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Last Updated: December 1, 2020

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Claims for Patent: 10,086,087

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Summary for Patent: 10,086,087
Title:Modified release formulations containing drug-ion exchange resin complexes
Abstract: A particulate, modified release barrier coated drug-cation exchange resin complex comprising a core composed of a drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. Methods of making and products containing this coated complex are described.
Inventor(s): Mehta; Ketan (Miami, FL), Tu; Yu-Hsing (West Windsor, NJ)
Assignee: Tris Pharma, Inc. (Monmouth Junction, NJ)
Application Number:15/619,637
Patent Claims: 1. An orally ingestible aqueous liquid suspension comprising: (A) modified release, barrier coated particulates which do not need an enteric coating to provide prolonged release which comprise: (i) a particulate drug-cation exchange resin complex comprising at least one drug bound to a pharmaceutically acceptable water insoluble cation exchange resin, wherein said particulate drug-cation exchange resin complex is of a size capable of passing through a number 40 mesh screen and wherein said at least one drug is amphetamine or dextro-amphetamine and (ii) about 20% w/w to about 50% w/w of a water permeable, water insoluble, non-ionic, modified release diffusion barrier coating based on the weight of the barrier coated particulates, said barrier coating having an elongation factor of about 125% to about 400% and which provides a modified release profile to the drug in said drug-cation exchange resin complex and which comprises: (a) a water-insoluble polymer, and (b) about 2.5% w/w to about 20% w/w of a plasticizer based on the weight of the barrier coating; (B) at least one of (iiia) and/or (iiib): (iiia) an uncoated particulate dextro-amphetamine-cation exchange resin complex of a size capable of passing through a number 40 mesh screen, wherein said uncoated dextro-amphetamine-cation exchange resin complex comprises dextro-amphetamine bound to a pharmaceutically acceptable water insoluble cation exchange resin, (iiib) an uncoated particulate amphetamine-cation exchange resin complex of a size capable of passing through a number 40 mesh screen, wherein said uncoated amphetamine-cation exchange resin complex comprises amphetamine bound to a pharmaceutically acceptable water insoluble cation exchange resin, and optionally at least one of (iiic) and/or (iiid): (iiic) amphetamine or a pharmaceutically acceptable salt thereof which is not complexed with an ion exchange resin, or (iiid) dextroamphetamine or a pharmaceutically acceptable salt thereof which is not complexed with an ion exchange resin; and/or (C) a pharmaceutically acceptable aqueous suspension base, wherein said barrier coated drug-cation exchange resin complex as defined in (A) and said at least one additional component as defined in (B) are suspended in said base, wherein the water insoluble polymer in said diffusion barrier coating comprises polyvinyl acetate.

2. The orally ingestible aqueous liquid suspension according to claim 1, wherein said diffusion barrier coating is cured.

3. The orally ingestible aqueous liquid suspension according to claim 1, wherein the plasticizer is selected from dibutyl sebacate, propylene glycol, polyethylene glycol, polyvinyl alcohol, triethyl citrate, acetyl triethyl citrate, acetyl tributyl citrate, tributyl citrate, or triacetin, or mixtures thereof.

4. The orally ingestible aqueous liquid suspension according to claim 1, wherein said diffusion barrier coating further comprises a stabilizer.

5. The orally ingestible aqueous liquid suspension according to claim 1, wherein the modified release, barrier coated particulates as defined in (A) comprise about 30% w/w to about 50% w/w of said diffusion barrier coating.

6. The orally ingestible aqueous liquid suspension according to claim 1, wherein the modified release, barrier coated particulates as defined in (A) comprise about 30% w/w to about 45% w/w by weight of said diffusion barrier coating.

7. The orally ingestible aqueous liquid suspension according to claim 1 which comprises said uncoated particulate dextro-amphetamine--cation exchange resin as defined in (B)(iiia).

8. The orally ingestible aqueous liquid suspension according to claim 1 which comprises said uncoated particulate amphetamine--cation exchange resin as defined in (B)(iiib).

9. The orally ingestible aqueous liquid suspension according to claim 1 which comprises at least one of said amphetamine or pharmaceutically acceptable salt as defined in (B)(iiic) and/or said dextro-amphetamine as defined in (B)(iiid).

10. The orally ingestible aqueous liquid suspension according to claim 1, wherein said cation exchange resin used to form the complex as defined in (A), (B)(iiia), and/or (B)(iiib) is a sulfonated copolymer comprising styrene and a divinylbenzene.

11. The orally ingestible aqueous liquid suspension according to claim 1, wherein the plasticizer is present in an amount of about 5% to about 10% by weight of the coating layer.

12. An orally ingestible aqueous liquid suspension comprising: (A) modified release, barrier coated particulates which do not need an enteric coating to provide prolonged release which comprise: (i) a particulate drug-cation exchange resin complex comprising at least one drug bound to a pharmaceutically acceptable water insoluble cation exchange resin, wherein said particulate drug-cation exchange resin complex is of a size capable of passing through a number 40 mesh screen and wherein said at least one drug is amphetamine or dextro-amphetamine and (ii) about 20% w/w to about 50% w/w of a water permeable, water insoluble, non-ionic, modified release diffusion barrier coating based on the weight of the barrier coated particulates, said barrier coating having an elongation factor of about 125% to about 400% and which provides a modified release profile to the drug in said drug-cation exchange resin complex and which comprises: (a) a water-insoluble polymer, and (b) about 2.5% w/w to about 20% w/w of a plasticizer based on the weight of the barrier coating; (B) at least one of (iiia) and/or (iiib): (iiia) an uncoated particulate dextro-amphetamine-cation exchange resin complex of a size capable of passing through a number 40 mesh screen, wherein said uncoated dextro-amphetamine-cation exchange resin complex comprises dextro-amphetamine bound to a pharmaceutically acceptable water insoluble cation exchange resin, (iiib) an uncoated particulate amphetamine-cation exchange resin complex of a size capable of passing through a number 40 mesh screen, wherein said uncoated amphetamine-cation exchange resin complex comprises amphetamine bound to a pharmaceutically acceptable water insoluble cation exchange resin, and optionally at least one of (iiic) and/or (iiid): (iiic) amphetamine or a pharmaceutically acceptable salt thereof which is not complexed with an ion exchange resin, or (iiid) dextroamphetamine or a pharmaceutically acceptable salt thereof which is not complexed with an ion exchange resin; and/or (C) a pharmaceutically acceptable aqueous suspension base, wherein said barrier coated drug-cation exchange resin complex as defined in (A) and said at least one additional component as defined in (B) are suspended in said base, wherein the drug ion exchange resin as defined in (A) further comprises a water insoluble polymer or copolymer, or hydrophilic polymer which forms a matrix with the drug--cation exchange resin complex which particulate drug-cation exchange resin complex-(water insoluble polymer or copolymer or a hydrophilic polymer) matrix is capable of passing through a number 40 mesh screen.

13. The orally ingestible aqueous liquid suspension according to claim 12, wherein the hydrophilic polymer as defined in (A) is present to form the drug--cation exchange resin complex--matrix and comprises a polyvinylpyrrolidone.

14. The orally ingestible aqueous liquid suspension according to claim 12, wherein the modified release, barrier coated particulates as defined in (A) comprise about 30% w/w to about 50% w/w of said diffusion barrier coating.

15. The orally ingestible aqueous liquid suspension according to claim 12, wherein the modified release, barrier coated particulates as defined in (A) comprise about 30% w/w to about 45% w/w by weight of said diffusion barrier coating.

16. The orally ingestible aqueous liquid suspension according to claim 12 which comprises said uncoated particulate dextro-amphetamine--cation exchange resin as defined in (B)(iiia).

17. The orally ingestible aqueous liquid suspension according to claim 12 which comprises said uncoated particulate amphetamine--cation exchange resin as defined in (B)(iiib).

18. The orally ingestible aqueous liquid suspension according to claim 12 which comprises at least one of said amphetamine or pharmaceutically acceptable salt as defined in (B)(iiic) and/or said dextro-amphetamine as defined in (B)(iiid).

19. The orally ingestible aqueous liquid suspension according to claim 12, wherein said cation exchange resin used to form the complex as defined in (A), (B)(iiia), and/or (B)(iiib) is a sulfonated copolymer comprising styrene and a divinylbenzene.

20. The orally ingestible aqueous liquid suspension according to claim 12, wherein the plasticizer is selected from dibutyl sebacate, propylene glycol, polyethylene glycol, polyvinyl alcohol, triethyl citrate, acetyl triethyl citrate, acetyl tributyl citrate, tributyl citrate, or triacetin, or mixtures thereof.

21. The orally ingestible aqueous liquid suspension according to claim 12, wherein the water insoluble polymer in said diffusion barrier coating comprises polyvinyl acetate.

22. The orally ingestible aqueous liquid suspension according to claim 21, wherein said diffusion barrier coating is cured.

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