Abstract: A process for obtaining a spray-dried high amylose sodium carboxymethyl starch comprising a major fraction of amorphous form and optionally a minor fraction of crystalline V form, is provided. The process comprises providing an amorphous pregelatinized high amylose sodium carboxymethyl starch (HASCA); dispersing the amorphous pregelatinized HASCA in a solution comprising water and at least one first pharmaceutically acceptable organic solvent miscible with water and suitable for spray-drying; and spray-drying the dispersion to obtain the spray-dried HASCA comprising a major fraction of amorphous form and optionally a minor fraction of crystalline V form, in the form of a powder. Also provided is a spray-dried HASCA sustained-release excipient. This excipient is useful for preparing a tablet for the sustained-release of at least one drug.

Abstract: Disclosed is a pharmaceutical sustained release tablet for oral administration of a drug which is made of a compressed blend of at least three dry powders including a powder of a drug, a powder of a sustained release matrix for the drug, and a powder of at least one electrolyte. The sustained release matrix consisting of an un-cross-linked high amylose starch wherein the high amylose is substituted by at least one organic substituent comprising at least one carboxyl group. This organic substituent is preferably a carboxyalkyl having 2 to 4 carbon atoms, its salt or mixture thereof. This tablet has the advantage of having an improved integrity.

Abstract: Cross-linked cellulose is an excellent binder disintegrant that can be used in the preparation of pharmaceutical tablets. The tablets that are so prepared are made of a compressed mixture of a powder of a pharmaceutically active ingredient with a powder of a pharmaceutical excipient including a pharmaceutically acceptable form of cross-linked cellulose in an amount up to 35% by weight with respect to the total weight of the tablet. The cross-linked cellulose is prepared by cross-linking microcrystalline or fibrous cellulose with a cross-linking agent such as epichlorhydrin in a relative amount of 2 to 50 g of cross-linking agent per 100 g of cellulose. Tests have proved that cross-linked cellulose is very easy to synthetise and has excellent binding/disintegrating properties that are function of the cross-linking degree. At low cross-linking degree, cross-linked cellulose is more a binder than a disintegrant whereas at high cross-linking degree, it is more a disintegrant than a binder.

Abstract: A pharmaceutical sustained release tablet for oral administration is made of a compressed blend of at least two dry powders including a powder of a pharmaceutical drug and a powder of a sustained release matrix for the drug. The sustained release matrix is made of substituted amylose prepared by reacting, in a basic medium, amylose with an organic substituent having a reactive function that reacts with the hydroxy groups of the amylose molecule. This substituent is preferably an epoxy or halogen alkane or alcohol with such a matrix controlled and sustained release of a drug are achieved with a remarkable close-to-linear profile and a release time of from 9 to 20 hours.

Abstract: The present invention is concerned with the manufacture of solid dosage units (pharmaceutical and others). More specifically, the invention is related to powders of cross-linked amylose, having a specific cross-linking degree for use as tablet binders and disintegrants.

Abstract: The present application is concerned with a solid slow release pharmaceutical dosage unit. More specifically, the invention is directed to a tablet form prepared by direct compression of cross-linked amylose (CLA) having a definite cross-linking degree, .alpha.-amylase and a pharmaceutical agent. The presence of the cross-linked amylose allows a sustained release of the drug, while the .alpha.-amylase permits the modulation of the release time. In other words, the release time of the drug is function of the amount of .alpha.-amylase in the tablet. The amount of .alpha.-amylase is defined in terms of Enzyme Units.