Determination of poly(ɛ-caprolactone) solubility parameters: Application to solvent substitution in a microencapsulation process

The evolution of regulation on chemical substances (i.e. REACH regulation) calls for the progressive substitution of toxic chemicals in formulations when suitable alternatives have been identified. In this context, the method of Hansen solubility parameters was applied to identify an alternative sol...

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Bibliographic Details
Published in:International journal of pharmaceutics 2010-01, Vol.383 (1), p.236-243
Main Authors: Bordes, C., Fréville, V., Ruffin, E., Marote, P., Gauvrit, J.Y., Briançon, S., Lantéri, P.
Format: Article
Language:English
Subjects:
Anisole
Biological and medical sciences
Chemical and Process Engineering
Drug Compounding - methods
Drug Compounding - trends
Engineering Sciences
Feasibility Studies
General pharmacology
Hansen solubility parameters
Life Sciences
Medical sciences
Microencapsulation
Pharmaceutical sciences
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Poly(ɛ-caprolactone)
Polyesters - chemical synthesis
Polyesters - metabolism
Solubility
Solvent substitution
Solvents - chemical synthesis
Solvents - metabolism
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Summary:The evolution of regulation on chemical substances (i.e. REACH regulation) calls for the progressive substitution of toxic chemicals in formulations when suitable alternatives have been identified. In this context, the method of Hansen solubility parameters was applied to identify an alternative solvent less toxic than methylene chloride used in a microencapsulation process. During the process based on a multiple emulsion (W/O/W) with solvent evaporation/extraction method, the solvent has to dissolve a polymer, poly(ɛ-caprolactone) (PCL), which forms a polymeric matrix encapsulating or entrapping a therapeutic protein as the solvent is extracted. Therefore the three partial solubility parameters of PCL have been determined by a group contribution method, swelling experiments and turbidimetric titration. The results obtained allowed us to find a solvent, anisole, able to solubilize PCL and to form a multiple emulsion with aqueous solutions. A feasibility test was conducted under standard operating conditions and allowed the production of PCL microspheres.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2009.09.023