Granule and orally disintegrating tablet comprising oxycodone

An orally disintegrating tablet comprising:

• (a) granules consisting essentially of a neutral core coated by:
• (a) oxycodone or a pharmaceutically acceptable salt of oxycodone, and (b) at least a binder, said oxycodone coating being further coated by a subcoat consisting of a compound soluble in gastric fluid and optionally an antistatic agent;
• wherein said subcoat is further coated by a taste-masking coating consisting of a polymer or copolymer with dialkylaminoalkyl(meth)acrylate units, which is insoluble at a pH above 5.5 but is soluble in gastric juice, and optionally an antistatic or a pore-forming agent, wherein the subcoat is adapted to avoid direct contact between the oxycodone or the pharmaceutically acceptable salt of oxycodone and the taste-masking coating such that degradation of oxycodone is inhibited and (b) at least one disintegrant and at least one diluent, wherein said disintegrant comprises crospovidone.

An orally disintegrating tablet comprising:

• (a) granules consisting essentially of a neutral core coated by:
• (i) oxycodone or a pharmaceutically acceptable salt of oxycodone, and (ii) at least one binding agent, said oxycodone coating being further coated by a subcoat consisting of a compound soluble in gastric fluid and optionally an antistatic agent;
• wherein said subcoat is further coated by a taste-masking coating consisting of a polymer or copolymer with dialkylaminoalkyl(meth)acrylate units, which is insoluble at a pH above 5.5 but is soluble in gastric juice, and optionally an antistatic or a pore-forming agent, wherein the subcoat is adapted to avoid direct contact between the oxycodone or the pharmaceutically acceptable salt of oxycodone and the taste-masking coating such that degradation of oxycodone is inhibited (b) acetaminophen which is not included within said granules, and (c) at least one disintegrant and at least one soluble diluent agent, wherein said disintegrant comprises crospovidone.

A granule consisting essentially of a neutral core coated by:

• (a) oxycodone or a pharmaceutically acceptable salt of oxycodone, and (b) at least a binding agent, said oxycodone coating being further coated by a subcoat consisting of a compound soluble in gastric fluids and optionally an antistatic agent, wherein said subcoat is further coated by a taste-masking coating consisting of a polymer or copolymer with dialkylaminoalkyl(meth)acrylate units which is insoluble at a pH above 5.5 but is soluble in gastric juice, and optionally an antistatic agent or a pore-forming agent, wherein the subcoat is adapted to avoid direct contact between the oxycodone or the pharmaceutically acceptable salt of oxycodone and the taste-masking coating such that at least 90% of oxycodone or pharmaceutically acceptable salt of oxycodone remains after storage for 14 days at 80° C. dry heat.

An orally disintegrating tablet comprising:

• (a) granules consisting essentially of a neutral core coated by:
• (i) oxycodone or a pharmaceutically acceptable salt of oxycodone, and (ii) at least a binder, said oxycodone coating being further coated by a subcoat consisting of a compound soluble in gastric fluid and optionally an antistatic agent;
• wherein said subcoat is further coated by a taste-masking coating consisting of a polymer or copolymer with dialkylaminoalkyl(meth)acrylate units which is insoluble at a pH above 5.5 but is soluble in gastric juice and optionally an antistatic or a pore-forming agent, wherein the subcoat is adapted to avoid direct contact between the oxycodone or the pharmaceutically acceptable salt of oxycodone and the taste-masking coating such that at least 90% of oxycodone or pharmaceutically acceptable salt of oxycodone remains after storage for 14 days at 80° C. dry heat and (b) at least one disintegrant and at least one diluent, wherein said disintegrant comprises crospovidone.