scholarly journals Design of Experiments for the Establishment of the Dissolution Test Conditions of Rupatadine Fumarate 10 mg tablets

2019 ◽  
Vol 9 (1-s) ◽  
pp. 331-336 ◽  
Author(s):  
Castillo Henríquez Luis ◽  
Madrigal Redondo German ◽  
Vargas Zúñiga Rolando ◽  
Carazo Berrocal Gustavo

Design of Experiments (DoE) is a statistical model that aims to determine if the factors under study affect the response, and if so, it determines the conditions under which this variable of interest can be optimized. In terms of pharmaceutical technology, independent variables are usually factors of the formulation, while dependent variables are properties of the product or parameters that indicate the performance of the process. Precisely, the dissolution test is a tool of interest for the developers of medicines since it allows them to evaluate the performance of a formulation designed in a solid pharmaceutical form, such as tablets. The present investigation used the design of experiments to establish and optimize the conditions of the dissolution test of a 10 mg Rupatadine fumarate tablets formulation, resulting in the use of HCl 0,1 N (pH 1) dissolution medium and a rotation speed of 100 rpm for the apparatus II USP, which allow the analysis of the product in a reproducible and reliable way. Keywords: Analysis of variances, Design of experiments, Dissolution test, Factorial design, Rupatadine Fumarate, Tablets, Test conditions.

2012 ◽  
Vol 48 (4) ◽  
pp. 801-810 ◽  
Author(s):  
Marcelo Antonio de Oliveira ◽  
Caroline Dutra Lacerda ◽  
André Fazôlo Bonella

Atorvastatin (ATV) is an antilipemic drug of great interest to the pharmaceutical industry. ATV does not appear in the monographs of Brazilian pharmacopoeia, and analytical methodologies for its determination have been validated. The chromatographic conditions used included: RP-18 column-octadecylsilane (250 x 4.6 mm, 5 mm), detection at 238 nm, mobile phase containing 0.1% phosphoric acid and acetonitrile (35:65% v/v), flow at 1.5 mL min-1, oven temperature at 30ºC, and injection volume of 10 mL. ATV is classified as a class II product, according to the biopharmaceutical classification system. As such, a dissolution test was proposed to evaluate pharmaceutical formulations on the market today, under the following conditions: water as a dissolution medium, 1000 mL as a volume, paddle apparatus at a rotation speed of 50 rpm, 80% (Q) in 15 minutes with UV spectrophotometer readings at 238 nm. In the pattern condition proposed as the ideal dissolution test, which appropriately differentiates amongst formulations, the generic product was not considered pharmaceutically equivalent; however, in other less differential dissolution methods, which also fall within appropriate legal parameters, this product could come to be regarded as generic.


METANA ◽  
2018 ◽  
Vol 14 (1) ◽  
pp. 25
Author(s):  
Hidayatul Masruroh ◽  
Ulla Disky Masruroh ◽  
Fransisca Sri Nugraheni ◽  
Vita Paramita

Selama berabad-abad susu telah dikenal sebagai bahan pangan yang dibutuhkan oleh manusia, karena susu banyak mengandung semua komponen bahan yang diperlukan oleh manusia. Kandungan terbesar susu adalah air dan lemak. Penelitian ini melakukan pengujian kandungan lemak pada susu sapi murni menggunakan gaya sentrifugasi, dengan tujuan untuk mengetahui pengaruh variabel berubah, berupa suhu yang digunakan dalam penimpanan susu yaitu 50C, 250C dan 300C, putaran yang digunakan selama percobaan yaitu 1772 rpm, 2080 rpm, 2455 rpm, 3266 rpm, dan 4080 rpm serta waktu yang digunakan yaitu 15 menit, 20 menit dan 25 menit terhadap pemisahan lemak dalam susu sapi murni. Uji analisa pada penelitian ini meliputi uji kandungan lemak, pH, densitas dan viskositas. Pada penelitian tersebut variabel paling optimal yaitu susu pada suhu 300C dengan kecepatan putaran 2455 rpm dan dalam waktu 25 menit mendapatkan hasil kandungan lemak sebesar 2,5ml. Sedangkan hasil pengukuran pH dari ketiga variabel mendapatkan hasil 6,5. Untuk densitas hasil yang didapat yaitu 1,014;1,052; 1,036 masing-masing pada suhu 50C,250C,300C dan untuk viskositas sebesar 1,46. Hasil penelitian menunjukkan bahwa tidak perbedaan signifikan pengaruh kecepatan putaran sentrifugasi terhadap densitas, pH maupun viskositas. Namun terdapat pengaruh putaran kecepatan sentrifugasi terhadap kadar lemak yang terpisahkan. Semakin tinggi suhu penyimpanan disertai peningkatan kecepatan putaran sentrifugasi, maka semakin tinggi kadar lemak yang terpisahkan.    Fat Content Separation Analysis from Dairy Milk by using Centrifuge For centuries dairy has been well known as the food needed by humans, due to its benefits for growth. The major content of milk is water and fat. This study examined the fat content of pure cow's milk using centrifugation force, with the aim to know the effect of independent variables, such as the temperature used in milk storage (5, 25 and 30 0C), the rotation speed of centrifugation (1772, 2080, 2455, 3266, and 4080 rpm) and the centrifugation time (15, 20 and 25 minutes) against the separation of fat in pure cow's milk. The analysis was including fat content test, pH, density and viscosity. In this study, the most optimum variables of fat content separation from milk (2.5 ml) were found at temperature of 300C with the centrifugation speed of 2455 rpm rotation and within 25 minutes. While, there were no different of the pH (6.5) and viscosity (1.46) regarding to the dependent variables. For the density, the results obtained are 1.014, 1.052; 1,036 for each at 50C, 250C, 300C. The result showed that there were no significant difference in the effect of centrifugation rotation speed to density, pH and viscosity. However, increasing the centrifugation rotation speed increased the fat content. The higher the storage temperature along with the increased speed of the centrifugation cycle, were resulted the higher the separated fat content.


2009 ◽  
Vol 45 (1) ◽  
pp. 67-73 ◽  
Author(s):  
Érika de Fátima Silva Oliveira ◽  
Roberta de Cássia Pimentel Azevedo ◽  
Rudy Bonfilio ◽  
Diego Borges de Oliveira ◽  
Gislaine Pereira Ribeiro ◽  
...  

Meloxicam is a broadly used drug in the therapeutics for the osteoarthritis and rheumatoid arthritis treatments in adults, and it is available in the Brazilian market, as tablet and capsule pharmaceutical forms. The present work aimed to establish conditions for accomplishment of the dissolution test of 15 mg meloxicam tablets (A and B test products), compared with the reference product, since there is no monograph about dissolution assays for meloxicam in official summaries. To optimize the conditions several parameters were tested and, according to obtained results, the use of pH 7.5 phosphate buffer (900mL, at 37 ± 0.5ºC) as dissolution medium, paddle method (apparatus 2), stirring speed of the dissolution medium at 100 rpm and collect time of 60 minutes were considered satisfactory. The samples were quantified by UV spectrophotometric method at 362 nm. The products presented kinetics of first-order. Dissolution efficiency values were of 83.25, 83.73 and 88.10% for the A, B and reference products, respectively. Factors f1 and f2 were calculated and similarity of the tested medicines was demonstrated. The dissolution test was validated presenting selectivity, linearity, precision and accuracy within of the acceptance criteria.


2018 ◽  
Vol 5 (1) ◽  
Author(s):  
Erik Wardhana, MM.

This study entitled "Analysis of Effect of Climate Organization and Competence Againt Employee PT. Hutama Karya ". The purpose of this study was to obtain information on the relationship between the free variable that organizational climate (X1) and competence (X2) with the dependent variable is employee performance (Y), either partially or simultaneously, This study used survey research methods with the correlational approach and predictive, which aims for the relationship and influence between independent and dependent variables. The sampling technique can be done randomly (simple random sampling) of 852 employees, which is considered to resprentatif is 89 people. And to solve problems, to analyze and examine the relationship and influence between the independent variables on the dependent variable used models kausalistik through regression analysis with SPSS 14.0


Author(s):  
Yesi Mutia Basri ◽  
Rosliana Rosliana

This research aim to examine the influence of personal background, political background, and council budget knowledge towards the role of DPRD on region financial control. This research is motivated by the fact that individual background will effect to individual behavior on political activity. Dependent variables in this research are personal background, political background, and council budges knowledge towards the role of DPRD on region financial control Independent variables are the role of DPRD on region financial control in planning, implementing, and responsibility steps. The data in this research consist of primary data that taken from questionnaires distributed directly to respondents. The collected are from 34 Respondents that members of DPRD at Pekanbaru. Hypothesis of this research are examine by using Multivariate Analysis of Variances (MANOVA). The result of this research HI personal background political background and budget knowledge have significant influence toward the role of DPRD on region financial control in planning steps.H2 personal background, politico I background and budget knowledge have no significant influence toward the role of DPRD on region financial control in Implementing steps. H3 personal background political background and budget knowledge have no significant influence toward the role of DPRD on region financial control in Controlling steps.


2021 ◽  
Vol 11 (11) ◽  
pp. 5072
Author(s):  
Byung-Kook Koo ◽  
Ji-Won Baek ◽  
Kyung-Yong Chung

Traffic accidents are emerging as a serious social problem in modern society but if the severity of an accident is quickly grasped, countermeasures can be organized efficiently. To solve this problem, the method proposed in this paper derives the MDG (Mean Decrease Gini) coefficient between variables to assess the severity of traffic accidents. Single models are designed to use coefficient, independent variables to determine and predict accident severity. The generated single models are fused using a weighted-voting-based bagging method ensemble to consider various characteristics and avoid overfitting. The variables used for predicting accidents are classified as dependent or independent and the variables that affect the severity of traffic accidents are predicted using the characteristics of causal relationships. Independent variables are classified as categorical and numerical variables. For this reason, a problem arises when the variation among dependent variables is imbalanced. Therefore, a harmonic average is applied to the weights to maintain the variables’ balance and determine the average rate of change. Through this, it is possible to establish objective criteria for determining the severity of traffic accidents, thereby improving reliability.


2021 ◽  
Vol 43 (2) ◽  
pp. 177-179 ◽  
Author(s):  
Chittaranjan Andrade

Students without prior research experience may not know how to conceptualize and design a study. This article explains how an understanding of the classification and operationalization of variables is the key to the process. Variables describe aspects of the sample that is under study; they are so called because they vary in value from subject to subject in the sample. Variables may be independent or dependent. Independent variables influence the value of other variables; dependent variables are influenced in value by other variables. A hypothesis states an expected relationship between variables. A significant relationship between an independent and dependent variable does not prove cause and effect; the relationship may partly or wholly be explained by one or more confounding variables. Variables need to be operationalized; that is, defined in a way that permits their accurate measurement. These and other concepts are explained with the help of clinically relevant examples.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 408-408
Author(s):  
Meeryoung Kim

Abstract Longevity is increasing in what is called the centenarian society. However, the average retirement age of Korea is the lowest among OECD countries. Because of increasing longevity, older adults need activities after retirement. Volunteering can be a substitute that allows Korean older adults to find a social identity. This study examined older adults’ volunteering and how many kinds of volunteering affected relational satisfaction differently. This study used the 6th additional wave of the Korean Retirement and Income Study (2016). The target population of this study was ages over 60 and the sample size was 280. For data analysis, multiple regressions were used. Demographic variables were controlled. As for independent variables, reasons for volunteering whether they were motivated for self or for others were used. For dependent variables, relational satisfaction, such as family, human relation and overall life satisfaction was used. Volunteers’ health is an important factor for relational satisfaction. If volunteering was self-motivated, satisfaction of both family and human relations were negatively affected. Reason for others also affected satisfaction of family and human relations negatively. Volunteering initiated by others increased satisfaction of family and human relations. Doing more than one kind of volunteering affected both satisfaction of family and human relations. For overall life satisfaction, the effect of volunteering for oneself was lower than other reasons. These findings implied that reasons for volunteering affected relational satisfaction differently. In addition, the activities of volunteering, such as taking part in one or more had different effects.


Author(s):  
Prithvi S. Kandhal ◽  
Kee Y. Foo ◽  
John A. D'Angelo

Significant differences in the volumetric properties of laboratory-designed and plant-produced hot-mix asphalt (HMA) generally exist as demonstrated by FHWA Demonstration Project No. 74. The volumetric properties include voids in the mineral aggregate (VMA) and voids in the total mix (VTM). Guidelines for HMA contractors are needed to reconcile these differences and maintain control of volumetric properties during HMA production. The HMA mix design and field production test data (such as asphalt content, gradation, and volumetric properties) from 24 FHWA demonstration projects were entered into a data base and statistically analyzed. The objective was to identify and, if possible, quantify the independent variables (such as asphalt content and the percentages of material passing the No. 200 and other sieves) that significantly affect dependent variables VMA and VTM. The statistical analysis methods consisted of correlation analysis, stepwise multiple-variable analysis, and linear-regression analysis. On the basis of preceding work, guidelines have been developed for HMA contractors to reconcile the differences between the volumetric properties of the job mix formula and the produced HMA mix.


1981 ◽  
Vol 89 (3) ◽  
pp. 501-510 ◽  
Author(s):  
Chehrzad Shakiban

AbstractAn exact sequence resolving the Euler operator of the calculus of variations for partial differential polynomials in several dependent and independent variables is described. This resolution provides a solution to the ‘Inverse problem of the calculus of variations’ for systems of polynomial partial equations.That problem consists of characterizing those systems of partial differential equations which arise as the Euler-Lagrange equations of some variational principle. It can be embedded in the more general problem of finding a resolution of the Euler operator. In (3), hereafter referred to as I, a solution of this problem was given for the case of one independent and one dependent variable. Here we generalize this resolution to several independent and dependent variables simultaneously. The methods employed are similar in spirit to the algebraic techniques associated with the Gelfand-Dikii transform in I, although are considerably complicated by the appearance of several variables. In particular, a simple algebraic proof of the local exactness of a complex considered by Takens(5), Vinogradov(6), Anderson and Duchamp(1), and others appears as part of the resolution considered here.


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