Oseltamivir Phosphate (OP) is an ethyl ester prodrug prescribed for the treatment of influenza virus infection. Current marketed formulations of OP supplemented with an adverse effect observed during postmarketing surveillance. These prerequisites are sufficed by developing a sustained release Dry Powder for Inhalation (DPI).
Objective of the present study was to develop OP-DPI by an innovative formulation approach comprising of Immediate (IR) and Sustained (SR) Release portions.
DPI formulation comprised of an IR and SR portions were prepared by spray drying technique using Hydroxy Propyl Methyl Cellulose (HPMC) as the rate-controlling polymer for SR portion. The spray-dried product further characterized for various pharmaco-technical, in-vitro and in-vivo parameters.
OP-DPI showed burst release of 49% within 15 min and further sustaining the drug release up to 9 hrs. The in-vitro aerodynamic performance of OP-DPI showed maximum deposition at stage 3 and Fine Particle Dose (FPD) of 1.08 mg indicating deposition in the upper respiratory tract. Solid state characterization by DSC and XRD indicated the partial amorphization OP due to spray drying. In-vivo toxicological examination revealed no sign of inflammation, indicating the safety of the developed formulation. Accelerated stability study as per ICH guidelines displayed no significant change in the solid-state characterization and drug related performance of OP-DPI.
Prepared novel and scalable OP-DPI may have potential to overcome the problems associated with existing marketed dosage forms of OP. Further, localized drug delivery of the antiviral drug through pulmonary route might be clinically benefited in controlling the viral proliferation.
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