Abuse deterrent dosage forms
Described herein are oral abuse deterrent pharmaceutical compositions, methods for making the same, and methods for treating pain by administering the pharmaceutical composition to a subject in need thereof. In particular, an oral abuse deterrent pharmaceutical composition comprising a soft capsule and a controlled release matrix comprising oxycodone are described.
1. A controlled release oral pharmaceutical composition comprising:
(a) about 35% to about 70% by mass glyceryl monolinoleate;
(b) about 20% to about 50% by mass polyethylene oxide having an average molecular weight (M v ) of about 1,00,000 to about 7,000,000; and
(c) one or more active pharmaceutical ingredients.
2. The composition of claim 1 , wherein the composition further comprises one or more pharmaceutically acceptable excipients.
3. The composition of claim 1 , wherein the composition further comprises one or more pharmaceutically acceptable antioxidants.
4. The composition of claim 3 , wherein the antioxidant comprises about 0.05% to about 0.5% of the composition by mass.
5. The composition of claim 3 , wherein the antioxidant comprises butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), or a combination thereof.
6. The composition of claim 1 , wherein the polyethylene oxide comprises a polyethylene oxide having an average molecular weight (M v ) of about 4,000,000.
7. The composition of claim 1 , wherein the composition comprises a mass ratio of polyethylene oxide to glyceryl monolinoleate of about 1:2.
8. The composition of claim 1 , wherein the composition comprises:
(a) about 35% to about 70% by mass of glyceryl monolinoleate;
(b) about 20% to about 50% by mass of polyethylene oxide; and
(c) about 1% to about 30% by mass of one or more active pharmaceutical ingredients.
9. The composition of claim 8 , further comprising:
(d) about 0.1% to about 0.4% by mass of BHA; and
(e) about 0.05% to about 0.1% by mass of BHT.
10. The composition of claim 1 , wherein the composition comprises:
(a) about 50% to about 70% by mass of glyceryl monolinoleate;
(b) about 25% to about 40% by mass of polyethylene oxide;
(c) about 0.1% to about 0.4% by mass of BHA;
(d) about 0.05% to about 0.1% by mass of BHT; and
(e) about 1% to about 20% of by mass of one or more active pharmaceutical ingredients.
11. An oral controlled release dosage form comprising a capsule encapsulating:
(a) about 50% to about 70% by mass glyceryl monolinoleate;
(b) about 25% to about 40% by mass polyethylene oxide comprising an average molecular weight (M v ) of about 1,00,000 to about 7,000,000; and
(c) about 1% to about 20% by mass of one or more active pharmaceutical ingredients; and
the dosage form having been heated to about 50° C. to about 80° C. for about 10 min to about 180 min, and cooled to room temperature by reducing the temperature at a rate of about 2° C. to about 10° C. per about 5 min to about 15 min.
12. The dosage form of claim 11 , wherein the amount of the one or more active pharmaceutical ingredients is about 5 mg to about 100 mg.
13. The dosage form of claim 11 , wherein the capsule is coated with a polyvinyl alcohol coating.
14. The dosage form of claim 11 , wherein the dosage form exhibits an in vitro dissolution rate at pH 1.2 of about 50% after about 90 minutes.
15. A kit for dispensing a controlled release dosage form comprising:
(a) one or more dosage forms of claim 11 ;
(b) one or more receptacles comprising a tamper evident, moisture proof packaging comprising blister or strip packs, aluminum blisters, transparent or opaque polymer blisters or pouches, polypropylene tubes, colored blister materials, tubes, bottles, or bottles optionally containing child-resistant features, optionally comprising a desiccant; and
(c) optionally, an insert comprising instructions or prescribing information for the dosage form.
16. A method for manufacturing an abuse deterrent dosage form comprising:
(a) combining about 35% to about 70% by mass glyceryl monolinoleate, about 20% to about 50% by mass polyethylene oxide having a molecular weight (M v ) of about 1,00,000 to about 7,000,000, and one or more active pharmaceutical ingredients;
(b) encapsulating the combination into capsules;
(c) incubating the capsules at about 50° C. to about 80° C. for about 10 min to about 180 min; and
(d) cooling the capsules to room temperature.
17. The method of claim 16 , wherein the capsules produced in step (b) are coated with a coating prior to the incubating of step (c).
18. The method of claim 16 , wherein the capsules are cooled in step (d) by reducing the temperature at a rate of about 2° C. to about 10° C. per about 5 to about 15 min.