Phenformin
Cancer
CANCER
Bulk phenformin was provided by the Division of Cancer Treatment and Diagnosis of the NCI under a materials transfer agreement. Phenformin was encapsulated at the Pharmaceutical Product Facility at Memorial Sloan Kettering Cancer Center (MSKCC) under cGMP procedures. The final product was evaluated for accuracy using UV-high-pressure liquid chromatography (HPLC) in accordance with USP <621>, uniformity of dosage USP <905>, dissolution USP <711>, water content (Karl Fischer) USP <921> as well as analysis for impurities in accordance with USP <232>. These tests were conducted after encapsulation and at 3, 6, 12, 24, and 36 months thereafter. The 50 mg Phenformin HCl (42.5 mg phenformin) capsules contained the following excipients: Microcrystalline Cellulose NF, Sorbitol Powder NF, Sodium Croscarmellose NF, and were encapsulated into Coni-Snap Hard Gelatin Capsule-size 3. These capsules were packaged into Rexam L-60 Screw-Loc Clear-Vu vials (13-dram vial) with child resistant closure. Each vial had a security foil tape. These phenformin capsules were used under an IND 130924 granted by the FDA.