Study 2 Nasal Pump Delivery System

Case Study 2 Nasal Pump Delivery System 

A wide range of over-the-counter and prescription pharmaceutical products use manually actuated pumps. A common example is the nasal spray container. When the design of these pumps allows contaminated products to be used, the patients and the manufacturer have a problem. This was the case, when palmitic, myristic, stearic, and oleic fatty acids (these are all non-formulation ingredients) were found in a nasal spray product. 

The drug formulation contains an active ingredient, a thixotropic adjunct to promote drug retention on mucosal surfaces, water, stabilizers, a buffer, and alcohol. 

Handbook for the Chemical Analysis of Plastic and Polymer Additives 

The original problem had been identified as the clogged pump. However in the course of the investigation, it became apparent that contaminants had entered the drug formulation due to interaction between the dmg and the container material, a potential health threat. Corrective actions were to replace the materials in the container and also to consider container material as possible contamination sources in the design stage. 

The investigation was begun after patient complaints that the pumps became blocked over time. Pumps typically deliver a low pressure, fine droplet-sized mist at a controlled dose rate. Proper control of the dose rate and spray pattern requires precision molding and assembly of the package components and consistent performance of these components when they are in contact with the drug product for extended periods, over a wide temperature range. These components are made of 

Valve Stem Ferrule /Piston pring Cap Spring Support Housing 

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Recently, a comparison study of deposition pattern of aqueous nasal spray pumps and non-portable nebulizers was published. The obtained controversial results showed a relative standard deviation of 35-80%. This demonstrates the variations in nasal anatomy and physiology from individual to individual. Other stud-ies indicate that differences in the spray performance, i.e., spray angle and particle size distribution, of delivery systems do not necessarily result in different in vivo deposition. 

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