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Kollicoat® Smartseal 100P for Developing Theophylline Pellets: Exploring Taste-Masking Potential for Pediatric
Neeraja Komanduri1, Mashan Almutairi2, Rasha M Elkanayati1
1Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, Oxford, MS 38677, USA.
Pharmaceutics
|April 26, 2025
Summary
Hot-melt extrusion (HME) successfully developed taste-masked theophylline pellets using Kollicoat® Smartseal 100P. This novel formulation significantly reduces bitter taste and improves drug release, enhancing patient compliance.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Materials Science
Background:
- Theophylline's bitter taste poses challenges for patient compliance, especially in pediatric and geriatric populations.
- Hot-melt extrusion (HME) is a promising technology for developing taste-masked drug formulations.
- Evaluating pH-dependent polymers is crucial for optimizing taste-masking and drug release profiles.
Purpose of the Study:
- To develop and evaluate taste-masked theophylline pellets using HME technology.
- To compare the efficacy of Kollicoat® Smartseal 100P, Eudragit® EPO, and Kollicoat® MAE 100-55 for taste-masking theophylline.
- To optimize drug loading and plasticizer concentration for improved taste masking and release characteristics.
Main Methods:
- Theophylline pellets were prepared using HME with varying drug loads (10-30%) and plasticizer (PEG 1500) concentrations.
- Characterization included differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), bitter threshold analysis, and in vitro release testing.
- Stability studies were conducted under accelerated conditions (40°C/75% RH) for three months.
Main Results:
- The optimized formulation (20% theophylline, 20% PEG 1500, 60% Kollicoat® Smartseal 100P) showed significantly reduced theophylline release in simulated salivary fluid (1.1% vs. 29.5% for pure drug).
- Taste masking efficacy was confirmed as drug release remained below the bitter threshold.
- Kollicoat® Smartseal 100P and Eudragit® EPO provided complete drug release in gastric fluid, while Kollicoat® MAE 100-55 showed limited release. The Kollicoat® Smartseal 100P formulation remained stable under accelerated conditions.
Conclusions:
- Kollicoat® Smartseal 100P is effectively utilized with HME for robust theophylline taste masking.
- The developed HME pellets offer a promising approach to enhance patient compliance through improved palatability.
- This study highlights a novel application of Kollicoat® Smartseal 100P in taste-masking technologies for oral drug delivery.
Keywords:
Eudragit® EPOKollicoat® Smartseal 100Phot-melt extrusionpediatric drug deliverytaste maskingtheophylline pelletsMore Related Videos
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