Collado CAK; Morales LIG; Gómez CM; Cazanave GD; Bellma MA; Achón TO

Language: Spanish
References: 7
Page: 181-189
PDF size: 144.34 Kb.

ABSTRACT

Technological development of a eye drops 0,1 % dexamethasone formula is presented on which a pre-stability study was conducted using different technological variants including that with the greater physical-chemical stability. From the above mentioned variant three pilot batches and their stability was studied over 24 months under accelerated storage conditions and by shelf life under environmental conditions. The results obtained at the end of the study showed the advantages of container protection from the light to achieve stability of the eye- drops dexamethasone from the point of view physical, chemical and microbiologic, bottling in low density polyethylene opaque plastic flask with a high density polypropylene top. Technological feasibility of this formula at industrial scale was showed obtaining an eye drops with good technological properties fulfilling with all the specifications required for the product at international level.

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