Pharma | Lovis 2000 M/ME and pH ME: Viscosity and pH of Nasal Sprays or Eye Drops

Nasal drug administration becomes increasingly important as an alternative to oral or injectable medication. To fulfill the expected performance, critical parameters such as viscosity and pH value have to be controlled. Lovis 2000 M/ME Microviscometer performs tests on low sample volume, can be combined with other measuring devices, and complies with 21 CFR part 11.

Nose sprays are a non-invasive and rapid drug administration method. As the nasal dosage form is cost-effective, easy to use and self-administrable, it has a high patient compliance. Traditionally, nasal drug administration was limited to treating common colds and nasal allergies. Recently, nasal drug administration has become increasingly important as an alternative to oral or injectable medication. For example, small molecular weight drugs, peptides, proteins, and vaccines can be absorbed through the nose. Thus, the drug is transferred directly into the central nervous system, bypassing the blood-brain barrier. The US FDA Chemistry, Manufacturing and Controls (CMC) guidance on nasal sprays recommends measurement of pH value, osmolality and viscosity as part of the drug product specification.

By increasing the residence time of the medication on the nasal mucosane membrane, the efficiency of drug absorption through the nasal mucosa is improved. A common approach is to increase the viscosity formulation by incorporating viscosity-enhancing agents. On the other hand, increasing the viscosity impacts the droplet size distribution, resulting in altered deposition in the nasal cavity. Therefore, it is crucial to find and set the correct viscosity for the specific application.

The local pH value inside the nasal cavity directly influences the rate and extent of drug absorption. It is suggested that the optimum pH value of nasal spray ranges from 4.5 to 6.5.

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