Particle diffusional layer thickness in a USP dissolution apparatus II: A combined function of particle size and paddle speed

Sheng, Jennifer; Sirois, Paul J.; Dressman, Jennifer B.; Amidon, Gordon L.

doi:10.1002/jps.21345

Cited by 46 publications

(47 citation statements)

References 42 publications

(55 reference statements)

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“…The surface area of the compound in contact with the solvent is directly proportional to the dissolution rate [84]. It can be manipulated by increasing or decreasing particle size.…”

Section: Surface Areamentioning

confidence: 99%

Variability in bioavailability of small molecular tyrosine kinase inhibitors

Herbrink

Nuijen

Schellens

et al. 2015

Cancer Treatment Reviews

107

100

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“…The surface area of the compound in contact with the solvent is directly proportional to the dissolution rate [84]. It can be manipulated by increasing or decreasing particle size.…”

Section: Surface Areamentioning

confidence: 99%

Variability in bioavailability of small molecular tyrosine kinase inhibitors

Herbrink

Nuijen

Schellens

et al. 2015

Cancer Treatment Reviews

107

100

View full text Add to dashboard Cite

“…For Ag + the diffusion coefficient is D = 8.5 × 10 −6 cm 2 s −1 at 273 K and 16.6 × 10 −6 cm 2 s −1 at 298 K. The diffusion coefficient is slightly larger for I − with 10.3 × 10 −6 cm 2 s −1 at 273 K and 20.0 × 10 −6 cm 2 s −1 at 298 K (Li and Gregory, 1974). For the liquid layer h, a value equal to the particle radius is often assumed (Sheng et al, 2008). Silver iodide is a sparingly soluble salt with a solubility product of around 10 −16 at 298 K (Hiemstra, 2012;Lyklema, 1966).…”

Section: B5 Contact Angle Of Water On Silver Iodidementioning

confidence: 99%

Ice nucleation efficiency of AgI: review and new insights

et al. 2016

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Abstract. AgI is one of the best-investigated ice-nucleating substances. It has relevance for the atmosphere since it is used for glaciogenic cloud seeding. Theoretical and experimental studies over the last 60 years provide a complex picture of silver iodide as an ice-nucleating agent with conflicting and inconsistent results. This review compares experimental ice nucleation studies in order to analyze the factors that influence the ice nucleation ability of AgI. The following picture emerges from this analysis: the ice nucleation ability of AgI seems to be enhanced when the AgI particle is on the surface of a droplet, which is indeed the position that a particle takes when it can freely move in a droplet. The ice nucleation by particles with surfaces exposed to air depends on water adsorption. AgI surfaces seem to be most efficient at nucleating ice when they are exposed to relative humidity at or even above water saturation. For AgI particles that are completely immersed in water, the freezing temperature increases with increasing AgI surface area. Higher threshold freezing temperatures seem to correlate with improved lattice matches as can be seen for AgI-AgCl solid solutions and 3AgI q NH 4 I q 6H 2 O, which have slightly better lattice matches with ice than AgI and also higher threshold freezing temperatures. However, the effect of a good lattice match is annihilated when the surfaces have charges. Also, the ice nucleation ability seems to decrease during dissolution of AgI particles. This introduces an additional history and time dependence for ice nucleation in cloud chambers with short residence times.

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“…Since the size of drug particles can significantly affect drug dissolution rate, the relatively larger particle size, a radius of 25 μm, to minimize the particle effects for dissolution was set as the mean particle size with a coefficient of variation (Le et al, 2006; Lin et al, 1982; Mutalik et al, 2008; Sheng et al, 2008; Takano et al, 2008; Tsume and Amidon, 2010). It is hard to predict the mean precipitation time because it depends on the formulation and physicochemical properties of drug compound.…”

Section: Methodsmentioning

confidence: 99%

The Biopharmaceutics Classification System: Subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC

Tsume

Mudie

Langguth

et al. 2014

European Journal of Pharmaceutical Sciences

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264

157

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The Biopharmaceutics Classification System (BCS) has found widespread utility in drug discovery, product development and drug product regulatory sciences. The classification scheme captures the two most significant factors influencing oral drug absorption; solubility and intestinal permeability and it has proven to be a very useful and a widely accepted starting point for drug product development and drug product regulation. The mechanistic base of the BCS approach has, no doubt, contributed to its wide spread acceptance and utility. Nevertheless, underneath the simplicity of BCS are many detailed complexities, both in vitro and in vivo which must be evaluated and investigated for any given drug and drug product. In this manuscript we propose a simple extension of the BCS classes to include subspecification of acid (a), base (b) and neutral (c) for classes II and IV. Sub-classification for Classes I and III (high solubility drugs as currently defined) is generally not needed except perhaps in border line solubility cases. It is well known that the , pKa physical property of a drug (API) has a significant impact on the aqueous solubility dissolution of drug from the drug product both in vitro and in vivo for BCS Class II and IV acids and bases, and is the basis, we propose for a sub-classification extension of the original BCS classification. This BCS sub-classification is particularly important for in vivo predictive dissolution methodology development due to the complex and variable in vivo environment in the gastrointestinal tract, with its changing pH, buffer capacity, luminal volume, surfactant luminal conditions, permeability profile along the gastrointestinal tract and variable transit and fasted and fed states. We believe this sub-classification is a step toward developing a more science-based mechanistic in vivo predictive dissolution (IPD) methodology. Such a dissolution methodology can be used by development scientists to assess the likelihood of a formulation and dosage form functioning as desired in humans, can be optimized along with parallel human pharmacokinetic studies to set a dissolution methodology for Quality by Design (QbD) and in vitro–in vivo correlations (IVIVC) and ultimately can be used as a basis for a dissolution standard that will ensure continued in vivo product performance.

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Particle diffusional layer thickness in a USP dissolution apparatus II: A combined function of particle size and paddle speed

Cited by 46 publications

References 42 publications

Variability in bioavailability of small molecular tyrosine kinase inhibitors

Variability in bioavailability of small molecular tyrosine kinase inhibitors

Ice nucleation efficiency of AgI: review and new insights

The Biopharmaceutics Classification System: Subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC

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