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.

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.

scholarly journals An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence

Materials ◽  
2021 ◽  
Vol 14 (3) ◽  
pp. 555
Author(s):  
Marilena Vlachou ◽  
Vangelis Karalis
Keyword(s):  
Mathematical Description ◽  
Development Process ◽  
Bioequivalence Study ◽  
In Vitro Dissolution ◽  
Monte Carlo Techniques ◽  
In Vivo Kinetics ◽  
Probability Of Success ◽  
Made In

The aim of this study was to develop a new in vitro–in vivo simulation (IVIVS) approach in order to predict the outcome of a bioequivalence study. The predictability of the IVIVS procedure was evaluated through its application in the development process of a new generic product of amlodipine/irbesartan/hydrochlorothiazide. The developed IVIVS methodology is composed of three parts: (a) mathematical description of in vitro dissolution profiles, (b) mathematical description of in vivo kinetics, and (c) development of joint in vitro–in vivo simulations. The entire programming was done in MATLAB® and all created scripts were validated through other software. The IVIVS approach can be implemented for any number of subjects, clinical design, variability and can be repeated for thousands of times using Monte Carlo techniques. The probability of success of each scenario is recorded and finally, an overall assessment is made in order to select the most suitable batch. Alternatively, if the IVIVS shows reduced probability of BE success, the R&D department is advised to reformulate the product. In this study, the IVIVS approach predicted successfully the BE outcome of the three drugs. During the development of generics, the IVIVS approach can save time and expenses.

Development of a Dissolution Test for Extended-Release Bromopride Pellets with In Vivo–In Vitro Correlation

2015 ◽  
Vol 22 (2) ◽  
pp. 24-33 ◽  
Author(s):  
Marcos Giovani R. da Silva ◽  
Nadia Maria Volpato ◽  
Eduardo C. Pinto ◽  
Lúcio M. Cabral ◽  
Valéria P. de Sousa
Keyword(s):  
Extended Release ◽  
Dissolution Test

In Vitro Dissolution and In Vivo Bioequivalence Evaluation of Two Metformin Extended‐Release Tablets

2020 ◽  
Author(s):  
Ziye Zhou ◽  
Chenxiang Wang ◽  
Min Li ◽  
Qin Lan ◽  
Chao Yu ◽  
...  
Keyword(s):  
Extended Release ◽  
In Vitro Dissolution

scholarly journals BIOEQUIVALENCE STUDY OF ANTIDIABETIC ACTIVITY BETWEEN TWO MARKETED FORMULATIONS OF METFORMIN ON GLUCOCORTICOID-INDUCED HYPERGLYCEMIA IN RABBIT

2017 ◽  
Vol 9 (4) ◽  
pp. 47
Author(s):  
Debanga Das ◽  
Jashabir Chakraborty ◽  
Suvakanta Dash
Keyword(s):  
Blood Glucose ◽  
Normal Saline ◽  
Bioequivalence Study ◽  
In Vitro Dissolution ◽  
Antidiabetic Activity ◽  
Control Group ◽  
In Vitro Tests ◽  
Weight Variation

Objective: Bioequivalence studies are the commonly accepted methods displaying therapeutic equivalence between two products. This study was conducted to evaluate the bioequivalence study of anti-diabetic activity between two formulations of metformin tablets which were marketed in India.Methods: In in vitro study five essential in vitro tests including disintegration, weight variation, hardness, friability and a comparative in vitro dissolution study were performed.Results: For in vivo study adult male rabbits were divided into three groups of two each. The first group is regarded as control group received 3 ml of normal saline daily by using the gastric tube for 15 d and the second and third group received (0.35 mg/Kg B.W. single dosage) of dexamethasone tablets which were powdered, dissolved in 3 ml of normal saline daily for 15 d. After 15 d the blood glucose of second and third group was estimated and after that received formulation X and formulation Y, dissolved in 3 ml of normal saline daily for 15 d at the dose of 0.5 gm/kg body weight orally. After 15 d again blood glucose of second and third group was estimated and compare the results of both the group. This shows the favourable response of metformin against glucocorticoid-induced renal damage and hyperglycemia.Conclusion: Results of this study showed that the extent, rate of absorption and anti-diabetic activity of two different formulations of metformin tablets are bioequivalent to each other.

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