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

Suman R Borsadiya¹, Dharmik M Mehta²

¹Department of Pharmaceutical Sciences, Faculty of Health Sciences, Marwadi University, Rajkot-Morbi Highway, Rajkot-360003, Gujarat, India.

Recent Advances in Drug Delivery and Formulation

|July 21, 2025

Summary

This summary is machine-generated.

This study developed modified-release minitabs for dysphagia patients, creating a novel sprinkle formulation for easier drug administration. The optimized formulation ensures sustained drug release for up to 8 hours.

Keywords:

DoE.Dysphasia minitabs modified release soft foods sprinkler formulation

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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.