An object of the present invention is to provide a crystal of an amino acid salt of HMB which is easy to handle and has high solubility, and to provide a method for producing the same. According to the present invention, the crystal of an amino acid salt of HMB can be precipitated by dissolving an amorphous amino acid salt of HMB in a solvent containing alcohol and stirring or allowing the solvent to left stand. In addition, the crystal of an amino acid salt of HMB can be precipitated by concentrating an aqueous HMB solution of an amino acid salt which has a pH of 2.5 to 11.0.

The invention relates to the compounds or its pharmaceutical acceptable polymorphs, solvates, enantiomers, stereoisomers and hydrates thereof. The pharmaceutical compositions comprising an effective amount of compounds of formula I, formula II formula III, formula IV, formula V, formula VI, formula VII, and formula VIII and the methods for the treatment of inflammatory skin diseases and cancer may be formulated for oral, buccal, rectal, topical, transdermal, transmucosal, lozenge, spray, intravenous, oral solution, nasal spray, oral solution, suspension, oral spray, buccal mucosal layer tablet, parenteral administration, syrup, or injection. Such compositions may be used to treatment of facial hirsutism, GI Polyps, rosacea, acne, melanoma, psoriasis, dermatitis and cancer including gliomas, gastrointestinal polyps, anaplastic astrocytoma and metastatic cancers.

The invention relates to the compounds or its pharmaceutical acceptable polymorphs, solvates, enantiomers, stereoisomers and hydrates thereof. The pharmaceutical compositions comprising an effective amount of compounds of formula I, formula II formula III, formula IV, formula V, formula VI, formula VII, and formula VIII and the methods for the treatment of inflammatory skin diseases and cancer may be formulated for oral, buccal, rectal, topical, transdermal, transmucosal, lozenge, spray, intravenous, oral solution, nasal spray, oral solution, suspension, oral spray, buccal mucosal layer tablet, parenteral administration, syrup, or injection. Such compositions may be used to treatment of facial hirsutism, GI Polyps, rosacea, acne, melanoma, psoriasis, dermatitis and cancer including gliomas, gastrointestinal polyps, anaplastic astrocytoma and metastatic cancers.

An object of the present invention is to provide a crystal of an amino acid salt of HMB which is easy to handle and has high solubility, and to provide a method for producing the same. According to the present invention, the crystal of an amino acid salt of HMB can be precipitated by dissolving an amorphous amino acid salt of HMB in a solvent containing alcohol and stirring or allowing the solvent to left stand. In addition, the crystal of an amino acid salt of HMB can be precipitated by concentrating an aqueous HMB solution of an amino acid salt which has a pH of 2.5 to 11.0.

An object of the present invention is to provide a crystal of an amino acid salt of HMB which is easy to handle and has high solubility, and to provide a method for producing the same. According to the present invention, the crystal of an amino acid salt of HMB can be precipitated by dissolving an amorphous amino acid salt of HMB in a solvent containing alcohol and stirring or allowing the solvent to left stand. In addition, the crystal of an amino acid salt of HMB can be precipitated by concentrating an aqueous HMB solution of an amino acid salt which has a pH of 2.5 to 11.0.

The present invention provides a composition for protecting the skin from heavy metals and formaldehyde, comprising at least one selected from the group consisting of trientine or trientine derivative of Formula (1), cyclen or cyclen derivative of Formula (2), cyclam or cyclam derivative of Formula (3), and a salt thereof.

The present invention provides a method for producing an amino acid aminoalkyl ester or an inorganic acid salt thereof by reacting a compound represented by general formula (I) shown below or a compound represented by general formula (III) shown below, or a salt thereof, and at least one compound selected from the group consisting of compounds represented by general formula (IV-I) shown below, compounds represented by general formula (IV-II) shown below, compounds represented by general formula (IV-III) shown below and compounds represented by general formula (IV-IV) shown below, or an inorganic acid salt thereof.

##STR00001##

The present invention provides a method for producing an amino acid aminoalkyl ester or an inorganic acid salt thereof by reacting a compound represented by general formula (I) shown below or a compound represented by general formula (III) shown below, or a salt thereof, and at least one compound selected from the group consisting of compounds represented by general formula (IV-I) shown below, compounds represented by general formula (IV-II) shown below, compounds represented by general formula (IV-III) shown below and compounds represented by general formula (IV-IV) shown below, or an inorganic acid salt thereof.

##STR00001##

Embodiments of the present disclosure are related to improved processes for making L-ornithine phenylacetate without using any silver salts or forming any L-ornithine intermediate salts, such as a benzoate salt. The present processes may be used in the commercial scale manufacturing of L-ornithine phenylacetate with high yields and low impurities.

Embodiments of the present disclosure are related to improved processes for making L-ornithine phenylacetate without using any silver salts or forming any L-ornithine intermediate salts, such as a benzoate salt. The present processes may be used in the commercial scale manufacturing of L-ornithine phenylacetate with high yields and low impurities.