In vitro dissolution medium with supramicellar surfactant concentration and its relevance for in vivo absorption

Gander, Bruno; Ventouras, K; Gurny, Robert; Doelker, Éric

doi:10.1016/0378-5173(85)90190-5

Cited by 17 publications

(7 citation statements)

References 7 publications

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“…The result for SGFsp+ was 0.03%, which was confirmed by Zhao (53). The CMC in So-SIFsp+ was 0.04%, which agrees with the results of Gander (54). The difference between SGFsp+ and So-SIFsp+ was due to differences in the ionic strength of the media (20).…”

Section: Mediasupporting

confidence: 80%

Flow-Through Cell Method and IVIVR for Poorly Soluble Drugs

Wähling¹,

Schröter²,

Hanefeld³

2011

Dissolution Technol.

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The percentage of poorly soluble compounds in drug discovery and development increases steadily. A variety of possibilities exists for increasing solubility and bioavailability; among them is the formation of salts. For the characterization of poorly soluble active pharmaceutical ingredients (API), it is necessary to develop appropriate analytical methods to determine relevant physicochemical properties. One important physicochemical parameter is the dissolution rate. As the flow-through cell (FTC) offers various advantages, such as operating with pH gradients and in sink conditions or applying unlimited amount of media, the FTC is particularly suitable for poorly soluble compounds. When developing an FTC method it is important to consider the physiological circumstances. By choosing the appropriate conditions for media, volume, flow rate, and so forth, it is possible to predict in vivo behavior. The focus of this work was to develop a small-scale FTC method for poorly soluble compounds designed for determining dissolution kinetics in the early development phase, where only limited amount of drug is available. The predictive power of the presented system could be demonstrated by an in vitro-in vivo relationship (IVIVR) study.

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Section: Mediasupporting

confidence: 80%

Flow-Through Cell Method and IVIVR for Poorly Soluble Drugs

Wähling¹,

Schröter²,

Hanefeld³

2011

Dissolution Technol.

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“…Dissolution of drugs from solid dosage forms is a key parameter in assessing the product quality and uniformity at the formulation stage as well as throughout the shelflife of the product 1 . In case of lipophilic drugs dissolution rate can be the rate-limiting step in the in vivo absorption process and hence the dissolution medium is a critical component of the test that can cause problems 2,3 .Therefore, dissolution method should be discriminative, reproducible, scientifically justifiable and more importantly biorelevant 4 . This clinical relevance of dissolution testing can be achieved in the context of Quality by Design derived from a specific case study for a BCS 2 compound 5 .…”

Section: Introductionmentioning

confidence: 99%

A Review on Development of Biorelevant Dissolution Medium

Bhagat¹

2014

J. Drug Delivery Ther.

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Dissolution testing is a valuable tool that provides key information about bioavailability or bioequivalency as well as batch to batch consistency of drug. Since the number of poorly soluble drug is increasing, the selection of adequate dissolution test for these becomes more and more important. Biorelevant is a term, used to describe a medium that has same relevance to the in vivo dissolution condition for the compound. The development of biorelevant dissolution medium includes simulation of gastrointestinal condition, hydrodynamic characteristics, and physicochemical parameters of drug, prediction of plasma profil e and lastly the development of IVIVC. Biorelevant dissolution testing designed with appropriate simulated media and hydrodynamics are useful from the early stages of drug discovery and development for identifying the biopharmaceutical performance of compound (i.e. solubility problems, food effects, precipitation in the small intestine) through the later stages of development to assist in formulation strategies and the establishment of IVIVC that will lead to reduction of the number of animal experimentation, bioavailability and bioequivalence studies. The aim of this review article is to provide comprehensive information on the steps that should be considered during developing biorelevant dissolution medium for poorly soluble drugs and the composition of biorelevant dissolution medium to predict in vivo performance more accurately than the compendia dissolution medium.

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“…Drugs that are practically insoluble are of increasing therapeutic interest, but it is well recognized that they may present particular problems related to bioavailability when administered orally. Since their dissolution rate can be the rate-limiting step in the in vivo absorption process, there is a definite need for the development of an appropriate dissolution medium 6 .…”

Section: Introductionmentioning

confidence: 99%

Development of Dissolution Medium for Poorly Water Soluble Drug Racecadotril

Prabu¹,

Singh²,

Kumar³

2009

Journal of Pharmaceutical Research

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A new dissolution medium was developed for the antidiarrhoeal drug, Racecadotril. The drug is poorly soluble in water; it is not official in any pharmacopoeia. In the present study was to develop a new dissolution medium for Racecadotril. The composition of the medium was selected based on the earlier information and solubility data of racecadotril at 37 ± 0.5º C. Solubility data revealed that water consisting of 3.0%w/ v sodium lauryl sulphate could be a suitable dissolution medium. The discriminating power of the selected dissolution medium relative to other dissolution mediums was evaluated and the results further justified the usage of 3.0%w/v sodium lauryl sulphate in water as dissolution medium for racecadotril.

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In vitro dissolution medium with supramicellar surfactant concentration and its relevance for in vivo absorption

Cited by 17 publications

References 7 publications

Flow-Through Cell Method and IVIVR for Poorly Soluble Drugs

Flow-Through Cell Method and IVIVR for Poorly Soluble Drugs

A Review on Development of Biorelevant Dissolution Medium

Development of Dissolution Medium for Poorly Water Soluble Drug Racecadotril

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