In vitro dissolution absorption system (IDAS2): Use for the prediction of food viscosity effects on drug dissolution and absorption from oral solid dosage forms

2020 ◽  
Vol 143 ◽  
pp. 105164
Author(s):  
Svitlana Silchenko ◽  
Nourdine Nessah ◽  
Jibin Li ◽  
Li-Bin Li ◽  
Yuehua Huang ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Drug Dissolution ◽  
In Vitro Dissolution ◽  
Absorption System ◽  
Solid Dosage Forms ◽  
Solid Dosage ◽  
Viscosity Effects

scholarly journals The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing

2012 ◽  
Vol 2 ◽  
pp. 1-8 ◽  
Author(s):  
Mubarak Nasser Al Ameri ◽  
Nanda Nayuni ◽  
K.G. Anil Kumar ◽  
David Perrett ◽  
Arthur Tucker ◽  
...  
Keyword(s):  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Dissolution Testing ◽  
Generic Medicines ◽  
Solid Dosage Forms ◽  
Solid Dosage

scholarly journals A comparative in vitro dissolution study of generic moxifloxacin immediate-release film coated tablets and referent pharmaceutical product

2019 ◽  
Vol 64 (02) ◽  
pp. 27-34
Author(s):  
Emilija Janeva ◽  
Liljana Anastasova ◽  
Irena Slaveska Spirevska ◽  
Tatjana Rusevska ◽  
Tanja Bakovska Stoimenova ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Pharmaceutical Product ◽  
Generic Product ◽  
In Vitro Dissolution ◽  
Dissolution Behavior ◽  
Solid Dosage Forms ◽  
Solid Dosage ◽  
Similarity Factor

Dissolution testing of generic immediate release solid dosage forms represents a valuable tool to obtain dissolution profiles and to establish the similarity/dissimilarity between tested dosage forms. In this study, the in vitro dissolution profiles of generic immediate-release moxifloxacin (MOX) film coated tablets and a referent pharmaceutical product were compared and evaluated. The dissolution behavior of the generic product was investigated in three different dissolution media (pH=1.2, 4.5 and 6.8). The amount of dissolved MOX was determined using validated UV spectrophotometric method. For comparison of the dissolution behavior, the similarity factor, f2, was used. The dissolution profile of the generic product showed a release of >85 % MOX in the time frame of 30 min, in all the tested dissolution media. The similarity factor, f2, calculated from the comparison of the dissolution profiles of the generic and the referent pharmaceutical product in pH=1.2 dissolution medium was 50, 58, thus the products were established as similar. Based on the results of our study, the dissolution similarity between the generic MOX immediate-release film coated tablet and the referent product could be successfully used as a part of the approach to ensure their in vivo bioequivalence. Keywords: moxifloxacin, immediate-release solid dosage forms, dissolution, in vitro similarity

scholarly journals Spectrophotometric method in comparative in vitro dissolution test of branded and generic ibuprofen tablets

2021 ◽  
Vol 38 (2) ◽  
pp. 147-155
Author(s):  
Ana Marković ◽  
Miroslava Spasić ◽  
Vesna Savić ◽  
Slavica Sunarić ◽  
Marija Tasić-Kostov
Keyword(s):  
Spectrophotometric Method ◽  
High Performance ◽  
Dosage Forms ◽  
Hplc Method ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Solid Dosage Forms ◽  
Solid Dosage ◽  
Branded Drugs

The dissolution test is a simple and important in vitro method for assessing the bioequivalence, which aims to compare the bioavailability of generic and branded drugs. It implies the use of a proper apparatus (usually pharmacopoeially defined) in which the dosage form is dissolved, and the dissolution process itself is monitored/quantified using an appropriate analytical method among which high-performance liquid chromatography (HPLC) is widely used. Spectrophotometry could be a significant substitute, through its advantages in terms of simplicity and costs of analysis. In the present study, possible differences in bioavailability between branded and generic ibuprofen coated tablets were predicted using a dissolution test for solid dosage forms. The ibuprofen content and the amount of ibuprofen released in the dissolution test were determined using a simple spectrophotometric method. Based on the obtained results, no significant differences in the dissolution rate of ibuprofen from generic and branded coated tablets were observed. It can be concluded that the spectrophotometric method applied for the dissolution test, among other suitable methods, could be used for bioequivalence screening in conditions where rapid and simple assessment is required or where HPLC method is not available.

In-Vitro Drug Dissolution Studies in Medicinal Compounds

2018 ◽  
Vol 25 (33) ◽  
pp. 4020-4036
Author(s):  
Burcin Bozal-Palabiyik ◽  
Bengi Uslu ◽  
Yalcin Ozkan ◽  
Sibel A. Ozkan
Keyword(s):  
Dosage Form ◽  
Dosage Forms ◽  
Drug Dissolution ◽  
Dissolution Testing ◽  
Solid Dosage Forms ◽  
Solid Dosage ◽  
The Media ◽  
Recent Trends ◽  
Selection Of

After oral administration, drug absorption from solid dosage forms depends on the release of the drug active compounds from the dosage form, the dissolution or solubilization of the drug under physiological conditions, and the permeability across the gastrointestinal tract. Dissolution testing is an essential part of designing more effective solid dosage forms in pharmaceutical industry. Moreover, dissolution testing contributes to the selection of appropriate formulation excipients for improving the dosage form efficiency. This study aims to analyze in-vitro drug dissolution testing in solid dosage forms since 2010 in order to present a comprehensive outlook of recent trends. In doing that the previous studies in the literature are summarized in the form of a table to demonstrate the apparatuses used for dissolution testing, the media in which the solid dosage form is dissolved, the method preferred for analysis from dissolution media, the conditions of analyses and the results obtained.

Polymer-free and polyvinylpirrolidone-based electrospun solid dosage forms for drug dissolution enhancement

2013 ◽  
Vol 49 (4) ◽  
pp. 595-602 ◽  
Author(s):  
Tamás Vigh ◽  
Tímea Horváthová ◽  
Attila Balogh ◽  
Péter Lajos Sóti ◽  
Gábor Drávavölgyi ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Drug Dissolution ◽  
Dissolution Enhancement ◽  
Solid Dosage Forms ◽  
Solid Dosage

Bioavailability and Biological Disposition of Methaqualone*

1974 ◽  
Vol 2 (2) ◽  
pp. 85-99 ◽  
Author(s):  
Robert D Smyth ◽  
Pramod B Chemburkar ◽  
P P Mathur ◽  
A F DeLong ◽  
A Polk ◽  
...  
Keyword(s):  
Intestinal Tract ◽  
Chronic Administration ◽  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Elimination Kinetics ◽  
Solid Dosage ◽  
Liver And Kidney ◽  
Gastro Intestinal Tract

The absorption of methaqualone from the gastro-intestinal tract is a dissolution—and not a permeability-rate limited process. Absorption from solution dosage forms can occur throughout the gastro-intestinal tract with maximum absorption from the intestine. Dissolution of solid dosage forms is favoured in the highly-acidic environment of the stomach and absorption of the in situ dissolved drug occurs in both stomach and upper small intestine. Methaqualone is found primarily in the plasma phase of whole blood and is highly bound to plasma proteins. The plasma elimination curve is biexponential with a rapid distributive phase and a slow elimination phase. The principle tissues of distribution are the metabolic and excretory tissues—liver and kidney — and lipid tissue. Metabolism occurs by hydroxylation of the methyl, tolyl and quinazolinone substituents via inducible hepatic microsomal oxidoreductases. Methaqualone is completely bio-transformed and excreted as O-glucuronide conjugates in urine and bile. Enterohepatic recirculation of metabolites occurs and is responsible for the prolonged urinary excretion profile. There is no change in absorption, distribution or elimination kinetics following chronic administration in man. Tablet and capsule formulations with good in vitro dissolution, stability and bioavailability characteristics were developed. Equivalent bioavailability of these tablet formulations was observed in the fasted and post-prandial state. Techniques were developed to correlate dissolution and absorption profiles of these formulations.

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.

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