Optimization and Quality by Design Approach for Piroxicam Fast Dissolving Tablet Formulations Using Box-Behnken Design

2020 ◽  
Vol 15 (2) ◽  
pp. 152-165
Author(s):  
Harekrishna Roy ◽  
Sisir Nandi ◽  
Ungarala Pavani ◽  
Uppuluri Lakshmi ◽  
Tamma Saicharan Reddy ◽  
...  

Background: The present study deals with the formulation and optimization of piroxicam fast dissolving tablets and analyzes the impact of an independent variable while selecting the optimized formulation utilizing Quality by Design (QbD) and Box-Behnken Design (BBD). Methods: Seventeen formulations were prepared by direct compression technique by altering the proportion of cross carmellose sodium, spray dried lactose and hydro propyl methyl cellulose (HPMC K4M). The BBD statistical technique was used to optimize formulations and correlate the relationship among all the variables. Also, the powder mixture characteristics and tablet physiochemical properties such as hardness, friability, drug content, Disintegration Time (DT) and dissolution test were determined using 900 ml of 0.1N HCl (pH-1.2) at 37 ± 0.5°C. Results: Significant quadratic model and second order polynomial equations were established using BBD. To find out the relationship between variables and responses, 3D response surface and 2D contour plot was plotted. A perturbation graph was also plotted to identify the deviation of the variables from the mean point. An optimized formula was prepared based on the predicted response and the resulting responses were observed to be close with the predicted value. Conclusion: The optimized formulation with the desired parameter and formulation with variables and responses can be obtained by BBD and could be used in the large experiment with the involvement of a large number of variables and responses.

Author(s):  
Uday Kumar Thummala ◽  
Eswar Guptha Maddi ◽  
Prameela Rani Avula

The fixed dose combination of ledipasvir (LDV) and sofosbuvir (SBV) is approved by USFDA in 2014 for the treatment of Hepatitis C virus infection and is available in the form of tablets. In the present work, the principal aim is to explore orodispersible films type dosage form to impart its characteristic advantages to these poorly soluble drugs so as to improve their bioavailability and ease of administration. Solid dispersions with low viscosity grade methyl cellulose A 15-LV (MC A 15-LV) at different ratios with LDV and SBV were prepared and evaluated to check their ability in improving the solubility of the drugs. The best drug to polymer ratio was selected to develop the films, using other excipients including plasticizer and superdisintegrant. Solvent casting method was used to develop the films. Three formulation parameters were selected as independent factors viz. thickness of the film (50-150 µm), concentration of superdisintegrant (sodium starch glycolate 6-10%) and concentration of plasticizer (polyethylene glycol 400, 10-20%). Disintegration time (DT), time for 90% dissolution (T90%) of LDV and time for 90% dissolution of SBV were taken as the response variables. The experiment was designed using Box-Behnken design. Among the polymers, MC A 15-LV produced maximum solubility at 1:2 ratio. The films obtained were found to have good tensile strength and % elongation with disintegration times in the range of 43-162 sec. The T90% values for LDV and SDV were found to be in the range of 8.4-21.2 min and 7.2-18.4 respectively. All the three formulation factors were found to have significant effect on the three responses. The optimum formulation was identified at 100 µm thickness, 10% superdisintegrant and 20% plasticizer which showed DT of 89 sec with T90% values of 8.4 min and 7.2 min for LDV and SBV respectively. The rapid disintegration and dissolution of the films signified that the set objective was achieved.


Author(s):  
Terry A. Byrd ◽  
Bruce R. Lewis ◽  
Douglas E. Turner

The knowledge and skills of information technology (IT) personnel have become of critical importance as the strategic value of IT in modern organizations has become apparent. In addition to technical skills traditionally expected of IT personnel, organizational, functional, and managerial skills have been increasingly cited as mandatory for these employees. This paper used a well-accepted typology of IT personnel knowledge and skills, and investigated its relationship to desirable technological traits in organizations and to technological variables that have been closely aligned to competitive advantage in organizations. This exploratory examination used the statistical technique of canonical correlation analysis to investigate the relationship between IT personnel knowledge and skills and the flexibility of information systems (IS) infrastructure. Additionally, the same technique was used to test the relationship between the knowledge and skills of these personnel and measures of IT contribution to competitive advantage. In both cases, the relationships were significant and positive. Implications of these findings and a call for further research into the strategic value of IT personnel knowledge and skills are discussed.


Author(s):  
K Kareemuddin Ansari ◽  
Neeraj Sharma

Valdecoxib is a selective COX- II inhibitor with anti – inflammatory, analgesic and antipyretic properties. The poor aqueous solubility of the drug leads to variable dissolution rates. In the present study an attempt has been made to prepare fast dissolving tablets of Valdecoxib in the oral cavity with enhanced dissolution rate. The fast dissolving tablets of Valdecoxib was prepared with some carriers (polymers) and super disintegrants such as Polyvinyl Pyrrolidone (PVP), Sodium Carboxy Methyl Cellulose (SCMC), Crospovidone NF and β – Cyclodextrin. The above mentioned all carriers and superdisintegrants were taken in different proportions of 5, 10, and 15%. All the formulations of the fast dissolving tablets of Valdecoxib were prepared by direct compression technique. The blend was examined for Angle of repose, Bulk density, Compressibility index and Hausner’s ratio. The prepared tablets were evaluated for hardness, drug content uniformity, friability, disintegration time and dissolution rate. An effective pleasant testing formulation released 99.88% drug within 10 minutes. The prepared formulations drug release was found to be comparable with the marketed dispersible tablets. Keywords: Fast dissolving tablets, Super-disintegrants, Valdecoxib, Crosspovidone, Sodium Carboxy Methyl Cellulose.


Author(s):  
V. T. Iswariya ◽  
P. Deepika ◽  
Sowjanya Battu

The goal of this research is to develop captopril mouth dissolving films and evaluate the impact of various formulation factors on the physical and mechanical properties of the films, as well as drug release behaviour. In different grades, hydroxypropyl methyl cellulose (HPMC E15 and K4M) was employed as the film forming polymer. Formulation disintegration times were determined to be in the range of (52 2.5 to 125.6 2.02 s). Formula F2 had the fastest disintegration time in vitro (52 2.5 s) and was determined to be acceptable for film production with ideal physicochemical qualities, faster disintegration, and optimal in vitro release. It may be concluded that the solvent casting approach can be used to make captopril mouth dissolving films with a higher dissolution rate and greater patient compliance.


2021 ◽  
Vol 920 (1) ◽  
pp. 012019
Author(s):  
N A M Hussin ◽  
C Z A Abidin ◽  
Fahmi ◽  
A H Ibrahim ◽  
R Ahmad ◽  
...  

Abstract The degradation of anthraquinone dye Reactive Blue 19 by using O3 and O3 / S2O8 2- in the advanced oxidation processes is studied to investigate the performance of these two systems. The response surface method with a Box-behnken Design was successfully applied to identify the relationship between operating variables such as initial concentration, S2O8 2- dosage and contact time in order to determine the optimum operating condition. The quadratic model for the percentage COD removal (response) proved to be significant for the degradation of the dye. The COD removal efficiency under Box-behnken Design and experimental test were found to be 96.2% and 83.9% under the optimum conditions. Furthermore, the result obtained showed that the O3 / S2O8 2- system is more effective than the O3 only in treating the Reactive Blue 19.


2021 ◽  
Vol 13 (3) ◽  
pp. 935-950
Author(s):  
R. Kayesh ◽  
M. R. H. Bhuiya ◽  
M. F. Islam ◽  
J. A. Chowdhury

Quality-by-design approach (QbD) was applied to develop an orally disintegrating tablet (ODT) formulation of aspirin and glycine. At first, the target quality profile and critical quality attributes (CQAs) of the product were identified. Risk assessment was accomplished by failure mode and effects analysis (FMEA) method to assess the factors having a significant effect on CQAs like disintegration time (DT), friability and assay of aspirin and glycine. Low substituted hydroxypropyl cellulose (L-HPC), croscarmellose sodium (CCS) and punch-diameter were found critical for DT and friability. The box-Behnken design was applied to optimize those 3 factors to reach a target DT of ≤ 30 sec. It was found that a punch-diameter between 8.7 ~ 9.3 mm, CCS in a range of 4 % ~ 5 %, and L-HPC in a range of 2 % ~ 8 % produced the best oral disintegrating property and reduced the risk. In summary, this work represented an excellent example of the application of QbD approach in ODT formulation development.


Author(s):  
Brynne D. Ovalle ◽  
Rahul Chakraborty

This article has two purposes: (a) to examine the relationship between intercultural power relations and the widespread practice of accent discrimination and (b) to underscore the ramifications of accent discrimination both for the individual and for global society as a whole. First, authors review social theory regarding language and group identity construction, and then go on to integrate more current studies linking accent bias to sociocultural variables. Authors discuss three examples of intercultural accent discrimination in order to illustrate how this link manifests itself in the broader context of international relations (i.e., how accent discrimination is generated in situations of unequal power) and, using a review of current research, assess the consequences of accent discrimination for the individual. Finally, the article highlights the impact that linguistic discrimination is having on linguistic diversity globally, partially using data from the United Nations Educational, Scientific and Cultural Organization (UNESCO) and partially by offering a potential context for interpreting the emergence of practices that seek to reduce or modify speaker accents.


2010 ◽  
Vol 20 (1) ◽  
pp. 3-8
Author(s):  
Dee Adams Nikjeh

Abstract Administrators and supervisors face daily challenges over issues such as program funding, service fees, correct coding procedures, and the ever-changing healthcare regulations. Receiving equitable reimbursement for speech-language pathology and audiology services necessitates an understanding of federal coding and reimbursement systems. This tutorial provides information pertaining to two major healthcare coding systems and explains the relationship of these systems to clinical documentation, the Medicare Physician Fee Schedule and equitable reimbursement. An explanation of coding edits and coding modifiers is provided for use in those occasional atypical situations when the standard use of procedural coding may not be appropriate. Also included in this tutorial is a brief discussion of the impact that the Medicare Improvements for Patients and Providers Act of 2008 (HR 6331 Medicare Improvements for Patients and Providers Act [MIPPA], 2008) has had on the valuation of speech-language pathology procedure codes.


2014 ◽  
Vol 22 (4) ◽  
pp. 194-201 ◽  
Author(s):  
Freda-Marie Hartung ◽  
Britta Renner

Humans are social animals; consequently, a lack of social ties affects individuals’ health negatively. However, the desire to belong differs between individuals, raising the question of whether individual differences in the need to belong moderate the impact of perceived social isolation on health. In the present study, 77 first-year university students rated their loneliness and health every 6 weeks for 18 weeks. Individual differences in the need to belong were found to moderate the relationship between loneliness and current health state. Specifically, lonely students with a high need to belong reported more days of illness than those with a low need to belong. In contrast, the strength of the need to belong had no effect on students who did not feel lonely. Thus, people who have a strong need to belong appear to suffer from loneliness and become ill more often, whereas people with a weak need to belong appear to stand loneliness better and are comparatively healthy. The study implies that social isolation does not impact all individuals identically; instead, the fit between the social situation and an individual’s need appears to be crucial for an individual’s functioning.


Crisis ◽  
2016 ◽  
Vol 37 (4) ◽  
pp. 265-270 ◽  
Author(s):  
Meshan Lehmann ◽  
Matthew R. Hilimire ◽  
Lawrence H. Yang ◽  
Bruce G. Link ◽  
Jordan E. DeVylder

Abstract. Background: Self-esteem is a major contributor to risk for repeated suicide attempts. Prior research has shown that awareness of stigma is associated with reduced self-esteem among people with mental illness. No prior studies have examined the association between self-esteem and stereotype awareness among individuals with past suicide attempts. Aims: To understand the relationship between stereotype awareness and self-esteem among young adults who have and have not attempted suicide. Method: Computerized surveys were administered to college students (N = 637). Linear regression analyses were used to test associations between self-esteem and stereotype awareness, attempt history, and their interaction. Results: There was a significant stereotype awareness by attempt interaction (β = –.74, p = .006) in the regression analysis. The interaction was explained by a stronger negative association between stereotype awareness and self-esteem among individuals with past suicide attempts (β = –.50, p = .013) compared with those without attempts (β = –.09, p = .037). Conclusion: Stigma is associated with lower self-esteem within this high-functioning sample of young adults with histories of suicide attempts. Alleviating the impact of stigma at the individual (clinical) or community (public health) levels may improve self-esteem among this high-risk population, which could potentially influence subsequent suicide risk.


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