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Physical properties and dissolution behaviour of nifedipine/mannitol solid dispersions prepared by hot melt method.
Int J Pharm. 2005 Mar 03; 291(1-2):51-8.IJ

Abstract

Solid dispersions of nifedipine (NIF) with mannitol in preparations containing 10 and 50% (w/w) of drug were manufactured by the hot melt method. Physical properties and the dissolution behaviour of binary systems as physical mixtures and solid dispersions were investigated. In all samples, the crystal structure of NIF was confirmed using differential scanning calorimetry (DSC) and scanning electron microscopy (SEM). Fourier transform infrared spectroscopy (FTIR) revealed, there was no interaction between drug and carrier, however, FTIR spectra indicated formation of thermodynamically less stable polymorph of mannitol. The dissolution rate of NIF from solid dispersions was markedly enhanced, the effect being stronger at higher drug loading (50%, w/w, NIF). The dissolution rate enhancement was attributed to improved wetting of NIF crystals due to mannitol particles, attached on the surface, as inspected by means of SEM. Thermal stability of NIF, mannitol and two other potential carbohydrate carriers (lactose and saccharose) during the hot melt procedure was investigated using 1H NMR. NIF was found to be thermically stable under conditions applied. As expected, among carriers only mannitol demonstrated suitable resistance to high temperature used in experiments.

Authors+Show Affiliations

Faculty of Pharmacy, University of Ljubljana, Askerceva 7m, 1000 Ljubljana, Slovenia.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

15707731

Citation

Zajc, Natalija, et al. "Physical Properties and Dissolution Behaviour of Nifedipine/mannitol Solid Dispersions Prepared By Hot Melt Method." International Journal of Pharmaceutics, vol. 291, no. 1-2, 2005, pp. 51-8.
Zajc N, Obreza A, Bele M, et al. Physical properties and dissolution behaviour of nifedipine/mannitol solid dispersions prepared by hot melt method. Int J Pharm. 2005;291(1-2):51-8.
Zajc, N., Obreza, A., Bele, M., & Srcic, S. (2005). Physical properties and dissolution behaviour of nifedipine/mannitol solid dispersions prepared by hot melt method. International Journal of Pharmaceutics, 291(1-2), 51-8.
Zajc N, et al. Physical Properties and Dissolution Behaviour of Nifedipine/mannitol Solid Dispersions Prepared By Hot Melt Method. Int J Pharm. 2005 Mar 3;291(1-2):51-8. PubMed PMID: 15707731.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Physical properties and dissolution behaviour of nifedipine/mannitol solid dispersions prepared by hot melt method. AU - Zajc,Natalija, AU - Obreza,Ales, AU - Bele,Marjan, AU - Srcic,Stane, Y1 - 2004/12/29/ PY - 2004/01/28/received PY - 2004/05/24/revised PY - 2004/07/26/accepted PY - 2005/2/15/pubmed PY - 2006/4/25/medline PY - 2005/2/15/entrez SP - 51 EP - 8 JF - International journal of pharmaceutics JO - Int J Pharm VL - 291 IS - 1-2 N2 - Solid dispersions of nifedipine (NIF) with mannitol in preparations containing 10 and 50% (w/w) of drug were manufactured by the hot melt method. Physical properties and the dissolution behaviour of binary systems as physical mixtures and solid dispersions were investigated. In all samples, the crystal structure of NIF was confirmed using differential scanning calorimetry (DSC) and scanning electron microscopy (SEM). Fourier transform infrared spectroscopy (FTIR) revealed, there was no interaction between drug and carrier, however, FTIR spectra indicated formation of thermodynamically less stable polymorph of mannitol. The dissolution rate of NIF from solid dispersions was markedly enhanced, the effect being stronger at higher drug loading (50%, w/w, NIF). The dissolution rate enhancement was attributed to improved wetting of NIF crystals due to mannitol particles, attached on the surface, as inspected by means of SEM. Thermal stability of NIF, mannitol and two other potential carbohydrate carriers (lactose and saccharose) during the hot melt procedure was investigated using 1H NMR. NIF was found to be thermically stable under conditions applied. As expected, among carriers only mannitol demonstrated suitable resistance to high temperature used in experiments. SN - 0378-5173 UR - https://www.unboundmedicine.com/medline/citation/15707731/Physical_properties_and_dissolution_behaviour_of_nifedipine/mannitol_solid_dispersions_prepared_by_hot_melt_method_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(04)00653-2 DB - PRIME DP - Unbound Medicine ER -