Development and in Vitro Characterization of the Ciprofloxacin Hydrochloride Orodispersible Tablets for Treating Oral Plaque
摘要
Ciprofloxacin HCl orodispersible tablets (ODT) were prepared by direct compression of a mixture of superdisintegrants, fillers, and flow enhancers after proper pre-compression analysis. Post-compression analysis was conducted for content uniformity and disintegration time-based screening of the formulation (disintegration time < 30 s). In vitro (IP type I) and ex-situ (buccal mucosa) analyses were performed in simulated mucosal (pH 7.4) and salivary (pH 6.4) phosphate buffers. Statistical analysis included two-way ANOVA, Pearson’s correlation coefficient (KPC), Student’s t-test, and Bootstrap f2. Pre-compression analysis indicated that flow properties were highly affected by superdisintegrant polymers, in the order of crosspovidone > sodium starch glycolate > croscarmellose sodium, along with talc and magnesium stearate. A similar trend was observed for disintegration time, with formulation F4 showing the shortest disintegration time, followed by F3. In vitro studies revealed that the formulation follows a Makoid-Banakar drug release model, with an initial burst release of 15% in the first 5 min at pH levels of 6.4 and 7.4. In contrast, the Peppas-Sahlin kinetic model fits the release profile in water. Ex-situ permeation studies revealed that F4 exhibited higher permeability and flux than F3 at both pH levels of 6.4 and 7.4, with an approximately 1.3-fold increase. This improvement is likely due to the higher presence of wetting-based superdisintegrants in F4.
Graphical AbstractIn vitro analysis of orodispersible tablets of Ciprofloxacin HCl