ApplicationReport-HPCi.pdfVIP

::: Application Report Viscosity and pH in One Step - Quality Parameters for Nasal Sprays Nasal drug delivery has become a popular route of drug administration also as an alternative to oral or injectable dosage forms. To fulfill the expected performance critical parameters such as viscosity and pH value have to be controlled. Relevant for: pharmaceutical industry Sample type: nasal sprays, eye drops CC by: Woodland Hills Pharmacy 1 Introduction formulation by incorporating viscosity-enhancing agents. On the other hand, increasing the viscosity impacts the Administration of drugs via spray dosage form through the droplet size distribution, resulting in altered deposition in nose is a non-invasive and rapid drug delivery method. As the nasal cavity. Therefore, it is crucial to find and set the the nasal dosage form is cost-effective, easy to use and correct viscosity for the special application. self-administrable, it has a high patient compliance. Traditionally, nasal drug delivery was limited to treating The US FDA Chemistry, Manufacturing and Controls common cold and nasal allergies. Recently, there has been (CMC) guidance on nasal sprays recommends a growing interest in developing nasal drug delivery measurement of pH value, osmolality and viscosity as part systems as an alternative to oral or injectable dosage of the drug product specification. forms, including small molecular weight drugs, peptides, proteins and vaccines. This enables the delivery of the drug directly to the central nervous