Delayed release softgel capsules
AssigneeR.P. Scherer Technologies, LLC
InventorsKarunakar Sukuru, Qi Fang
Life of this patent
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Abstract
Delayed release softgel capsules including a fill material and a pH dependent shell composition. In one embodiments, the pH dependent shell composition includes gelatin, pectin, dextrose, and from about 0.5 wt % to about 10 wt % of a synthetic polymer. In an alternative embodiment, the pH dependent shell composition includes gelatin, pectin, dextrose, and an organic acid. The delayed release nature of the capsules inhibits premature release of the fill material in acidic pHs (such as pH of from any of about 1.2 to about 6).
Claims40
A delayed release softgel capsule comprising:
- (a) a fill material;
- and
- (b) a pH dependent shell composition,
- wherein the fill material comprises at least one active agent, and
- wherein the pH dependent shell composition comprises gelatin, pectin, dextrose, and from about 0.5 wt. % to about 10 wt. % of a synthetic polymer, based on total weight of the dry pH dependent shell composition.
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A method for tuning the pH dependent dissolution profile of a delayed release softgel capsule comprised of a fill material encapsulated in a pH dependent shell composition, the method comprising adjusting an amount of pectin and an amount of synthetic polymer in the pH dependent shell composition to attain a target pH dependent dissolution profile in acidic medium and/or in buffer medium.
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A delayed release softgel capsule comprising:
- (a) a fill material;
- and
- (b) a pH dependent shell composition,
- wherein the fill material comprises at least one active agent, and
- wherein the pH dependent shell composition comprises gelatin, pectin, dextrose, and an organic acid.
-52. (canceled)
-60. (canceled)
A method for tuning the pH dependent dissolution profile of a delayed release softgel capsule comprised of a fill material encapsulated in a pH dependent shell composition, the method comprising adjusting an amount of pectin and an amount of organic acid in the pH dependent shell composition to attain a target pH dependent dissolution profile in acidic medium and/or in buffer medium.
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A delayed release softgel capsule comprising:
- (a) a fill material;
- and
- (b) a pH dependent shell composition,
- wherein the fill material comprises at least one active agent, and
- wherein the pH dependent shell composition comprises a film former and from about 0.5 wt. % to about 10 wt. % of a synthetic polymer, based on total weight of the dry pH dependent shell composition.
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-74. (canceled)
A delayed release softgel capsule comprising:
- (a) a fill material;
- and
- (b) a pH dependent shell composition,
- wherein the fill material comprises at least one active agent, and
- wherein the pH dependent shell composition comprises a film former and an organic acid.
-82. (canceled)
Dependencies are inferred from the claim text.