Pharmaceutical superdisintegrant
AssigneeEdward Mendell Co., Inc.
InventorJohn Staniforth
Life of this patent
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Abstract
Superdisintegrants which provide improved compressibility compared to prior art superdisintegrants and which does not negatively impact the compressibility of formulations which include high-dose drugs, and methods for obtaining the same are disclosed. The superdisintegrants include a particulate agglomerate of coprocessed starch or cellulose and a sufficient amount of an augmenting agent to increase the compactibility of the superdisintegrant. The augmented superdisintegrant provides a fast disintegration of a solid dosage form when incorporated in sufficient quantity therein, without untowardly affecting the compactibility of the solid dosage form (relative to the solid dosage form without the superdisintegrant).
Claims17
A method of obtaining a highly compactible, superdisintegrating drug-ready complex, comprising:
- co-transforming amorphous regions of amylose/amylo-pectin superdisintegrant material in etherified granules using lubricant-binder emulsion technology, said amorphous regions are transformed into crystalline regions, wherein the step of co-transforming using lubricant-binder technology comprises:
- a) preparing a hot or heated colloidal solution of an augmenting agent;
- b) adding to said solution said amylose/amylo-pectin superdisintegrant material to form a stirrable suspension at a temperature sufficient to allow said superdisintegrant to swell without bursting;
- c) filtering said stirrable suspension;
- and
- d) drying said stirrable suspension, to obtain said superdisintegrating drug-ready complex.
A method of obtaining a highly compactible, superdisintegrating drug-ready complex, comprising:
- co-transforming amorphous regions of amylose/amylo-pectin superdisintegrant material in etherified granules using lubricant-binder emulsion technology, said amorphous regions are transformed into crystalline regions, wherein the step of co-transforming using lubricant-binder technology comprises:
- a) preparing a hot or heated colloidal solution of an augmenting agent selected from the group consisting of a soluble polymer, a surfactant, an oil, and mixtures thereof;
- b) adding said amylose/amylo-pectin superdisintegrant material to form a stirrable suspension at a temperature sufficient to allow said superdisintegrant to swell without bursting, to obtain an augmented superdisintegrant co-transformation product;
- and
- c) drying said stirrable suspension, to obtain said superdisintegrating drug-ready complex.
A method of obtaining a highly compactible, superdisintegrating drug-ready complex, comprising:
- co-transforming amorphous regions of amylose/amylo-pectin superdisintegrant material in etherifled granules using lubricant-binder emulsion technology, said amorphous regions are transformed into crystalline regions, wherein the step of co-transforming using lubricant-binder technology comprises:
- a) preparing a hot or heated suspension of said amylose/amylo-pectin superdisintegrant material to a temperature sufficient to allow said superdisintegrant to swell without bursting;
- b) adding a suitable amount of an augmenting agent, to obtain an augmented superdisintegrant co-transformation product;
- and
- c) drying said stirrable suspension, to obtain said superdisintegrating drug-ready complex.
Dependencies are inferred from the claim text.