Spill resistant formulations containing clays
AssigneeTaro Pharmaceuticals U.S.A., Inc.
InventorsSatish Asotra, Xiaoli Wang, Zoltan Bodor
Life of this patent
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Abstract
The invention relates to novel spill resistant formulations comprising either a weak base or a weak acid as the pharmaceutical ingredient, a liquid base, a clay and a water soluble cellulose ether. The clay and cellulose ether allow for a broader pH range into which the pharmaceutically active agent may be dispersed or dissolved, and therefore allows for easier preparation and formulation of the pharmaceutical composition.
Claims35
A pharmaceutical formulation, comprising a weakly basic pharmaceutically active ingredient, a liquid base, a clay selected from the group consisting of laponite, bentonite, montmorillonite, beidelite, hectorite, saponite and stevensite and mixtures thereof in an amount from about 0.25% (w/w) to about 0.5% (w/w), and at least one water soluble cellulose ether in an amount from about 0.8% (w/w) to about 2.0% (w/w), wherein the pharmaceutical formulation is orally ingestible and exhibits the following spill resistant characteristics:
- a) a viscosity within the range of about 5,000 to about 25,000 cps using a Brookfield viscometer at a spindle speed of 20 rpm;
- b) a viscometric yield value of a semi-solid;
- a spill-resistant consistency permitting the composition to be squeezed by light manual pressure through a channel of about 1-5 mm;
- c) the yield value allows the formulation to spread in a spoon bowl sufficiently quickly for accurate measurement, and to remain in the spoon bowl without spilling for several seconds on spoon inversion, tilting and vibration;
- d) homogeneity such that the components do not separate under conditions of use;
- and
- e) a storage stability such that the foregoing properties are retained for at least two months of storage at accelerated stability conditions of elevated temperature and humidity.
A pharmaceutical formulation, comprising a weakly acidic pharmaceutically active ingredient, a liquid base, a clay selected from the group consisting of laponite, bentonite, montmorillonite, beidelite, hectorite, saponite and stevensite and mixtures thereof, and at least one water soluble cellulose ether in an amount from about 0.8% (w/w) to about 2.0% (w/w), wherein the pharmaceutical formulation is orally ingestible and exhibits the following spill resistant characteristics:
- a) a viscosity within the range of about 5,000 to about 25,000 cps using a Brookfield viscometer at a spindle speed of 20 rpm;
- b) a viscometric yield value of a semi-solid;
- a spill-resistant consistency permitting the composition to be squeezed by light manual pressure through a channel of about 1-5 mm;
- c) the yield value allows the formulation to spread in a spoon bowl sufficiently quickly for accurate measurement, and to remain in the spoon bowl without spilling for several seconds on spoon inversion, tilting and vibration;
- d) homogeneity such that the components do not separate under conditions of use;
- and
- e) a storage stability such that the foregoing properties are retained for at least two months of storage at accelerated stability conditions of elevated temperature and humidity.
A pharmaceutical formulation, comprising a pharmaceutically active ingredient, a liquid base, clay, and at least one water soluble cellulose ether, wherein the clay and cellulose ether are combined in amounts in a range that provides spill-resistant characteristics comprising sufficient viscosity, yield value, and stability across a pH range of about 3 to about 10, and wherein the pharmaceutical formulation is orally ingestible.
Dependencies are inferred from the claim text.