Development of technology of sodium cromoglycate eye drops

Asta Marija Inkėnienė, Rimantas Klimas, Kristina Ramanauskienė

Department of Drug Technology and Social Pharmacy, Kaunas University of Medicine, Lithuania

Key words: sodium cromoglycate, eye drops, technology, sterile filtration, polyvinyl, alcohol, hypromellose.

Summary. Ophthalmologic preparation of sodium cromoglycate can be successfully employed both as a preventive means and as a treatment of allergic eye diseases. The objective of this research was to select the composition of sodium cromoglycate eye drops and to develop the technology using which it would be possible to produce aqueous and prolonged-release sodium cromoglycate eye drops.

Materials and methods. Sodium cromoglycate 2% and 4% solution-eye drops; sodium cromoglycate 4% solution – prolonged-release eye drops. In order to evaluate the quality and stability of these eye drops methods of qualitative and quantitative analysis were applied.

Results. On the basis of the research data compositions of 2% and 4% sodium cromoglycate eye drops and prolonged-release sodium cromoglycate 4% eye drops were chosen. Experimental batches were prepared and investigated according to developed experimental schemes of technologies of 2% and 4% sodium cromoglycate eye drops and prolonged-release sodium cromoglycate 4% eye drops.

Technological properties of polymeric substances, i.e. hypromellose and polyvinyl alcohol, and their solutions were evaluated. The obtained results showed that polyvinyl alcohol improved the solubility of sodium cromoglycate in water. For sterile filtration of the viscous solution of prolonged-release sodium cromoglycate eye drops the filtration system of two prefilters and sterilizing membrane filter was developed and optimal temperature of 35–40°C of filtered solution was determined.

Correspondence to A. M. Inkėnienė, Department of Drug Technology and Social Pharmacy, Kaunas University of Medicine, A. Mickevičiaus 9, 44307 Kaunas, Lithuania. E-mail: vtfo@kmu.lt

Received 17 December 2004, accepted 29 May 2005