Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS): A rapid test for enteric coating thickness and integrity of controlled release pellet formulations
| Autor: | Seán McSweeney, Stephen Fitzpatrick, Anas Alfarsi, Patricia Sherry, Dara Fitzpatrick, Ken J. Devine, Amy Dillon, Brendan T. Griffin, Stephan Henken, Jacob Krüse |
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| Rok vydání: | 2017 |
| Předmět: |
Materials science
Chemistry Pharmaceutical Pellets Pharmaceutical Science 02 engineering and technology engineering.material 01 natural sciences Coating 0103 physical sciences medicine Dissolution testing Composite material 010306 general physics Dissolution Chromatography High Pressure Liquid Spectrum Analysis Acoustics Broadband acoustic resonance dissolution spectroscopy Hydrogen-Ion Concentration 021001 nanoscience & nanotechnology Enteric coating Controlled release Hypromellose Delayed-Action Preparations BARDS engineering Tablets Enteric-Coated 0210 nano-technology Enteric coated pellets Layer (electronics) Omeprazole medicine.drug |
| Zdroj: | International journal of pharmaceutics. 544(1) |
| ISSN: | 1873-3476 |
| Popis: | There are no rapid dissolution based tests for determining coating thickness, integrity and drug concentration in controlled release pellets either during production or post-production. The manufacture of pellets requires several coating steps depending on the formulation. The sub-coating and enteric coating steps typically take up to six hours each followed by additional drying steps. Post production regulatory dissolution testing also takes up to six hours to determine if the batch can be released for commercial sale. The thickness of the enteric coating is a key factor that determines the release rate of the drug in the gastro-intestinal tract. Also, the amount of drug per unit mass decreases with increasing thickness of the enteric coating. In this study, the coating process is tracked from start to finish on an hourly basis by taking samples of pellets during production and testing those using BARDS (Broadband Acoustic Resonance Dissolution Spectroscopy). BARDS offers a rapid approach to characterising enteric coatings with measurements based on reproducible changes in the compressibility of a solvent due to the evolution of air during dissolution. This is monitored acoustically via associated changes in the frequency of induced acoustic resonances. A steady state acoustic lag time is associated with the disintegration of the enteric coatings in basic solution. This lag time is pH dependent and is indicative of the rate at which the coating layer dissolves. BARDS represents a possible future surrogate test for conventional USP dissolution testing as its data correlates directly with the thickness of the enteric coating, its integrity and also with the drug loading as validated by HPLC. |
| Databáze: | OpenAIRE |
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