GELLING AGENT-BASED DOSAGE FORM
The present invention generally relates to dosage forms for oral administration including one or more gelling agents. In particular, the present invention is directed to gelling agent-based dosage forms that are easily administered and taken, or swallowed. The present invention is also directed to gelling agent-based dosage forms that exhibit relatively low syneresis, are thermally stable, exhibit substantially constant active ingredient concentration, and/or exhibit one or more advantageous rheological properties. In particular, the present invention is directed to such gels containing one or more omega-3 fatty acids. The gelling agent-based dosage forms of the present invention are suitable for administration of a relatively large dose of active ingredient. The gelling agent-based dosage forms of the present invention are also suitable for administration of multiple active ingredients. Dosage forms of the present invention also provide tamper resistance and, thus, prevent recovery or diversion of active ingredients contained therein. The gelling agent-based dosage forms are also suitable for use as gastro-retentive and sustained release dosage forms.
1 . An aqueous gel composition, the composition comprising:
an active ingredient,
one or more gelling agents selected from the group consisting of locust bean gum, iota-carrageenan, kappa-carrageenan, gellan gum, and combinations thereof;
a rheology modifier selected from the group consisting of xanthan gum, locust bean gum, guar gum, methyl cellulose, and combinations thereof;
a syneresis controlling agent selected from the group consisting of konjac flour, gum tragacanth, pullulan, gellan gum, and combinations thereof; and
water.
2 . The composition of claim 1 wherein the one or more gelling agents comprise locust bean gum and iota-carrageenan, the rheology modifier comprises xanthan gum, and the syneresis controlling agent comprises gum tragacanth.
3 . The composition of claim 2 , wherein:
locust bean gum constitutes from about 0.1 to about 1 wt % of the composition,
iota-carrageenan constitutes from about 0.1 to about 1 wt % of the composition,
xanthan gum constitutes from about 0.1 to about 2 wt % of the composition, and
gum tragacanth constitutes from about 0.1 to about 1 wt % of the composition.
4 . The composition of claim 1 wherein the one or more gelling agents comprise locust bean gum and iota-carrageenan, the rheology modifier comprises xanthan gum, and the syneresis controlling agent comprises konjac flour.
5 . The composition of claim 4 , wherein:
locust bean gum constitutes from about 0.1 to about 1 wt % of the composition,
iota-carrageenan constitutes from about 0.1 to about 1 wt % of the composition,
xanthan gum constitutes from about 0.1 to about 2 wt % of the composition, and
konjac flour constitutes from about 0.1 to about 1 wt % of the composition.
6 . The composition of claim 1 wherein the one or more gelling agents comprise locust bean gum and iota-carrageenan, the rheology modifier comprises xanthan gum, and the syneresis controlling agent comprises konjac flour and gum tragacanth.
7 . The composition of claim 6 , wherein:
locust bean gum constitutes from about 0.1 to about 1 wt % of the composition,
iota-carrageenan constitutes from about 0.1 to about 1 wt % of the composition,
xanthan gum constitutes from about 0.1 to about 2 wt % of the composition,
konjac flour constitutes from about 0.1 to about 1 wt % of the composition, and
gum tragacanth constitutes from about 0.1 to about 1 wt % of the composition.
8 . The composition of claim 2 wherein the weight ratio of locust bean gum to iota-carrageenan is from about 40:60 to about 60:40.
9 . The composition of claim 1 further comprising a source of potassium ions, a source of sodium ions, a source of calcium ions, or a combination thereof, in a proportion of from about 0.1 to about 1 wt %.
10 . The composition of claim 1 wherein the one or more gelling agents comprise locust bean gum, the rheology modifier comprises xanthan gum, and the syneresis controlling agent comprises konjac flour.
11 . The composition of claim 10 , wherein:
locust bean gum constitutes from about 0.1 to about 1 wt % of the composition,
xanthan gum constitutes from about 0.1 to about 2 wt % of the composition, and
konjac flour constitutes from about 0.1 to about 1 wt % of the composition.
12 . The composition of claim 10 , further comprising a source of potassium ions, a source of sodium ions, a source of calcium ions, or a combination thereof in a proportion of from about 0.1 to about 1 wt %.
13 . The composition of claim 1 wherein the one or more gelling agents comprise locust bean gum and kappa-carragenan, the rheology modifier comprises xanthan gum, and the syneresis controlling agent comprises pullulan.
14 . The composition of claim 13 , wherein:
locust bean gum constitutes from about 0.1 to about 1 wt % of the composition,
kappa-carrageenan constitutes from about 0.1 to about 1 wt % of the composition,
xanthan gum constitutes from about 0.1 to about 2 wt % of the composition, and
pullulan constitutes from about 0.1 to about 1 wt % of the composition.
15 . The composition of claim 14 , further comprising a source of potassium ions, a source of sodium ions, a source of calcium ions, or a combination thereof in a proportion of from about 0.1 to about 1 wt %.
16 . The composition of claim 1 wherein the one or more gelling agents comprise locust bean gum, the rheology modifier comprises xanthan gum, and the syneresis controlling agent comprises gellan gum.
17 . The composition of claim 16 , wherein:
locust bean gum constitutes from about 0.1 to about 1 wt % of the composition,
xanthan gum constitutes from about 0.1 to about 2 wt % of the composition, and
gellan gum constitutes from about 0.1 to about 1 wt % of the composition.
18 . The composition of claim 1 wherein water constitutes at least about 40 wt % of the composition.
19 . The composition of claim 1 wherein water constitutes from about 40 to about 70 wt % of the composition.
20 . The composition of claim 1 wherein the active ingredient constitutes at least about 5 wt % of the composition.
21 . The composition of claim 1 wherein the active ingredient is a pharmaceutically active ingredient selected from the group consisting of anti-tussives, decongestants, antihistamines, analgesics, anti-inflammatory agents, and combinations thereof.
22 . The composition of claim 1 wherein the active ingredient is selected from the group consisting of nutraceuticals, vitamins, minerals, dietary supplements, and combinations thereof.