Simultaneous measurement of liquid-phase and solid-phase transformation kinetics in rotating disc and channel flow cell dissolution devices

Lehto, Paula; Aaltonen, Jaakko; Niemelä, Pentti; Rantanen, Jukka; Hirvonen, Jouni; Tanninen, Veli Pekka; Peltonen, Leena

doi:10.1016/j.ijpharm.2008.07.001

Cited by 18 publications

(21 citation statements)

References 18 publications

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“…Thus, it is possible to obtain data on the chemical purity and equivalence of drugs from different sources. This information is related to the variability of raw material available on the market, which results from distinctive synthesis processes, especially in the final stages of crystallization, and may lead to different particle sizes, degrees of hydration, habits, and crystalline forms for a single drug (16,19,32,33).…”

Section: Intrinsic Dissolutionmentioning

confidence: 99%

“…Changes on the material surface of the compressed drug during the intrinsic dissolution test may also occur, such as the conversion of amorphous atorvastatin into crystalline atorvastatin (38), the transformation of diclofenac salt into its acid form (37), the hydration of anhydrous forms of carbamazepine and theophylline (16,33), and the conversion of rifampicin into a more stable polymorph (39).…”

Section: Intrinsic Dissolutionmentioning

confidence: 99%

“…A good correlation of results is observed compared with the fixed-disk system and even other systems not detailed in pharmacopeias but tested in several studies to determine the intrinsic dissolution rate. The latter include the flowcell system and a miniature apparatus (Mini-IDR) similar to the rotating disk (32,33,36,42,43).…”

Section: Apparatus Used To Determine the Idrmentioning

confidence: 99%

“…The presence of positive curvature may indicate some experimental problem, while negative curvature may be related to the transition of the crystal form on the surface of the compressed drug or inadvertent achievement of the saturation point of the dissolution medium (16,17,33).…”

Section: Calculating Idr and Analyzing Test Datamentioning

confidence: 99%

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Intrinsic Dissolution as a Tool for Evaluating Drug Solubility in Accordance with the Biopharmaceutics Classification System

Issa¹,

Ferraz²

2011

Dissolution Technol.

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The Biopharmaceutics Classification System (BCS) is a tool that was created to categorize drugs into different groups according to their solubility and permeability characteristics. Through a combination of these factors and physiological parameters, it is possible to understand the absorption behavior of a drug in the gastrointestinal tract, thus contributing to cost and time reductions in drug development, as well as reducing exposure of human subjects during in vivo trials. Solubility is attained by determining the equilibrium under conditions of physiological pH, while different methods may be employed for evaluating permeability. On the other hand, the intrinsic dissolution rate (IDR), which is defined as the rate of dissolution of a pure substance under constant temperature, pH, and surface area conditions, among others, may present greater correlation to the in vivo dissolution dynamic than the solubility test. The purpose of this work is to discuss the intrinsic dissolution test as a tool for determining the solubility of drugs within the scope of the Biopharmaceutics Classification System (BCS).

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Section: Intrinsic Dissolutionmentioning

confidence: 99%

Section: Intrinsic Dissolutionmentioning

confidence: 99%

Section: Apparatus Used To Determine the Idrmentioning

confidence: 99%

Section: Calculating Idr and Analyzing Test Datamentioning

confidence: 99%

See 2 more Smart Citations

Intrinsic Dissolution as a Tool for Evaluating Drug Solubility in Accordance with the Biopharmaceutics Classification System

Issa¹,

Ferraz²

2011

Dissolution Technol.

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“…APIs are commercially manufactured by different processes, resulting in variable characteristics like particle sizes, degree of hydration and crystalline forms. Intrinsic dissolution testing makes it possible to obtain data on the chemical purity and equivalence of the available APIs (2)(3)(4). It has been a key parameter during the development of new molecules, because the test can be executed with a small quantity and can predict potential dissolution problems (2,5).…”

Section: Introductionmentioning

confidence: 99%

Intrinsic dissolution testing: A tool for determining the effect of processing on dissolution behavior of the drug

Khan¹,

Iqbal²,

Khan³

et al. 2017

Dissolution Technol.

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Intrinsic dissolution testing has been applied for characterization of pure API with respect to its dissolution behavior. The effect of formulation factors and processing parameters on dissolution rate is evaluated by dissolution testing of the final product, which is a time and resource-consuming process. Our objective was to use intrinsic dissolution testing for determining the effect of processing parameters on drug release. In the present study, an intrinsic dissolution testing method was developed for atenolol and validated according to the standard guidelines using USP-recommended dissolution media. Various experimental variables (compaction pressure and rotation speed of the disk) were optimized by studying at three levels. Atenolol was subjected to granulation in a super mixer granulator by applying standard wet granulation protocols. Granulation time and binder concentration were taken as process variables while dissolution rate was a response variable. Dissolution media had no interference with sample analysis, and all validation parameters for the developed method were in an acceptable range (%RSD > 1). The intrinsic dissolution rate of atenolol (1.84 ± 0.13 mg/cm 2 min) was high due to its better solubility in dissolution media. The dissolution rate of atenolol was decreased by granulating with PVP under different conditions. We concluded that intrinsic dissolution testing method can be applied for determining the effect of processing parameters on dissolution rate of the API at the pre-compression level. This method will reduce experimentation for optimization of dissolution rate and will spare time and resources.

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Solvent-Mediated Solid Phase Transformations of cArbamazepine: Effects of Simulated Intestinal Fluid and Fasted State Simulated Intestinal Fluid

Lehto

Aaltonen

Tenho

et al. 2009

Journal of Pharmaceutical Sciences

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Simultaneous measurement of liquid-phase and solid-phase transformation kinetics in rotating disc and channel flow cell dissolution devices

Cited by 18 publications

References 18 publications

Intrinsic Dissolution as a Tool for Evaluating Drug Solubility in Accordance with the Biopharmaceutics Classification System

Intrinsic Dissolution as a Tool for Evaluating Drug Solubility in Accordance with the Biopharmaceutics Classification System

Intrinsic dissolution testing: A tool for determining the effect of processing on dissolution behavior of the drug

Solvent-Mediated Solid Phase Transformations of cArbamazepine: Effects of Simulated Intestinal Fluid and Fasted State Simulated Intestinal Fluid

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