Polymeric coatings for a multiple-unit pulsatile delivery system: preliminary study on free and applied films

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems

Background:

• Pulsatile drug delivery systems (PDDS) require precise control over drug release timing.
• Adapting existing swellable/erodible PDDS to multiple-unit configurations necessitates modified coating strategies.

Purpose of the Study:

• To develop insoluble films for coating hydroxypropyl methylcellulose (HPMC)-based pulsatile systems.
• To evaluate the impact of superdisintegrants on film properties for enhanced water penetration control and delayed release onset.

Main Methods:

• Preparation of Eudragit(®)NE free films incorporating varying concentrations (10-20%) of superdisintegrants (Explotab(®)V17, Ac-Di-Sol(®), Kollidon(®)CL, Kollidon(®)CL-M) via spraying.
• Assessment of film hydration, water permeability, and tensile properties.
• Preliminary drug release studies using two-layer devices.

Main Results:

• Superdisintegrant addition generally enhanced film hydration and permeability, often concentration-dependently.
• Explotab(®)V17 significantly increased film permeability while minimally affecting tensile properties, especially in the wet state.
• The Eudragit(®)NE film with 20% Explotab(®)V17 showed promise for delaying release onset in preliminary device studies.

Conclusions:

• Insoluble Eudragit(®)NE films containing superdisintegrants are viable for modifying PDDS.
• Explotab(®)V17 is a suitable superdisintegrant for optimizing film permeability in these systems.
• This approach allows for effective delay of drug release with reduced coating thickness.