Journal of Food and Pharmaceutical Sciences
Article In Press 2026

Formulation of Theophylline Sustained-Release Tablets with a Combination of Eudragit RS 100 and Lactose

Trisnaningtyas, Meysiska (Unknown)
Ikasari, Endang Diyah (Unknown)
Intan Martha Cahyani (Unknown)



Article Info

Publish Date
22 Jan 2026

Abstract

Sustained-release (SR) delivery of Theophylline is pharmaceutically essential due to its narrow therapeutic index and the need to maintain controlled plasma exposure. This study aims to investigate the release kinetics and matrix-modifying roles of Eudragit RS 100 and lactose in three SR tablet formulations of Theophylline. Tablets were produced with the wet granulation method and evaluated for physicochemical properties, dissolution behavior according to USP specifications, and kinetic model fitting. The physicochemical evaluation revealed clear differences among formulations. F-1 exhibited the highest hardness (10.48 ± 0.10 kg/cm²) but excessive friability (2.40 ± 0.01%), whereas F-2 and F-3 showed lower hardness values (8.25 ± 0.03 and 8.03 ± 0.02 kg/cm²) with acceptable friability (0.32 ± 0.03% and 0.34 ± 0.03%). Granule flow properties improved progressively from F-1 to F-3, as indicated by reduced Carr’s Index (16.17 ± 0.16 to 11.58 ± 0.32%) and Hausner Ratio (1.193 to 1.131), accompanied by increased flow rates (12.12 ± 0.03 to 14.48 ± 0.53 g/s) (p < 0.05). These physicochemical differences were reflected in dissolution behavior and drug-release kinetics, confirming the matrix-modifying effects of Eudragit RS 100 and lactose. Kinetic modeling demonstrated formulation-dependent release mechanisms: F-1 showed the highest correlation with the zero-order model (R² = 0.9858), suggesting a near constant drug-release rate, whereas F-2 exhibited the best fit to a second-order model (R² = 0.9635), indicating concentration-dependent release. In contrast, F-3 was optimally described by the Korsmeyer–Peppas model (R² = 0.9545), consistent with anomalous transport governed by combined diffusion and polymer relaxation.

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Journal Info

Abbrev

JFPS

Publisher

Subject

Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Immunology & microbiology Materials Science & Nanotechnology Medicine & Pharmacology Neuroscience

Description

Journal of Food and Pharmaceutical Sciences offers scientists, researchers, and other professionals to share knowledge of scientific advancements. The journal will publish original research articles, review articles, short communication, and letter to editor. The area of focus should cover all ...