scholarly journals Formulation and characterization of acyclovir based topical microemulsions by QBD approach

2019 ◽  
Vol 9 (1) ◽  
pp. 237-243
Author(s):  
Asish Dev ◽  
Jayesh Dwivedi ◽  
Munira Momin
Keyword(s):  
Risk Assessment ◽  
Phase Diagrams ◽  
Dosage Form ◽  
Design Space ◽  
Uv Spectroscopy ◽  
Independent Variables ◽  
Dsc Studies ◽  
Product Profile ◽  
Oil Concentration

Objective: The proposed study is focussed at developing acyclovir microemulsions for topical drug delivery systems.  QbD was applied for better understanding of the process and to generate design space, using quality target product profile, critical quality attributes, and risk assessment. The aim of the experiment is to prepare a safe, efficacious, stable and patient compliant microemulsion dosage form of Acyclovir. Materials and methods: Pre-formulation studies were carried out which helped in developing a suitable dosage form. UV, FTIR and DSC studies were done for pre-formulation and post-formulation evaluations. QbD was applied to generate design space, using QTPP, CQA, and risk assessment. Microemulsions of acyclovir were developed by using 32 factorial designs. Pseudo terneary phase diagrams were constructed to screen various surfactants and co-surfactants for the preparation of microemulsions. Two independent variables Oil Concentration (X1) and Smix Concentration (X2) at three levels low, medium and high were selected and response surface plots were generated. The microemulsions were prepared by plotting pseudo terneary phase diagrams. Various characterizations that were carried out include % transmittance, Viscosity and % drug release. Statistical analyses of batches and surface response studies were done to understand the effect of various independent variables on the dependent variables. Results and Discussions: The λmax was confirmed at 251 nm by UV spectroscopy. The melting point was determined experimentally to be 2460C which confirms the drug to be Acyclovir. FTIR and DSC studies confirmed that the drug is Acyclovir.  Conclusion: The study indicates that microemulsions of Acyclovir by QbD approach were successfully developed. Keywords: Microemulsion, Acyclovir, DoE, QbD

scholarly journals Quality by Design based formulation and evaluation of acyclovir microsponges

2019 ◽  
Vol 9 (1) ◽  
pp. 54-60
Author(s):  
Asish Dev ◽  
Jayesh Dwivedi ◽  
Munira Momin
Keyword(s):  
Risk Assessment ◽  
Drug Release ◽  
Dosage Form ◽  
Design Space ◽  
Oral Drug Delivery ◽  
Kinetic Modelling ◽  
Uv Spectroscopy ◽  
Diffusion Method ◽  
Oral Drug ◽  
Factorial Designs

Objective: The proposed study is focussed at developing acyclovir microsponges for oral drug delivery systems.  QbD was applied for better understanding of the process and to generate design space, using quality target product profile, critical quality attributes, and risk assessment. The aim of the experiment is to prepare a safe, efficacious, stable and patient compliant microsponge dosage form of Acyclovir. Materials and methods: Pre-formulation studies were carried out which helped in developing a suitable dosage form. UV, FTIR, DSC, and SEM studies were done for pre-formulation and post-formulation evaluations. QbD was applied to generate design space, using QTPP, CQA, and risk assessment. Microsponges of acyclovir were developed by 23 factorial designs. Three variables Drug: Polymer ratio (X1), Concentration of surfactant (X2) and Stirring speed (RPM) (X3) at two levels low and high were selected and response surface plots were generated. The microsponges were prepared by Quassi-emulsion solvent diffusion method. Various characterizations that were carried out include entrapment efficiency, percentage yield, particle size determination, in-vitro drug release studies and kinetic modelling of drug release. Statistical analyses of batches and surface response studies were done to understand the effect of various independent variables on the dependent variables. Results and Discussions: The λmax was confirmed at 251 nm by UV spectroscopy. The melting point was determined experimentally to be 2460C which confirms the drug to be Acyclovir. FTIR and DSC studies confirmed that the drug is Acyclovir. Eight trials were taken as per the by 23 factorial designs.  Conclusion: The study indicates that microsponges of Acyclovir by QbD approach were successfully developed. Keywords: Microsponge, Acyclovir, DoE, QbD

Characterization of Maximum Current Capacity for Microprocessor Sockets

2005 ◽  
Author(s):  
David Song ◽  
Ashish Gupta ◽  
Chia-Pin Chiu
Keyword(s):  
Risk Assessment ◽  
Computational Modeling ◽  
Carrying Capacity ◽  
Infrared Camera ◽  
Experimental Results ◽  
Array Type ◽  
Maximum Current ◽  
Modeling And Experiments ◽  
Subsequent Risk

This paper presents the current-carrying-capacity (CCC) characterization of a land-grid-array type microprocessor socket. This CCC study has been performed using both computational modeling and experiments using infrared camera. A subsequent risk assessment was performed against the maximum allowed temperature at the point of pressure contact of socket pin for the use-condition socket pin current and motherboard temperature. The results from the modeling and the experimental results are compared.

Characterization of the Polymyxin D Synthetase Biosynthetic Cluster and Product Profile ofPaenibacillus polymyxaATCC 10401

2017 ◽  
Vol 80 (5) ◽  
pp. 1264-1274 ◽  
Author(s):  
Charles A. Galea ◽  
Meiling Han ◽  
Yan Zhu ◽  
Kade Roberts ◽  
Jiping Wang ◽  
...  
Keyword(s):  
Product Profile

An approach to rapid characterization of DMD copy number variants for prenatal risk assessment

2021 ◽  
Author(s):  
Hui‐Lin Chin ◽  
Kieran O'Neill ◽  
Kristal Louie ◽  
Lindsay Brown ◽  
Kamilla Schlade‐Bartusiak ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Copy Number ◽  
Copy Number Variants ◽  
Prenatal Risk ◽  
Rapid Characterization

Development and Characterization of a Buccoadhesive Dosage Form of Oxycodone Hydrochloride

1996 ◽  
Vol 22 (5) ◽  
pp. 445-450 ◽  
Author(s):  
B. Parodi ◽  
E. Russo ◽  
G. Caviglioli ◽  
S. Cafaggi ◽  
G. Bignardi
Keyword(s):  
Dosage Form ◽  
Oxycodone Hydrochloride

Characterization of present and future precipitation through bivariate copulas and its use in risk assessment of infrastructure

2015 ◽  
pp. 4295-4302
Author(s):  
O Morales-Nápoles ◽  
D Worm ◽  
L Abspoel-Bukman ◽  
J Huibregtse ◽  
W Courage
Keyword(s):  
Risk Assessment

scholarly journals P077 Reliability of the Clinical Characterization of Isolated REM Sleep Behavior Disorder

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A46-A46
Author(s):  
D Levendowski ◽  
J Lee-Iannotti ◽  
D Shprecher ◽  
C Guevarra ◽  
P Timm ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Rem Sleep ◽  
False Positive ◽  
False Negative ◽  
Rem Sleep Behavior Disorder ◽  
Behavior Disorder ◽  
Sleep Behavior ◽  
Negative Case ◽  
Rem Sleep Without Atonia

Abstract Purpose Compare agreements between polysomnography-based (PSG) diagnosis of isolated REM-sleep-behavior-disorder (iRBD) and Non-REM-Hypertonia (NRH), a novel biomarker independently associated with synucleinopathy-related neurodegenerative diseases. Methods Sixteen patients with histories of dream-enactment-behavior (DEB)(women=38%; age:64.6±13.0) underwent PSG with simultaneously-recorded Sleep Profiler (SP). Two boarded sleep neurologists independently characterized iRBD. Physician1 combined abnormal qualitative REM-sleep-without-atonia (RSWA) by submental electromyography, with video-confirmation of probably DEB. Physician2 relied solely on qualitative RSWA. SP was auto-staged, technically reviewed, and reprocessed for automated abnormal NRH detection. Kappa scores measured physician and NRH agreements. Results In the 14 records with REM sleep, iRBD was characterized in: Physician1=64%, Physician2=79%, NRH=71% of the records. Across the three methods, unanimous iRBD agreement occurred in 57% of the records (positive=7, negative=1). The between-physician agreement in iRBD classifications was fair (kappa=0.32). The agreement between NRH and Physician1 was moderate (kappa=0.52) versus slight with Physician2 (kappa=0.05). NRH comparisons to consensus physician agreement yielded one false-positive and one false-negative iRBD finding. Physician2 classified: a) iRBD in two cases that were negative by Physician1 and NRH, and b) one negative case that Physician1 and NRH characterized as iRBD. Physician1 identified one negative case that was classified iRBD by Physician2 and NRH. Additionally, NRH was abnormal in one of the two records with no REM sleep. Discussion NRH may assist in iRBD risk assessment, given it agreed with at least one physician in 86% of the cases and the between-physician iRBD agreement was only fair. NRH also characterized iRBD-risk in patients with insufficient REM sleep for RSWA assessment.

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