Non-burst releasing pharmaceutical composition
Described herein are controlled release oral pharmaceutical compositions and methods for making the same. These pharmaceutical compositions provide a non-burst release of one or more active pharmaceutical ingredients. In particular, a non-burst controlled release oral pharmaceutical composition comprising a capsule and an abuse deterrent controlled release matrix comprising one or more active pharmaceutical ingredients are described.
1. An abuse deterrent oral pharmaceutical composition comprising a tamper resistant controlled release matrix comprising:
(a) about 50% to about 65% by weight oleic acid or glyceryl monolinoleate;
(b) about 25% to about 35% by weight polyethylene oxide;
(c) 1% to about 5% by weight ethylcellulose having a viscosity of about 20 cP;
(d) 1% to about 5% by weight sodium lauryl sulfate; and
(e) 1.5% to about 10% by weight hydrocodone;
wherein the matrix is resistant to tampering and prevents the burst release of the one or more active pharmaceutical ingredients and is encapsulated in a capsule shell.
2. The composition of claim 1 , wherein the matrix further comprises one or more antioxidants.
3. The composition of claim 2 , wherein the antioxidant comprises about 0.05% to about 0.5% by weight of the total matrix mass.
4. The composition of claim 1 , wherein the polyethylene oxide comprises a polyethylene oxide having a molecular weight (M v ) of about 3,000,000, about 4,000,000, about 5,000,000; about 6,000,000, about 7,000,000, about 8,000,000, about 9,000,000, or about 10,000,000.
5. The composition of any one of claim 2 , wherein the antioxidant comprises alpha tocopherol, beta tocopherol, gamma tocopherol, delta tocopherol, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), citric acid, ascorbic acid, carnosic acid, carnosol, rosmanol, epirosmanol, isorosmanol, methyl carnosate, rosmarinic acid, eugenol, eugenyl acetate, clove bud extract, methanolic extract, epigallocatechin gallate, epicatechin gallate, epigallocatechin, epicatechin, or a combination thereof.
6. The composition of claim 1 , wherein the tamper resistant controlled release matrix forms a semisolid elastic composition after being heated at a temperature of about 50° C. to about 90° C. for a time period of about 0.1 hours to about 3 hours.
7. The composition of claim 1 , wherein the capsule shell comprises a soft capsule shell.
8. A tamper resistant oral pharmaceutical composition comprising a tamper resistant controlled release matrix comprising:
(a) about 50% to about 65% by weight of oleic acid;
(b) about 25% to about 35% by weight polyethylene oxide having a molecular weight of from about 3,000,000 to about 7,000,000;
(c) about 1% to about 5% by weight ethylcellulose having a viscosity of about 20 cP;
(d) about 1% to about 5% by weight of sodium lauryl sulfate; and
(e) about 1.5% to about 10% by weight of oxycodone or hydrocodone;
wherein the matrix is resistant to tampering and has controlled release properties.
9. A method for treating, reducing the symptoms or onset of, or prophylaxis of pain stemming from diabetic neuropathy, chronic arthritis, osteoarthritis, rheumatoid arthritis, acute tendonitis, bursitis, headaches, migraines, chronic neuropathies, shingles, premenstrual symptoms, sports injuries, malignancy, radiculopathy, sciatica/sciatic pain, sarcoidosis, necrobiosis, lipoidica or granuloma annulare comprising administering to a subject in need thereof the pharmaceutical composition according to claim 1 .
10. A method for reducing the burst release of one or more active ingredients from a pharmaceutical composition comprising providing the pharmaceutical composition according to claim 1 .
11. An abuse deterrent oral pharmaceutical composition comprising a tamper resistant controlled release matrix, wherein the tamper resistant controlled release matrix comprises a means for preventing the crushing, grating, grinding, cutting, solvating, or dissolving of the tamper resistant controlled release matrix comprising:
(a) about 50% to about 65% by weight of oleic acid;
(b) about 25% to about 35% by weight polyethylene oxide having a molecular weight of from about 3,000,000 to about 7,000,000;
(c) about 1% to about 5% by weight ethylcellulose having a viscosity of about 20 cP;
(d) about 1% to about 5% by weight of sodium lauryl sulfate;
(e) about 1.5% to about 10% by weight of hydrocodone; and
(f) about 0.05% to about 0.5% by weight of one or more antioxidants.
12. The composition of claim 2 , wherein the antioxidant comprises one or more of butylated hydroxytoluene (BHT), or butylated hydroxyanisole (BHA).
13. The composition of claim 8 , further comprising:
(f) about 0.25% by weight BHT; and
(g) about 0.1% by weight BHA.