Bioequivalence Study of Paracetamol Tablets: In Vitro-In Vivo Correlation

2000 ◽  
Vol 26 (8) ◽  
pp. 821-828 ◽  
Author(s):  
Adriana Domínguez R. ◽  
Raúl L. Medina ◽  
Marcela Hurtado P.
Keyword(s):  
Bioequivalence Study

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.

scholarly journals Pharmacokinetics of EDP-420 after Multiple Oral Doses in Healthy Adult Volunteers and in a Bioequivalence Study

2009 ◽  
Vol 53 (8) ◽  
pp. 3218-3225 ◽  
Author(s):  
Li-Juan Jiang ◽  
Yat Sun Or
Keyword(s):  
Systemic Exposure ◽  
Bioequivalence Study ◽  
Respiratory Pathogens ◽  
Capsule Formulation ◽  
Dose Study ◽  
Effect Of Food ◽  
Tract Infections ◽  
Oral Doses

ABSTRACT EDP-420 (also known as EP-013420, or S-013420) is a first-in-class bridged bicyclolide currently in clinical development for the treatment of respiratory tract infections (RTI) and has previously shown favorable pharmacokinetic (PK) and safety profiles after the administration of single oral doses of a suspension to healthy volunteers. Here we report its PK profile after the administration of multiple oral doses of a suspension to healthy adults. Bioequivalence between suspension and capsule formulations, as well as the effect of food, is also reported. The most important PK features of EDP-420 observed in these clinical studies are its long half-life of 17 to 18 h and its high systemic exposure, which support once-daily dosing and treatment durations potentially shorter than those of most other macrolide antibiotics. EDP-420 is readily absorbed following oral administration in both suspension and capsule formulations. In the multiple-oral-dose study, steady state was achieved on day 1 by using a loading dose of 400 mg/day, followed by 2 days of 200 mg/day. A high-fat meal had no effect on the bioavailability of EDP-420 administered in a capsule formulation. EDP-420 was well tolerated, with no serious or severe adverse events reported, and no subject was discontinued from the study due to an adverse event. Based on its human PK and safety profiles, together with its in vitro/in vivo activities against common respiratory pathogens, EDP-420 warrants further development, including trials for clinical efficacy in the treatment of RTI.

scholarly journals In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium

Pharmaceutics ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 558 ◽  
Author(s):  
Marival Bermejo ◽  
Jessica Meulman ◽  
Marcelo Gomes Davanço ◽  
Patricia de Oliveira Carvalho ◽  
Isabel Gonzalez-Alvarez ◽  
...  
Keyword(s):  
Latin American ◽  
Bioequivalence Study ◽  
Immediate Release ◽  
Dissolution Medium ◽  
Time Scaling ◽  
Health Authorities ◽  
Medium Level ◽  
One Step

The aim of the present study was to bring additional evidence regarding a biopredictive dissolution medium containing 1% sodium lauryl sulphate (SLS) to predict the in vivo behavior of carbamazepine (CBZ) products. Twelve healthy volunteers took one immediate release (IR) dose of either test and reference formulations in a bioequivalence study (BE). Dissolution profiles were carried-out using the medium. Level A in vitro–in vivo correlations (IVIVC) were established using both one-step and two-step approaches as well as exploring the time-scaling approach to account for the differences in dissolution rate in vitro versus in vivo. A detailed step by step calculation was provided to clearly illustrate all the procedures. The results show additional evidence that the medium containing 1% SLS can be classified as a universal biopredictive dissolution tool, and that both of the approaches used to develop the IVIVC (one and two-steps) provide good in vivo predictability. Therefore, this biopredictive medium could be a highly relevant tool in Latin-American countries to ensure and check the quality of their CBZ marketed products for which BE studies were not requested by their regulatory health authorities.

Bioequivalence study of nitrofurantoin tablets: in vitro-in vivo correlation

1986 ◽  
Vol 28 (2-3) ◽  
pp. 167-175 ◽  
Author(s):  
Arturo A. Lopez ◽  
Martha M. Molina ◽  
Helgi C. Jung ◽  
Angelica G. Dorantes ◽  
Ofelia O. Espejo ◽  
...  
Keyword(s):  
Bioequivalence Study

Bioanalytical approaches, bioavailability assessment, and bioequivalence study for waiver drugs: In vivo and in vitro perspective

2010 ◽  
Vol 27 (2) ◽  
pp. 32-41 ◽  
Author(s):  
Md. Faiyazuddin ◽  
Sarfaraz Ahmad ◽  
Gulam Mustafa ◽  
Farhan J. Ahmad ◽  
Faiyaz Shakeel
Keyword(s):  
Bioequivalence Study

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.

scholarly journals Parameters to be Considered in A Bioequivalence Study of Drug

2021 ◽  
Vol 9 (8) ◽  
pp. 1693-1701
Author(s):  
Nilesh Chougale
Keyword(s):  
Crossover Study ◽  
In Vitro Study ◽  
Bioequivalence Study ◽  
Pharmacokinetic Studies ◽  
Test Drug ◽  
Healthy Individuals ◽  
Reference Drug ◽  
Potential Test

Abstract: Bioequivalence is a word used to describe the biological equivalency of two proprietary medication preparations. When two medications are bioequivalent, it indicates they are expected to be the same. Pharmacokinetic studies are used to determine bioequivalence between two medications, such as a reference drug (FDA approved drug) and a potential test drug (marketed generic drug), by administering each drug to volunteers in a cross-over research (healthy individuals). To prepare a drug many aspects need to take into consideration such as in vivo and in vitro study, pharmacokinetics, pharmacodynamics and bioavailability of the drug. While designing a drug fasting, oral, crossover study of the drug needs to perform.

Clinical relevance of the pharmacokinetic characteristics of an abuse-deterrent, extended-release, injection-molded morphine tablet

2017 ◽  
Vol 13 (2) ◽  
pp. 111 ◽  
Author(s):  
Jeffrey M. Dayno, MD ◽  
Gwendolyn Niebler, DO ◽  
John Lawler, BS ◽  
Torben Elhauge, MSc ◽  
Karsten Lindhardt, MSc, PhD, DBE
Keyword(s):  
Steady State ◽  
Extended Release ◽  
Food Effect ◽  
Bioequivalence Study ◽  
Effect Study ◽  
In Silico Studies ◽  
Injection Molded ◽  
Clinically Significant

Objective: To characterize the pharmacokinetics (PK) and in vitro alcohol dissolution characteristics of extended-release (ER), injection-molded (IM) morphine tablets with abuse-deterrent (AD) features (morphine-ADER-IMT).Design: In vivo, in vitro, and in silico studies were conducted. A randomized, two-cohort study evaluated the bioequivalence of morphine-ADER-IMT (60 mg) to morphine ER (60 mg; MS Contin®; Purdue Pharma LP, Stamford, CT) and characterized the effect of food on the PK profile of morphine-ADER-IMT. A three-treatment, three-period crossover study assessed the bioequivalence of morphine-ADERIMT (30 and 2 × 15 mg) to morphine ER (30 mg). Bioequivalence studies were performed in healthy male and female subjects (18-55 y of age) in the presence of naltrexone blockade. PK modeling was performed to assess steady-state bioequivalence for morphine-ADER-IMT 60 mg compared with morphine ER 60 mg. In vitro alcohol dissolution studies were performed with morphine-ADER-IMT (15 and 60 mg).Results: Fifty-nine and 56 subjects completed the 60-mg bioequivalence/food effect study and 30-mg bioequivalence study, respectively. Bioequivalence of morphine-ADER-IMT 60, 30, and 2 × 15 mg and morphine ER was demonstrated to comparable doses of morphine ER. No clinically significant food effect was observed with morphine-ADER-IMT. Treatment-emergent adverse events were similar among all treatment groups. Steady-state modeling indicated bioequivalence between morphine-ADER-IMT 60 mg and morphine ER 60 mg when administered every 8 or 12 hours. No evidence of alcohol dose-dumping was observed with morphine-ADER-IMT.Conclusions: Morphine-ADER-IMT, an ER morphine formulation with robust AD features, has a clinical PK profile that is well suited for patients with chronic pain.

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.

Sign in / Sign up

Export Citation Format

Share Document