METHOD OF CHEMICAL TAGGING OF TABLETS USING THE COATING

Abstract

A method of chemically tagging tablet coatings and readout of the tag includes addition of the specific mass of the tagging substance to the coating and preparation of coatings with the tagging substance. The method additionally includes extraction of the compounds present in the tablet coating and chromatographic analysis of the compounds present in the coating. Further, the method includes comparison of the absolute, non-unitary concentration values and paraben mass to authenticate the results.

Claims

1. A method of chemical tagging of tablets, the method comprising: providing a tagging substance; preparing a coating for the tablets including the tagging substance; and applying the coating to the tablets, wherein the tagging substance includes a tag defined as reciprocal, absolute, and nonunitary ratio of the tagging substances.

2. The method according to the claim 1, wherein the tagging substance includes parabens.

3. The method according to the claim 1, wherein the method is used for any type of coating.

4. The method according to the claim 1, wherein the tagging substance does not change pharmacokinetic and pharmacodynamic properties of the coating.

5. The method according to the claim 1, wherein an absolute value of a ratio between a normalised concentration and a normalised mass of added tagging substances is no greater than 0.02.

6. A method of chemically tagging tablet coatings and readout of the tag, the method comprising: adding a specific mass of a tagging substance to the coating; preparing coatings with the tagging substance; extracting compounds present in the tablet coating; chromatographic analysis of the compounds present in the coating; and comparing absolute, non-unitary concentration values and paraben mass to authenticate the results.

7. A tablet comprising: a tablet coating having a specific mass of a tagging substance, wherein the tagging substance includes a tag defined as reciprocal, absolute, and nonunitary ratio of the tagging substances.

Description

EXAMPLE 1

[0023] 1. 5 g of the coating “I” was weighed four times using an analytical weight. [0024] 2. The concentration of specific parabens (A-D) was added to each weighed amount according to Tab. 2. [0025] 3. The samples with parabens were thoroughly homogenised [0026] 4. The prepared coating was used to prepare tablets [0027] 5. The coating was scraped from the tablets in the amount of 0.5 g per sample [0028] 6. The scraped coating was extracted by vigorous shaking in 5 mL of acetonitrile for 15 minutes [0029] 7. The sample was centrifuged, filtered through the Teflon syringe filter and transferred to the chromatographic vial [0030] 8. High-performance liquid chromatography was used for the analysis of the paraben concentrations in the sample—operational parameters: C18 column, 50×4.6 mm, 1.8 μm bead, isocratic flow (acetonitrile:water—30:70), 1 mL/min; sample volume: 5 μL, analysis time: 12 minutes. [0031] 9. The result was used to calculate the concentration in the sample based on five-point calibration curves for each tested compound. [0032] 10. The obtained results were normalised according to the formula:

(concentration of the selected compound)/(sum of the concentrations of all compounds determined in the sample) [0033] 11. The concentrations of the added compounds were normalised according to the formula:

(mass of the selected compound)/(mass of all compounds added to the sample) [0034] 12. After normalisation, the results were compared by subtraction of the normalised value of the obtained concentration from the normalised mass value of the added compounds. [0035] 13. If the result lower than the absolute value of 0.02 is obtained, the result is considered correct, and the code identity is confirmed.

EXAMPLE 2

[0036] 1. 1 g of the coating “II” was weighed four times using an analytical weight. [0037] 2. The concentration of specific parabens (E-I) was added to each weighed amount according to Tab. 2. [0038] 3. The samples with parabens were thoroughly homogenised [0039] 4. The prepared coating was used to prepare tablets [0040] 5. The coating was scraped from the tablets in the amount of 0.5 g per sample [0041] 6. The scraped coating was extracted by vigorous shaking in 5 mL of acetonitrile for 15 minutes [0042] 7. The sample was centrifuged, filtered through the Teflon syringe filter and transferred to the chromatographic vial [0043] 8. High-performance liquid chromatography was used for the analysis of the paraben concentrations in the sample—operational parameters: C18 column, 50×4.6 mm, 1.8 μm bead, isocratic flow (acetonitrile:water—30:70), 1 mL/min; sample volume: 5 μL, analysis time: 12 minutes. [0044] 9. The result was used to calculate the concentration in the sample based on five-point calibration curves for each tested compound. [0045] 10. The obtained results were normalised according to the formula:

(concentration of the selected compound)/(sum of the concentrations of all compounds determined in the sample) [0046] 11. The concentrations of the added compounds were normalised according to the formula:

(mass of the selected compound)/(mass of all compounds added to the sample) [0047] 12. After normalisation, the results were compared by subtraction of the normalised value of the obtained concentration from the normalised mass value of the added compounds. [0048] 13. If the result lower than the absolute value of 0.02 is obtained, the result is considered correct, and the code identity is confirmed.

[0049] The tagging method can be used universally, regardless of the coating composition and the coated active substance. Thanks to the easy analytical method, it is possible to verify the authenticity of the tablet in most of the analytical laboratories.