Soft, chewable gelatin-based pharmaceutical oral formulations: a technical approach
Morten J Dille1, Magnus N Hattrem2, Kurt I Draget1
1a Department of Biotechnology , Norwegian University of Science and Technology (NTNU) , Trondheim , Norway.
Pharmaceutical Development and Technology
|May 24, 2017
Summary
This study developed a novel gelatin-based soft chewable tablet for easier oral drug delivery. These novel drug delivery systems offer good stability and taste masking for active pharmaceutical ingredients (APIs).
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Drug Delivery
Background:
- Oral drug delivery via hard tablets and capsules poses challenges for individuals with dysphagia.
- A need exists for alternative, patient-friendly dosage forms.
Purpose of the Study:
- To formulate and characterize a novel, self-preserved, soft chewable tablet using a gelatin matrix.
- To evaluate the stability, rheological properties, and drug release of the soft chewable formulation.
Main Methods:
- Gelatin (8.8-10%) in water formed the soft tablet matrix.
- Three active pharmaceutical ingredients (APIs) were incorporated: Ibuprofen, Acetaminophen, and Meloxicam.
- Microbial stability was achieved using sorbitol and xylitol; rheological properties were assessed via oscillation measurements.
Main Results:
- Soft-chew formulations demonstrated good stability for all tested APIs for up to 24 months.
- The ibuprofen formulation showed dissolution comparable to standard oral tablets and good microbial stability.
- Rheological properties confirmed the gelatin gel nature of the formulation.
Conclusions:
- Easy-to-swallow, taste-masked soft chewable tablets with extended shelf life are feasible for various APIs.
- This novel drug delivery format addresses limitations of conventional oral dosage forms.
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