From the P2a paper:
"Sterile injectable bryostatin 1 and diluent were manufactured by Lyophilization Technology, Inc., Ivyland, PA.
Bryostatin 1 was produced as a sterile lyophilized cake in 10ml lyophilized sterile vials containing 50g bryostatin 1 and 2.5mg Povidone C17, USP. Placebo was prepared identically except that bryostatin 1 was omitted. Sterile PET Diluent was made in 10ml sterile vials and contained 1ml solution of polyethylene glycol 400 (60%), dehydrated ethanol, USP (30%), and Polysorbate 80, USP (10%), v/v. Povidone C17 was a generous gift of Ashland Chemical Co., Wayne, NJ.
Pure bryostatin 1 was stored at–20?C. The bryostatin 1, placebo, and PET diluent drug product were stored in controlled access chambers at +2 to +8?C. The identity, purity, and stability of the drug substance and drug product were confirmed by mass spectrometry [36], HPLC, UV spectroscopy, and IR spectroscopy at 6-month intervals. The identity, ethanol content, and viscosity of the PET diluent were also confirmed at 6-month intervals. Moisture content was measured at 6-month intervals by pulsed coulometric KF titration using Hydranal Coulomat AK (Sigma-Aldrich) in a Mettler Toledo C20 titrator. Sterility and endotoxin content were confirmed every 6 months by Alcami, Wilmington, NC.
Bryostatin 1 or placebo was administered by dissolving the contents of one vial in 1ml PET diluent, followed by dilution with 9ml of 0.9% sodium chloride injection, USP. This solution was then injected into a 250-ml Baxter non-DEHP-non-PVC Intravia polyolefin-lined saline IV bag. Hospira polyethylene lined tubing was used. The bryostatin 1 was administered to the EA patient by drip infusion over a period of 1h. PVC tubing and bags were avoided because previous research showed that bryostatin 1 could bind to PVC.
Stability tests showed that the bryostatin 1 concentration thus prepared was stable at room temperature in PVC-free infusion bags for at least 21 days. Bryostatin was stable in glass vials containing 9ml saline for at least 10 days at room temperature. Aqueous solutions of bryostatin were found to bind to PVC containers but not to polypropylene or glass. Bryostatin dissolved as 10% solutions in ethanol or DMSO was stable for at least 30 days in glass containers."
