Prilling of API/fatty acid suspensions: Screening of additives for drug release modification
| Autor: | G. Van Assche, T. De Beer, Matthieu Boone, B. G. De Geest, Valérie Vanhoorne, E. De Coninck, Chris Vervaet |
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| Přispěvatelé: | Materials and Chemistry, Physical Chemistry and Polymer Science |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Prill
Drug Compounding Drug Storage Pharmaceutical Science Poloxamer 02 engineering and technology 030226 pharmacology & pharmacy Excipients Poloxamers 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Drug Stability Pulmonary surfactant Controlled release Dissolution Acetaminophen chemistry.chemical_classification Active ingredient Multiparticulate dosage forms Chromatography Prilling Fatty Acids Fatty acid 021001 nanoscience & nanotechnology Drug Liberation Kinetics Paracetamol Solubility chemistry Delayed-Action Preparations Behenic acid 0210 nano-technology |
| Popis: | Current study screened additives which could modify the drug release from prills made of an active pharmaceutical ingredient/fatty acid (API/FA) suspension, without negatively influencing the processability and/or stability of the formulation. Therefore, 11 additives (i.e. emulsifiers, pore-formers and FA-based lubricants) were added in a 20% concentration to a paracetamol/behenic acid formulation. Two additives, Kolliphor® P338 and P407 provided complete drug release in less than 1 h, as their thermoreversible gel formation resulted in a disintegration of the prills. Lower Kolliphor® P338 or P407 concentrations (2.5–10%) resulted in a complete but slower drug release in 24 h as the prills no longer disintegrated and the release mechanism was dominated by pore-formation. Prills with a robust drug release profile (i.e. independent of pH and surfactant concentration of the dissolution medium) were obtained after the addition of ≥5% Kolliphor® P338 or P407 to the FA-based formulation. Based on a 6-month stability study, it was concluded that Kolliphor® P407 was a suitable additive to modify the drug release profile of API/FA suspension-based prills when formulations were stored below 25 °C at low relative humidity. |
| Databáze: | OpenAIRE |
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