scholarly journals Evaluation of a Modified Flow-Through Method for Predictive Dissolution and In Vitro/In Vivo Correlations of Immediate Release and Extended Release Formulations

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Hanxi Yi ◽  
Fan Liu ◽  
Guoqing Zhang ◽  
Zeneng Cheng
Keyword(s):  
Extended Release ◽  
Immediate Release ◽  
In Vitro Dissolution ◽  
In Vivo Absorption ◽  
Flow Through ◽  
Felodipine Er ◽  
Extended Release Formulations ◽  
Potential Tool

The present study evaluated the ability of a modified flow-through method for predicting in vivo performance of immediate release (IR) and extended release (ER) formulations. In vitro dissolution of two model drugs, paracetamol IR tablets and felodipine ER tablets, was investigated under tuned conditions using the modified flow-through method and compared with the compendial quality control (QC) basket method. The in vivo absorption properties of paracetamol IR tablets and felodipine ER tablets were investigated in healthy volunteers. In vitro-in vivo correlation (IVIVC) analysis was performed based on the obtained in vitro and in vivo data. Our results demonstrated that the compendial QC method was not able to reflect in vivo actual absorption, while satisfactory discriminatory power and comparable in vitro dissolution/in vivo absorption were achieved for both paracetamol IR tablets and felodipine ER tablets by the modified flow-through method. This study indicated that the modified flow-through method is a potential tool to reflect in vivo performance of the IR and ER formulations.

In vitro dissolution method fitted to in vivo absorption profile of rivaroxaban immediate-release tablets applying in silico data

2017 ◽  
Vol 44 (5) ◽  
pp. 723-728 ◽  
Author(s):  
Nathalie R. Wingert ◽  
Natália O. dos Santos ◽  
Sarah C. Campanharo ◽  
Elisa S. Simon ◽  
Nadia M. Volpato ◽  
...  
Keyword(s):  
In Silico ◽  
Immediate Release ◽  
In Vitro Dissolution ◽  
Absorption Profile ◽  
Dissolution Method ◽  
In Vivo Absorption

Bioequivalence Study Between Two Extended-Release Formulations of Theophylline Using Saliva

1997 ◽  
Vol 13 (4) ◽  
pp. 177-180
Author(s):  
Helena M Payssé ◽  
Marta Vázquez ◽  
Pietro L Fagiolino
Keyword(s):  
Extended Release ◽  
Bioequivalence Study ◽  
Average Concentration ◽  
Crossover Design ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Tablet Form ◽  
Extended Release Formulations

Objective: To assess the bioequivalence between two extended-release formulations of theophylline using saliva as the biologic fluid. Design: Randomized two-way crossover design. Participants: Eight healthy, nonsmoking volunteers (7 women, 1 man) between 23 and 41 years of age took a single dose (250 mg) of two extended-release formulations of theophylline (form A, tablet; form B, capsule). Results: Significant differences were found at 2, 4, 6, and 8 hours (p < 0.001), with the in vitro dissolution test between both formulations. ANOVA for AUC, maximum concentration (Cmax), average concentration, and %Cmax – 100 showed significant differences between both formulations in the in vivo trial. Conclusions: The tablet and capsule formulations of extended-release theophylline are bioinequivalent when saliva is used as the biologic fluid for performing these studies.

Relationship between amorphous solid dispersion in vivo absorption and in vitro dissolution: phase behavior during dissolution, speciation, and membrane mass transport

2018 ◽  
Vol 292 ◽  
pp. 172-182 ◽  
Author(s):  
Venecia Wilson ◽  
Xiaochun Lou ◽  
Donald J. Osterling ◽  
Deanne F. Stolarik ◽  
Gary Jenkins ◽  
...  
Keyword(s):  
Mass Transport ◽  
Phase Behavior ◽  
Solid Dispersion ◽  
Amorphous Solid ◽  
In Vitro Dissolution ◽  
Amorphous Solid Dispersion ◽  
In Vivo Absorption

scholarly journals Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

2021 ◽  
Vol 24 ◽  
pp. 548-562
Author(s):  
Matthias Shona Roost ◽  
Henrike Potthast ◽  
Chantal Walther ◽  
Alfredo García-Arieta ◽  
Ivana Abalos ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Quantitative Composition ◽  
Modified Release ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.

scholarly journals Effect of Gastric Fluid Volume on the In Vitro Dissolution and In Vivo Absorption of BCS Class II Drugs: a Case Study with Nifedipine

2016 ◽  
Vol 18 (4) ◽  
pp. 981-988 ◽  
Author(s):  
Ahmed M. Nader ◽  
Sara K. Quinney ◽  
Hala M. Fadda ◽  
David R. Foster
Keyword(s):  
Class Ii ◽  
Gastric Fluid ◽  
Fluid Volume ◽  
In Vitro Dissolution ◽  
Bcs Class Ii ◽  
Gastric Fluid Volume ◽  
In Vivo Absorption

Identify super quality markers from prototype-based pharmacokinetic markers of Tangzhiqing tablet (TZQ) based on in vitro dissolution/ permeation and in vivo absorption correlations

Phytomedicine ◽  
2018 ◽  
Vol 45 ◽  
pp. 59-67 ◽  
Author(s):  
Ziqiang Li ◽  
Jia Liu ◽  
Yazhuo Li ◽  
Xi Du ◽  
Yanfen Li ◽  
...  
Keyword(s):  
In Vitro Dissolution ◽  
In Vivo Absorption ◽  
Quality Markers

Evaluating the bioequivalence of metronidazole tablets and analyzing the effect of in vitro dissolution on in vivo absorption based on PBPK modeling

2019 ◽  
Vol 45 (10) ◽  
pp. 1646-1653 ◽  
Author(s):  
Shuqi Zhang ◽  
Mengna Fang ◽  
Qi Zhang ◽  
Xiaoting Li ◽  
Tianhong Zhang
Keyword(s):  
Pbpk Modeling ◽  
In Vitro Dissolution ◽  
In Vivo Absorption

scholarly journals Crushed Tablets: Does the Administration of Food Vehicles and Thickened Fluids to Aid Medication Swallowing Alter Drug Release?

2014 ◽  
Vol 17 (2) ◽  
pp. 207 ◽  
Author(s):  
Yady Juliana Manrique-Torres ◽  
Danielle J Lee ◽  
Faiza Islam ◽  
Lisa M Nissen ◽  
Julie A.Y. Cichero ◽  
...  
Keyword(s):  
Drug Release ◽  
Orange Juice ◽  
Immediate Release ◽  
Drug Dissolution ◽  
In Vitro Dissolution ◽  
Simulated Gastric Fluid ◽  
Drug Bioavailability ◽  
Thickening Agents

Purpose. To evaluate the influence of co-administered vehicles on in vitro dissolution in simulated gastric fluid of crushed immediate release tablets as an indicator for potential drug bioavailability compromise. Methods. Release and dissolution of crushed amlodipine, atenolol, carbamazepine and warfarin tablets were tested with six foods and drinks that are frequently used in the clinical setting as mixers for crushed medications (water, orange juice, honey, yoghurt, strawberry jam and water thickened with Easythick powder) in comparison to whole tablets. Five commercial thickening agents (Easythick Advanced, Janbak F, Karicare, Nutilis, Viscaid) at three thickness levels were tested for their effect on the dissolution of crushed atenolol tablets. Results. Atenolol dissolution was unaffected by mixing crushed tablets with thin fluids or food mixers in comparison to whole tablets or crushed tablets in water, but amlodipine was delayed by mixing with jam. Mixing crushed warfarin and carbamazepine tablets with honey, jam or yoghurt caused them to resemble the slow dissolution of whole tablets rather than the faster dissolution of crushed tablets in water or orange juice. Crushing and mixing any of the four medications with thickened water caused a significant delay in dissolution. When tested with atenolol, all types of thickening agents at the greatest thickness significantly restricted dissolution, and products that are primarily based on xanthan gum also delayed dissolution at the intermediate thickness level. Conclusions. Dissolution testing, while simplistic, is a widely used and accepted method for comparing drug release from different formulations as an indicator for in vivo bioavailability. Thickened fluids have the potential to retard drug dissolution when used at the thickest levels. These findings highlight potential clinical implications of the addition of these agents to medications for the purpose of dose delivery and indicate that further investigation of thickened fluids and their potential to influence therapeutic outcomes is warranted. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

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