abstract |
A pharmaceutical solution comprising 8 wt% buprenorphine and a biocompatible solvent selected from the group consisting of N-methyl-2-pyrrolidone (NMP), dimethyl sulfoxide (DMSO), dimethyl acetamide (DMAC), and a combination thereof, wherein the solution does not comprise a biodegradable polymer. The buprenorphine may be present as a free base or a pharmaceutically acceptable salt form. The solution may further comprise a glycol. The glycol may be polyethylene glycol, propylene glycol or mixtures thereof. The polyethylene glycol may have a molecular weight between 100 and 1000, and may be selected from PEG300 or PEG400. The solution may further comprise 0.01-10 wt% of an antioxidant selected from ascorbic acid, vitamin E, butylated hydroxytoluene (BHT) or butylated hydroxyanisole (BHA). The composition may comprise 0-10 wt% water. The solution may be sterile. The pharmaceutical solution may be for use as a medicament, particularly in the treatment of opioid dependence or pain. The solution is administered via subcutaneous injection to provide a subcutaneous depot having sustained release characteristics. |