Formulation and process optimization of naproxen nanosuspensions stabilized by hydroxy propyl methyl cellulose

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Poorly water-soluble drugs like naproxen (NPX) exhibit limited bioavailability.
• Nanosuspension technology offers a promising approach to enhance drug solubility and dissolution.
• Controlling particle size and drug content is crucial for effective nanosuspension formulation.

Purpose of the Study:

• To develop and optimize naproxen (NPX) nanosuspensions using a precipitation-ultrasonication technique.
• To investigate the impact of HPMC concentration and ultrasonication time on nanosuspension characteristics.
• To evaluate the drug release profile and characterize the optimized nanosuspensions.

Main Methods:

• Precipitation-ultrasonication method for nanosuspension preparation.
• 3(2) factorial design to study the effects of HPMC concentration (X1) and ultrasonication time (X2).
• Characterization using SEM, DSC, XRD, FT-IR, and dissolution testing.

Main Results:

• Optimized nanosuspensions achieved a mean particle size of 530.55 nm with spherical morphology.
• DSC and XRD indicated minor crystalline changes, while FT-IR confirmed no significant NPX-HPMC interactions.
• Optimized formulation (1.36% HPMC, 13.9 min ultrasonication) yielded desired particle size (727.97 nm), drug content (95.59%), and rapid drug release (8.67 min).
• Nanosuspensions demonstrated markedly higher dissolution rates than pure NPX.

Conclusions:

• Precipitation-ultrasonication is an effective method for preparing naproxen nanosuspensions.
• HPMC concentration and ultrasonication time significantly influence nanosuspension properties.
• The optimized nanosuspensions show enhanced dissolution, suggesting improved bioavailability potential for naproxen.