Multilayer laminar co-extrudate as a novel controlled release dosage form

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Drug Delivery Systems

Background:

• Oral drug administration remains a primary route for systemic therapy.
• Developing advanced dosage forms is crucial for optimizing therapeutic efficacy and patient compliance.
• Continuous manufacturing processes offer potential for efficient and scalable drug production.

Purpose of the Study:

• To design and evaluate a novel oral dosage form using laminar extrusion.
• To investigate the influence of formulation components and extrusion parameters on dosage form quality.
• To characterize drug release kinetics from multi-layered extrudates.

Main Methods:

• Preparation of various material mixtures including microcrystalline cellulose (MCC), hydroxypropyl methylcellulose (HPMC), and dicalcium phosphate (DCP).
• Manufacturing of mono, bi, and tri-layer extrudates via laminar extrusion.
• Evaluation of extrudate properties: extrudability, drying, water uptake, swelling, and in vitro drug release.

Main Results:

• High-quality extrudates were achieved with higher HPMC molecular weight and fraction, specific extrusion rates, and slow drying.
• Extrudate swelling was significantly influenced by HPMC content and type, and the presence of MCC or DCP.
• Drug release rate was modulated by drug solubility, HPMC fraction, diluent type (DCP vs. MCC), and the number of layers.

Conclusions:

• Laminar extrusion is a viable technology for manufacturing controlled-release oral dosage forms continuously.
• Tailoring the number and type of layers allows for precise control over drug release profiles.
• Formulation optimization, particularly HPMC characteristics and diluent choice, is key to achieving desired drug delivery performance.