PHARMACEUTICAL PREPARATION COMPRISING PHENYLALANINE DERIVATIVE
The disclosed pharmaceutical preparation comprises a compound represented by the chemical formula (A) or a pharmaceutically acceptable salt thereof, which is dispersed in a matrix consisting of a water-soluble high molecular weight substance; and Crospovidone: The pharmaceutical preparation is excellent in the solubility and the storage stability even if the amount of the compound or the salt included in each individual dosage unit is increased.
1 . A pharmaceutical preparation comprising the compound represented by the chemical formula (A) or a pharmaceutically acceptable salt thereof, which is dispersed in a matrix consisting of a water-soluble high molecular weight substance, and Crospovidone:
2 . The pharmaceutical preparation as set forth in claim 1 , wherein the water-soluble high molecular weight substance is at least one member selected from the group consisting of celluloses or derivatives thereof selected from methyl cellulose, hypromellose, hydroxypropyl cellulose, hydroxypropyl-methyl cellulose phthalate, hydroxypropyl-methyl cellulose acetate succinate, carboxymethyl-ethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, and cellulose acetate phthalate; synthetic polymer selected from polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl-acetal diethylamino acetate, aminoalkyl methacrylate copolymer E, aminoalkyl methacryl copolymer RS, methacrylic acid copolymer L, methacrylic acid copolymer LD, methacrylic acid copolymer S, and carboxy vinyl polymer; and naturally occurring polymers or saccharides selected from gum Arabic, sodium alginate, alginic acid propylene glycol ester, agar, gelatin, tragacanth gum, and xanthane gum.
3 . The pharmaceutical preparation as set forth in claim 1 , wherein the water-soluble high molecular weight substance is at least one member selected from the group consisting of methyl cellulose, hypromellose, hydroxypropyl cellulose, polyethylene glycol, polyvinyl alcohol and polyvinyl pyrrolidone.
4 . The pharmaceutical preparation as set forth in claim 1 , wherein it comprises a granulated product formed from a dispersion obtained by dispersing the compound represented by the foregoing chemical formula (A) or a pharmaceutically acceptable salt thereof in the matrix of the water-soluble high molecular weight substance, and Crospovidone.
5 . The pharmaceutical preparation as set forth in claim 1 , wherein it comprises 14 to 40% by mass of the compound represented by the foregoing chemical formula (A) or a pharmaceutically acceptable salt thereof, the water-soluble high molecular weight substance in an amount ranging from 0.1 to 10 parts by mass per one part by mass of the compound or the pharmaceutically acceptable salt thereof; and 0.1 to 20% by mass of Crospovidone.
6 . The pharmaceutical preparation as set forth in claim 1 , wherein it further comprises sodium Cros-carmellose.
7 . The pharmaceutical preparation as set forth in claim 1 , wherein it further comprises an excipient.
8 . The pharmaceutical preparation as set forth in claim 7 , wherein the excipient is at least one member selected from the group consisting of mannitol, pre gelatinized starch and crystalline cellulose.
9 . The pharmaceutical preparation as set forth in claim 1 , wherein it is in the form of a tablet.
10 . The pharmaceutical preparation as set forth in claim 9 , wherein it is in the form of a coating tablet whose surface is covered with a coating agent.
11 . The pharmaceutical preparation as set forth in claim 10 , wherein the coating agent is at least one member selected from the group consisting of aminoalkyl methacrylate copolymer E, hypromellose, methyl cellulose, methyl-hydroxyethyl cellulose, Opadry, calcium carmellose, sodium carmellose, polyvinyl pyrrolidone, polyvinyl alcohol, dextrin, pullulan, gelatin, agar and gum Arabic.