Pharmaceutical Product Development

Customization of CD-enabled pharmaceutical formulations, life-cycle management

Incorporating new
APIs into final products
might prove challenging: stability, solubility, bioavailability, etc.
issues may arise. Several
attributes of these substances
can be favorably altered
by cyclodextrins.

Cyclodextrins themselves
can also be utilized as APIs in
certain cases, well supported
by recent findings.

CycloLab offers conducting
interaction studies to select the
most effective cyclodextrin for
your molecule, proof of concept
studies and development of a
new formulation with the
selected cyclodextrin.

The developed formulation is
optimized and preliminary stability
studies are performed. CycloLab
also supports its customers with all
analytical aspects related to the
formulation, reporting to authorities,
IP issues (including life cycle
management) and relevant
documentation.

Once the new formulation is
finalized, CycloLab can assist
you with the manufacturing of
the selected cyclodextrin,
even under cGMP conditions,
conducting in vitro
bioequivalence studies, etc.

The work often result in generating
intellectual property, which, of course,
belongs to the sponsor. Patents of
some recent works on agomelatine,
dapagliflozin and cinacalcet are now
public.

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