DoE-Optimized Minitabs: Fabricating a Promising Modified-Release Sprinkle Formulation

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems

Background:

• Dysphagia significantly impacts quality of life, particularly in geriatric and pediatric populations.
• Sprinkle formulations offer a viable administration route for patients with swallowing difficulties.
• Developing modified-release sprinkle formulations presents significant formulation challenges.

Purpose of the Study:

• To formulate modified-release minitabs of etoricoxib as a sprinkle formulation.
• To address the challenges in creating modified-release sprinkle dosage forms.

Main Methods:

• Minitabs (3.2 mm diameter, ~22 mg weight) were manually manufactured using a metal mold and punch system.
• A 3x2 complete factorial design optimized independent factors: HPMC K4M (X1) and K100M (X2).
• Dependent factors optimized included hardness, friability, and drug release at 2, 4, and 8 hours.

Main Results:

• The optimized formulation demonstrated sustained drug release for up to 8 hours.
• The final dosage form consisted of a hard gelatin capsule containing approximately 22 minitabs.
• This sprinkle formulation is designed for administration over soft foods.

Conclusions:

• The developed formulation serves as a platform for modified-release sprinkle formulations of various drugs.
• Further investigations with different drugs are feasible using this optimized formulation approach.