Improved properties of glass vials for primary packaging with atomic layer deposition.

• ALD is a versatile method for creating functional barriers for primary packaging materials. • ALD metal oxide coatings prevented formation of extractables and leachables as analyzed by hydrolytic resistance, water conductivity and ICP-OES in standard test conditions. • Functionality, such as transparent protection from UV–Vis light or hydrophilicity/hydrophobicity, could be tailored by ALD films. Novel pharmaceuticals and drug delivery devices may require better performance from the packaging material e.g., in terms of extractables and leachables, and unwanted interactions. To address this, we applied atomic layer deposition (ALD) to build nanometer-range SiO 2 , ZrO 2 and Al 2 O 3 -TiO 2 films on primary packaging glass. Controlled modification of the surface also enabled creation of functionality without affecting visual appearance of the material. ALD-coated Type I borosilicate vials were compared to uncoated ones, and tailored functionality was presented by appropriate measurements. The tested ALD coatings formed a barrier on glass against extractables and leachables, from the vial and the coating alike. A good ALD coating prevents any leakage into the stored drug product. Hydrolytic resistance results improved by 85–92 %, and these results correlated well with straightforward water conductivity measurements. Opposite to uncoated borosilicate glass vials, no extracted elements could be detected from the extracts of the coated vials with stable ALD films. Improved surface integrity was observed with electron microscopy as well. ALD films increased hydrophilicity of the surface and tuning the ALD film thickness and composition allowed precise blocking of UV light wavelengths, without affecting transparency. As a conclusion, ALD is a versatile method to create barrier and functional films on primary packaging materials. [ABSTRACT FROM AUTHOR]