Comparison of the Wetting Properties of Three Commonly Used Simulated Intestinal Fluids Used as Dissolution Media in the Characterization of Drugs

Spiegeleer, Bart De; Baert, Bram; Vangheluwe, Elien; Becue, Ilse; Smet, Jan De; Spanoghe, Pieter; Wille, Christophe; Meeren, Paul Van der; Slegers, Guido

doi:10.1007/s10953-007-9150-5

Cited by 3 publications

(1 citation statement)

References 17 publications

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“…Phosphate buffers, often resembling physiological conditions, are the most often used base solvents (60%), followed by non-buffered water (15%) or normal saline (sodium chloride) solutions (15%). Often, these phosphate buffers are derived from and are similar to those used in dissolution tests for oral dosage forms (25). To prevent bacterial degradation of the drug under investigation (26), antimicrobial preservative agents are used as an additive in 15% of the cases.…”

Section: Spilanthol Applicationmentioning

confidence: 99%

A New Discriminative Criterion for the Development of Franz Diffusion Tests for Transdermal Pharmaceuticals

Baert¹,

Boonen²,

Burvenich³

et al. 2010

J Pharm Pharm Sci

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-PURPOSE.In vitro skin/membrane permeation profiling of topical pharmaceuticals is an important overall quality attribute in the evaluation of product consistency and it is also used for IVIVR (in vitro -in vivo relationship) purposes in product development and change control. Franz diffusion cell (FDC) experiments are emerging as a generally accepted methodology in this field, where the choice of operational conditions requires a data-supported justification towards the discriminating power of the test. A response function is therefore proposed to objectively quantify the discriminating power. METHODS. We evaluated the usefulness of the proposed response function by studying one of the operational conditions, i.e. the influence of receptor medium composition, on the FDC in vitro penetration behaviour of the model compound testosterone formulated in four different topical preparations, using both artificial membranes and dermatomed human skin. A second application is a FDC test system for spilanthol. RESULTS. From the obtained cumulative amount of the active (testosterone or spilanthol) in the receptor fluid versus time curves, the permeability coefficient Kp of testosterone from each formulation was calculated. The evaluation of the discriminating power of the different media was performed using our new objective response function based upon an equal spread criterion of normalised Kp values. CONCLUSION. The proposed new criterion was found to be useful for the rational design of an in vitro diffusion test for transdermal pharmaceuticals. We demonstrated significant differences in discriminating power between the different media used: (a) for testosterone-containing formulations, it was shown that HPBCD-containing media are more discriminative compared to ethanol-or BSA-containing media; (b) for spilanthol-containing formulations, PBS containing formulations also gave better discriminating results than ethanol-based receptor media. __________________________________________________________________________________________

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Section: Spilanthol Applicationmentioning

confidence: 99%

A New Discriminative Criterion for the Development of Franz Diffusion Tests for Transdermal Pharmaceuticals

Baert¹,

Boonen²,

Burvenich³

et al. 2010

J Pharm Pharm Sci

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A novel family 9 β-1,3(4)-glucanase from thermoacidophilic Alicyclobacillus sp. A4 with potential applications in the brewing industry

Bai

Wang

Zhang

et al. 2010

Appl Microbiol Biotechnol

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An endo-beta-1,3(4)-glucanase gene, Agl9A, was cloned from Alicyclobacillus sp. A4 and expressed in Pichia pastoris. Its deduced amino acid sequence shared the highest identity (48%) with an endo-beta-1,4-glucansae from Alicyclobacillus acidocaldarius that belongs to family 9 of the glycoside hydrolases. The purified recombinant Agl9A exhibited relatively wide substrate specificity, including lichenan (109%), barley beta-glucan (100%), CMC-Na (15.02%), and laminarin (6.19%). The optimal conditions for Agl9A activity were pH 5.8 and 55 degrees C. The enzyme was stable over a broad pH range (>60% activity retained after 1-h incubation at pH 3.8-11.2) and at 60 degrees C (>70% activity retained after 1-h incubation). Agl9A was highly resistant to various neutral proteases (e.g., trypsin, alpha-chymotrypsin, and collagenase) and Neutrase 0.8L (Novozymes), a protease widely added to the mash. Under simulated mashing conditions, addition of Agl9A (20 U/ml) or a commercial xylanase (200 U/ml) reduced the filtration rate (26.71% and 20.21%, respectively) and viscosity (6.12% and 4.78%, respectively); furthermore, combined use of Agl9A (10 U/ml) and the xylanase (100 U/ml) even more effectively reduced the filtration rate (31.73%) and viscosity (8.79%). These characteristics indicate that Agl9A is a good candidate to improve glucan degradation in the malting and brewing industry.

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Use of biorelevant dissolution media in dissolution tests as a predictive method of oral bioavailability

Rocha¹,

Prado

2022

Braz. J. Pharm. Sci.

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Comparison of the Wetting Properties of Three Commonly Used Simulated Intestinal Fluids Used as Dissolution Media in the Characterization of Drugs

Cited by 3 publications

References 17 publications

A New Discriminative Criterion for the Development of Franz Diffusion Tests for Transdermal Pharmaceuticals

A New Discriminative Criterion for the Development of Franz Diffusion Tests for Transdermal Pharmaceuticals

A novel family 9 β-1,3(4)-glucanase from thermoacidophilic Alicyclobacillus sp. A4 with potential applications in the brewing industry

Use of biorelevant dissolution media in dissolution tests as a predictive method of oral bioavailability

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