Controlled release formulations comprising morphine sulphate for continuous treatment of pain

摘要

The disclosure relates to the use of a pharmaceutical composition comprising: (a) a matrix composition comprising: (i) an active drug substance; and (ii) at least one polyglycol, said matrix composition having a cylindrical shape optionally with tapered end(s), said matrix being surrounded by:(b) a coating having at least one opening exposing one surface of said matrix, said coating being substantially impermeable to an aqueous medium; in the manufacture of a medicament for the continuous treatment of pain, wherein the medicament is formulated to be administered once daily for at least 3 days, so as to relieve or ameliorate pain for at least 24 hours after daily intake and the average number of daily Break Through Pain episodes determined in at least 30 steady state individuals is at the most 2. The disclosure particularly relates to the use of a pharmaceutical composition comprising morphine sulphate as the active drug, a mixture of polyethylene oxide 200,000 and polyethylene oxide 300,000 as polyglycol, poloxamer as plasticizer, mannitol as stabilizer, a mixture of carrageenan and hydroxypropylmethyl cellulose as gelling agent, butylated hydroxytoluene as antioxidant and a mixture of polylactic acid and polyethylene oxide as the coating for the continuous treatment of pain; and it also relates to the use of a pharmaceutical composition comprising morphine sulphate as the active drug, polyethylene oxide 300,000 as polyglycol, poloxamer as plasticizer, a mixture of mannitol and butylated hydroxytoluene as stabilizer and a mixture of ethylcellulose, cetostearyl alcohol and titanium dioxide as the coating for the continuous treatment of pain as described herein.