Process for spray drying amino acid compositions
AssigneeW. R. Grace & Co.
InventorJohn J. Blouin
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Abstract
A process is disclosed whereby a depyrogenated solution comprising one or more amino acids is converted to a dried, amorphous product by spray drying. The solution optionally may contain one or more additional components, such as salts, buffers, lipids, vitamins, trace elements and electrolytes. Products may be prepared according to this method which are suitable for enteral or parenteral nutritive therapeutic use.
Claims23
A process for preparing a dried, amorphous product comprising at least one amino acid, said process comprising:
- (a) dissolving at least one amino acid in a solvent,
- (b) driving the resulting solution in a spray drier by injecting the amino acid solution, at a temperature of about 70.degree. to about 90.degree. C., into said spray drier by means of an atomizing nozzle while introducing into said spray drier heated, sterile air or inert gas, while operating said spray drier such that the outlet temperature is about 95.degree. to about 150.degree. C., and
- (c) collecting the dried, amorphous product, said product characterized by (i) being physically and chemically homogeneous, (ii) having a moisture content of up to about 7 percent, (iii) dissolving substantially instantaneously in a liquid carrier, and (iv) having a dissolution profile such that the distribution of dissolved amino acid in solution is substantially completely uniform over time.
A process for preparing a dried composition comprising one or more amino acids and suitable for use in parenteral nutritive thereapy, comprising:
- (a) dissolving at least one chemically pure amino acid in a solvent meeting FDA requirements for use in preparation of products for parenteral use, spray drying the prepared solution under sterile conditions by injecting the resulting amino acid solution, at a temperature of about 70.degree. to about 90.degree. C., into a spray drier by means of an atomizing nozzle while introducing into said spray drier heated, sterile air or inert gas, while operating said spray drier such that the outlet temperature is about 95.degree. to about 150.degree. C., and
- (c) collecting the dried product under sterile conditions, said product characterized by (i) being physically and chemically homogeneous, (ii) having a moisture content of up to about 7 percent, (iii) dissolving substantially instantaneously in a liquid carrier, and (iv) having a dissolution profile such that the distribution of dissolved amino acid in solution is substantially completely uniform over time.
Dependencies are inferred from the claim text.