Biosynthesized Poly(3-Hydroxybutyrate-co-3-hydroxyvalerate) As Biocompatible Microcapsules with Extended Release for Busulfan and Montelukast

An extended release dosage form based on encapsulating the challenging drug busulfan within microspheres of the biodegradable, biocompatible and biosynthesized poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) polyester was achieved. The used (PHBV) polymer was biosynthesized by the halophilic archaeon Haloferax mediterranei from date waste biomass as feed-stock. PHBV microspheres of 1.2-2.1 mu m diameter were successfully fabricated and loaded with busulfan with an encapsulation efficiency of 29.2 +/- 0.2%. In addition, PHBV microspheres of 1.5-3.5 mu m diameter and loaded with montelukast sodium (MK) drug were also fabricated with an encapsulation efficiency of 16.0 +/- 0.4%. The double-emulsion solvent evaporation method was used to fabricate the drug-loaded microspheres. The drug-loaded microspheres have been characterized by XRD, FTIR and SEM, and confirmed to be successfully fabricated. The drugs in vitro release profiles have shown extended release for up to 3 days in case of busulfan and 8 h in case of montelukast sodium. The in vitro release profiles for busulfan and montelukast suggest that these drug-loaded microcapsules can be efficiently used as new dosage forms to solve the current issues of busulfan administration protocols, and to introduce a new dosage form for montelukast with extended release performance.