Development of controlled release osmotic pump tablet of glipizide solid dispersion

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Materials Science

Background:

• Glipizide (GZ) is a poorly water-soluble drug requiring enhanced delivery systems.
• Osmotic pump tablets offer controlled drug release but require optimization for poorly soluble drugs.
• Solid dispersion (SD) technology can improve the solubility and release of hydrophobic drugs like glipizide.

Purpose of the Study:

• To develop controlled release osmotic pump tablets (COPT) utilizing glipizide solid dispersion (SD).
• To optimize the formulation of glipizide SD for enhanced dissolution and controlled release.
• To evaluate the in vitro performance of the developed COPT against a marketed product.

Main Methods:

• Glipizide solid dispersions (SD) were prepared using Poloxamer 188 via hot melt method and optimized.
• Elementary osmotic pump (EOP) tablets were designed without a delivery orifice, using osmogen in the coating.
• A 3(2) factorial design investigated the effects of osmogen (potassium chloride) and hydrophilic polymer (polyethylene oxide WSR 303) on drug release.

Main Results:

• Optimized glipizide solid dispersions exhibited improved solubility and drug content.
• Pharmacotechnical evaluation of core and coated tablets met acceptable standards.
• In vitro drug release demonstrated a zero-order pattern, directly influenced by hydrophilic polymer and inversely by osmogen, confirming osmotic release.

Conclusions:

• Novel oral controlled release glipizide tablets were successfully developed using an osmotic system with glipizide solid dispersion.
• The developed COPT formulation provides a viable alternative for glipizide delivery, achieving zero-order release kinetics.
• This approach enhances the therapeutic potential of glipizide through improved oral bioavailability and sustained release.