Intrathecal baclofen pharmaceutical dosage forms and related delivery system
According to the subject invention, there is disclosed, a dosage and packaging configuration which includes the use of color-coded pre-filled syringes and vials to fill and refill infusion systems with existing and new dosage forms of intrathecal baclofen.
1. A process for preparation of drug delivery system consisting of a packaged and labeled syringe pre-filled with a sterile solution of baclofen containing up to 0.5% by weight of (4-chlorophenyl)-2-pyrrolidone, for intrathecal delivery comprising the steps of:
(i) adding sodium chloride solution to baclofen, wherein the baclofen is not filtered, to form a solution of baclofen having a concentration of 0.5 mg/ml, 2.0 mg/ml, or 3.0 mg/ml, wherein the pH of the baclofen solution is in the range of about 4.5 to about 8.0 or about 5.0 to about 7.0;
(ii) sterilizing the solution of baclofen obtained in step (i) by steam heating at 121° C. so that the sterilization time (F 0 ) for the resulting terminally sterilized solution is 7 minutes;
(iii) filling a syringe with 5 ml to 40 ml of the sterile solution of step (ii) and wherein the syringe has an internal surface treated to reduce reactivity of the internal surface;
(iv) color coding a plunger and/or label of the syringe depending on the amount of said baclofen in said pre-filled syringe; and
(v) closing a dispensing end of the syringe with a leur-lock tip, thereby forming the packaged and labeled pre-filled syringe.
2. The process of claim 1 , wherein said color coding system is on said plunger.
3. The process of claim 1 , wherein said color coding system is on the plunger and a label of said packaged and labeled pre-filled syringe.
4. The process of claim 3 , wherein said color coding system is on a label of said packaged and labeled pre-filled syringe.
5. The process of claim 1 , wherein said color coding system is also indicative of the amount of said baclofen in said pre-filled syringe.