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Hello-
=20
My question is if anyone has a standard list of vehicles to use for Oral =
and/or
IV dosing in a preferred order.
I would like to compare to my list- and update where I find necessary.
Thank you
=20
Jaclyn Stevens
Drug Dispensary -UM
Formulation Scientist=
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The following message was posted to: PharmPK
Hi Jaclyn Stevens,
The selection of the formulation for NCE molecule is depend on the
physicochemical properties so there is no standard list of excipients but we
need to have a planed strategy for excipients selection . For oral drug delivery
we need to follow following path way
1. Suspension formulation by using suspending agents like Methyl cellulose, HEC
HPMC low mol weight etc
2. If we could not achieve the desire results we need to go for another approach
like co solvent solubilization
3. Addition of surfactants
4. Addition of co solvent and surfactant
5. Adjusting the pH of the formulation
6. Advance formulation like SMEDDS and nanosuspension, nanocrystals formulation
etc
And in case of IV formulation we need to see the solubility of the compound in
various suitable vehicles than we need to select following order
1. Aqueous based solution formulation
2. Co-solvent
3. Surfactant
4. pH adjustment
The total quantity of excipients used in formulation is decided on the basis of
the IIG limit (US FDA data base), in house data or published literature.
If you need any more clarification I will happy to help you
Regards
Ashok Kumar Meena
--
Ashok Kumar Meena
Pharmaceutical Development, Jubilant drug discovery center, #96, Industrial
Suburb, 2nd Stage, Yeshwanthpur
Bangalore-560022
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Dear Jaclyn
Hope followoing articles may be useful for you.
1. Lee YC, Zocharski PD, Samas B. An intravenous formulation decision tree
for discovery compound formulation development. Int J Pharm. 2003 Mar
6;253(1-2):111-9.
2. Bittner B, Mountfield RJ. Intravenous administration of poorly soluble
new drug entities in early drug discovery: the potential impact of formulation
on pharmacokinetic parameters. Curr Opin Drug Discov Devel. 2002 Jan;5(1):59-71.
Review.
Regards
PRASHANT
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