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compounding Daclatasvir yourself
Hi, I will be posting on this shortly. Here's a short video of the professionals doing it. Although they have nice machines there are simple versions where you put the 1/2 capsules in, then add the medication. Then fill up any remaining space with filler. Then tip it all out, have a good mix and repeat the process. Put the caps on and you're done.
If you look here:
You will see this list of excipients (other stuff in the tablet that is not Daclatasvir)
6.1 List of excipients
Silicon dioxide (E551)
So given that BMS mix it with lactose I would use that as your filler.
You can get lactose from the supermarket/chemist baby formula section and use that as your filler. It's just milk sugar.
You want a brand with a fine grind (about the same as the active) so it's easy to mix the two parts evenly.
You can grind something too coarse into a fine powder with an ordinary mortar and pestle if needs be.
I spoke with a compounding herbalist who advised to use a filler of similar granularity to the daclatasvir. Since contacting James about this subject earlier today i came up with another method in which I fill the caps with filler first, then tip it out and weigh it, then work out how much dac per number of caps (in my case a 50 cap machine would need 3g dac for the 50 caps = 60mg/cap), then take the weight of the dac from the filler (e.g: 10g filler for 50 caps would equate to 7g filler + 3g dac ) then mix it up thoroughly, so I can fill the caps half full and be confident that each has the required 60mg. Though I finally understand the process above!
Am even thinking of using turmeric or beetroot powder so I know it's all well mixed by the colour!
Huge thanks James for posting this, as everyone has likely heard that the compounding pharmacy professional association has put out an alert we may be asking them to manufacture our capsules and that "purity and efficacy cannot be guaranteed " when sourcing generics from OS. Ho hum.
Thankyou very much James .I have encountered the deplorable stance taken by the Compounding Pharmacy Industry, the "business" that compounded my first three months supply, declined to do my second three months supply - a purely commercial decision. If that is the value system they adhere to ,I am glad I am not amongst them. I was not going to say anything - thankyou for prompting me Seaside and the information on the capping device,
Heartfelt thanks James ,.People like yourself and Greg Jefferys are making such a positive impact on so many peoples lives.
This is what I did, which I originally posted on another forum:
"I spent days googling different variations and combinations of words, and making phone calls to try finding a compounding pharmacist who would make the API up into a useable form. Most of them couldn't get me off the phone fast enough when they realised I wasn't a doctor/clinic/hospital/pharma. One was quite helpful, and explained to me that their insurance doesn't cover them for this type of thing.
I ended up buying some small digital scales, which I first calibrated. Then I put the Dac into the big end of pharmaceutical grade gelatin capsules (size 3, which I had check weighed at 40mg), then weighed them with the capsule cap loosely fitted. It was trial and error, but I soon got a feel for aproximately the correct amount without having to re-weigh several times. I weighed each batch of 20 filled capsules to check that the total weight was 20x1 dose + capsule, which they were. After a couple of hours, and all the caps tightly pressed on, voila! my Dac in swallowable form. "
I can't see the point in putting medically inert substances into the caps. It makes the job an awful lot more complicated.
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1135my concern is the coating. you look like you are using gel caps. My understanding is that when drugs are trialled all components of the product are included as part of the "test" ie therefore if you are trying to replicate a product the filler you use needs to be consistent with the original product (ie benign regarding drug-drug interactions and most importantly approximate any effects on bioavailability of the active ingredient - because if this is altered then there are implications for dosing adjustments). Additionally if the original product has a coating - then the coating affects where in the gut the active ingredient is ultimately delivered and this again may have implications for where and therefore how much of the active ingredient gets absorbed into the system - and again for dosing adjustments. We seem to be advocating gel caps here - is BMS Daclatasvir in gel caps or coated.
Im not saying that any of these factors will have a significant effect on our "generic" approximations, - it might in this case make bugger all difference. But we don't know so I think we need the advice of a chemist who can not only mechanically put the bits together - but one who has sufficiently advanced chemistry acumen to be able to look at the BMS Daclatasvir Analytic Profile and assure us as to what excipients and coatings (or whether gel caps are ok) to use. Im maybe too cautious but I need to get this right - Im end stage 4 and don't need any resistance issues but Im unlikely to get a second shot at this if I proceed. regards all Archer
Fem. Gen 1a.18.4 kPa. IL28b - CT. Cirrhosis 4B/c. MELD 11. Portal Hypertension. Ascites. Varices. (Gr.3). post surgical Coma 2011- Tx denied. 15/09 - INR 1.2 platelets 58 (150-450) albumin 32 (35-50) bilirubin 40 (2-20) ALT 183 (0-45) AST 281(0-41) GGT 39(0-45). Liver lesions AFP 16 <8.
I spent weeks and weeks researching this because I was having all the same worries and doubts that you are. I found the (highly informative) report I've attached. Section 2.2.3 set me on the right path.
I researched all the excipients, and the only one that concerned me was Croscarmellose Sodium, which is a 'superdisintigrant'. I suspected that it's only use was to ensure the hard Daklinza pills broke up quickly and became bioavailable in the stomach.But if you're using an API in a gelatin capsule, that's going to happen anyway.
I had been corresponding with a HepC infected Doctor here in the UK who was basically saying all the things you are. He wanted to send his APIs to Aus to get them compounded, but I thought that was a bad idea. He contacted compounding chemists in Aus and told me this:
"I've spoken to Oz pharmacists as well and they confirmed what you say. Just put the stuff into capsule and swallow. My sof/dac is winging over here. Will start when I get it and hope for the best."
Anyway, I'm on Indian Sof pills and Mesochem Dac API I put straight into gelatin caps. The Sof doesn't work on it's own, and after 15 days I'm virus undetected.
I am attaching the report for Sovaldi, similar to the one attached by Alsdad for Daklinza. See Section 2.2.3.
Alsdad, or anybody - do you see anything there that might make a difference for the encapsulation of Sof, compared to Dac?
It's an immediate release medicine, and all the excipients are bog-standard ones that don't do anything more than get the pill into one's stomach and help it to break up there (you can google each one with the word 'excipient' added to find out more).
You can just load the API straight into a pharmaceutical grade gelatin capsule. It'll do the same job as branded or generic Sovaldi.
The Torpac Profunnel is an amazing little device. It has three parts: a base where you put the large half of the empty cap, a funnel that fits over the base and a tamping rod. All medical stainless steel. Comes in various sizes and includes 1000 empty caps.
400mg of sofosbuvir, firmly tamped down, will almost fill the large part of a "00" capsule. I made my sof and led in separate caps. No waste to speak of. This is worth the price-$75.00 U.S.
G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24