Biomedical Engineering Reference
In-Depth Information
Table 6
Excipient selection guideline
a
Gel/gelable
solution
Component
Solution
Suspension
Emulsion
Ointment
DS
√
√
√
√
√
Buffer
-
√
√
√
√
Tonicity agent
-
√
√
√
√
Surfactant
O
O
-
√
√
Other solubilizing agent
O
-
O
O
-
Suspending agent
-
-
-
-
√
Viscosity agent
O
O
O
O
-
Gelling agent
O
O
O
O
-
Preservative
-
√
√
√
√
Preservative aid
O
O
O
O
-
Antioxidant
O
O
O
O
-
Oil
-
-
√
-
√
Water
√
√
√
√
-
Petrolatum
-
-
-
-
√
pH adjuster (acid/base)
√
√
√
√
-
Target pH
Preferred 5-7.5
-
Target osmolality
Preferred 250-350 mOsm/kg
-
Target viscosity
As required per product profile
√
: required; O: optional
a
Adapted from Lang JC (1995) Ocular drug delivery conventional ocular formulations. Adv Drug Deliv Rev 16: 39-43
ICH Q8 guideline [
30
]. Table
6
provides a guidance on selection
of excipients and target physical characteristics of ophthalmic
formulations.
5 CMC: Development Pharmaceutics
CMC of drug product consist of several key components that are
available in e-CTD format (3.2.P.1-3.2.P.8) and are summarized
below. Each section has more detailed subsections to cover all
pertinent aspects of product:
l
3.2.P.1: Description and Composition of the Drug Product
l
3.2.P.2: Pharmaceutical Development
l
3.2.P.3: Manufacture
