Reverse engineering and formulation by QBD of olopatadine hydrochloride ophthalmic solution

Reverse engineering of innovator product’s formulation is a cost-effective strategy for accelerating generic product development. The total market share for olopatadine hydrochloride (OLH) ophthalmic solution used as an antihistamine in US is nearly $230 million dollars. By using ‘Differential solub...

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Bibliographic Details
Published in:Journal of pharmaceutical investigation 2018, 48(3), , pp.279-293
Main Authors: Ahmed, Zahid Zaheer, Khan, Furquan Nazimuddin, Shaikh, Darakhshan Afreen
Format: Article
Language:English
Subjects:
Biomedical and Life Sciences
Biomedicine
Original Article
약학
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Summary:Reverse engineering of innovator product’s formulation is a cost-effective strategy for accelerating generic product development. The total market share for olopatadine hydrochloride (OLH) ophthalmic solution used as an antihistamine in US is nearly $230 million dollars. By using ‘Differential solubility technique’ and 3 2 factorial designs for separation of components, nine different batches were prepared. The separated quantities of OLH and excipients i.e. benzalkonium chloride (BKC), sodium chloride (NaCl) and sodium phosphate dibasic (Na 2 HPO 4 ) were 0.111, 0.01, 0.65 and 0.5 g respectively. Statistical analysis by ANOVA resulted significant model having P values
ISSN:2093-5552
2093-6214
DOI:10.1007/s40005-017-0312-1