Lysozyme Mucoadhesive Tablets Obtained by Freeze-Drying.

Area of Science:

• Pharmaceutical Technology
• Biomaterials Science
• Oral Drug Delivery

Background:

• Lysozyme is a promising agent for treating oral microbial infections.
• Challenges include achieving prolonged release and preventing protein denaturation in oral dosage forms.

Purpose of the Study:

• To develop and characterize lysozyme mucoadhesive tablets using freeze-drying for sustained oral delivery.
• To evaluate the impact of formulation composition on drug release, mucoadhesion, and enzyme activity.

Main Methods:

• Tablets were prepared using alginate (ALG) cross-linked with calcium ions and various grades of hydroxypropyl methylcellulose (HPMC).
• Characterization included swelling, erosion, in vitro mucoadhesion, lysozyme activity assays, drug release studies, and antimicrobial efficacy testing against Staphylococcus aureus.
• Stability was assessed after storage at 5°C for 3 months.

Main Results:

• Formulations with HPMC K100 showed rapid erosion and were discarded.
• All other formulations provided sustained release over 6 hours.
• Lysozyme activity significantly decreased at higher protein concentrations (5% and 10% w/w) but remained stable at 1% w/w.
• The alginate/HPMC E5 (7/3 ratio) formulation demonstrated efficacy against S. aureus and maintained lysozyme activity after 3 months of refrigerated storage.

Conclusions:

• Freeze-dried mucoadhesive tablets are a feasible approach for sustained lysozyme delivery in oral applications.
• Optimizing protein concentration (1% w/w) is crucial for maintaining lysozyme activity and therapeutic efficacy.
• The developed alginate-HPMC E5 formulation shows potential for treating oral infections caused by S. aureus.