Scintigraphic Study to Investigate the Effect of Food on a HPMC Modified Release Formulation of UK-294,315

2009 ◽  
Vol 98 (4) ◽  
pp. 1568-1576 ◽  
Author(s):  
J. Davis ◽  
J. Burton ◽  
A.L. Connor ◽  
R. Macrae ◽  
I.R. Wilding
Keyword(s):  
Modified Release ◽  
Release Formulation ◽  
Effect Of Food ◽  
Scintigraphic Study

Employment of Quality by Design approach via Response Surface Methodology to Optimize and Develop Modified Release formulation of Hydrochlorothiazide

2020 ◽  
Vol 16 ◽  
Author(s):  
Vikas D Singhai ◽  
Rahul Maheshwari ◽  
Swapnil Sharma ◽  
Sarvesh Paliwal
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Quality By Design ◽  
Management Tool ◽  
Contour Plot ◽  
P Value ◽  
Average Weight ◽  
Content Uniformity ◽  
Modified Release ◽  
Release Formulation

Background: Heart attack predominantly occurs during the last phase of sleep and early morning hours, causing millions of death worldwide. Hydrochlorothiazide (HCTZ) is recommended drug for the prevention of heart disease but its long action (>4 h) dosage form is lacking in the commercial market and development of extended-release formulation may have industrial significance. Regulatory agencies emphasize Quality by Design based approach for product development to entrust quality in the product. Objective: Aim of the current research was to develop a quality product profile of HCTZ modified-release tablets (MRT; ~14 h) by applying Response Surface Methodology using computational QbD approach. Methods: Three independent factors were identified by qualitative and quantitative risk assessment. Statistical terms like p-value, lack of fit, sum of square, R-squared value, model F value and linear equations were determined. Graphical tools like normal plot of residual, residual vs predicted plot and box cox plot were used to verify model selection. Graphical relationship among the critical, independent variables was represented using the Contour plot and 3-D surface plot. Design space was identified by designing overlay plot using response surface design. Results: Excellent correlation was observed between actual and predicted values. Similarity Factor (F2) of reproducible trials was 78 and 79 and content uniformity was 100.9% and 100.4%. Average weight, hardness, thickness, diameter and friability were within acceptable limits. Conclusions: QbD approach along with quality risk management tool provided an efficient and effective paradigm to build quality MRT of HCTZ.

Can Acid Control Be Improved with a Modified-Release Formulation of a Proton Pump Inhibitor?

2008 ◽  
Vol 103 ◽  
pp. S19
Author(s):  
Kerstin Röhss ◽  
Clive Wilder-Smith ◽  
Mohamed Sagar ◽  
Sara Bokelund-Singh ◽  
Peter Nagy ◽  
...  
Keyword(s):  
Proton Pump Inhibitor ◽  
Proton Pump ◽  
Modified Release ◽  
Release Formulation ◽  
Acid Control

scholarly journals Bioanalysis and in-vivo studies of clarithromycin modified release solid dosage formulations by liquid chromatography-mass spectroscopy

2020 ◽  
Vol 11 (1) ◽  
pp. 87-92
Author(s):  
Nagarajan Janaki Sankarachari Krishnan ◽  
Elango Kannan
Keyword(s):  
Biological Fluid ◽  
Internal Standard ◽  
In Vivo Studies ◽  
Pharmacokinetic Parameters ◽  
Modified Release ◽  
Reference Formulation ◽  
Release Formulation ◽  
Solid Dosage ◽  
Test Formulation

The current study was undertaken to develop the new bioanalytical method and validation for determining Clarithromycin by LC-MS Method and as well as to conduct in vivo studies. Princeton octadecyl silane column (10 cm x 4.6 mm id, 5µm) used as adsorbent and cyanomethane: 0.5 % Methanoic acid was treated as the eluent for the separation of the analyte from the biological fluid in an isocratic mode having the ratio 60:40 % v/v and 0.5 ml/min as flow rate, and injection volume was set as 20 µl. APCI and the mass detected of Clarithromycin and Azithromycin (act as internal standard) was detected at 748.45 and 749.70, respectively. Developed bioanalytical methods have been used to quantify the Pharmacokinetic parameters like Cmax, Tmax, AUC0-t & AUC0-∞, Keli, and t1/2 studied and the values for reference formulation (3.382µg/ml, 7.333 h, 114.429µg.h/ml, 131.435µg.h/ml, 0.031 h-1, and 23.397h respectively) and the test formulation (3.847 µg/ml, 7.417 h, 132.318 µg.h/ml, 151.388 µg.h/ml, 0.031 h-1, and 23.187 h, respectively) were compared and found to be bioequivalent. Based on our study, the test formulation of Clarithromycin modified-release formulation containing 500 mg of Clarithromycin is Bioequivalent to that of the reference.  Compare to our method (LC-MS) is simple, sensitive, precise as well as comparable with the reference formulation of the modified release product of clarithromycin 500 mg.

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