Process to reduce endotoxin in gelatin
AssigneeCatalent U.K. Swindon Zydis Limited
InventorsYik Teng WONG, Khojasteh SHIRKHANI, Ami HITCHING, Sarah STEWART
Life of this patent
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Abstract
The present disclosure is directed to processes for reducing the endotoxin level in gelatin and the resulting gelatin with low endotoxin content. The process includes dissolving a salt in a gelatin solution and filtering the gelatin-salt solution using anion exchange to reduce the endotoxin level. After reducing the endotoxin level of the gelatin-salt solution, the low endotoxin gelatin-salt solution is desalted to remove the salt, thereby producing a low endotoxin gelatin solution.
Claims23
A method for reducing endotoxin in gelatin, comprising:
- dissolving a salt in a gelatin solution comprising gelatin and a solvent to form a gelatin-salt solution, wherein the endotoxin content of the gelatin is at least 6,000 EU/g;
- filtering the gelatin-salt solution through an anion exchange adsorber such that a filtrate gelatin-salt solution has an endotoxin content of less than 2,500 EU/g;
- and
- desalting the filtrate gelatin-salt solution to form a low endotoxin gelatin solution that has an endotoxin content of less than 2,500 EU/g.
A low endotoxin gelatin solution prepared by a process comprising:
- dissolving salt in a gelatin solution comprising gelatin and a solvent to form a gelatin-salt solution, wherein the endotoxin content of the gelatin is at least 6,000 EU/g of gelatin;
- filtering the gelatin-salt solution through an anion exchange adsorber such that a filtrate gelatin-salt solution has an endotoxin content of less than 2,500 EU/g;
- desalting the filtrate gelatin-salt solution to form a low endotoxin gelatin solution that has an endotoxin content of less than 2,500 EU/g.
A low endotoxin gelatin solution comprising a solvent and a gelatin, wherein the gelatin has an endotoxin content of less than 2,500 EU/g.
A method of producing a dosage form for the delivery of a pharmaceutically active ingredient comprising:
- dissolving salt in a gelatin solution comprising gelatin and a solvent to form a gelatin-salt solution, wherein the endotoxin content of the gelatin is at least 6,000 EU/g;
- filtering the gelatin-salt solution through an anion exchange adsorber such that a filtrate gelatin-salt solution has an endotoxin content of less than 2,500 EU/g;
- desalting the filtrate gelatin-salt solution to form a low endotoxin gelatin solution that has an endotoxin content of less than 2,500 EU/g;
- dosing a formulation comprising the low endotoxin gelatin solution into a preformed mold;
- and
- freeze drying the low endotoxin gelatin solution to form the dosage form.
A dosage form for the delivery of a pharmaceutically active ingredient prepared by a process comprising:
- dissolving salt in a gelatin solution comprising gelatin and a solvent to form a gelatin-salt solution, wherein the endotoxin content of the gelatin is at least 6,000 EU/g;
- filtering the gelatin-salt solution through an anion exchange adsorber such that a filtrate gelatin-salt solution has an endotoxin content of less than 2,500 EU/g;
- desalting the filtrate gelatin-salt solution to form a low endotoxin gelatin solution that has an endotoxin content of less than 2,500 EU/g;
- dosing a formulation comprising the low endotoxin gelatin solution into a preformed mold;
- and
- freeze drying the low endotoxin gelatin solution to form the dosage form.
Dependencies are inferred from the claim text.