<p>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 &lt; 30&#xa0;s). In vitro (IP type I) and <i>ex-situ</i> (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 &gt; sodium starch glycolate &gt; 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&#xa0;min at pH levels of 6.4 and 7.4. In contrast, the Peppas-Sahlin kinetic model fits the release profile in water. <i>Ex-situ</i> 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.</p> Graphical Abstract <p><i>In vitro </i>analysis of orodispersible tablets of Ciprofloxacin HCl</p> <p></p>

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Development and in Vitro Characterization of the Ciprofloxacin Hydrochloride Orodispersible Tablets for Treating Oral Plaque

  • Ishu Garg,
  • Aditi Sayana,
  • Urmi Chaurasia,
  • Ashish Uniyal,
  • Shivani Rawat,
  • Madhu Verma,
  • Iti Chauhan

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 Abstract

In vitro analysis of orodispersible tablets of Ciprofloxacin HCl