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CA-3277071-C - SOFTGEL CAPSULES AND A METHOD FOR PREPARING THE SOFTGEL CAPSULES

CA3277071CCA 3277071 CCA3277071 CCA 3277071CCA-3277071-C

Abstract

Disclosed herein is a method for preparing a softgel capsule including treating a soflgel capsule with a solution including a calcium salt, wherein the softgel capsule includes a fdl material and a shell composition including pectin.

Inventors

  • Haitao Li
  • Qi Fang
  • Karunakar Sukuru

Assignees

  • R.P. SCHERER TECHNOLOGIES, LLC

Dates

Publication Date
20260505
Application Date
20231213
Priority Date
20221214

Claims (19)

  1. WHAT IS CLAIMED IS: 1. A method for treating a softgel capsule comprising: applying a treatment solution to a softgel capsule, wherein the treatment solution comprises a calcium salt and a sugar, wherein the softgel capsule comprises a fill material and a shell composition.
  2. 2. The method of claim 1, wherein the calcium salt comprises calcium chloride, calcium citrate, calcium gluconate, calcium lactate or a combination thereof.
  3. 3. The method of claim 1 or 2, wherein the solution further comprises hydrochloric acid.
  4. 4. The method of any one of claims 1 to 3, wherein the solution further comprises water.
  5. 5. The method of any one of claims 1 to 4, wherein the sugar comprises dextrose.
  6. 6. The method of any one of claims 1 to 5, wherein the calcium salt is included in an amount of about 1 wt% to about 25 wt%, based on the total weight of the solution.
  7. 7. The method of claim 3, wherein the pH of the solution is less than 3.
  8. 8. The method of claim 5, wherein the dextrose is included in an amount of about 0.1 wt% to about 20 wt%, based on the total weight of the solution.
  9. 9. The method of any one of claims 1 to 8, wherein the shell composition comprises a plasticizer, pectin, gellan gum, dextrose, gelatin, or a combination thereof.
  10. 10. The method of claim 9, wherein the plasticizer comprises glycerin, sorbitol, sorbitol sorbitan solution, triacetin, polysorbate, or combinations thereof.
  11. 11. The method of claim 9, wherein the plasticizer comprises glycerin, sorbitol sorbitan solution, or a combination thereof. 36
  12. 12. The method of claim 9, wherein the plasticizer is sorbitol sorbitan solution.
  13. 13. The method of any one of claims 1 to 12, further comprising drying the capsules after treating the capsules.
  14. 14. The method of claim 13, wherein the drying is performed by tumble drying the capsules.
  15. 15. The method of claim 13, wherein the drying occurs for about 5 minutes to about 6 hours.
  16. 16. The method of claim 13, wherein the drying is performed in a drying chamber or a drying tunnel.
  17. 17. The method of any one of claims 1 to 16, further comprising adding the softgel capsule to washing treatment equipment, and applying the treatment solution for a time period of about 5 seconds to about 10 minutes.
  18. 18. The method of claim 17, wherein the washing treatment equipment is fully automatic.
  19. 19. The method of claim 17, wherein the washing treatment equipment is jacketed, and the washing equipment is cooled or chilled using an external chiller.

Description

1 SOFTGEL CAPSULES AND A METHOD FOR PREPARING THE SOFTGEL CAPSULES CROSS REFERENCE TO RELATED APPLICATION(S) [0001] The present application claims priority to U.S. Provisional Patent Application No. 63/432,445 filed on December 14, 2022. FIELD OF THE INVENTION [0002] The present invention relates to a method for preparing a softgel capsule including treating the softgel capsule with a solution including a calcium salt, such as calcium chloride. A softgel capsule is also provided including a fill material and a shell composition, wherein the shell composition includes calcium ions. BACKGROUND OF THE INVENTION [0003] Soft capsules, in particular, soft gelatin capsules (or softgel capsules), provide a dosage form which is more readily accepted by patients, since the capsules are easy to swallow and need not be flavored in order to mask any unpleasant taste of the active agent. Softgel encapsulation of drugs further provides the potential to improve the bioavailability' of the pharmaceutical agents. For example, active ingredients may be rapidly released in liquid form as soon as the gelatin shell ruptures. [0004] Efforts have been made to create enteric dosage forms. Enteric dosage forms are designed to protect the contents of the dosage form from gastric conditions. For example, enteric dosage forms have been developed in which conventional enteric polymers (i.e., acid-insoluble polymers) are added in the capsule shell. It has been found that electrostatic attraction may occur in such capsules shell such that a complex coacervates may form in the shell, which are insoluble in acidic pH but dissolve at neutral and basic pH. [0005] Accordingly, there is currently a need to improve the method of preparing the softgel capsule to improve the pH tolerance in enteric dissolution and disintegration and robustness of the shell. SUMMARY OF THE INVENTION [0006] The present invention is directed to a method for preparing a softgel capsule. The method includes treating a softgel capsule \vi.th a solution including a calcium salt, such as calcium chloride, wherein the softgel capsule comprises a fill material and a shell composition. In some embodiments, the solution may further include hydrochloric acid. In some embodiments, the solution may further include ,,,,ater. In some embodiments, the solution may further include a sugar. The sugar may be dextrose. [0007] In some embodiments of the method, the calcium salt may be included in an amount of about 1 \v1% to about 25 wt%, about 2 wt% to about 22 v,1%, about 3 vv1% to about 20 wt%, about 4 wt% to about 18 \\1%, about 5 \\1% to about 16 wt%, about 6 wt% to about 14 \\1%, or about 7 wt% to about 12 \vt%, based on total weight of the solution. [0008] In some embodiments, the solution may have a pH of less than about 3. [0009] In some embodiments, the dextrose may be included in an amount of about 0.1 \\1% to about 20 wt%, about 1 \\1% to about 19 wt%, about 2 ,:vt% to about 18 wt%, about 3 wt% to about 16 wt%, about 4 vv1% to about 14 \\1%, about 5 w1% to about 12 \v1%, or about 6 \\1% to about 10 vvt%, based on total weight of the solution. [0010] In some embodiments, the shell composition may include a plasticizer, pectin, gellan gum, dextrose, gelatin, or a combination thereof. In some embodiments of the shell composition, the plasticizer may include glycerin, sorbitol, sorbitol sorbitan solution, triacetin, polysorbate, or combinations thereof. In other embodiments, the plasticizer may include glycerin, sorbitol sorbitan solution, or a combination thereof. In yet another embodiment, the plasticizer may be sorbitol sorbitan solution. [0011] In some embodiments, the method may further include drying the capsules after treating the capsules. In some embodiments, the drying may be performed by tumble drying the capsules. The drying may occur for about 1 hour, about 1.5 hours, about 2 hours, about 3 hours, or about 4 hours. In some embodiments, the drying may be performed in a drying chamber or a drying tunnel. [0012] In some embodiments of the method. the treating may include usmg a washing/chilling treatment equipment for a pre-determined time period. The washing/chilling treatment equipment may be fully automatic. In some embodiments, the pre-determined time period is about 2.5 seconds, about 5 seconds, about 10 seconds. about 15 seconds, about 20 seconds, about 25 seconds, about 30 seconds, 2 3 about 35 seconds, about 40 seconds, about 45 seconds, about 50 seconds, about 55 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, about 6 minutes, about 7 minutes, about 8 minutes, about 9 minutes, or about 10 minutes. [0013] In another embodiment of the present disclosure, a softgel capsule is provided. The softgel capsule includes a fill material including an active agent and a shell composition, wherein the shell composition includes calcium ions. [0014] In some embodiments, the shell composition may include pectin. The pectin may be