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

Pharmaceutical Development and Technology
Morten J DilleKurt I Draget

Abstract

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. 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. 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 t...Continue Reading

References

Aug 16, 2002·Pharmaceutical Research·Russell S J Keast, Paul A S Breslin
Feb 1, 1961·Journal of Pharmaceutical Sciences·K T KOSHY, J L LACH
Aug 20, 2005·Drug Development and Industrial Pharmacy·Lance R ShawBarbara R Conway
Nov 10, 2013·Nucleic Acids Research·Vivian LawDavid S Wishart
Nov 26, 2013·Clinics in Geriatric Medicine·Abraham KhanMorris Traube
Apr 27, 2017·Clinical Pharmacology in Drug Development·Magnus N HattremKurt I Draget

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