Interchangeability Issues with Glaucoma Medicines Using Latanoprost as an Example

The possible interchangeability of eye drops was analyzed using glaucoma medicines containing latanoprost as examples. It was shown that the reference and generic drugs could be identical with respect to composition of active ingredients when manufactured from the same pharmaceutical substance but c...

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Bibliographic Details
Published in:Pharmaceutical chemistry journal 2018-02, Vol.51 (11), p.1021-1024
Main Authors: Bunyatyan, N. D., Filippova, O. V., Romanov, B. K., Prokof’ev, A. B.
Format: Article
Language:English
Subjects:
Analysis
Drug therapy
Drugs
Generic drugs
Glaucoma
Health aspects
Medicine
Ophthalmic drugs
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
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Summary:The possible interchangeability of eye drops was analyzed using glaucoma medicines containing latanoprost as examples. It was shown that the reference and generic drugs could be identical with respect to composition of active ingredients when manufactured from the same pharmaceutical substance but could differ in the excipient composition, in particular, have a different buffer and osmolality that could produce differences in their clinical effects. An analysis of the literature showed that the therapeutic efficacy and safety could vary for pharmaceutically equivalent drugs. The lack of therapeutic equivalence on the background of pharmaceutical equivalence could be caused by the use of different packaging and different dosing systems. Therefore, results from clinical trials must be compared to confirm the interchangeability of eye drops.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-018-1732-6