| abstract |
A pharmaceutical composition in single dosage form formulated for sublingual administration, wherein the single dosage form is a bilayer film comprising a first layer and a second layer; wherein the first layer comprises: (i) 10 to 75% (w / w) apomorphine or an acid addition salt thereof; (ii) 0.5 to 16% (w / w) of a low molecular weight polymer having a weight average molecular weight of 5 kDa to 50 kDa selected from hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose and methyl cellulose; and (iii) 4 to 35% (w / w) of a high molecular weight polymer having a weight average molecular weight greater than 60 kDa selected from hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, and methyl cellulose. , and the second layer comprises (i) a pH neutralizing agent that is pyridoxine, and (ii) 15 to 50% (w / w) of a high molecular weight polymer having a weight average molecular weight greater than 60 kDa selected from hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, and methyl cellulose. |