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  • A novel approach for predicting the dissolution profiles of pharmaceutical tablets.

A novel approach for predicting the dissolution profiles of pharmaceutical tablets.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V (2015-07-15)
Raphael Paus, Elena Hart, Yuanhui Ji
ABSTRACT

In this paper, the intrinsic dissolution profiles of naproxen (NAP) at pH values of 1.5 and 3.0 and of trimethoprim (TMP) at pH values of 1.5, 3.0, 5.0, 6.5 and 7.2 were measured. Meanwhile, the dissolution profiles of NAP and TMP from cylindrical tablets were measured at different temperatures (298.15K, 305.15K, 301.15K and 310.15K) and stirring speeds (50rpm, 100rpm and 150rpm) as well as at different pH values (1.5, 3.0, 5.0, 6.5 and 7.2). Additionally the pH-dependent solubilities of both APIs were measured and modeled. The chemical-potential-gradient model combined with the perturbed-chain statistical associating fluid theory (PC-SAFT) was applied to predict the dissolution profiles of the cylindrical tablets of NAP and TMP under different conditions based on the analysis of their intrinsic dissolution profiles as well as on the determination of the surface-area reduction of the API tablets during dissolution. It was shown that the predicted dissolution profiles of the tablets under different conditions were in a good accordance with the experimental findings.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
N-Acetyl-D-penicillamine, for HPLC derivatization, ≥99.0% (T)
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Trimethoprim, ≥98.5%
Sigma-Aldrich
Trimethoprim, ≥99.0% (HPLC)
Sigma-Aldrich
di-Sodium hydrogen phosphate dihydrate, BioUltra, for molecular biology, ≥99.0% (T)
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Hydrochloric acid solution, 1.0 N, BioReagent, suitable for cell culture
Sigma-Aldrich
Hydrochloric acid solution, 1 M
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Hydrochloric acid solution, 0.01 M
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di-Sodium hydrogen phosphate dihydrate, meets analytical specification of Ph. Eur., BP, 98.5-101% (calc. to the dried substance)
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Hydrochloric acid, meets analytical specification of Ph. Eur., BP, NF, fuming, 36.5-38%
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Hydrochloric acid, 37 wt. % in H2O, 99.999% trace metals basis
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Hydrogen chloride solution, 2.0 M in diethyl ether
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Hydrogen chloride solution, 1.0 M in diethyl ether
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Hydrochloric acid, puriss., 24.5-26.0%
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Hydrochloric acid, ACS reagent, 37%
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Hydrochloric acid, ACS reagent, 37%
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Hydrogen chloride solution, 4.0 M in dioxane
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Hydrochloric acid, puriss. p.a., ACS reagent, reag. ISO, reag. Ph. Eur., fuming, ≥37%, APHA: ≤10
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Hydrogen chloride solution, 1.0 M in acetic acid
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di-Sodium hydrogen phosphate dihydrate, puriss. p.a., reag. Ph. Eur., 98.5-101.0% (calc. to the dried substance)
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Hydrochloric acid solution, 32 wt. % in H2O, FCC
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Hydrogen chloride solution, 3 M in cyclopentyl methyl ether (CPME)
Supelco
Hydrochloric acid solution, volumetric, 0.1 M HCl (0.1N), endotoxin free
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Hydrochloric acid, 36.5-38.0%, BioReagent, for molecular biology
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Hydrochloric acid solution, ~6 M in H2O, for amino acid analysis
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Hydrochloric acid, JIS special grade, 35.0-37.0%
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Hydrochloric acid solution, 12 M
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Hydrochloric acid solution, 6 M
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Hydrochloric acid solution, 2 M
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Hydrochloric acid, SAJ first grade, 35.0-37.0%
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Hydrochloric acid solution, 0.05 M