Highly compactable and durable direct compression excipients and excipient systems
AssigneeSPI Pharma, Inc.
InventorsJohn Tillotson, Cecil Propst
Life of this patent
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Abstract
The present invention relates to solid dispersions including, but not limited to, co-processed carbohydrates with different solubilities and concentrations, which have a microcrystalline plate structure. The solid dispersions, excipient systems and formulations of the present invention are highly compactable and durable and when compressed into solid dosage forms demonstrate uniform densification, low friability at low pressures, and/or relatively constant low disintegration times at various hardnesses. The solid dosage forms of the present invention demonstrate superior organoleptics, disintegration, and/or robustness.
Claims31
A solid dispersion comprising a combination of at least three co-processed polyols with different solubilities in water and/or concentrations in water, wherein the solid dispersion has a microcrystalline plate structure arranged in layers, and wherein the at least three co-processed polyols comprises mannitol in an amount of about 70 wt % to about 99.5 wt %, maltitol in an amount of about 0.5 wt % to about 30 wt %, and sorbitol in an amount of about 0.5 wt % to about 30 wt %.
A solid dispersion comprising a combination of at least three co-processed polyols with different solubilities in water and/or concentrations in water, wherein the solid dispersion has a microcrystalline plate structure arranged in layers, and wherein the at least three co-processed polyols comprises mannitol in an amount of about 70 wt % to about 99.5 wt %, lactitol in an amount of about 0.5 wt % to about 30 wt %, and sorbitol in an amount of about 0.5 wt % to about 30 wt %.
A solid dosage form comprising a solid dispersion which comprises a combination of at least three co-processed polyols with different solubilities in water and/or concentrations in water, wherein the solid dispersion has a microcrystalline plate structure arranged in layers, and wherein the at least three co-processed polyols comprises mannitol in an amount of about 70 wt % to about 99.5 wt %, maltitol in an amount of about 0.5 wt % to about 30 wt %, and sorbitol in an amount of about 0.5 wt % to about 30 wt %.
A solid dosage form comprising a solid dispersion which comprises a combination of at least three co-processed polyols with different solubilities in water and/or concentrations in water, wherein the solid dispersion has a microcrystalline plate structure arranged in layers, and wherein the at least three co-processed polyols comprises mannitol in an amount of about 70 wt % to about 99.5 wt %, lactitol in an amount of about 0.5 wt % to about 30 wt %, and sorbitol in an amount of about 0.5 wt % to about 30 wt %.
Dependencies are inferred from the claim text.