Modified protein excipient for delayed-release tablet

摘要

The present invention relates to delayed release oral formulations comprising active ingredients and modified proteins used as excipients. The proteins have chemical modifications such as succmylation, deammation, glytarylation or phosphorylation which decrease the isoelectric point of the protein compared to the protein's native isoelectric point and enhance protem-protem interactions, thereby reducing solubility and swelling, and delaying release of the active ingredient when the formulation is ingested orally. Particularly, the invention relates to tablets that comprise an excipient of chemically-modified food proteins such as soy proteins or -lactoglobulm useful for delaying release of an active ingredient such as a pharmaceutical drug or a probiotic.

主权项

1. A pressed solid matrix comprising: an active ingredient in admixture with an excipient comprising a soy protein or a β-lactoglobulin wherein the soy protein and the β-lactoglobulin are chemically modified at between 25% to 100% of their available sites by way of: succinylation, acetylation, octenyl-succinylation or glutarylation, whereby said excipient when mixed with an active ingredient to form a mixture and then pressed in a solid matrix, causes a reduced swelling of the pressed solid matrix at acidic pH-and a delayed-release of said active ingredient upon oral ingestion.