Leakage and discoloration of Eye drops are very frequent and market complaint in USA market. In this Article I will try to explain these issues in three different steps like: Eye drop bottle and Cap design problems, Polymer compatibility problems with product and Leachable issues from Bottle Label.

Leakage and discolouration of Eye drops are very frequent and market complaint in USA market. In this Article I will try to explain these issues in three different steps like: Eye drop bottle and Cap design problems, Polymer compatibility problems with product and Leachable issues from Bottle Label. 

Structure of the CAP: 

• Position of the SPIKE should be at the center of the Cap that it exactly places on top of the Nozzle. Else first-time spike will pierce the nozzle but from next time on wards it will place outside the tip of the nozzle and product leakage observe. 
• Height of the SPIKE is most important to avoid product Leakage. 
• Rigidity of the SPIKE is most important. 

Discolouration of Product observed 

• After analyzing of the bottle polymer this has been observed quantity of the pigments are more compare to the standard. 
• Excess pigments slowly leach with the product. 
• After analyzing the polymer this has also been observed quantity of Additives are more and which was leached and mix with product and discoloration observed. 
• Polymer Leachables are Polybutylene terephthalate (PBT) is a widely used polyester plastic in medical device and MDI valve components. 
• PBT oligomers and other residuals or degradants can be similarly leached from the valve components fabricated from this material. 

Impact of Leachables in Drugs 

• Increased Toxicity 
• Interfere Assay 
• “Ph” change. 

Bottle Label 

Multiple inks, coating and adhesive are using during label printing. 

• Printed Label Leachables are Phtoinitiators 1-benzoylcyclohexanol and 2- hydroxyl-2-methylprophenone from ink used on labels of HDPE and glass bottles were found to migrate into a solid product. 
• Adhesive Leachabels are Particulates Protein and Peptide Aggregation 

UV Curable Printing INK

For an extractables from a device component the AET (μg/g) can be determined

using Equation 1: Equation 1

AET = SCT.Dt

Dd m

Dd- Doses per day

Dt- Total Labelled doses

m - mass of component

The AET (μg/device) for a drug delivery device (e.g. an MDI) can be determined

from Equation 2:

AET = SCT. Dt

Dd

Dd- Doses per day

Dt- Total Labelled doses

TDS-GC/MS of polymeric material Photolysis of triaryl sulfonium salts

GC-MS Chromatogram of a Heptane Extract of a Polystyrene Component