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Title: Melts of octaacetyl sucrose as oral-modified release dosage forms for delivery of poorly soluble compound in stable amorphous form
Authors: Haznar-Garbacz, Dorota
Kamińska, Ewa
Żakowiecki, Daniel
Lachmann, Marek
Kamiński, Kamil
Garbacz, Grzegorz
Dorożyński, Przemysław
Kulinowski, Piotr
Keywords: acetylated saccharides; modified release; sustained release; amorphous drugs; biorelevant dissolution stress test; oral osmotic system
Issue Date: 2018
Citation: AAPS PharmSciTech, Vol. 19, Issue 2 (2018), s. 951-960
Abstract: The presented work describes the formulation and characterization of modified release glassy solid dosage forms (GSDFs) containing an amorphous nifedipine, as a model BCS (Biopharmaceutical Classification System) class II drug. The GSDFs were prepared by melting nifedipine together with octaacetyl sucrose. Dissolution profiles, measured under standard and biorelevant conditions, were compared to those obtained from commercially available formulations containing nifedipine such as modified release (MR) tablets and osmotic release oral system (OROS). The results indicate that the dissolution profiles of the GSDFs with nifedipine are neither affected by the pH of the dissolution media, type and concentration of surfactants, nor by simulated mechanical stress of biorelevant intensity. Furthermore, it was found that the dissolution profiles of the novel dosage forms were similar to the profiles obtained from the nifedipine OROS. The formulation of GSDFs is relatively simple, and the dosage forms were found to have favorable dissolution characteristics.
DOI: 10.1208/s12249-017-0912-0
ISSN: 1530-9932
Appears in Collections:Artykuły (WNŚiT)

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