A novel drug delivery system and method of preparation thereof

Claim 2

A drug delivery system comprising; (a) a drug; and (b) a hydrophobic matrix comprising : (i) an emulsifier; (ii) an edible material having a melting point in the range of from 25 0 C to 100 0 C chosen from fatty acids having an iodine value of from 1 to 10, natural waxes, synthetic waxes and mixtures thereof; and (iii) at least one glyceride.

Claim 3

A delivery system according to Claim 1, wherein the drug is chosen from: antitussants, antihistamines, decongestants, alkaloids, mineral supplements, ion exchange resins, anti-cholesterolemic agents, anti-lipid agents, antiarrhythmics, antipretics, analygesics, appetite supressants, expectorants, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, anti-infectives, psychotropics, antimanics, stimulants, laxatives, decongestants, gastrointestinal sedatives, antidiarrhoial preparations, anti-anginal drugs, vaso-dialators, antiarry- thmics, anti-hypertensive drugs, vasoconstrictors and migrane treatments, antibiotics, tranquilizers, antipsychotics, antitumor drugs, anti-coagulants and antithrombotic drugs, hypnotics, sedatives, antiemetics, anti-nauseants, anticonvulsants, neuromuscular drugs, hyper- and hypoglycaemic agents, thyroid and antithyroid preparations, diuretics, anti-spasmodics, uterine relaxants, mineral and nutritional additives, antiobesity drugs, anabolic drugs, erythropoietic drugs, antiasthmatics, expectorants, cough suppressants, mucolytics, anti-uricemic drugs, and mixtures thereof.

Claim 4

A delivery system according to Claim 1 or 2, wherein the drug is potassium chloride.

Claim 5

A delivery system according to Claim 1 or 2, wherein the drug is cholestyramine.

Claim 6

A delivery system according to Claim 1, wherein the drug is chosen from potassium chloride, calcium carbonate, dextromethorphan, pseudsephedrine and mixtures thereof.

Claim 7

A delivery system according to any preceding claim, wherein the emulsifier is lecithin.

Claim 8

A delivery system according to any preceding claim, wherein the fatty acid is chosen from: hydrogenated palm oil, hydrogenated palm kernel oil, hydrogenated peanut oil, hydrogenated rapeseed oil, hydrogenated rice bran oil, hydrogenated soybean oil, hydrogenated cottonseed oil, hydrogenated sunflower oil and mixtures thereof.

Claim 9

A delivery system according to any preceding claim wherein the fatty acid is present in an amount of from 61% to 95% by weight of the delivery system, the fatty acid preferably being refined hydrogenated palm oil present in an amount of from 63% to 90% by weight of the delivery system.

Claim 10

A delivery system according to any preceding claim, wherein the glyceride is present in an amount of from 0.5% to 20% by weight of the delivery system.

Claim 11

A delivery system according to any preceding claim, wherein the glyceride is a distilled monoglyceride present in an amount of from 1% to 3 % by weight of the delivery system.

Claim 12

A delivery system according to Claim 6 or any one of Claims 7 to 10 when appendant to Claim 6, wherein the lecithin is present in an amount of from 0.5% to 9%.

Claim 13

A delivery system according to any preceding claim, having a melting point in the range of from 25 0 C to 90o C .

Claim 14

A delivery system according to any preceding claim, having a particle size of from 200 to 30 U.S. Standard mesh size.

Claim 15

A delivery system according to any preceding claim, further comprising a sweetener.

Claim 16

A composite having a substantially hydrophobic exterior comprising (a) an agglomerated mixture of a core material comprising a drug, and a matrix wherein the matrix comprises: (i) from 0.5% to 20% fat soluble lecithin; (ii) from 61% to 90% of an edible material having a melting point in the range of from 25 0 C to 100 0 C chosen from a fatty acid having an iodine value of from 1 to about 10; natural waxes; synthetic waxes; and mixtures thereof; and (iii) from 0.5% to 20% of a glyceride; the composite having a melting point in the range of from 20°C to 90°C.

Claim 17

A composite having a substantially hydrophobic exterior comprising (a) an agglomerated mixture of a core material comprising a drug, and a matrix wherein the matrix comprises: (i) from 0.5% to 20% fat soluble lecithin; (ii) from 61% to 90% of an edible material having a melting point in the range of from 25 0 C to 100 0 C chosen from a fatty acid having an iodine value of from 1 to about 10; natural waxes; synthetic waxes; and mixtures thereof; and (iii) from 0.5% to 20% of a glyceride; the composite having a melting point in the range of from 20°C to 90°C.

Claim 18

A composite according to Claim 15 contained in one of the following: a confectionery product; a chewing gum product; or a pharmaceutical preparation.