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We are working on an ophthalmic suspension formulation. To study the
dissolution of drug from this formulation, apparatus like the USP4
(which is used for a comparable suspension injection) is probably not
warranted since the volume of the dissolution fluid involved (in-
vivo) is too low. A suitable apparatus for simulation of in-vivo
condition in-vitro would be a test cell . I could think of the Franz
diffusion cell as an alternative. However the membrane to be used
etc. are open issues. Since there is no official method prescribed, I
would like to know what is the industry/scientific community standard
for the evaluation of ophthalmic suspensions. Any experience with
regulatory agencies is also welcome.
Regards,
S. Pramanick
R&D (Formulations)
FDC Mumbai, India
E-Mail : pramanick.aaa.fdcindia.com
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