Abstract: A solid dispersion comprising: (a) a pharmaceutical active ingredient or a nutraceutical active ingredient having a low solubility; and (b) sodium or potassium alginate. In addition, a drug dosage form prepared from such a solid dispersion.

Abstract: A nanosuspension comprising (a) a pharmaceutical active ingredient or nutraceutical active ingredient having low solubility; (b) at least one alginate selected from the group consisting of (i) sodium alginate having a viscosity of 100 mPa·s or less in a 1% solution in water at 20° C. and (ii) potassium alginate; and (c) water. Also, a drug dosage form prepared from such a nanosuspension.

Abstract: A nanosuspension comprising (a) a pharmaceutical active ingredient or nutraceutical active ingredient having low solubility; (b) at least one alginate selected from the group consisting of (i) sodium alginate having a viscosity of 100 mPa·s or less in a 1% solution in water at 20° C. and (ii) potassium alginate; and (c) water. Also, a drug dosage form prepared from such a nanosuspension.

Abstract: A solid dispersion comprising: (a) a pharmaceutical active ingredient or a nutraceutical active ingredient having a low solubility; and (b) sodium or potassium alginate. In addition, a drug dosage form prepared from such a solid dispersion.

Abstract: This invention relates to a composition comprising physically modified, partially pregelatinized starch, which is useful as a multi-functional excipient for solid dosage forms, a method of making such composition, and solid dosage forms prepared using the composition. Such composition is characterized by a predominance of particles having both birefringent and non-birefringent portions, a sedimentation volume of between 1.5 and 9 ml/g, and a cold water solubility of between 1 and 8%. This free-flowing starch may have an average particle size greater than 30 ?m, and a moisture content of between 5 and 12% by weight. The 500 mg placebo tablet prepared from such composition at 13 kN using a manual tablet press equipped with a 1.11 cm ( 7/16?) standard concave punches has a crushing strength of at least 160 Newtons, and a disintegration time of no more than 10 minutes.

Abstract: The present invention is directed to a solid form comprising an active ingredient and croscarmellose, wherein: (i) the croscarmellose has a median particle size of ?56 microns, (ii) the croscarmellose is present in an amount of ?4% by weight based on the total weight of the solid form, and (iii) the solid form is a tablet, capsule, caplet, lozenge or granule. The present invention is also directed to a method of decreasing the disintegration time (for example, in water) of a solid form that comprises croscarmellose in an amount ?4% by weight based on the total weight of the solid form.

Abstract: The disclosure is directed to fine particle croscarmellose and its use in various compositions such as solid dosage forms. More specifically, the present disclosure relates to fine particle croscarmellose having a median particle size of 5 ?m to 36 ?m and a volume mean diameter of 40 ?m or less. The specific surface area is typically 0.3 m2/g or more. The fine particle croscarmellose is useful as a disintegrant.

Abstract: The invention is directed to the functionality and performance of superdisintegrants in orally disintegrating tablets (ODT). The invention can be an aged direct compression ODT having between about 0.3% to about 2% (wt/wt) sodium croscarmellose relative to the total weight of the ODT, a polyol matrix, optionally a lubricant, and an active pharmaceutical or nutraceutical ingredient, in which after storage for four months the ODT has a disintegration time using an excess water test that is less than 30 seconds and a tensile strength greater than 0.5 MPa. The invention is also directed to a direct compression ODT, consisting essentially of about 0.5% to 2.0% sodium croscarmellose, from 0.1% to 2.0% lubricant, an API, up to 10% (wt/wt) microcrystalline cellulose, optionally one or more colorants, sweeteners, fragrances, flavor compounds, and/or flavor blockers, and the balance spray-dried mannitol.

Abstract: The invention provides films and film forming compositions that can be applied onto a tissue surface. The film and the film forming composition comprise at least one polycarboxylated polymer and at least one polysaccharide.

Abstract: Mucoadhesive tablets have a convex surface, a diameter to cup depth ratio of 4-20 and a cup depth to edge thickness ratio of greater than 0.75 swiftly adheres and conforms to the contacting tissue. The tablets are used to administer actives such as, for example, benzocaine.

Abstract: A hydrogel forming system which comprises a hydrophobic macromer with unsaturated group terminated ends and a hydrophilic polymer which is a polysaccharide containing hydroxy groups which are reacted with unsaturated group introducing compound, is convertible by free radical polymerization to form a hydrogel containing a three dimensional crosslinked polymer network containing hydrophobic and hydrophilic components. Agent can be entrapped in the polymer network, e.g., drugs, macromolecules or synthetic or natural polymers, for controlled release therefrom. In one embodiment, a vascular stent is coated with hydrogel with therapeutic agent entrapped therein.

Abstract: This invention relates to a composition comprising physically modified, partially pregelatinized starch, which is useful as a multi-functional excipient for solid dosage forms, a method of making such composition, and solid dosage forms prepared using the composition. Such composition is characterized by a predominance of particles having both birefringent and non-birefringent portions, a sedimentation volume of between 1.5 and 9 ml/g, and a cold water solubility of between 1 and 8%. This free-flowing starch may have an average particle size greater than 30 ?m, and a moisture content of between 5 and 12% by weight. The 500 mg placebo tablet prepared from such composition at 13 kN using a manual tablet press equipped with a 1.11 cm ( 7/16?) standard concave punches has a crushing strength of at least 160 Newtons, and a disintegration time of no more than 10 minutes.

Abstract: A hydrogel forming system which comprises a hydrophobic macromer with unsaturated group terminated ends and a hydrophilic polymer which is a polysaccharide (e.g. dextran) containing hydroxy groups which are reacted with unsaturated group introducing compound, is convertible by free radical polymerization to form a hydrogel containing a three dimensional crosslinked polymer network containing hydrophobic and hydrophilic components. Agent can be entrapped in the polymer network, e.g., drugs, macromolecules or synthetic or natural polymers, for controlled release therefrom.

Abstract: A hydrogel forming system which comprises a hydrophobic macromer with unsaturated group terminated ends and a hydrophilic polymer which is a polysaccharide containing hydroxy groups which are reacted with unsaturated group introducing compound, is convertible by free radical polymerization to form a hydrogel containing a three dimensional crosslinked polymer network containing hydrophobic and hydrophilic components. Agent can be entrapped in the polymer network, e.g., drugs, macromolecules or synthetic or natural polymers, for controlled release therefrom. In one embodiment, a vascular stent is coated with hydrogel with therapeutic agent entrapped therein.

Abstract: A hydrogel forming system which comprises a hydrophobic macromer with unsaturated group terminated ends and a hydrophilic polymer which is a polysaccharide containing hydroxy groups which are reacted with unsaturated group introducing compound, is convertible by free radical polymerization to form a hydrogel containing a three dimensional crosslinked polymer network containing hydrophobic and hydrophilic components. Agent can be entrapped in the polymer network, e.g., drugs, macromolecules or synthetic or natural polymers, for controlled release therefrom. In one embodiment, a vascular stent is coated with hydrogel with therapeutic agent entrapped therein.

Abstract: A hydrogel forming system which comprises a hydrophobic macromer with unsaturated group terminated ends and a hydrophilic polymer which is a polysaccharide containing hydroxy groups which are reacted with unsaturated group introducing compound, is convertible by free radical polymerization to form a hydrogel containing a three dimensional crosslinked polymer network containing hydrophobic and hydrophilic components. Agent can be entrapped in the polymer network, e.g., drugs, macromolecules or synthetic or natural polymers, for controlled release therefrom. In one embodiment, a vascular stent is coated with hydrogel with therapeutic agent entrapped therein.

Abstract: A hydrogel forming system which comprises a hydrophobic macromer with unsaturated group terminated ends and a hydrophilic polymer which is a polysaccharide (e.g., dextran) containing hydroxy groups which are reacted with unsaturated group introducing compound, is convertible by free radical polymerization to form a hydrogel containing a three dimensional crosslinked polymer network containing hydrophobic and hydrophilic components. Preferably, the hydrophobic polymer is prepared by reacting diol obtained by converting hydroxy of terminal carboxylic acid group of poly(lactic acid) to aminoethanol group and reacting the hydroxyls of the diol with an unsaturated group introducing compound which is acryloyl chloride or isocyanate having an unsaturated group at one end of the molecule.

Abstract: A hydrogel forming system which comprises a hydrophobic macromer with unsaturated group terminated ends and a hydrophilic polymer which is a polysaccharide containing hydroxy groups which are reacted with unsaturated group introducing compound, is convertible by free radical polymerization to form a hydrogel containing a three dimensional crosslinked polymer network containing hydrophobic and hydrophilic components. Agent can be entrapped in the polymer network, e.g., drugs, macromolecules or synthetic or natural polymers, for controlled release therefrom. In one embodiment, a vascular stent is coated with hydrogel with therapeutic agent entrapped therein.

Abstract: A hydrogel forming system which comprises a hydrophobic macromer with unsaturated group terminated ends and a hydrophilic polymer which is a polysaccharide (e.g., dextran) containing hydroxy groups which are reacted with unsaturated group introducing compound, is convertible by free radical polymerization to form a hydrogel containing a three dimensional crosslinked polymer network containing hydrophobic and hydrophilic components. Agent can be entrapped in the polymer network, e.g., drugs, macromolecules or synthetic or natural polymers, for controlled release therefrom.

Abstract: A hydrogel forming system which comprises a hydrophobic macromer with unsaturated group terminated ends and a hydrophilic polymer which is a polysaccharide containing hydroxyl groups which are reacted with unsaturated group introducing compound, is convertible by free radical polymerization to form a hydrogel containing a three dimensional crosslinked polymer network containing hydrophobic and hydrophilic components. Preferably, the hydrophobic polymer is prepared by reacting the hydroxyls of a diol obtained by converting hydroxy of terminal carboxylic acid group of poly(lactic acid) to aminoethanol group, with an unsaturated group introducing compound which is acryloyl chloride or isocyanate having an unsaturated group at one end of the molecules.