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Methylphenidate extended release chewable tablet

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اقرأ أكثر حفظ في قائمتي
  • Publication Date:
    April 25, 2023
  • معلومة اضافية
    • Patent Number:
      11633,389
    • Appl. No:
      17/070824
    • Application Filed:
      October 14, 2020
    • نبذة مختصرة :
      An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.
    • Inventors:
      Tris Pharma, Inc. (Monmouth Junction, NJ, US)
    • Assignees:
      TRIS PHARMA, INC (Monmouth Junction, NJ, US)
    • Claim:
      1. A methylphenidate chewable tablet comprising a solid uniform dispersion comprising: a sustained release racemic methylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, racemic methylphenidate - cation exchange resin complex in an optional polymeric matrix, wherein when present the polymeric matrix comprises the racemic methylphenidate -cation exchange resin complex and a water-insoluble polymer or copolymer or a water-soluble polymer or copolymer; wherein the barrier coating comprises a water-insoluble, water-permeable, pH-independent polymer and a plasticizer; wherein the barrier coating is present in an amount of about 20 % w/w to about 50% w/w % based on the weight of the coated racemic methylphenidate-cation exchange resin complex-optional matrix, is over the racemic methylphenidate-cation exchange resin complex-optional matrix, and provides a sustained release profile to the racemic methylphenidate in the sustained release racemic methylphenidate component; and at least one immediate release racemic methylphenidate component which provides a release of the racemic methylphenidate in the at least one immediate release component in less than about 30 minutes as determined in an in vitro dissolution assay; wherein about 50% w/w to about 90% w/w of the racemic methylphenidate in the tablet is provided by the sustained release racemic methylphenidate component based on the total amount of racemic methylphenidate in the chewable tablet; and pharmaceutically acceptable excipients.
    • Claim:
      2. The racemic methylphenidate chewable tablet according to claim 1 , wherein at least one immediate release methylphenidate component releases in about 10 minutes.
    • Claim:
      3. The racemic methylphenidate chewable tablet according to claim 1 , the sustained release racemic methylphenidate component provides about 60% w/w to about 80% w/w of the racemic methylphenidate in the chewable tablet, based on the total amount of racemic methylphenidate in the tablet.
    • Claim:
      4. The racemic methylphenidate chewable tablet according to claim 1 , the sustained release racemic methylphenidate component provides about 70% w/w of the racemic methylphenidate in the chewable tablet, based on the total amount to racemic methylphenidate in the tablet.
    • Claim:
      5. The racemic methylphenidate chewable tablet according to claim 1 , wherein the at least one immediate release components comprises an immediate release racemic methylphenidate-cation exchange resin complex in an amount of about 10% w/w to about 20% w/w of the total racemic methylphenidate in the chewable tablet.
    • Claim:
      6. The racemic methylphenidate chewable tablet according to claim 2 , wherein the at least one immediate release component comprises uncomplexed racemic methylphenidate or a pharmaceutically acceptable salt thereof.
    • Claim:
      7. The racemic methylphenidate chewable tablet according to claim 6 , wherein the uncomplexed racemic methylphenidate or pharmaceutically acceptable salt thereof is about 10% w/w to about 20% w/w of the total racemic methylphenidate in the chewable tablet.
    • Claim:
      8. The racemic methylphenidate chewable tablet according claim 6 , wherein the racemic methylphenidate or pharmaceutically acceptable salt thereof is racemic methylphenidate HCl.
    • Claim:
      9. The racemic methylphenidate chewable tablet according to claim 1 , wherein the methylphenidate HCl in an amount of about 15% w/w of the total racemic methylphenidate in the chewable tablet.
    • Claim:
      10. The racemic methylphenidate chewable tablet according to claim 1 , wherein the composition comprises an immediate release component racemic methylphenidate-cation exchange resin complex in an amount of about 15% w/w of the total racemic methylphenidate in the chewable tablet.
    • Claim:
      11. The racemic methylphenidate chewable tablet according to claim 1 , wherein the total immediate release racemic methylphenidate components are about 30% w/w of the total racemic methylphenidate in the chewable tablet.
    • Claim:
      12. The racemic methylphenidate chewable tablet according to claim 1 , wherein the tablet has a hardness in the range of about 8 kp to about 23 kp.
    • Claim:
      13. The racemic methylphenidate chewable tablet according to claim 1 , wherein the barrier coating comprises about 2.5% w/w to about 15% w/w of a plasticizer or combination of plasticizers.
    • Claim:
      14. The racemic methylphenidate chewable tablet according to claim 1 , wherein the water insoluble, water-permeable, pH-independent barrier coating has a tensile strength in a range of about 150% to about 400% and is (a) a cured, water-permeable, non-ionic, pH-independent barrier coating comprising polyvinylacetate, a stabilizer, and a plasticizer; (b) a pH-independent, acrylic based coating comprising a polymer or copolymer comprising ethyl acrylate and methyl methacrylate; or (c) a solvent-based ethylcellulose coating.
    • Claim:
      15. The racemic methylphenidate chewable tablet according to claim 1 , wherein the barrier coating over the racemic methylphenidate-cation exchange resin complex-optional matrix of (a) is a cured, water-insoluble, water-permeable, non-ionic, pH-independent barrier coating comprises about 70 to about 90% w/w polyvinylacetate, a stabilizer, and about 2 to about 10% w/w of a plasticizer.
    • Claim:
      16. The racemic methylphenidate chewable tablet according to claim 1 , wherein the barrier coating layer is about 25% to about 35%, by weight, of the coated racemic methylphenidate-cation exchange resin complex-optional matrix.
    • Claim:
      17. The racemic methylphenidate chewable tablet according to claim 1 , wherein the chewable tablet provides a pharmacokinetic profile in which the methylphenidate has at least one of: a geometric mean for area under the curve (AUC)0-∞ of about 110 ng-hr/mL to about 140 ng-hr/mL and a geometric mean Cmax of about 10 ng/mL to about 15 ng/mL, under fasted and fed conditions in adults following a single oral administration of a chewable tablet comprising the equivalent of 40 mg racemic methylphenidate HCl.
    • Claim:
      18. The racemic methylphenidate chewable tablet according to claim 1 , wherein the tablet provides a single plasma concentration peak for methylphenidate.
    • Claim:
      19. The racemic methylphenidate chewable tablet according to claim 1 , wherein the tablet can be scored and is readily titrated.
    • Claim:
      20. The racemic methylphenidate chewable tablet according to claim 1 , wherein the polymeric matrix is present and comprises polyvinylpyrolidone.
    • Claim:
      21. The racemic methylphenidate chewable tablet according to claim 1 , wherein pharmacokinetic profile further comprises the 90% confidence intervals of the geometric test/reference ratios of one or more of AUC0-3 or AUC0-4 of FIG. 1 .
    • Claim:
      22. The chewable racemic methylphenidate chewable tablet according to claim 1 , wherein the methylphenidate plasma concentration, as determined under fasted and fed conditions following a single oral administration of said chewable tablet at a dose equivalent to 40 mg racemic methylphenidate HCl in adults, is equivalent to the plasma concentration curve of FIG. 1 from about 0 to about 8 hours.
    • Claim:
      23. The racemic methylphenidate chewable tablet according to claim 1 , wherein the chewable tablet provides a therapeutically effective amount of methylphenidate in under about 1 hour and through about 8 hours following oral ingestion by a patient having attention deficit hyperactivity disorder.
    • Claim:
      24. The racemic methylphenidate chewable tablet according to claim 1 , wherein said tablet comprises the equivalent of 40 mg racemic methylphenidate HCl.
    • Claim:
      25. The racemic methylphenidate chewable tablet according to claim 1 , wherein said tablet comprises the equivalent of 20 mg racemic methylphenidate HCl.
    • Claim:
      26. The racemic methylphenidate chewable tablet according to claim 1 , wherein said tablet comprises the equivalent of 30 mg racemic methylphenidate HCl.
    • Claim:
      27. A methylphenidate chewable tablet comprising a solid uniform dispersion which comprises: a sustained release racemic methylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, racemic methylphenidate-cation exchange resin complex in an optional polymeric matrix, wherein when present the polymeric matrix comprises the racemic methylphenidate-cation exchange resin complex and a water-insoluble polymer or copolymer or a water-soluble polymer or copolymer, wherein the barrier coating comprises a water-insoluble, water-permeable, pH-independent polymer and a plasticizer, and wherein the barrier coating is present in an amount of about 20% w/w to about 50% w/w % based on the weight of the coated racemic methylphenidate-cation exchange resin complex-optional matrix, is over the racemic methylphenidate-cation exchange resin complex-optional matrix, and provides a sustained release profile to the racemic methylphenidate in the sustained release racemic methylphenidate component; and a first immediate release racemic methylphenidate component which provides a release of the racemic methylphenidate in the at least one immediate release component in less than about 30 minutes as determined in an in vitro dissolution assay, wherein the at least one immediate release component comprises uncomplexed racemic methylphenidate or a pharmaceutically acceptable salt thereof; and a second immediate release racemic methylphenidate component which comprises an immediate release methylphenidate-cation exchange resin complex; wherein about 50% w/w to about 90% w/w of the racemic methylphenidate in the tablet is provided by the sustained release racemic methylphenidate component based on the total amount of racemic methylphenidate in the chewable tablet; and pharmaceutically acceptable excipients.
    • Claim:
      28. The racemic methylphenidate chewable tablet according to claim 27 , wherein the barrier coating of the barrier coated racemic methylphenidate-cation exchange resin complex-optional matrix comprises about 2.5% w/w to about 15% w/w of a plasticizer or combination of plasticizers.
    • Claim:
      29. The racemic methylphenidate chewable tablet according to claim 27 , wherein the chewable tablet provides a therapeutically effective amount of methylphenidate in under about 1 hour and through about 8 hours following oral ingestion by a patient having attention deficit hyperactivity disorder.
    • Claim:
      30. The racemic methylphenidate chewable tablet according to claim 27 , wherein said chewable tablet is capable of being divided and retaining the extended release profile for methylphenidate, and a pharmacokinetic profile in which the methylphenidate has a geometric mean for area under the curve (AUC)0-∞ of about 110 ng-hr/mL to about 140 ng-hr/mL and a geometric mean Cmax of about 10 ng/mL to about 15 ng/mL under fasted and fed conditions following a single oral administration of an chewable tablet comprising 40 mg racemic methylphenidate HCl in adults.
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      Teva's Post-Trial Opening Brief (redacted), Tris Pharrna, Inc. v. Teva Pharmaceuticals USA, Inc., C.A. No. 2:20-cv-05212, pp. 1-56, Aug. 25, 2022. cited by applicant
      Teva's Post-Trial Responsive Brief (redacted), Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc., C.A. No. 2:20-cV-05212, pp. 1-47, Aug. 25, 2022. cited by applicant
      Teva's Post-Trial Responsive Brief (2nd submission, redacted), Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc., C.A. No. 2:20-cv-05212, pp. 1-47, Aug. 25, 2022. cited by applicant
      Opinion (amended), Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc., C.A. No. 2:20-cv-05212, pp. 1-66, Sep. 6, 2022. cited by applicant
      Order (amended), Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc., C.A. No. 2:20-cv-05212, pp. 1-2, Sep. 6, 2022. cited by applicant
    • Primary Examiner:
      Young, Micah Paul
    • Attorney, Agent or Firm:
      Howson & Howson
      Kodroff, Cathy A.
    • الرقم المعرف:
      edspgr.11633389