In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report

2020 ◽  
Vol 22 (4) ◽  
Author(s):  
Sandra Suarez-Sharp ◽  
Andreas Abend ◽  
Thomas Hoffelder ◽  
David Leblond ◽  
Poonam Delvadia ◽  
...  
Keyword(s):  
Product Quality ◽  
Drug Product ◽  
In Vitro Dissolution ◽  
Summary Report ◽  
Similarity Assessment ◽  
Workshop Summary

Maraviroc Oral Disintegration Tablet: Analytical Design of Experiments (DoE) for Assessment and Comparison of In-Vitro Dissolution Profiles

2021 ◽  
Vol 17 ◽  
Author(s):  
Akula Ramesh ◽  
Jagadish P C ◽  
Vinay Jhawar ◽  
Proneel Das ◽  
Prajakta Patil ◽  
...  
Keyword(s):  
Drug Product ◽  
Hplc Method ◽  
In Vitro Dissolution ◽  
Dissolution Profile ◽  
Compression Technique ◽  
Disintegration Time ◽  
Reference Drug ◽  
Orally Disintegrating Tablet ◽  
Rp Hplc

Background: The bioavailability of a drug in a solid oral dose depends on its release from the drug product and its balance in dissolution. Compared with a reference drug, the newly developed formulation needs to establish bioequivalence by comparing the dissolution profile. Objective: To compare dissolution profiles of a newly developed maraviroc oral disintegration tablet and the reference Axentri® tablet. The current research was designed to establish and validate an integral analytical consistency by Quality by Design (QbD) approach to quantify maraviroc from dissolution samples using the RP-HPLC method. Methods: Maraviroc was formulated into an orally disintegrating tablet using a direct compression technique at different concentrations of sodium starch glycolate as super disintegrants and talc and magnesium stearate as glidants. The dissolution test in 0.1N HCl was performed according to standard procedures to predict bioequivalence. The results of dissolution tests were analyzed using the QbD Box Behnken Design multivariate RP-HPLC method. Results: The optimized formulation (F2) was selected as it showed 90% drug release in 5 min and a disintegration time of 22 sec with dissolution profiles to the marketed reference to meet the FDA requirements of f2 similarity factor statistics. The integrated analytical QbD method was statistically analyzed by ANOVA, counter-plot, and 3D response surface plots, which demonstrated that the model is statistically significant. The developed method was validated as per ICH guidelines Q2 (R1). Conclusion : In conclusion, maraviroc oral disintegrating tablets have been well prepared, and superior statement consistency is established by the implementation of the QbD analytical method for orally disintegrating tablet excellence and adoption.

Monte Carlo Simulation Using Microsoft Excel to Estimate the Probability of Passing USP Dissolution Test

2021 ◽  
Vol 25 (5) ◽  
Author(s):  
Prashanth Sambaraju
Keyword(s):  
Drug Product ◽  
Simulated Data ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Solid Dosage Forms ◽  
Microsoft Excel ◽  
Solid Dosage ◽  
Basic Functions

Dissolution test evaluates the release of drug from oral solid dosage forms. In vitro dissolution test is important in assuring the batch-to-batch quality of drug product. The paper describes an intuitive and easy procedure for generating simulated data in Microsoft Excel spreadsheet. From the generated data, probability of passing the USP dissolution test is calculated by using Excel in built functions. Users familiar with the basic functions of Excel will be able use this spreadsheet, without the need for any specialized training. The user can input or change existing values for mean, standard deviation, Q & there by obtain the probability of passing the dissolution test. The results from this method can be used to predict the probability of passing dissolution test for future samples and thereby optimize the process during the process validation.

DEVELOPMENT OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ANALYSIS OF AMLODIPINE AND VALSARTAN IN COMBINED DOSAGE FORM AND IN VITRO DISSOLUTION STUDIED

2018 ◽  
Vol 11 (5) ◽  
pp. 200
Author(s):  
Olga Yuryeva ◽  
Yuliya Kondratova ◽  
Liliya Logoyda
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Drug Product ◽  
Drug Dissolution ◽  
In Vitro Dissolution ◽  
Combination Drug ◽  
Chromatography Method ◽  
Liquid Chromatography Method

 Objective: A simple, rapid, and reproducible high-performance liquid chromatography method was developed for the simultaneous determination of amlodipine and valsartan in their combined dosage forms and for drug dissolution studies.Methods: A C18 column (Zorbax Eclipse ХDB-C18, 5 μm, 2.1 mm × 150 mm) and a mobile phase of water:acetonitrile:trifluoroacetic acid (55:45:0.1 v/v/v) mixture were used for separation and quantification. Analyses were run at a flow rate of 0.4 mL/min and at ambient temperature. The injection volume was 5 μL and the ultraviolet detector was set at 265 nm. The method was validated as per ICH guidelines.Results: Under these conditions, amlodipine and valsartan were eluted at 1.64 min and 4.08 min, respectively. Total run time was shorter than 7 min. The results were 99.6 ± 0.6 and 98.5 ± 0.8 for amlodipine and valsartan, respectively. Valsartan was released within 15 min (98.32%) and amlodipine was also released within 30 min (96.16%) both at a pH of 6.8.Conclusion: The developed method was applied successfully for quality control assay of amlodipine and valsartan in their combination drug product and in vitro dissolution studies.

In Vitro Biopredictive Methods: A Workshop Summary Report

2020 ◽  
Author(s):  
Xavier J.H. Pepin ◽  
Jennifer Dressman ◽  
Neil Parrott ◽  
Poonam Delvadia ◽  
Amitava Mitra ◽  
...  
Keyword(s):  
Summary Report ◽  
Workshop Summary

Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part I. Mechanistic modelling of drug product dissolution to derive a P-PSD for PBPK model input

2019 ◽  
Vol 142 ◽  
pp. 421-434 ◽  
Author(s):  
Xavier J.H. Pepin ◽  
Natalie J. Sanderson ◽  
Alexander Blanazs ◽  
Shveta Grover ◽  
Timothy G. Ingallinera ◽  
...  
Keyword(s):  
Pbpk Model ◽  
Drug Product ◽  
In Vitro Dissolution ◽  
Mechanistic Modelling ◽  
Model Input

scholarly journals Test of dissolution and comparison of in vitro dissolution profiles of coated ranitidine tablets marketed in Bahia, Brazil

2014 ◽  
Vol 50 (1) ◽  
pp. 83-89 ◽  
Author(s):  
Aníbal de Freitas Santos Júnior ◽  
Igor Santos Barbosa ◽  
Venyson Lima dos Santos ◽  
Rangel Leal Silva ◽  
Edimar Caetite Junior
Keyword(s):  
Drug Product ◽  
Drug Dissolution ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Reference Drug ◽  
H2 Antagonist ◽  
Similar Product ◽  
Dissolution Efficiency ◽  
Antagonist Action

Ranitidine is an antisecretory drug with H2 antagonist action useful in treating gastric and duodenal disorders. The dissolution test is used to obtain and compare dissolution profiles and establish similarities of pharmaceutical forms. The aim of this study was to compare the dissolution profiles of 150-mg coated ranitidine tablets of a reference drug (product A) and a generic (product B) and a similar (product C) drug marketed in Bahia, Brazil using a simple, fast and inexpensive ultraviolet method. Dissolution was determined using a USP type 2 apparatus at 50 rpm with 900 mL of distilled water at 37.0 ± 0.5 oC for 1h. The dissolution test was performed in compliance with the American Pharmacopoeia (USP-32). Dissolution efficiency and difference (f1) and similarity (f2) factors were calculated and evaluated. The proposed quantification methodology for drug dissolution test was validated, presenting accuracy, linearity and precision within the acceptance criteria. Products A, B and C showed dissolution efficiency values of 59.29, 73.59 and 66.67%, respectively. Factors f1 and f2 were calculated and showed that the profiles of products A, B and C were dissimilar. However, all the products released ranitidine satisfactorily, with at least 80% of the drug dissolved within 30 min.

Dissolution Testing in Drug Product Development: Workshop Summary Report

2019 ◽  
Vol 21 (2) ◽  
Author(s):  
Andreas Abend ◽  
David Curran ◽  
Jesse Kuiper ◽  
Xujin Lu ◽  
Hanlin Li ◽  
...  
Keyword(s):  
Product Development ◽  
Drug Product ◽  
Dissolution Testing ◽  
Summary Report ◽  
Workshop Summary

scholarly journals HPLC method development for the simultaneous analysis of amlodipine and valsartan in combined dosage forms and in vitro dissolution studies

2010 ◽  
Vol 46 (4) ◽  
pp. 761-768 ◽  
Author(s):  
Mustafa Çelebier ◽  
Mustafa Sinan Kaynak ◽  
Sacide Altınöz ◽  
Selma Sahin
Keyword(s):  
Method Development ◽  
Drug Product ◽  
Dosage Forms ◽  
Hplc Method ◽  
Drug Dissolution ◽  
In Vitro Dissolution ◽  
Combination Drug ◽  
Dissolution Studies ◽  
Ultraviolet Detector

A simple, rapid and reproducible HPLC method was developed for the simultaneous determination of amlodipine and valsartan in their combined dosage forms, and for drug dissolution studies. A C18 column (ODS 2, 10 μm, 200 x 4.6 mm) and a mobile phase of phosphate buffer (pH 3.6 , 0.01 mol L-1):acetonitrile: methanol (46:44:10 v/v/v) mixture were used for separation and quantification. Analyses were run at a flow-rate of 1 mL min-1 and at ambient temperature. The injection volume was 20 μL and the ultraviolet detector was set at 240 nm. Under these conditions, amlodipine and valsartan were eluted at 7.1 min and 3.4 min, respectively. Total run time was shorter than 9 min. The developed method was validated according to the literature and found to be linear within the range 0.1 - 50 μg mL-1 for amlodipine, and 0.05 - 50 μg mL-1 for valsartan. The developed method was applied successfully for quality control assay of amlodipine and valsartan in their combination drug product and in vitro dissolution studies.

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