scholarly journals Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-Compacted Ciprofloxacin Hydrochloride Immediate-Release Tablets

2012 ◽  
Vol 13 (4) ◽  
pp. 1243-1254 ◽  
Author(s):  
Raafat Fahmy ◽  
Ravikanth Kona ◽  
Ramesh Dandu ◽  
Walter Xie ◽  
Gregg Claycamp ◽  
...  
INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (09) ◽  
pp. 48-60
Author(s):  
V. S Chudiwal ◽  
◽  
S. Shahi ◽  
S. Chudiwal

The objective of the present study was to develop sustained release gastro-retentive (SRGR) tablet formulation of bepotastine besilate for once-a-day dosing using quality by design (QbD) approach. Quality target product profile (QTPP) of bepotastine besilate SRGR tablet formulation was defined and critical quality attributes (CQAs) were identified. Potential risk factors were identified using fish bone diagram and failure mode effect analysis (FMEA) tool and screened by Plackett–Burman design and finally bepotastine besilate SRGR tablet formulation was optimized using Box–Behnken design. It was observed that formulation variables X1: hydrophobic release controlling agent (mg/tab) and X2: hydrophilic release controlling agent (mg/tab) have strikingly influenced drug release (%) (Y1), while floating lag time (min) (Y2) was significantly impacted by formulation variable X4: gas generating agent (mg/tab). A design space plot within which the CQAs remained unchanged was established at lab scale. In conclusion, this study demonstrated the suitability of a hydrophobic-hydrophilic polymer combination along with gas generating agent to achieve SRGR tablet formulation for once-a-day dosing of bepotastine besilate using systematic QbD approach.


2020 ◽  
Vol 1 (1) ◽  
pp. 162-173
Author(s):  
Dinesh Kumar Kushwaha ◽  
◽  
Dilbagh Panchal ◽  
Anish Sachdeva ◽  
◽  
...  

Failure Mode Effect Analysis (FMEA) is popular and versatile approach applicable to risk assessment and safety improvement of a repairable engineering system. This method encompasses various fields such as manufacturing, healthcare, paper mill, thermal power industry, software industry, services, security etc. in terms of its application. In general, FMEA is based on Risk Priority Number (RPN) score which is found by product of probability of Occurrence (O), Severity of failure (S) and Failure Detection (D). As human judgement is approximate in nature, the accuracy of data obtained from FMEA members depend on degree of subjectivity. The subjective knowledge of members not only contains uncertainty but hesitation too which in turn, affect the results. Fuzzy FMEA considers uncertainty and vagueness of the data/ information obtained from experts. In order to take into account, the hesitation of experts and vague concept, in the present work we propose integrated framework based on Intuitionistic Fuzzy- Failure Mode Effect Analysis (IF-FMEA) and IF-Technique for Order Preference by Similarity to Ideal Solution (IF-TOPSIS) techniques to rank the listed failure causes. Failure cause Fibrizer (FR) was found to be the most critical failure cause with RPN score 0.500. IF-TOPSIS has been implemented within IF-FMEA to compare and verify ranking results obtained by both the IF based approaches. The proposed method was presented with its application for examining the risk assessment of cutting system in sugar mill industry situated in western Uttar Pradesh province of India. The result would be useful for the plant maintenance manager to fix the best maintenance schedule for improving availability of cutting system.


2018 ◽  
Vol 8 (1) ◽  
pp. 40-46 ◽  
Author(s):  
Tsehaye Dedimas Beyene ◽  
◽  
Sisay Geremew Gebeyehu ◽  
Azemeraw Tadesse Mengistu ◽  
◽  
...  

Bioanalysis ◽  
2019 ◽  
Vol 11 (23) ◽  
pp. 2175-2188 ◽  
Author(s):  
Carolina Attallah ◽  
María C Rodríguez ◽  
Victoria Lozano ◽  
Marina Etcheverrigaray ◽  
Marcos Oggero

Aim: Nowadays, IFN-α is considered a promising therapeutic target for systemic lupus erythematosus. An immuno-PCR (iPCR) was developed to quantify low amounts of IFN-α in human plasma followed by a deep analysis of the methodologic robustness throughout quality by design approach. Results: An accurate, sensitive, selective and versatile iPCR was validated. The critical iPCR procedural steps were identified, applying a Plackett–Burman design. Also, this assay demonstrated an outstanding LOD of 0.3 pg/ml. A significant aspect relies on its high versatility to detect and quantify other cytokines in human plasma as the appropriate biotinylated antibody is employed. Conclusion: This reliable iPCR assay can be clinically used as an alternative method for quantitating and detecting low IFN-α2b concentrations in human plasma samples.


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