Stability of Olmesartan Medoxomil Extemporaneous Suspensions

2021 ◽  
pp. 875512252110517
Author(s):  
Prapanna Bhattarai ◽  
Timothy McPherson ◽  
Marcelo Nieto ◽  
William M. Kolling
Keyword(s):  
United States ◽  
High Performance ◽  
Room Temperature ◽  
Physical Stability ◽  
Olmesartan Medoxomil ◽  
Storage Condition ◽  
The United States ◽  
Priority List ◽  
Study Results ◽  
Stability Data

Background: Olmesartan medoxomil (OLM) is only available in the United States as tablets. The United States Pharmacopoeia (USP) has placed OLM on its priority list of preparations that require stability data to support practitioner compounding. Objective: The purpose of the study was to develop a stability-indicating assay and then determine the beyond-use date (BUD) for an extemporaneous OLM suspension. Methods: A reverse-phase high-performance liquid chromatography (HPLC) assay was developed and validated according to guidelines for USP official compounded monographs. OLM 2 mg/mL suspensions were compounded with Ora-Sweet and Ora-Plus and stored at room temperature or in a refrigerator. Suspensions were assayed periodically over 90 days for OLM concentration and observed for physical stability. The pH was measured at the beginning and end of the study. Results: The OLM concentration remained above 97% of the starting concentration for 90 days when stored in the refrigerator and above 94% of the starting concentration for 90 days when stored at room temperature. The suspension pH did not change and indicators of physical stability were unchanged for 90 days. Conclusion: OLM 2 mg/mL suspensions were chemically and physically stable at room temperature and in the refrigerator for 90 days. The BUD may be set at 90 days under either storage condition.

scholarly journals Stability and Beyond-Use Date of a Compounded Thioguanine Suspension

2020 ◽  
pp. 875512252095243
Author(s):  
Sagar S. Gilda ◽  
William M. Kolling ◽  
Marcelo Nieto ◽  
Timothy McPherson
Keyword(s):  
United States ◽  
High Performance ◽  
Room Temperature ◽  
Physical Stability ◽  
The United States ◽  
Chromatography Method ◽  
Priority List ◽  
Significant Difference ◽  
Stability Data ◽  
Liquid Chromatography Method

Background: Thioguanine (TG) is available only in the form of 40 mg tablets in the United States, and the patient population in which TG is used comprises mostly children. Recognizing its importance as a therapeutic agent and limited stability data for its compounded preparation, the United States Pharmacopoeia has listed TG in its priority list of compounded preparations monographs. Objective: The goal of the present study was to generate stability data and establish a beyond-use date for compounded TG suspension. Methods: Suspensions were compounded using TG tablets and ORA-Plus and ORA-Sweet as vehicles. A robust high-performance liquid chromatography method was developed and validated. TG and guanine (G) in suspensions were quantified immediately after compounding and at regular intervals for 90 days. Physical stability of suspensions was evaluated by observation of organoleptic properties. Results: Results from the study indicate that average TG levels in suspensions remained above 90% of the starting concentration and G formation was less than 2.5% for 90 days. There was no statistically significant difference in the amount of TG degraded over 90 days between suspensions stored at room temperature and in refrigerated conditions. There was also no statistically significant difference in G concentration of suspensions between day 0 and day 90. Conclusion: TG suspensions are stable for 90 days when stored at room temperature or refrigerated conditions and the beyond-use date can be set to 90 days.

scholarly journals Evaluating High Performance the Evidence-Based Way: The Case of the Swagelok Transformers

SAGE Open ◽  
2017 ◽  
Vol 7 (4) ◽  
pp. 215824401773680
Author(s):  
André de Waal
Keyword(s):  
United States ◽  
North American ◽  
High Performance ◽  
The United States ◽  
Evidence Based ◽  
High Performing ◽  
The North ◽  
Effective Interventions ◽  
Study Results ◽  
High Performance Organization

Many of the publications on achieving high performance have been written by North American researchers and consultants, and the case companies they described originate mainly from the United States. However, there is a lack of long-term studies that subject the described techniques to rigorous evidence-based management research in North American companies, to test the ideas in practice over a period of time to evaluate their relevance to managerial practice. In this article, we evaluate the high performance organization (HPO) Framework, a scientifically validated technique for helping organizations become high performing, in the North American context. This framework evaluates the strengths and weaknesses of the internal organization of a company, using a questionnaire. This questionnaire was applied in 2013 at seven Swagelok locations in the United States and Canada. From the questionnaire improvement opportunities were identified on which the locations subsequently worked. In 2015, the questionnaire was repeated to evaluate the effects of these improvements on the locations’ performance and to identify the most effective interventions. The study results show that the application of the HPO Framework had different outcomes depending on local circumstances. Some locations experienced a growth while other locations used the framework to battle the consequences of adverse economic circumstances. All locations agreed that the HPO Framework had been instrumental, in a positive way, to the development of their organization and its people.

Stability of Ziprasidone Mesylate in an Extemporaneously Compounded Oral Solution

2010 ◽  
Vol 15 (2) ◽  
pp. 138-141
Author(s):  
Kelsey Green ◽  
Roy C. Parish
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Physical Stability ◽  
Storage Condition ◽  
High Performance Liquid Chromatographic ◽  
Oral Solution ◽  
Fluorescent Light ◽  
Light Illumination ◽  
Liquid Preparation ◽  
Liquid Chromatographic

ABSTRACT OBJECTIVES To formulate a liquid preparation of ziprasidone in a convenient concentration to allow dosing of less than 20 mg and of sufficient chemical and physical stability to enable an entire prescription or course of treatment to be prepared in a single batch. METHODS Geodon for injection (ziprasidone mesylate), 20 mg/mL, was diluted to 2.5 mg/mL in a commercially available sugar-free and alcohol-free, flavored syrup and stored at room temperature under ambient fluorescent light illumination, at room temperature in darkness, and under refrigeration. The ziprasidone content was measured in samples at various time intervals using a stability-indicating high-performance liquid chromatographic method. RESULTS When refrigerated, the ziprasidone syrup that was compounded in a commercially available, sugar-free and alcohol-free vehicle maintained at least 90% of stated potency for at least 6 weeks. Samples stored under other conditions were less stable, underscoring the manufacturer's labeling regarding refrigerated storage of the reconstituted injection. CONCLUSIONS The findings suggest that chemical and physical stability are maintained for 2 weeks under refrigeration, allowing the convenience of compounding for the long-term needs of a particular patient, rather than daily compounding. The only storage condition we recommend is refrigeration at 5°C.

Measurement of Perceived Interpersonal and Societal Anti-Muslim Discrimination in the United States

Assessment ◽  
2020 ◽  
pp. 107319112097338
Author(s):  
Naheed Ahmed
Keyword(s):  
United States ◽  
Online Survey ◽  
Qualitative Data ◽  
High Reliability ◽  
The United States ◽  
Discrimination Index ◽  
Muslim Americans ◽  
Study Results ◽  
Development And Validation ◽  
Component Models

Background: Hate crimes against Muslim Americans have increased exponentially in the past 20 years, but there is currently no scale for measuring perceived anti-Muslim discrimination in the United States. To fill this gap, this study used a mixed-method approach to develop scales for measuring perceived anti-Muslim discrimination. Method: Qualitative data informed the development and validation of the 19-item Societal Anti-Muslim Discrimination Index and the 9-item Interpersonal Anti-Muslim Discrimination Index. Quantitative data ( N = 347) were collected from Muslim Americans using an online survey and used to assess the anti-Muslim indexes. Results: Qualitative data contributed to the refinement scale items. Quantitative results indicated one-component models and modest to high reliability of the Interpersonal Anti-Muslim Discrimination Index (.77) and Societal Anti-Muslim Discrimination Index (.88) scales. Discussion: Study results established the validity of these novel scales for measuring the distinct facets of anti-Muslim discrimination not captured by the Everyday Discrimination Index. These scales will facilitate research on anti-Muslim discrimination and the health implications of this form of religious-based discrimination.

Stability of dronabinol capsules when stored frozen, refrigerated, or at room temperature

2016 ◽  
Vol 73 (14) ◽  
pp. 1088-1092 ◽  
Author(s):  
Michael F. Wempe ◽  
Alan Oldland ◽  
Nancy Stolpman ◽  
Tyree H. Kiser
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Oxidative Degradation ◽  
Storage Condition ◽  
Sesame Oil ◽  
Forced Degradation ◽  
Product Packaging ◽  
Time Points ◽  
The Stability ◽  
Minimal Reduction

Abstract Purpose Results of a study to determine the 90-day stability of dronabinol capsules stored under various temperature conditions are reported. Methods High-performance liquid chromatography (HPLC) with ultraviolet (UV) detection was used to assess the stability of dronabinol capsules (synthetic delta-9-tetrahydrocannabinol [Δ9-THC] mixed with high-grade sesame oil and other inactive ingredients and encapsulated as soft gelatin capsules) that were frozen, refrigerated, or kept at room temperature for three months. The dronabinol capsules remained in the original foil-sealed blister packs until preparation for HPLC–UV assessment. The primary endpoint was the percentage of the initial Δ9-THC concentration remaining at multiple designated time points. The secondary aim was to perform forced-degradation studies under acidic conditions to demonstrate that the HPLC–UV method used was stability indicating. Results The appearance of the dronabinol capsules remained unaltered during frozen, cold, or room-temperature storage. Regardless of storage condition, the percentage of the initial Δ9-THC content remaining was greater than 97% for all evaluated samples at all time points over the three-month study. These experimental data indicate that the product packaging and the sesame oil used to formulate dronabinol capsules efficiently protect Δ9-THC from oxidative degradation to cannabinol; this suggests that pharmacies can store dronabinol capsules in nonrefrigerated automated dispensing systems, with a capsule expiration date of 90 days after removal from the refrigerator. Conclusion Dronabinol capsules may be stored at room temperature in their original packaging for up to three months without compromising capsule appearance and with minimal reduction in Δ9-THC concentration.

FORCED DEGRADATION STUDIES OF OLMESARTAN MEDOXOMIL AND CHLORTHALIDONE: DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP‑HPLC METHOD

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (03) ◽  
pp. 39-45
Author(s):  
A Sherje ◽  
A. Sonalkar ◽  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Olmesartan Medoxomil ◽  
The United States ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Forced Degradation ◽  
Uv Detector ◽  
Tablet Dosage

A reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of olmesartan medoxomil (OLME) and chlorthalidone (CHLOR) in tablet dosage form. The analysis was performed on Inertsil ODS C18 (250 x 4.6 mm, 5 μ) using KH2PO4 phosphate buffer (pH) and acetonitrile as mobile phase in the proportion of 60: 40 v/v at flow rate of 1.0 mL/min. Detection of drugs was carried out in isocratic mode using UV detector at 275 nm. The retention time of OLME and CHLOR was 13.9 ± 0.1 min. and 4.4 ± 0.5 min., respectively and the total run time was 20 min. The method was validated according to the requirements of the United States Pharmacopeia. The percentage recoveries was found to be in the range of 98.9 - 100.7%. The method was successfully applied to the assay of OLME and CHLOR in tablet dosage form.

Honesty among lawyers: Moral character, game framing, and honest disclosures in negotiations

2021 ◽  
Author(s):  
Taya R. Cohen ◽  
Erik G Helzer ◽  
Robert Creo
Keyword(s):  
United States ◽  
Moral Character ◽  
The United States ◽  
Law Students ◽  
Study Results ◽  
Cognitive Framing

Lawyers have broad discretion in deciding how honestly to behave when negotiating. We propose that lawyers’ choices about whether to disclose information to correct misimpressions by opposing counsel are guided by their moral character and their cognitive framing of negotiation. To investigate this possibility, we surveyed 215 lawyers from across the United States, examining the degree to which honest disclosure is associated with lawyers’ moral character and their tendency to frame negotiation in game-like terms—a construal of negotiation that we label game framing. We hypothesize that the more that lawyers view negotiation through a game frame—that is, the more they view negotiation as an adversarial context with arbitrary and artificial rules—the less honest they will be in situations in which honest disclosure is not mandated by professional rules of conduct. We further hypothesize that lawyers with higher levels of moral character will apply a game frame to negotiation to a lesser degree than will lawyers with lower levels of moral character, and that honesty when negotiating will be higher when lawyers have higher versus lower levels of moral character. Our study results support these hypotheses. This work suggests that focusing on game-like aspects of negotiation can induce a less moral and ethical mindset. To the extent that teaching law students to “think like a lawyer” encourages them to adopt a game frame of negotiation, we can expect such training to reduce the likelihood of honest disclosure.

MSV(L): Continuing the Legacy of Army Waterborne Capability

2021 ◽  
Author(s):  
David Richard Toepler ◽  
Nathan Leightner
Keyword(s):  
United States ◽  
United States Army ◽  
High Performance ◽  
The United States ◽  
Engineering Management ◽  
Fourth Quarter ◽  
Detailed Design ◽  
New Class ◽  
Source Selection ◽  
Primary Mission

The United States Army operates several classes of landing craft, which provide combatant commanders with waterborne maneuver capabilities essential for accomplishing a range of critical missions unique to the Army. These missions involve transport of personnel, cargo, and equipment from advanced bases and large sealift ships to ports, inland riverine regions, as well as remote undeveloped coastlines and beaches. Recognizing the significant roles these vessels play and will continue to play in achieving Army objectives, Army leadership allocated funding to design and build a new class of high performance landing craft: Maneuver Support Vessel (Light) (MSV(L)). The primary mission of MSV(L) is to conduct movement and maneuver of combat-configured Brigade Combat Team force elements such as one M1A2 main battle tank, or two Stryker vehicles, or four Joint Light Tactical Vehicles, each with its crew. MSV(L) will have beaching capability and be able to operate at speeds significantly in excess of any current Army landing craft. The Army Watercraft Systems organization was tasked with overseeing development of requirements and specifications, source selection and acquisition, along with contract, finance, and engineering management of the MSV(L) Program. A contract to develop the detailed design and build a series of vessels was awarded in September 2017. Launch of the initial vessel is planned during the fourth quarter of 2021.

High-Performance Steels in the United States

2005 ◽  
pp. 11-44
Author(s):  
M. Myint Lwin ◽  
Alexander D. Wilson ◽  
Vasant C. Mistry
Keyword(s):  
United States ◽  
Driving Force ◽  
High Performance ◽  
The United States ◽  
Atmospheric Conditions ◽  
Iron And Steel ◽  
Federal Highway ◽  
The U.S ◽  
Steel Institute

<p>In 1992, the U.S. Federal Highway Administration (FHWA) initiated an effort with the American Iron and Steel Institute (AISI) and the U. S. Navy (Navy) to develop new high-performance steels (HPS) for bridges. The driving force for this project was the need to develop improved higher strength, improved weldability, higher toughness steels to improve the overall quality and fabricability of steels used in bridges in the United States. It was furthermore established that such steels should be "weathering". By this is meant the ability to perform without painting under normal atmospheric conditions.</p>

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