Minimal Regulatory Hurdles

• The primary constituent of Ceramisphere particles is amorphous silica which is FDA approved for human use as non-injectables in the clinic: Oral, topical, dental, sublingual, rectal, vaginal, transdermal and more recently, as an injectable diagnostic for human trial.
• Flexibility to manufacture with pharmaceutically acceptable excipients.

Low Toxicity

• Silica particles are biocompatible and biodegradable i.e. the particles dissolve in biological fluids at physiological pH.
• Extremely low toxicity even at the intravenous dose of 200mg/Kg.

Controlled Release

• Controlled release can be achieved from hours to months: This has been demonstrated for oral delivery, subcutaneous delivery and topical delivery.

Excellent Protection of the Bioactive During and After Encapsulation

• No denaturation of the bioactive during encapsulation: The process of encapsulation, modification or storage does not change the structural and functional properties of the encapsulated bioactive.
• Physical and chemical protection during application or storage: Due to its inert nature and durability the silica matrix provides exceptional physical and chemical protection to the encapsulated bioactive against the surrounding environmente.g. enzymes, temperature changes and low pH.

Versatility

• Ability to tailor both particle size (10 nm -100 µm) and release rates provide the flexibility crucial for biological applications.
• Encapsulation of a wide range of biomolecules: Small Molecule Drugs (hydrophilic and hydrophobic), Small Peptides (1KDa), Large Proteins (>300 Kda), Oligonucleotides, DNA/RNA.
• Compatible with different routes of administration: Topical, Subcutaneous, Intravenous, Muscular and Mucosal (Oral and Intranasal).