Online citations, reference lists, and bibliographies.
← Back to Search

Modeling And Comparison Of Dissolution Profiles.

P. Costa, J. S. Sousa Lobo
Published 2001 · Chemistry, Medicine

Cite This
Download PDF
Analyze on Scholarcy
Share
Over recent years, drug release/dissolution from solid pharmaceutical dosage forms has been the subject of intense and profitable scientific developments. Whenever a new solid dosage form is developed or produced, it is necessary to ensure that drug dissolution occurs in an appropriate manner. The pharmaceutical industry and the registration authorities do focus, nowadays, on drug dissolution studies. The quantitative analysis of the values obtained in dissolution/release tests is easier when mathematical formulas that express the dissolution results as a function of some of the dosage forms characteristics are used. In some cases, these mathematic models are derived from the theoretical analysis of the occurring process. In most of the cases the theoretical concept does not exist and some empirical equations have proved to be more appropriate. Drug dissolution from solid dosage forms has been described by kinetic models in which the dissolved amount of drug (Q) is a function of the test time, t or Q=f(t). Some analytical definitions of the Q(t) function are commonly used, such as zero order, first order, Hixson-Crowell, Weibull, Higuchi, Baker-Lonsdale, Korsmeyer-Peppas and Hopfenberg models. Other release parameters, such as dissolution time (tx%), assay time (tx min), dissolution efficacy (ED), difference factor (f1), similarity factor (f2) and Rescigno index (xi1 and xi2) can be used to characterize drug dissolution/release profiles.
This paper references
kinetics to explain release of highly water soluble drugs from porous Tsong
Edition. Taylor (1996)
10.3109/03639049409050190
In-Vitro Release Kinetics of Salbutamolsulphate Microcapsules Coated with Both Eudragit Rs 100 and Eudragit RL 100
R. Bhanja (1994)
10.1111/j.2042-7158.1978.tb13253.x
On methods of expressing dissolution rate data
J. A. Goldsmith (1978)
10.1111/j.2042-7158.1975.tb09378.x
The concept of dissolution efficiency
K. A. Khan (1975)
10.1177/009286159603000427
Statistical Assessment of Mean Differences between Two Dissolution Data Sets*
Y. Tsong (1996)
10.1002/JPS.2600521210
MECHANISM OF SUSTAINED-ACTION MEDICATION. THEORETICAL ANALYSIS OF RATE OF RELEASE OF SOLID DRUGS DISPERSED IN SOLID MATRICES.
T. Higuchi (1963)
10.1111/j.2042-7158.1972.tb08930.x
Letters to the Editor: Linearization of dissolution rate curves by the Weibull distribution
F. Langenbucher (1972)
In-vitro dissolution behavior of some sustained-release theophylline dosage forms.
S. Lin (1989)
10.1016/0378-5173(83)90064-9
Mechanisms of solute release from porous hydrophilic polymers
R. Korsmeyer (1983)
Biologically Active Agents
Drug release from theory, fractal geometry and dosage form. Pharm. Acta Helv. 64, wax matrices. I. Analysis of data with first-order kinetics and with the 34–39. diffusion-controlled model
H Leuenberger (1968)
10.1002/JPS.2600561005
Establishment of sink conditions in dissolution rate determinations. Theoretical considerations and application to nondisintegrating dosage forms.
M. Gibaldi (1967)
Effect of drug loading and
J. A. (1991)
10.1016/S0168-3659(98)00196-5
In vitro release modulation from crosslinked pellets for site-specific drug delivery to the gastrointestinal tract. I. Comparison of pH-responsive drug release and associated kinetics.
V. Pillay (1999)
10.1002/JPS.2600551112
Investigation of factors influencing release of solid drug dispersed in inert matrices. II. Quantitation of procedures.
S. J. Desai (1966)
10.1002/JPS.2600671034
Versatile kinetic-approach to analysis of dissolution data.
P. Pedersen (1978)
10.1002/JPS.2600570207
Drug release from wax matrices. II. Application of a mixture theory to the suflanilamide--wax system.
J. B. Schwartz (1968)
On the assessment of similarity of drug Pedersen Versatile kinetic approach to analysis dissolution profiles -A simulation study of dissolution data
H L Ju (1978)
10.3109/03639049509026658
A simple model based on first order kinetics to explain release of highly water soluble drugs from porous dicalcium phosphate dihydrate matrices
N. Mulye (1995)
Preparation and in vitro dissolution tests of egg Peppas Analysis of Fickian and non-Fickian drug release albumin microcapsules of nitrofurantoin
H W Jun (1983)
10.2307/2531919
Repeated Measurement: Split-Plot Trend Analysis Versus Analysis of First Differences
J. Gill (1988)
ON THE ASSESSMENT OF SIMILARITY A SIMULATION STUDY OF DRUG DISSOLUTION PROFILES
H. L. Ju (1997)
Drug release from sustained - release theophylline dosage forms
B. J. Schwartz
10.1002/JPS.2600810318
Dissolution of fludrocortisone from phospholipid coprecipitates.
G. Vudathala (1992)
Influence of formulation variables and Farmaceutica
L. N. Prista (1995)
Analysis of Fickian and non-Fickian drug release from polymers.
N. Peppas (1985)
Mathematical comparison of dissolu - theophylline microspheres
J. W. Moore (1996)
Influence of shape
J. Cobby (1974)
10.1016/0168-3659(94)00085-9
Zero-order release from biphasic polymer hydrogels
C. Varelas (1995)
Controlled release: mechanisms and release.
R. W. Baker (1974)
10.1177/009286159603000428
Methods to Compare Dissolution Profiles*
J. Polli (1996)
10.1016/0378-5173(94)00418-5
Modelling of drug release from polymer matrices: Effect of drug loading
Silvia Kocova Ei-Arini (1995)
estrogen tablets bioequivalence guidance
Chemistry, Manufacturing, and Controls Controlled release: mechanisms and Documentation. Center for Drug Evaluation and Research (CDER), rates
Postapproval Scale-Up (1974)
Drug release from sustained-release theophylline dosage forms. Pharm. Acta Helv. 64, wax matrices. II. Application of a mixture theory to the sulfanilamide– 236–240. wax system
S Y Lin (1968)
10.1002/JPS.2600630516
Influence of shape factors on kinetics of drug release from matrix tablets. I. Theoretical.
J. Cobby (1974)
Analysis of Fickian and non - Fickian drug release albumin microcapsules of nitrofurantoin
N. A. Peppas (1985)
21 , differences between two dissolution data sets
P. J. Niebergall (1963)
10.1137/1.9781611971972
The Mathematics Of Diffusion
J. Crank (1956)
10.1111/j.2042-7158.1977.tb11368.x
Interpretation of dissolution rate data from in vitro testing of compressed tablets
S. Kitazawa (1977)
10.1016/0378-5173(95)04356-X
Nonlinear data fitting for controlled release devices: An integrated computer program
D. Lu (1996)
factor f as a criterion for assessment of similarity between dissolution 1980 . Controlled release of 3 , 5 - diester prodrugs of 5 - fluoro - 2 - deox - 2 profiles
T. Kawaguchi
In-vitro dissolution behavior of some sustained-release theophylline dosage forms.
Lin Sy (1989)
10.1002/JPS.2600820313
Pharmacokinetic profile of flosequinan in patients with compromised renal function.
B. Gallo (1993)
10.1016/S0168-3659(98)00022-4
Evaluation and comparison of dissolution data derived from different modified release dosage forms: an alternative method.
V. Pillay (1998)
Effect of compaction pressure on the dissolution efficiency of some direct compression systems.
Khan Ka (1972)
Linearization of dissolution rate curves by the Inert monolithic device with a central hole for constant drug release . Weibull distribution
F. Langenbucher (1972)
double compression process: application of a hadamard matrix and
S. Kitazawa (1977)
10.3109/10837459609031435
Optima: a windows-based program for computer-aided optimization of controlled-release dosage forms.
D. R. Lu (1996)
10.1002/JPS.2600630517
Influence of shape factors on kinetics of drug release from matrix tablets. II. Experimental.
J. Cobby (1974)
10.1021/JS9600538
Modeling of drug release from erodible tablets.
I. Katzhendler (1997)
10.1016/S0031-6865(97)00051-4
Dissolution properties of praziquantel--PVP systems.
S. K. el-Arini (1998)
10.1177/009286159703100426
Statistical Evaluation of Similarity Factor f2 as a Criterion for Assessment of Similarity between Dissolution Profiles
J. Liu (1997)
Formulation des comprimes a liberá
R. W. Korsmeyer (1980)
Statistical comparison between dissolution Higuchi, W.I., 1962. Analysis of data on the medicament release from profiles of drug products
S C Chow (1997)
10.1021/IE50260A018
Dependence of Reaction Velocity upon surface and Agitation
A. Hixson (1931)
10.1002/JPS.2600551114
Investigation of factors influencing release of solid drug dispersed in inert matrices. IV. Some studies involving the polyvinyl chloride matrix.
S. J. Desai (1966)
10.1002/JPS.2600551113
Investigation of factors influencing release of solid drug dispersed in inert matrices. 3. Quantitative studies involving the polyethylene plastic matrix.
S. J. Desai (1966)
Bioequivalence. Pharm. Res
A Rescigno (1992)
[Formulation of sustained release tablets. I. Inert matrices].
J. L. Salomen (1980)
10.4324/9780203211595
Introduction to percolation theory
D. Stauffer (1985)
Nonlinear data fitting for lar weight cellulose acetate propionate
D. R. Lu
factor f as a criterion for assessment of similarity between dissolution 1980. Controlled release of 3,5-diester prodrugs of 5-fluoro-2-deox- 2 profiles yuridine from poly-L-lactic acid microspheres
J P Liu (1996)
Dissolution rate Varelas Zero-order release from studies. II. Dissolution of particles under conditions of rapid agitation. biphasic polymer hydrogels
P J Niebergall (1963)
10.1002/JPS.2600501018
Rate of release of medicaments from ointment bases containing drugs in suspension.
T. Higuchi (1961)
10.1002/JPS.2600541012
Investigation of factors influencing release of solid drug dispersed in inert matrices.
S. J. Desai (1965)
Preparation and in vitro dissolution tests of egg
H.W (1983)
Controlled release : mechanisms and Documentation
R. W. Baker (1974)
Controlled Release of Biologically Active Agents
R. W. Baker (1987)
Matrix type controlled release systems: I. Effect of percolation on drug dissolution kinetics.
J. Bonny (1991)
10.1002/JPS.2600581021
Interpretation of percent dissolved-time plots derived from in vitro testing of conventional tablets and capsules.
J. Wagner (1969)
10.1002/JPS.2600510825
Analysis of data on the medicament release from ointments.
W. Higuchi (1962)
Formulation des comprimes a libera - ́ Mechanism of solute release from porous hydrophilic polymers
J.-L. Salomon (1980)
Drug release from theory , fractal geometry and dosage form
B. J. Percolation Schwartz
Matrix type controlled release percolation threshold
J. D. Bonny (1991)
10.1111/j.2042-7158.1980.tb13002.x
Physical interpretation of parameters in the Rosin‐Rammler‐Sperling‐Weibull distribution for drug release from controlled release dosage forms
F. N. Christensen (1980)
10.1021/JS960307P
Application of binary polymer system in drug release rate modulation. 2. Influence of formulation variables and hydrodynamic conditions on release kinetics.
H. Kim (1997)
10.1002/JPS.2600791108
Controlled release of 3',5'-diester prodrugs of 5-fluoro-2'-deoxyuridine from poly-L-lactic acid microspheres.
T. Seki (1990)
Mathematical comparison of dissolution profiles
J. S. Moore (1996)
10.1021/JS960473X
Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets.
J. Polli (1997)
64 , wax matrices . II . Application of a mixture theory to the sulfanilamide – 236 – 240 . wax system
J. P. Liu (1997)
Statistical assessment of mean dicalcium phosphate dihydrate matrices
Y. Tsong (1996)
10.1177/009286159603000403
Statistical Issues on the FDA Conjugated Estrogen Tablets Bioequivalence Guidance
J. Liu (1996)
Application of binary polymer system
H. Kim (1997)
W.I., 1968a. Drug release from theory, fractal geometry and dosage
H. Leuenberger (1989)
Statisti - hardness on the desintegration time and the dissolution rate of cal optimization of a controlled release formulation obtained by a uncoated caffeine tablets
P. Romero (1991)
J. Pharm. Sci
10.3109/03639048909052539
Statistical Optimization of a Controlled Release Formulation Obtained by a Double Compression Process: Application of an Hadamard Matrix and a Factorial Design
A. P. Romero (1989)
10.1016/0378-5173(91)90071-U
MATHEMATICAL MODELLING OF DRUG RELEASE FROM HYDROXYPROPYLMETHYLCELLULOSE MATRICES : EFFECT OF TEMPERATURE
J. L. Ford (1991)
10.1002/JPS.2600570206
Drug release from wax matrices. I. Analysis of data with first-order kinetics and with the diffusion-controlled model.
J. B. Schwartz (1968)
Control of drug release
R.K (1986)
10.1080/10543409708835184
Statistical comparison between dissolution profiles of drug products.
S. C. Chow (1997)
Effect of compaction pressure on the dissolution efficiency of some direct compression systems.
K. A. Khan (1972)
Effect of compaction pressure
J. E. Polli (1997)
10.1016/0378-5173(83)90129-1
Preparation and in vitro dissolution tests of egg albumin microcapsules of nitrofurantoin
H. W. Jun (1983)
Effect of drug ( core ) particle size on the forms
A. J. Shukla (1989)
10.1111/j.2042-7158.1975.tb09397.x
Effects of hardness on the disintegration time and the dissolution rate of uncoated caffeine tablets
Shikifumi Kitazawa (1975)
64 , wax matrices . I . Analysis of data with first - order kinetics and with the 34 – 39 . diffusion - controlled model
S. Y. Lin (1989)
Dependence of reaction velocity upon tion of parameters in the Rosin–Rammler–Sperling–Weibull
F. N. Christensen (1980)
Dissolution of fludrocortisone from Human Medicines
G. K. Vudathala (1992)
Zero-order release from studies. II. Dissolution of particles under conditions of rapid agitation
P. J. Niebergall (1995)
Release Polymeric Formulations Influence of shape can Chemical Society
J Ameri-Cobby (1974)
RL Drug Dev. Ind. Pharm
Inert monolithic device with a central hole for constant drug release
M.E.Sangalli Mesangalli (1994)
10.1002/JPS.2600520310
Dissolution rate studies. II. Dissolution of particles under conditions of rapid agitation.
P. J. Niebergall (1963)



This paper is referenced by
10.1248/CPB.C12-00502
Formulation, characterization and optimization of valsartan self-microemulsifying drug delivery system using statistical design of experiment.
B. K. Poudel (2012)
Electrodeless electro hydrodynamic printing of personalized drug dosages
Ezinwa Elele (2011)
Processing of polymer-based systems for improved performance and controlled release
Jia Ma (2011)
Archive of SID Development of matrix type transdermal patches of lercanidipine hydrochloride: physicochemical and in-vitro characterization
T. S. Mamatha (2010)
10.5897/AJPP12.586
Effects of different manufacturing methods on pharmaceutical properties and release kinetic models of ketoprofen sustained-release microparticles
Thau-Ming Cham (2012)
10.1201/B15403-15
Inorganic Nanoparticle Materials for Controlled Drug Delivery Systems
Rafael Melo Freire (2013)
Formulation, Development and Evaluation of Extended Release Matrix Tablets of NSAID by Using Combination of Hydrophilic and Hydrophobic Polymers Yadav
Yadav Vijay (2014)
FORMULATION AND EVALUATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE FILM COATED TABLETS
U Srilatha (2015)
10.1080/03602559.2016.1253734
Development of In Situ Gelling Inserts by Lyophilization for Nasal Delivery of Terbutaline Sulfate
Vivek Jadhav (2017)
Engineering of Human Acid Phosphatase Enzyme Sensitive Nanomedicine for HIV/AIDS Prevention by Topical Route
Albert Nguessan Ngo (2018)
10.7324/japs.2019.90708
Characterization of Eudragit types and Kollidon SR inter-polymer complexes and their effects on the drug release
Syaiful Choiri (2019)
10.31351/vol27iss2pp77-92
Formulation and In- Vitro Evaluation of Spherical Crystal Agglomerates of Ebastine by Quasi Emulsion Solvent Diffusion Method
marwah mohammed hareeja (2018)
Hydrodynamic effects of a cannula in a USP dissolution testing apparatus 2
Qianqian Liu (2013)
10.5772/28446
Solid State and Thermal Behavior of 17β-Estradiol in Ammonioethyl Methacrylate Ester Copolymer
Chutima Wiranidchapong (2012)
Formulation and In-Vitro Evaluation of Antiemetic Orodispersible Combination Tablets of Domperidone and Cinnerizine by using various Superdisintegrants
R. Shaikh (2015)
10.22159/ijpps.2016v8i11.13806
CONTROLLED-RELEASE EFFERVESCENT FLOATING MATRIX TABLETS OF METFORMIN USING COMBINATION OF POLYMERS
Meenakshi Bhavesh Patel (2016)
Formulation and Characterization of Fixed Dose Combined Trilayer Tablets of Niacin and Rosuvastatin Calcium
Babita Kumari (2017)
Research Article CODEN: IJPRNK ISSN: 2277-8713 Hassan M. Elsabbagh., IJPRBS, 2016; Volume 5(1): 45-67 IJPRBS
Hassan Mohamed EL-Sabbagh (2016)
Formulation and optimization of effervescent floating tablet of diltiazem hydrochloride using response surface methodolgy
Ajay Kumar Tiwari (2015)
10.3390/pharmaceutics12020105
Development of a Biodegradable Subcutaneous Implant for Prolonged Drug Delivery Using 3D Printing
S. Stewart (2020)
10.7282/T3KW5KGJ
Characterization and functional studies of electrospun/sprayed complexes loaded with phytochemicals
Zhenyu Lin (2018)
AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES FORMULATION AND IN-VITRO EVALUTION OF SUSTAINED RELEASE TABLET OF NIFIDIPINE USING HYDROPHILIC POLYMER Donga
Jj (2013)
10.1016/j.ijbiomac.2019.06.048
Phenytoin/sildenafil loaded poly(lactic acid) bilayer nanofibrous scaffolds for efficient orthopedics regeneration.
I. Ali (2019)
FORMULATION AND EVALUATION OF COLON SPECIFIC DRUG DELIVERY SYSTEM OF ZALTOPROFEN
Pramod D. Mahajan (2014)
10.1016/j.actbio.2007.11.009
L-Trp adsorption into silica mesoporous materials to promote bone formation.
F. Balas (2008)
10.1208/s12249-008-9175-0
Formulation of Sustained-Release Dosage Form of Verapamil Hydrochloride by Solid Dispersion Technique Using Eudragit RLPO or Kollidon®SR
J. Sahoo (2008)
Pilocarpine Hydrochloride Loaded Pluronic F127/hyaluronic Acid Solu- tions for a Potential Ocular Delivery
S. B. Lee (2008)
10.1080/17458080903531013
Inorganic-based phytohormone delivery vector of 2-chloroethylphosphonate nanohybrid: a new stimulating compound with controlled release property to increase latex production
M. Hussein (2010)
KINETIC MODELING AND DISSOLUTION PROFILES COMPARISON: AN OVERVIEW
Hussain Lokhandwala (2013)
10.14227/DT230216P14
Development and Validation of a Discriminating Dissolution Method for Atorvastatin Delayed-Release Nanoparticles Using a Flow-Through Cell: A Comparative Study Using USP Apparatus 4 and 1
S. Gite (2016)
10.1016/j.ijbiomac.2019.09.229
Silica Coating of Carboxymethyl Tamarind Kernel Polysaccharide Beads to Modify the Release Characteristics.
D. Kumar (2019)
Study of controlled release of active pharmaceutical ingredients from functionalized nanoclays and polymer matrices
J. Ha (2011)
See more
Semantic Scholar Logo Some data provided by SemanticScholar