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Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form.
AAPS PharmSciTech. 2018 Feb; 19(2):951-960.AP

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.

Authors+Show Affiliations

Faculty of Pharmacy, Department of Drug Form Technology, Wroclaw Medical University, Borowska 211A, 50-556, Wroclaw, Poland. dorota.haznar-garbacz@umed.wroc.pl.Department of Pharmacognosy and Phytochemistry, Medical University of Silesia in Katowice, School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, ul. Jagiellonska 4, 41-200, Sosnowiec, Poland.Physiolution GmbH, Walther-Rathenau-Str. 49a, 17489, Greifswald, Germany.Physiolution GmbH, Walther-Rathenau-Str. 49a, 17489, Greifswald, Germany.Institute of Physics&SMCEiBI, University of Silesia, ul 75 Pulku Piechoty 1, 41-500, Chorzow, Poland.Physiolution GmbH, Walther-Rathenau-Str. 49a, 17489, Greifswald, Germany.Department of Pharmaceutical Technology and Biopharmaceutics, Pharmaceutical Faculty, Jagiellonian University, ul. Medyczna 9, 30-688, Kraków, Poland.Institute of Technology, Faculty of Mathematics, Physics and Technical Science, Pedagogical University of Cracow, ul. Podchorążych 2, 30-084, Kraków, Poland.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29098644

Citation

Haznar-Garbacz, Dorota, et al. "Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form." AAPS PharmSciTech, vol. 19, no. 2, 2018, pp. 951-960.
Haznar-Garbacz D, Kaminska E, Zakowiecki D, et al. Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form. AAPS PharmSciTech. 2018;19(2):951-960.
Haznar-Garbacz, D., Kaminska, E., Zakowiecki, D., Lachmann, M., Kaminski, K., Garbacz, G., Dorożyński, P., & Kulinowski, P. (2018). Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form. AAPS PharmSciTech, 19(2), 951-960. https://doi.org/10.1208/s12249-017-0912-0
Haznar-Garbacz D, et al. Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form. AAPS PharmSciTech. 2018;19(2):951-960. PubMed PMID: 29098644.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form. AU - Haznar-Garbacz,Dorota, AU - Kaminska,Ewa, AU - Zakowiecki,Daniel, AU - Lachmann,Marek, AU - Kaminski,Kamil, AU - Garbacz,Grzegorz, AU - Dorożyński,Przemysław, AU - Kulinowski,Piotr, Y1 - 2017/11/02/ PY - 2017/03/29/received PY - 2017/10/23/accepted PY - 2017/11/4/pubmed PY - 2018/7/3/medline PY - 2017/11/4/entrez KW - acetylated saccharides KW - amorphous drugs KW - biorelevant dissolution stress test KW - modified release KW - oral osmotic system KW - sustained release SP - 951 EP - 960 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 19 IS - 2 N2 - 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. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/29098644/Melts_of_Octaacetyl_Sucrose_as_Oral_Modified_Release_Dosage_Forms_for_Delivery_of_Poorly_Soluble_Compound_in_Stable_Amorphous_Form_ L2 - https://dx.doi.org/10.1208/s12249-017-0912-0 DB - PRIME DP - Unbound Medicine ER -