From Greg Jefferys homestead site
Sept 20, 2015:
(Making capsules from API (active ingredient powder)
Last time we were in touch, I was looking for a doctor to give me a
prescription for Indian Sofosbuvir. I didn't find one and ended up
ordering APIs from Mesochem.
My Sovosbuvir and Ledipasvir APIs arrived this week and I have been
looking for a compounding chemist to make up the capsules. I found one
on Friday afternoon who was happy to make it up (maybe she hadn't read
her mail yet). I asked her what the procedure was for encapsulating APIs
and the system she told me was far simpler and more accurate than
anything I have come across on the web. I give it here in case you want
to publish it for anyone else who is in this position.
She first weighs out the total amount of the API. So in my case, that's
400 mg Sofosbuvir + 90mg Ledipasvir for 12 weeks, so 84x400mg = 33.6
grams of Sof and 84x90mg = 7.56 grams of Led. Note that this does not
require a multi thousand dollar milligram scale. 1/10th gram accuracy is
plenty. 1/10th gram over 84 capsules is .1/84 = 1/840 = about 1
milligram error for each capsule. This is well inside any reasonable
tolerance. A .1 gm scale costs under $100.
Then put the weighed APIs into a measuring cylinder. Measuring cylinders
cost under $10 at any laboratory glassware dealer. Use the smallest that
will hold the entire batch. Add excipient (e.g. lactose) to the cylinder
to make up the correct volume. The chemist already knows the correct
volume, because she's done this before, but the rest of us have to find
the correct volume before we start, which is done by carefully filling
84 capsules with lactose and pouring them into the cylinder. Whatever
volume results is what we have to make up the final mixture to.
Pour the API/excipient mixture into a bowl and mix well. This sounds
like the hardest part of the whole procedure.
Fill the 84 capsules with the mixture. If everything has been done
carefully and accurately the mixture will just fill the capsules without
any waste. If it was thoroughly mixed, the APIs are now distributed
evenly at the correct dosage over the 84 capsules.
One thing she mentioned was that 400 mg Sof + 90 mg Led is a lot to put
in one capsule, and its probably easier to make 168 capsules of 200 mg +
45 mg (i.e. 2 capsules per day), which is easily done by changing the
volume the mixture is made up to.
I left my APIs with her since she said she could have them ready by
Tuesday, but since I need 24 weeks of therapy, I will probably make up
the next batch myself.
(I should also add that in conversations I have had with two doctors on this subject they have both told me that minor variations in the amount of active ingredient between capsules is not critical. Even with factory manufactured meds the absorbsion of active ingredients by the body varies slightly from day to day so we do not have to worry if one capsule has 400mg of API and the next has 394mg and the next 406 milligrams.)
M, 57, Live in Wellington,NZ.
Genotype 1a diagnosed in 2013.
Treating for the first time since October 31 with Buyers Club Sof/Led. Thanks so much guys. Minimal side effects apart from sore throat at the start..
Viral load 5.4m when treatment started, Undetected at 4 weeks, 8 weeks, End of Treatment and 12-weeks post EOT. Yay!