Objective To prepare vitamin B2 sustained-release tablets and investigate their in vitro release rate.
Methods The single-factor experiments were conducted to investigate the effects of hydroxypropyl methylcellulose (HPMC) specifications, HPMC amount, filler ratio, tablet shape, tablet weight, and tablet hardness on drug release behavior. Subsequently, an orthogonal experimental design was applied to systematically optimize the three key factors: HPMC amount, filler proportion, and tablet hardness.
Results The optimal prescription process was determined as follows: HPMC K4M with a content of 12% was used; the ratio of microcrystalline cellulose to lactose in the filler was 1 ∶ 1; the tablet design was elliptical, with a weight of 500 mg and a hardness controlled between 190-240 N. Under these conditions, the in vitro release curve of vitamin B2 sustained-release tablets demonstrated a sustained-release profile, and the drug was released smoothly within 12 hours.
Conclusion The vitamin B2 sustained-release tablets obtained through optimization have ideal in vitro sustained-release performance, good process reproducibility, and stable quality, providing experimental basis and reference for further development of sustained-release formulations and related new technologies.
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