant changes in the configuration of the systemThe importance of such effect on many engineering applications, such asthe dynamic behaviour of helicopter blades, flexible rotor arms, turbineblades, etc., is well known. The analysis is carried out only for one-dimensional elements in 2D.

Mesh tying on curved interfaces in 3D

In this work, a mortar method is implemented for tying arbitrary dissimilar 3D meshes, i.e. 3D meshes with curved, non‐matching interfaces. The 3D method requires approximations to the surface integrals specified by the projection of the displacement jump across the interface onto the Lagrange multiplier space. The numerical integration scheme is presented and several Lagrange multiplier interpolation schemes are considered. Furthermore, some implementational issues such as how to handle boundary conditions will be described such that stability is retained. Finally, the implementation will be demonstrated in numerical simulations and comparison of different formulations will be made.

Mokslo vertybinio neutralumo problema

Straipsnyje analizuojama šiuolaikinių diskusijų mokslo vertybinio neutralumo klausimais priešistorė. Išskiriami trys mokslo vertybinio neutralumo problemos aspektai: loginis (deskriptyvinių teiginių ir vertinimų dichotomija ir „Hume'o principas“), metodologinis (reikalavimas priimti ir atmesti hipotezes vien pažintinių vertybių pagrindu), etinis (draudimas mokslo vardu ginti ir skelbti nepažintines vertybes) ir trys diskusijos šiuo klausimu etapai. Analizuojami neutralumo principo šalininkų argumentai, pateikti pirmų dviejų tos diskusijos etapų metu. Ypatingas dėmesys skiriamas keblumams, su kuriais susidūrė šio principo pagrindimas: tai duomenų statistinio reikšmingumo lygmens pasirinkimo priklausomybės nuo nepažintinių vertybių problema, kuri iškyla tikrinant statistines hipotezes (ji yra aktuali loginiam empirizmui), taip pat problema, kaip suderinti sprendimų ir faktų dichotomiją su bazinių teiginių konvencionalumo teze (su ja susiduria kritinis racionalizmas). Aptariami neomarksistinės „kritinės teorijos“ kritinio socialinio mokslo uždavinių sampratos ypatumai, nulėmę jos ryžtingą opoziciją mokslo vertybinio neutralumo principui. Kaip atskaitos taškas skirtingoms mokslo vertybinio neutralumo principo redakcijoms išdėstyti ir palyginti imamos klasikinės vokiečių sociologo Maxo Weberio (1864-1920) formuluotės. Ypatingas dėmesys skiriamas Weberio teiginiams apie „kultūros mokslų“ vertybinių prielaidų kintamumą, anticipuojantiems kai kurias postpozityvistinės mokslo filosofijos idėjas. Lyginant Weberio pažiūras į racionalią diskusiją dėl „galutinių“ vertinimų su povėberinės analitinės metaetikos idėjomis, kvestionuojamas požiūris (jį reiškia A. Maclntyre ir W. G. Runcimanas), kad Weberis buvo nonkognityvistas. Weberio pasisakymai šiuo klausimu interpretuojami kaip kvazitranscendentalinės praktinio proto dialektikos apmatai, kurie gali būti gretinami su Kanto transcendentaline teorinio proto dialektika.

DNA vaccination by immersion and ultrasound to trout viral haemorrhagic septicaemia virus

This work reports preliminary data on the application of a novel method, ultrasound, for the DNA vaccination of rainbow trout. First, the best formulations were selected that increased the transfer by immersion of a plasmid coding for the green fluorescent protein (GFP) gene into trout fry. Quantification of GFP expression by fluorescence in the fin cells was used to study time course, DNA concentration dependence and comparison of different formulations. The best GFP expression results were obtained with short pulses of ultrasound, DOTAP liposomes and recombinant bacteria or bactofection. Other liposomes or microencapsulation formulations resulted in a GFP fluorescence similar to background values. Second, DNA immersion-vaccination of immunocompetent fingerling trout with the selected formulations was performed by using a plasmid coding for the glycoprotein G gene of the viral haemorrhagic septicaemia virus (VHSV). The immunization of fingerling trout was estimated by measuring humoral antibody, lymphoproliferation and VHSV challenge responses. Short pulses of low intensity ultrasound were the only method by which both humoral antibody responses and survival after VHSV challenge were obtained. Immersion DNA-vaccination using short pulses of ultrasound could eventually lead to a practical way to vaccinate small fish.

Lung deposition of budesonide in asthmatics: a comparison of different formulations

Lung deposition of budesonide administered from a pressurized metered dose inhaler (pMDI), with and without a large volume spacer (Nebuhaler®) attached, and from Turbuhaler®, were compared in an open, crossover, randomized study in eight asthmatic patients under optimum inhalation conditions using a 99mTc-tracer and scintigraphic imaging. The total and regional deposition of aerosol in the lungs as well as the oropharyngeal deposition was determined. The percentage of dose in the whole lung was 11.9±5.0% (mean±S.D.) from a pMDI, 38.4±10.2% from a pMDI with Nebuhaler and 26.1±10.5% from Turbuhaler. The mean lung deposition from Turbuhaler was significantly greater ( p=0.0005) than that from a pMDI alone, and a pMDI with Nebuhaler gave significantly greater lung deposition compared with a pMDI ( p<0.0001) and Turbuhaler ( p=0.02). No significant difference was observed in central lung deposition between Turbuhaler and Nebuhaler administrations, whereas Nebuhaler gave a greater intermediate and peripheral lung deposition. Administrations via pMDI and pMDI with Nebuhaler gave higher peripheral/central ratios (∼1.2) vs 0.64 with Turbuhaler. The total lung deposition of budesonide via a pMDI and Turbuhaler in asthmatic patients in the present study was comparable with that previously found in healthy subjects.