Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-02

AUTHORS

Dorota Haznar-Garbacz, Ewa Kaminska, Daniel Zakowiecki, Marek Lachmann, Kamil Kaminski, Grzegorz Garbacz, Przemysław Dorożyński, Piotr Kulinowski

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. More... »

PAGES

951-960

Identifiers

URI

http://scigraph.springernature.com/pub.10.1208/s12249-017-0912-0

DOI

http://dx.doi.org/10.1208/s12249-017-0912-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1092508844

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29098644


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