Soft, chewable gelatin-based pharmaceutical oral formulations: a technical approach

Abstract

Objective: Hard tablets and capsules for oral drug delivery cause problems for people experiencing dysphagia. This work describes the formulation and properties of a gelatin based, self-preserved, and soft chewable tablet as an alternative and novel drug delivery format.

Materials and methods: Gelatin (8.8–10% in 24.7–29% water) constituted the matrix of the soft, semi-solid tablets. Three different pharmaceuticals (Ibuprofen 10%, Acetaminophen 15%, and Meloxicam 1.5%) were tested in this formulation. Microbial stability was controlled by lowering the water activity with a mixture of sorbitol and xylitol (45.6–55%). Rheological properties were tested applying small strain oscillation measurements. Taste masking of ibuprofen soft-chew tablets was achieved by keeping the ibuprofen insoluble at pH 4.5 and keeping the processing temperature below the crystalline-to-amorphous transition temperature.

Results: Soft-chew formulations showed good stability for all three pharmaceuticals (up to 24 months), and the ibuprofen containing formulation exhibited comparable dissolution to a standard oral tablet as well as good microbial stability. The rheological properties of the ibuprofen/gelatin formulation had the fingerprint of a true gelatin gel, albeit higher moduli, and melting temperature.

Conclusions: The results suggest that easy-to-swallow and well taste-masked soft chewable tablet formulations with extended shelf life are within reach for several active pharmaceutical ingredients (APIs).

Keywords:

• Drug formulation
• soft-chew
• gelatin
• ibuprofen
• dysphagia
• taste masking

Acknowledgments

The authors would like to thank Dr. Merel Hazewindus for providing support in manuscript preparation, and Kåre A. Kristiansen for performing GC/LC-MS analyses for the stability studies. Vitux Pharma AS provided financial support for this study.

Disclosure statement

Vitux Pharma AS is a fully owned subsidiary of Vitux Group AS. MNH is a full-time employee of Vitux AS, whereas KID holds a part-time engagement in Vitux Pharma AS. MJD declares no competing interests.