Soft, chewable gelatin-based pharmaceutical oral formulations: a technical approach. (28th May 2018)

• Record Type: Journal Article
• Authors: Dille, Morten J.; Hattrem, Magnus N.; Draget, Kurt I.
• Is Part Of: Pharmaceutical development and technology. Volume 23:Number 5(2018)
• Page Start: 504
• Page End: 511
• Publication Date: 2018-05-28
• Subjects: Drug formulation -- soft-chew -- gelatin -- ibuprofen -- dysphagia -- taste masking; Drug delivery systems -- Periodicals; Pharmaceutical technology -- Periodicals; Drugs -- Administration -- Research -- Periodicals; Drug Delivery Systems -- Periodicals; Pharmaceutical Preparations -- Periodicals; Technology, Pharmaceutical -- Periodicals; 615
• DOI: 10.1080/10837450.2017.1332642
• Languages: English
• ISSNs: 1083-7450

Abstract

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).