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A comparative study of the effect of spray drying and hot-melt extrusion on the properties of amorphous solid dispersions containing felodipine.
J Pharm Pharmacol. 2014 Feb; 66(2):275-84.JP

Abstract

OBJECTIVES

To compare the properties of solid dispersions of felodipine for oral bioavailability enhancement using two different polymers, polyvinylpyrrolidone (PVP) and hydroxypropyl methylcellulose acetate succinate (HPMCAS), by hot-melt extrusion (HME) and spray drying.

METHODS

Felodipine solid dispersions were prepared by HME and spray drying techniques. PVP and HPMCAS were used as polymer matrices at different drug : polymer ratios (1 : 1, 1 : 2 and 1 : 3). Detailed characterization was performed using differential scanning calorimetry, powder X-ray diffractometry, scanning electron microscopy and in-vitro dissolution testing. Dissolution profiles were evaluated in the presence of sodium dodecyl sulphate. Stability of different solid dispersions was studied under accelerated conditions (40°C/75% RH) over 8 weeks.

KEY FINDINGS

Spray-dried formulations were found to release felodipine faster than melt extruded formulations for both polymer matrices. Solid dispersions containing HMPCAS exhibited higher drug release rates and better wettability than those produced with a PVP matrix. No significant differences in stability were observed except with HPMCAS at a 1 : 1 ratio, where crystallization was detected in spray-dried formulations.

CONCLUSIONS

Solid dispersions of felodipine produced by spray drying exhibited more rapid drug release than corresponding melt extruded formulations, although in some cases improved stability was observed for melt extruded formulations.

Authors+Show Affiliations

Centre for Pharmaceutical Engineering Science, School of Life Sciences, University of Bradford, Bradford, UK.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

24433426

Citation

Mahmah, Osama, et al. "A Comparative Study of the Effect of Spray Drying and Hot-melt Extrusion On the Properties of Amorphous Solid Dispersions Containing Felodipine." The Journal of Pharmacy and Pharmacology, vol. 66, no. 2, 2014, pp. 275-84.
Mahmah O, Tabbakh R, Kelly A, et al. A comparative study of the effect of spray drying and hot-melt extrusion on the properties of amorphous solid dispersions containing felodipine. J Pharm Pharmacol. 2014;66(2):275-84.
Mahmah, O., Tabbakh, R., Kelly, A., & Paradkar, A. (2014). A comparative study of the effect of spray drying and hot-melt extrusion on the properties of amorphous solid dispersions containing felodipine. The Journal of Pharmacy and Pharmacology, 66(2), 275-84. https://doi.org/10.1111/jphp.12099
Mahmah O, et al. A Comparative Study of the Effect of Spray Drying and Hot-melt Extrusion On the Properties of Amorphous Solid Dispersions Containing Felodipine. J Pharm Pharmacol. 2014;66(2):275-84. PubMed PMID: 24433426.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative study of the effect of spray drying and hot-melt extrusion on the properties of amorphous solid dispersions containing felodipine. AU - Mahmah,Osama, AU - Tabbakh,Rami, AU - Kelly,Adrian, AU - Paradkar,Anant, Y1 - 2013/07/10/ PY - 2013/03/20/received PY - 2013/05/24/accepted PY - 2014/1/18/entrez PY - 2014/1/18/pubmed PY - 2014/9/11/medline KW - dissolution rate KW - hot-melt extrusion KW - solid dispersion KW - spray drying KW - stability SP - 275 EP - 84 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 66 IS - 2 N2 - OBJECTIVES: To compare the properties of solid dispersions of felodipine for oral bioavailability enhancement using two different polymers, polyvinylpyrrolidone (PVP) and hydroxypropyl methylcellulose acetate succinate (HPMCAS), by hot-melt extrusion (HME) and spray drying. METHODS: Felodipine solid dispersions were prepared by HME and spray drying techniques. PVP and HPMCAS were used as polymer matrices at different drug : polymer ratios (1 : 1, 1 : 2 and 1 : 3). Detailed characterization was performed using differential scanning calorimetry, powder X-ray diffractometry, scanning electron microscopy and in-vitro dissolution testing. Dissolution profiles were evaluated in the presence of sodium dodecyl sulphate. Stability of different solid dispersions was studied under accelerated conditions (40°C/75% RH) over 8 weeks. KEY FINDINGS: Spray-dried formulations were found to release felodipine faster than melt extruded formulations for both polymer matrices. Solid dispersions containing HMPCAS exhibited higher drug release rates and better wettability than those produced with a PVP matrix. No significant differences in stability were observed except with HPMCAS at a 1 : 1 ratio, where crystallization was detected in spray-dried formulations. CONCLUSIONS: Solid dispersions of felodipine produced by spray drying exhibited more rapid drug release than corresponding melt extruded formulations, although in some cases improved stability was observed for melt extruded formulations. SN - 2042-7158 UR - https://www.unboundmedicine.com/medline/citation/24433426/A_comparative_study_of_the_effect_of_spray_drying_and_hot_melt_extrusion_on_the_properties_of_amorphous_solid_dispersions_containing_felodipine_ L2 - https://doi.org/10.1111/jphp.12099 DB - PRIME DP - Unbound Medicine ER -