Fast dissolving softgel capsules including ibuprofen

HK40138040APending Publication Date: 2026-09-25R P SCHERER TECH INC
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Patent Information

Application Number
HK62026124755
Authority / Receiving Office
HK · HK
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-18
Filing Date
2026-06-12
Publication Date
2026-09-25
Estimated Expiration
2044-09-11

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Abstract

Disclosed in certain embodiments is a soft gel capsule comprising a filler material comprising ibuprofen or a pharmaceutically acceptable salt thereof and a shell composition comprising a non-gelatin bio-based polymer when dissolved in 900 ml of 50 mM phosphate buffer (pH 7.2) and deionized water at 37 DEG C using a USP device I at a basket speed of 75-200 rpm or using a USP device II at a paddle speed of 75 RPM, the membrane completely dissolves within less than 30 minutes.
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Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480059870.8 (22) Application Date 2024.09.12 (30) Priority Data 63 / 538,952 2023.09.18 US (85) PCT International Application Entering National Phase Date 2026.03.18 (86) PCT International Application Application Data PCT / US2024 / 046395 2024.09.12 (87) PCT International Application Publication Data WO2025 / 064293 EN 2025.03.27 (71) Applicant R.P. Scherer Technology Co., Ltd. Address Nevada, USA (72) Inventors S.A. Kim Q.Fang K. Sukuru A. Genadios (74) Patent Agency Beijing Liu Shen Law Firm 11105 Patent Attorney Qin Jian (51) Int.Cl. A61K 9 / 48 (2006.01) A61K 31 / 192 (2006.01) A61K 9 / 28 (2006.01) A61P 29 / 00 (2006.01) (54) Invention Title Including Ibuprofen Instant Soft Gel Capsules (57) Abstract In some embodiments, a soft gel capsule is disclosed comprising a filling material containing ibuprofen or a pharmaceutically acceptable salt thereof and a shell composition comprising a non-gelatin biobased polymer, when used at 37°C with USP device I at a basket speed of 75-200 rpm or with USP device II at 75 When the RPM was dissolved in 900 ml of 50 mM phosphate buffer (pH 7.2) and deionized water, the membrane completely dissolved in less than 30 minutes. Claims: 3 pages; Description: 12 pages; Drawings: 6 pages; CN 122138824 A 2026.06.02 CN 1 22 13 88 24 A

Claims

1. A soft gel capsule comprising: Filler formulations containing ibuprofen; and Shell compositions comprising non-gelatin bio-based polymers; The shell composition dissolved in less than 20 minutes according to a dissolution test using the USP device Paddle II at 75 rpm in 250 mL of 50 mM phosphate buffer (pH 7.2).

2. The soft gel capsule of claim 1, wherein at least 80% of the filling formulation is released in less than 25 minutes.

3. The soft gel capsule of claim 1, wherein the non-gelatin bio-based polymer comprises carrageenan, maltodextrin, pullulan, or a combination thereof.

4. The soft gel capsule of claim 1, wherein the shell composition further comprises a synthetic polymer.

5. The soft gel capsule according to claim 4, wherein the synthetic polymer is polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, high molecular weight polyethylene glycol, povidone, surfactant, nonionic triblock copolymer or a combination thereof.

6. The soft gel capsule according to claim 5, wherein the synthetic polymer is a nonionic triblock copolymer.

7. The soft gel capsule of claim 6, wherein the nonionic triblock copolymer comprises polyethylene oxide and polypropylene oxide blocks.

8. The soft gel capsule according to claim 5, wherein the surfactant is sodium lauryl sulfate.

9. The soft gel capsule of claim 1, wherein the shell composition further comprises a non-animal-derived gelling agent.

10. The soft gel capsule of claim 9, wherein the non-animal-derived gelling agent comprises starch, pregelatinized starch, xanthan gum, agar, pectin, sugar, sugar-derived alcohol, cellulose derivatives, cellulose polymers, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose, microcrystalline cellulose, attapulgite, bentonite, dextrin, alginate, kaolin, lecithin, magnesium aluminum silicate, carbomer, carboplatin, silica, guar gum, Danish agar, egg white powder, lactalbumin, soy protein, chitosan, or combinations thereof.

11. The soft gel capsule of claim 1, wherein the shell composition further comprises a plasticizer.

12. The soft gel capsule of claim 1, wherein the shell composition further comprises a buffer.

13. The soft gel capsule of claim 1, wherein the shell composition dissolves in less than 15 minutes, less than 10 minutes, or less than 5 minutes.

14. The soft gel capsule of claim 9, wherein the non-animal-derived gelling agent comprises carrageenan.

15. The soft gel capsule of claim 14, wherein the carrageenan comprises 1-carrageenan, κ-carrageenan, λ-carrageenan, or a combination thereof.

16. The soft gel capsule of claim 9, wherein the non-animal gelling agent does not contain starch.

17. The soft gel capsule of claim 9, wherein the amount of the non-animal gelling agent is about 10% to about 50% (w / w) of the shell composition.

18. The soft gel capsule of claim 14, wherein the amount of carrageenan is about 2 to about 30% (w / w).

19. The soft gel capsule of claim 1, wherein it comprises less than 10%, less than 5%, or less than 1% of an animal-derived gelling agent.

20. The soft gel capsule of claim 1, wherein the membrane does not contain animal-derived gelling agents.

21. The soft gel capsule of claim 11, wherein the plasticizer comprises glycerin, glycerol, sorbitol, sorbitol dehydrated sorbitol solution, triacetin, polysorbate, or a combination thereof.

22. The soft gel capsule of claim 21, wherein the polysorbate comprises Tween 20, Tween 80, or a combination thereof.

23. The soft gel capsule of claim 11, wherein the amount of said plasticizer is about 15 to about 75% (w / w) of the shell composition.

24. The soft gel capsule of claim 12, wherein the amount of the buffer is about 0.1% to about 5% (w / w) of the shell composition.

25. The soft gel capsule of claim 12, wherein the buffer comprises disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium bicarbonate, sodium citrate, disodium phosphate, calcium phosphate, calcium hydrogen phosphate, tricalcium phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, potassium phosphate, or a combination thereof.

26. The soft gel capsule of claim 1, wherein the polymer is present in the following amounts: about 1 to about 70% (w / w), about 2 to about 65% (w / w), about 5 to about 60% (w / w), about 10 to about 55% (w / w), about 15 to about 50% (w / w), about 20 to about 45% (w / w), about 25 to about 40% (w / w), or about 30 to about 35% (w / w) of the shell composition.

27. The soft gel capsule of claim 3, wherein the polymer is pullulan.

28. The soft gel capsule film of claim 27, wherein the amount of pullulan is about 1 to about 30% (w / w), about 2 to about 25% (w / w), about 4 to about 20% (w / w), about 5 to about 15% (w / w), or about 7.5 to about 12.5% ​​(w / w) of the shell composition.

29. The soft gel capsule of claim 3, wherein the polymer is maltodextrin.

30. The soft gel capsule of claim 29, wherein the amount of maltodextrin is about 10 to about 50% (w / w), about 15 to about 45% (w / w), about 20 to about 40% (w / w), or about 25 to about 35% (w / w) of the shell composition.

31. The soft gel capsule according to claim 3, wherein the polymer is pullulan and maltodextrin.

32. The soft gel capsule of claim 31, wherein the amount of said polymer is about 1 to about 70% (w / w), about 5 to about 65% (w / w), about 10 to about 60% (w / w), about 15 to about 55% (w / w), about 20 to about 50% (w / w), about 25 to about 45% (w / w), or about 30 to about 40% (w / w) of the shell composition.

33. The soft gel capsule of claim 1, wherein the filling formulation further comprises a solvent, an ionizing agent, or a combination thereof.

34. The soft gel capsule of claim 33, wherein the solvent comprises polyethylene glycol, water, or a combination thereof.

35. The soft gel capsule of claim 33, wherein the ionizing agent comprises potassium hydroxide, sodium hydroxide, or a combination thereof.

36. The soft gel capsule of claim 1, wherein the ibuprofen content is about 15 to about 65% (w / w) of the filling formulation.

37. The soft gel capsule of claim 33, wherein the solvent content is about 20% to about 70% (w / w) of the filling formulation.

38. The soft gel capsule of claim 34, wherein the content of polyethylene glycol is from about 20% to about 65% (w / w) of the filling formulation.

39. The soft gel capsule of claim 34, wherein the water content is from about 0.1% to about 55% (w / w) of the filling formulation.

40. The soft gel capsule of claim 33, wherein the ionizing agent is present in an amount of about 0.5% to about 15% (w / w) of the filling formulation.

41. The soft gel capsule of claim 1, wherein the soft gel capsule has a stability of at least 99%, at least 97%, at least 95%, at least 93%, or at least 90% at 30°C / 65% RH for 1 month, 3 months, 6 months, or 12 months.

42. The soft gel capsule of claim 1, wherein the soft gel capsule has a stability of at least 99%, at least 97%, at least 95%, at least 93%, or at least 90% at 25°C / 60% RH for 1 month, 3 months, 6 months, or 12 months.

43. The soft gel capsule of claim 1, wherein the soft gel capsule has a stability of at least 99%, at least 97%, at least 95%, at least 93%, or at least 90% at 40°C / 75% RH for 1 month, 3 months, 6 months, or 12 months.

44. The soft gel capsule according to claim 1, wherein the ibuprofen content is from about 150 mg to about 1000 mg.

45. A method for treating pain or inflammation, comprising administering a soft gel capsule according to any one of claims 1 to 44 to a subject in need.

46. ​​A method for preparing soft gel capsules, comprising: Prepare a shell composition comprising a non-gelatin bio-based polymer; Preparation of filler formulations containing ibuprofen; and The filling formulation is encapsulated in the shell composition.

47. A soft gel capsule comprising: Filler formulations containing ibuprofen or pharmaceutically acceptable salts thereof; and Shell compositions comprising non-gelatin bio-based polymers; The shell composition dissolved in less than 20 minutes according to the dissolution test using USP device I at a basket speed of 75-200 rpm or using USP device II at a paddle speed of 50-1000 rpm in 200-1000 mL or 200-400 mL of 50 mM phosphate buffer (pH 7.2).

48. A soft gel capsule comprising: Filler formulations containing ibuprofen or pharmaceutically acceptable salts thereof; and Shell compositions comprising non-gelatin bio-based polymers; The shell composition dissolved in less than 20 minutes according to the dissolution test using USP device III at 30-100 DPM or using USP device paddle III at 50-100 rpm in 200-400 mL of 50 mM phosphate buffer (pH 7.2).

49. A soft gel capsule comprising: Filler formulations containing ibuprofen; and Shell compositions comprising non-gelatin bio-based polymers; The shell composition dissolved in less than 20 minutes according to a dissolution test using a USP device II at a paddle speed of 75 rpm in 900 mL of 50 mM phosphate buffer (pH 7.2).