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a formulation question-how to use Palmitic acid as excipient

Posted: Sun Feb 06, 2011 4:58 pm
by kwfx
Dear all:

Now I am trying to use Palmitic acid as an excipient vehicle for my API (vitamin D5) and fill in the soft gel capsule.

The palmetic acid came as solid, since the melting point is around 50 degree, shall I warm it at 50 degree oven to transfer it to liquid and then add API? Or shall I mix the palmitic acid with some other excipient because I am not sure if it will trun back into solid stage after sitting at room temperature. If yes what other excipient is compatible with palmitic acid? I am not a formulator so I am quite confused.

Thanks.

Re: a formulation question-how to use Palmitic acid as excip

Posted: Mon Feb 07, 2011 3:56 pm
by DR
Capsules tend to start melting at or below 37°C. Is there any chance you can leave this aspect of your project to formulators who know how to fill soft gel capsules etc.? This is not really the place to get into all of the ins and outs of this topic...

Re: a formulation question-how to use Palmitic acid as excip

Posted: Mon Feb 07, 2011 7:52 pm
by JGK
I'm no expert but I'd be willing to bet a rather large amount of cash that if you heat palmitic acid to liquefy it and then let it return to to room temperature it will solidify.

Re: a formulation question-how to use Palmitic acid as excip

Posted: Wed Feb 09, 2011 3:50 pm
by Consumer Products Guy
Now I am trying to use Palmitic acid as an excipient vehicle for my API (vitamin D5)
Is there a regulatory/legal requirement to use palmitic acid as the excipient, or did a group of pointy-haired management decide that you had to use palmitic acid (like they've got a tank car of it from another project that they need to use up somehow, so they don't look bad) ?

Agree with others, this will solidify upon cooling, as will most of the larger saturated fatty acids. Without knowing more, I couldn't say whether shorter fatty acids, or fatty acid methyl ester, would be suitable.
I am not a formulator so I am quite confused.
Then why are you "blessed" with this project ?