Advance Care Directive Preferences in Women Veterans: A Snapshot.

Prior research characterizes mainly male veteran preferences at end of life using the Veterans Administration Advance Directive (VA AD), there has been no specific studies focusing on women veteran's preferences concerning whether the AD is to be strictly (S) followed or to serve as a general guide (G). The purpose of this study was to describe women veteran preferences for life-sustaining treatments (LSTs) in various illness situations to assist providers in discussing end-of-life decisions. Additionally, we compared previously published LST preferences of male veterans with the study's sample. Using a descriptive retrospective approach, data was collected from 484 women veterans ADs between January 2010 and December 2019. Findings revealed that women tended to trend in the same direction as men, preferring to have advance directives serve as general guidance over being strictly followed. Unconscious/Coma/Vegetative was the only factor that was statistically significant for affecting the choice of following the AD.

Capsule Machine Validation.

Instrumentation has become an integral function for any compounding operation, particularly for hard-gelatin capsules. This study examined the use of a capsule machine in a simulated compounding operation. It is an instrument that is reasonably priced and can deliver 24 capsules within ten minutes of operation. Capsule Connection LLC suggests the use of this machine for filling capsules with herbal or vitamin preparations. Moreover, this instrument may be used for training pharmacy students in a pharmaceutics/compounding laboratory. The main objective of the research was to calibrate and validate a capsule formulation for acetaminophen using the Capsule Machine from Capsule Connection LLC. Twenty Capsule Machines were purchased from Capsule Connection LLC. The machines were first calibrated and then validated using spray-dried lactose monohydrate powder. Based on the results obtained from the calibration and validation process, a powder mixture containing acetaminophen was prepared by mixing acetaminophen with lactose in a glass mortar using the geometric dilution method. The labeled amount of acetaminophen per capsule was 81 mg. Capsules generated from this compounding operation were tested using the United States Pharmacopeia content uniformity test. The calibration and validation processes were repeated twice with lactose monohydrate. The overall average weights for size-0 capsule shells and lactose-filled capsules were 94.61 mg and 545.77 mg, respectively. On average, the content of a capsule was estimated to be 451.16 mg of powder. A powder mixture was prepared to make 480 capsules (20 machines, each producing 24 capsules). This mixture was made of 38.88 g of acetaminophen and 177.68 g of lactose. A 3% amount of additional powder was added to account for the powder loss during the operation. All capsule machines passed the United States Pharmacopeia content uniformity test. The average amount of acetaminophen per capsule was 98.91% of the labeled amount. Only less than 5% of the capsules were lost during the filling operation of lactose in capsules and none lost with the acetaminophen capsules. The Capsule Machine from Capsule Connection LLC produced capsules containing acetaminophen with high reproducibility and accuracy.

Predictive Performance Comparison of Computed Linear and Quadratic Multivariate Models for In-Situ UV Fiber Optics Tablet Dissolution Testing.

A present investigation aimed for multivariate modeling as a solution to resolve inaccuracy in dissolution testing experienced in the use of in-situ UV fiber optics dissolution systems (FODS) due to signal saturation problems. This problem is specifically encountered with high absorbance of moderate to high dose formulations. A high absorbance not only impede a real-time assessment but can also result in inaccurate dissolution profiles. Full spectra (F) and low absorbance regions (L) were employed to develop linear and quadratic (Q) partial least squares (PLS) and principal component regression (PCR) models. The conventional dissolution of atenolol, ibuprofen, and metformin HCl immediate-release (IR) tablets followed by HPLC analysis was used as a reference method to gauge multivariate models' performance in the 'built-in' Opt-Diss model. The linear multivariate modeling outputs resulted in accurate dissolution profiles, despite the potentially high UV signal saturation at later time points. Conversely, the 'built-in' Opt-Diss model and multivariate quadratic models failed to predict dissolution profiles accurately. The current studies show a good agreement in the predictions across both low absorbance region and full spectra, demonstrating the multivariate models' robust predictability. Overall, linear PLS and PCR models showed statistically similar results, which demonstrated their applicative flexibility for using FODS despite signal saturation and provides a unique alternative to traditional and labor-intensive UV or HPLC dissolution testing.

Assessment and clinical utility of pharmacogenomics by healthcare practitioners in North Carolina.

Aim: Perceived knowledge, use and perceptions of pharmacogenomics (PGx) testing were assessed among healthcare practitioners in North Carolina. Materials & methods: A validated survey was distributed to various healthcare professionals and analyzed for differences among the groups. Results: The majority of the 744 survey respondents acknowledged the perceived benefits of PGx testing, but indicated either never or rarely using it. A substantial percentage of practitioners reported educational experiences but the majority had received no training. Among groups reporting using PGx testing, barriers to implementation were cost and insufficient training. Conclusion: The perceived cost of PGx testing and insufficiency or lack of training are major contributing factors to the infrequent use of PGx testing by healthcare providers in North Carolina.

Correction to: Employing Multivariate Statistics and Latent Variable Models to Identify and Quantify Complex Relationships in Typical Compression Studies.

During the transmission process in publishing the article online, the equal (=) sign was replaced with "0" in Equations 1 to 5. The original article has been corrected.

Employing Multivariate Statistics and Latent Variable Models to Identify and Quantify Complex Relationships in Typical Compression Studies.

The effect of storage condition (% RH) on flufenamic acid:nicotinamide (FFA:NIC) cocrystal compressibility, compactibility, and tabletability profiles was not observed after visual evaluation or linear regression analysis. However, multivariate statistical analysis showed that storage condition had a significant effect on each compressional profile. Shapiro and Heckel equations were used to determine the compression parameters: porosity, Shapiro's compression parameter (f), densification factor (Da), plastic yield pressure (YPpl), and elastic yield pressure (YPel). Latent variable models such as exploratory factor analysis, principal component analysis, and principal component regression were employed to decode complex hidden main, interaction, and quadratic effects of % RH and the compression parameters on FFA:NIC tablet mechanical strength (TMS). Statistically significant correlations between f and Da, f and YPpl, and Da and YPel supported the idea that both rearrangement and fragmentation, and plastic deformation are important to FFA:NIC TMS. To the authors knowledge, this is the first time that simultaneously operating dual mechanisms of fragmentation and plastic deformation in low and midrange compression, and midrange plastic deformation have been identified and reported. A quantitative PCR model showed that f, Da, and YPel had statistically significant main effects along with a significant antagonist storage condition-porosity "conditional interaction effect". f exhibited a 2.35 times greater impact on TMS compared to Da. The model root-mean-square error at calibration and prediction stages were 0.04 MPa and 0.08 MPa, respectively. The R2 values at the calibration stage and at the prediction stage were 0.9005 and 0.7539, respectively. This research demonstrated the need for caution when interpreting the results of bivariate compression data because complex latent inter-relationships may be hidden from visual assessment and linear regression analysis, and result in false data interpretation as illustrated in this report.

Lubricant-Sensitivity Assessment of SPRESS® B820 by Near-Infrared Spectroscopy: A Comparison of Multivariate Methods.

The predictability of multivariate calibration models, calculated with offline near-infrared spectroscopy (NIRS), assessing impact of magnesium stearate (MgSt) fraction, blending time, and compression force on the tablet breaking force (TBF) of SPRESS® B820 was statistically compared. Tablets of lubricated SPRESS® B820 were prepared by varying lubrication and compression conditions using 24 full factorial design. Tablets were scanned in reflection mode on a benchtop NIRS. A qualitative principal component analysis and quantitative principal component regression (PCR) and partial least square (PLS) regression relationship between lubricant concentration, blending time, compression force, preprocessed NIR spectra, and measured TBF was calculated with calibration data set. The predictability of calibration models was validated with independent data set. Expected qualitative correlations between MgSt blending time and TBF and a nonlinear relationship between MgSt fraction and TBF were observed. Predictability of PLS comprehensive (0.25%-1% w/w MgSt) model was significantly different from individual 0.25%, 0.5%, and 1.0% w/w MgSt PLS models. In addition, PLS calibration models' predictability was different from PCR calibration models. Thus, added lubrication fraction and adopted multivariate methodology should be selected carefully during the calibration and validation stages as it may have a significant impact on the predictability of the developed models.

Physico-Mechanical Properties of Coprocessed Excipient MicroceLac® 100 by DM(3) Approach.

PURPOSE: To determine the effect of relative humidity (RH) and hydroxypropyl methylcellulose (HPMC) on the physico-mechanical properties of coprocessed MacroceLac(®) 100 using 'DM(3)' approach. METHODS: Effects of RH and 5% w/w HPMC on MacroceLac(®) 100 Compressibility Index (CI) and tablet mechanical strength (TMS) were evaluated by 'DM(3)'. The 'DM(3)' approach evaluates material properties by combining 'design of experiments', material's 'macroscopic' properties, 'molecular' properties, and 'multivariate analysis' tools. A 4X4 full-factorial experimental design was used to study the relationship of MacroceLac(®) 100 molecular properties (moisture content, dehydration, crystallization, fusion enthalpy, and moisture uptake) and macroscopic particle size and shape on CI and TMS. A physical binary mixture (PBM) of similar composition to MacroceLac(®) 100 was also evaluated. Multivariate analysis of variance (MANOVA), principle component analysis, and partial least squares (PLS) were used to analyze the data. RESULTS: MANOVA CI ranking was: PBM-HPMC > PBM > MicroceLac(®)100 > MicroceLac(®)100-HPMC (p < 0.0001). MANOVA showed PBM's and PBM-HPMC's TMS values were lower than MicroceLac(®)100 and MicroceLac(®)100-HPMC (p < 0.0001). PLS showed that % RH, HPMC, and several molecular properties significantly affected CI and TMS. CONCLUSIONS: Significant MicroceLac(®)100 changes occurred with % RH exposure affecting performance attributes. HPMC physical addition did not prevent molecular or macroscopic matrix changes.

Formulation and optimization of potassium iodide tablets.

The use of potassium iodide (KI) as a protective agent against accidental radioactive exposure is well established. In this study, we aimed to prepare a KI tablet formulation using a direct compression method. We utilized Design of Experiment (DoE)/mixture design to define the best formulation with predetermined physical qualities as to its dissolution, hardness, assay, disintegration, and angle of repose. Based on the results from the DoE, the formulation had the following components (%w/w): Avicel 48.70%, silicon dioxide 0.27%, stearic acid (1.00%), magnesium stearate 2.45%, and dicalcium phosphate 18.69%, in addition to potassium iodide 28.89% (130 mg/tablet). This formulation was scaled-up using two tablet presses, a single-punch press and a rotary mini tablet press. The final scaled-up formulation was subjected to a variety of quality control tests, including photo-stability testing. The results indicate that potassium iodide tablets prepared by a rotary mini tablet press had good pharmaceutical characteristics and a shelf-life of 25 days when stored at room temperature protected from light.

Evaluation of the moisture prediction capability of near-infrared and attenuated total reflectance fourier transform infrared spectroscopy using superdisintegrants as model compounds.

The superdisintegrants (SDs) moisture content measurement by near-infrared (NIR) spectroscopy and attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopy has been evaluated against thermogravimetric analysis as a reference method. SDs with varying moisture content were used to build calibration and independent model verification data sets. Calibration models were developed based on the water-specific NIR and ATR-FTIR spectral regions using partial least-square regression methods. Because of the NIR water low molar absorptivity, NIR spectroscopy handled higher moisture content (∼81%, w/w) than ATR-FTIR (∼25%, w/w). A two-way ANOVA test was performed to compare R(2) values obtained from measured and predicted moisture content (5%-25%, w/w) of SDs. No statistically significant difference was observed between the predictability of NIR and ATR-FTIR methods (p = 0.3504). However, the interactions between the two independent variables, SDs, and analytical methods were statistically significant (p = 0.0002), indicating that the predictability of the analytical method is material dependent. Thus, it would be important to recognize this highly dependent material and analytical method interaction when using NIR moisture analysis in process analytical technology to analyze and control critical quality and performance attributes of raw materials during processing with the goal of ensuring final product quality attributes.

Impact of a pill box clinic to improve systolic blood pressure in veterans with uncontrolled hypertension taking 3 or more antihypertensive medications.

BACKGROUND: Two-thirds of Americans who are prescribed antihypertensive medications are not at a blood pressure (BP) goal of <140/90 mmHg, and low adherence is identified as a primary cause of inadequate control. Improved adherence to antihypertensive medications has been shown to enhance BP control and reduce the risk of cardiovascular complications. This study investigated the effectiveness of a pill box clinic to improve BP in veterans with uncontrolled hypertension taking 3 or more antihypertensive medications. OBJECTIVES: To (a) investigate the reduction of systolic BP by 10 mmHg from pre-intervention to post-intervention (primary outcome) and (b) investigate the percentage of patients meeting goal blood pressure--as defined by The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7)--and percentage of patient adherence to antihypertensive medications (secondary outcomes). METHODS: Patients with uncontrolled hypertension currently taking at least 3 antihypertensive medications were enrolled in this prospective pre/post study. Under the supervision of a pharmacist, each patient was provided two 7-day pill boxes to organize all antihypertensive medications. In addition, baseline BP and previous history of nonadherence were documented. Following the initial encounter, patients attended 2 follow-up appointments, at 2 and 4 weeks, for refill of pill boxes, BP measurement, and adherence assessment. A chi-square test was used for categorical outcomes and logistic regression for nominal outcomes as well as descriptive statistics, as appropriate. RESULTS: Sixty patients were enrolled, with 50 completing appointments 1 and 2, and 45 completing all 3 appointments. Of those, 24% and 31% achieved at least a 10 mmHg reduction in systolic BP from baseline to appointments 2 and 3, respectively (P = 0.438). Systolic BP readings for appointments 1, 2, and 3 were not statistically significant (mean [SD]: 134.1 [11.8], 131.9 [9.4], and 130.6 [11.4], respectively). Goal BP per JNC7 was achieved by 44% and 51% of patients at appointments 2 and 3, respectively, compared with baseline (P = 0.201). All patients had ≥ 80% adherence to antihypertensive medications, assessed via pill counts at the second and third appointments. CONCLUSION: Although results were not statistically significant, the pill box clinic resulted in clinically significant reductions in systolic BP by 10 mmHg, as well as an increased number of patients meeting prescribed BP goals.

Does incorporation of thromboelastography improve bleeding prediction following adult cardiac surgery?

Cardiopulmonary bypass (CPB) coagulopathy increases utilization of allogenic blood/blood products, which can negatively affect patient outcomes. Thromboelastography (TEG) is a point-of-care measurement of clot formation and fibrinolysis. We investigated whether the addition of TEG parameters to a clinically based bleeding model would improve the predictability of postoperative bleeding. A total of 439 patients' charts were retrospectively investigated for 8-h chest tube output (CTO) postoperatively. For model 1, the variables recorded were patient age, gender, body surface area, clopidogrel use, CPB time, first post-CPB fibrinogen serum level, first post-CPB platelet count, first post-CPB international normalized ratio, the total amount of intraoperative cell saver blood transfused, and postoperative first ICU hematocrit level. Model 2 had the model 1 variables, TEG angle, and maximum amplitude. The outcome was defined as 0-8-h CTO. The predictor variables were placed into a forward stepwise regression model for continuous outcomes. Analysis of variance with adjusted R was used to assess the goodness-of-fit of both predictive models. The predictive accuracy of the model was examined using CTO as a dichotomous variable (75th percentile, 480 ml) and receiver operating characteristic curves for both models. Advanced age, male gender, preoperative clopidogrel use for 5 days or less, greater cell saver blood utilization, and lower postoperative hematocrit levels were associated with increased 8-h CTO (P < 0.05). Adding TEG angle and maximum amplitude to model 1 did not improve CTO predictability. When TEG angle and maximum amplitude were added as predictor factors, the predictability of the bleeding model did not improve.

Rheologic Profile, Specific Gravity, Surface Tension, and pH of Fifteen Over-the-Counter Preparations.

Knowledge of the physical characteristics of commercially available over-the-counter preparations can aid the compounding pharmacist in preparing medication. In this study, 15 over-the-counter products were studied with regard to their specific gravity, surface tension, pH, and rheologic profile. The specific gravities of all the products were greater than 1, with the exceptions of Nivea Lotion and rubbing alcohol, which were less than 1. The majority of the products had an acidic pH. With the exception of two products, Citrucel and Chloraseptic, all products demonstrated a surface tension value less than that of water (72.8 dynes/cm). Chloraseptic had the lowest Newtonian viscosity (1.27 cPs), whereas Vicks DayQuil had the highest (098.86 cPs). Citrucel exhibited dilatant-type flow; Suave Shampoo, herbal shampoo, Tangerine Tickle Herbal Shampoo, and Metamucil pseudoplastic flow; the remaining non-Newtonian formulations, plastic flow profiles.

Physical Characteristics of Selected Over-the-Counter Medications.

The physical characteristics of over-the-counter medications may be useful to the compounding pharmacist in preparing dosage forms by serving as physical limits for the basis of choice of vehicles and supporting ingredients for formulations. In this study, three bottles of 16 different products were tested for their specific gravity, pH, suface tension and rheological properties. All products tested were heavier than water, with the exception of the lotions. The pH value varied greatly among the products, and the lotions were neutral to slightly acidic; the other preparations were acidic with the exception of Dulcolax and Maalox, which showed a basic pH. Aqueous solutions had a surface tension very close in value to water; all other products that were tested exhibited lower surface tension than water. The viscosity of the products varied greatly; lotions and suspensions demonstrated shear-thinning properties of either plastic or pseudoplastic type; and all solutions had low viscosity similar to that of water, except for Children's Dimetapp and Vicks Nyquil, which showed a somewhat higher viscosity than water.

Preparation and characterization of a compounded aqueous human insulin suspension.

Human insulin, used in the management of diabetes, is commercially available in the form of solutions or suspensions for injection. This study investigated the preparation and characterization of an oral suspension for insulin. The suspension was prepared by adding human insulin to aqueous soy extract and adjusting the pH of the preparation to 4.0. The mean diameters of insulin particles at this pH were measured to be 29.93 and 28.30 micrometers for volume-surface mean and volume-number mean, respectively. After 24 hours of the suspension standing at room temperature, the sedimentation volume reached a constant value of 0.22. The suspension exhibited shear-thinning rheological properties, since its viscosity decreased when the rate of shear was increased. The formulation was stable for about 18 days when stored in the refrigerator (4 deg C). Compared to a simple solution of insulin stored at a similar acidic pH reported in the literature, the stability of insulin in the suspension has improved over 2000-fold.