CHEWABLE SOFT CAPSULE HAVING IMPROVED INGESTION PROPERTY AND METHOD FOR PRODUCING SAME

• US 20100239638A1
• Filed: 06/11/2010
• Published: 09/23/2010
• Est. Priority Date: 02/26/1999
• Status: Active Grant

• Current Assignee: Hidekazu Shodai, Noboru Nagafuji, Toshitada Toyoda, Yuka Okada
• Original Assignee: Hidekazu Shodai, Noboru Nagafuji, Toshitada Toyoda, Yuka Okada
• Inventors: Okada, Yuka, Toyoda, Toshitada, Nagafuji, Noboru, Shodai, Hidekazu
• Granted Patent: US 8,372,428 B2
• Time in Patent Office: Days
• US Class Current: 424/439
• CPC Class Codes: A23G 1/042 Manufacture or treatment of liquid, cream, paste, granule, shred or powder
• CPC Class Codes: A23G 1/30 Cocoa products, e.g. chocolate; Substitutes therefor
• CPC Class Codes: A23G 1/54 Composite products, e.g. layered laminated, coated, filled
• CPC Class Codes: A23G 3/0205 Manufacture or treatment of liquids, pastes, creams, granules, shred or powder
• CPC Class Codes: A23G 3/36 characterised by the composition containing organic or inorganic compounds
• CPC Class Codes: A23G 3/54 Composite products, e.g. layered, coated, filled
• CPC Class Codes: A23P 10/30 Encapsulation of particles, e.g. foodstuff additives
• CPC Class Codes: A61K 47/06 Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

A soft capsule in which a shell is filled with fill material, and the fill material is in a solid or semi-solid form at room temperature. The soft capsule may be a chewable capsule, and the fill material may comprise a low melting point additive. The content of the low melting point additive may be 10% or more with respect to the total weight of the fill material, and may have a melting point of about 20 to 50° C. The low melting point additive may be selected from the group consisting of chocolate base, lard, coconut oil and macrogol (polyethylene glycol) as well as a combination thereof.

Claims

1-33. -33. (canceled)

34. A soft capsule comprising a fill material filling a shell,

wherein the fill material is in a solid or semi-solid form at room temperature and the fill material comprises a low melting point additive comprising a chocolate base comprising cacao butter,

wherein said soft capsule has been subjected to aging for 5 to 64 hours at a temperature of 30 to 40°

C. so that a major amount of V-type cacao butter crystals and minor amount of VI-type cacao butter crystals are formed such that the shell and fill material are homogenized with each other; and

wherein the soft capsule is a chewable capsule.

35. A soft capsule according to claim 34, wherein the content of the low melting point additive is 10% or more with respect to the total weight of the fill material.

36. A soft capsule according to claim 35, wherein the content of the low melting point additive is 30% or more with respect to the total weight of the fill material.

37. A soft capsule according to claim 36, wherein the content of the low melting point additive is 50% or more with respect to the total weight of the fill material.

38. A soft capsule according to claim 34, wherein the melting point of the low melting point additive is about 20 to 50°

C.

39. A soft capsule according to claim 34, wherein the low melting point additive further comprises a second ingredient selected from lard, coconut oil, polyethylene glycol, or combinations thereof.

40. A soft capsule according to claim 34, wherein the chocolate base further comprises bitter chocolate.

41. A soft capsule according to claim 34, wherein the fill material further comprises a sweetening agent.

42. A soft capsule according to claim 41, wherein the sweetening agent is selected from the group consisting of aspartame, disodium glycyrrhizinate, saccharin sodium, stevia and thaumatin as well as a combination thereof.

43. A soft capsule according to claim 42, wherein the fill material comprises cacao butter and aspartame.

44. A soft capsule according to claim 41, wherein the fill material further comprises a saccharide.

45. A soft capsule according to claim 44, wherein the saccharide is selected from the group consisting of sucrose, D-mannitol, xylitol, erythritol, D-sorbitol, maltose, reduced maltose syrup and maltitol as well as a combination thereof.

46. A soft capsule according to claim 41, wherein the fill material further comprises an aromatic.

47. A soft capsule according to claim 46, wherein the aromatic is chocolate flavor.

48. A soft capsule according to claim 34, wherein the shell comprises the following components (A) and (B):

(A) gelatin; and

(B) one or more plasiticizers selected from (b1) to (b3), wherein a total of 100 to 600 weight parts of the plasticizers is present in the shell with respect to 100 weight parts of gelatin;

(b1) glycerin,

(b2) saccharide plasticizer selected from the group consisting of sucrose, fructose, D-mannitol, xylitol, erythritol, D-sorbitol, maltose, reduced maltose syrup, maltitol, sucrose alcohol and isomerized sugar as well as a combination thereof, and

(b3) glycol selected from the group consisting of propylene glycol and polyethylene glycol as well as a combination thereof.

49. A soft capsule according to claim 48, wherein the plasticizers (B) include the glycerin (b1).

50. A soft capsule according to claim 48, wherein the shell further comprises (C) water-insoluble cellulose, wherein 5 to 100 weight parts of water-insoluble cellulose is present in the shell with respect to 100 weight parts of the gelatin.

51. A soft capsule according to claim 48, wherein the shell further comprises (D) a sweetener.

52. A soft capsule according to claim 51, wherein the sweetener (D) is selected from the group consisting of saccharin sodium, stevia and thaumatin as well as a combination thereof.

53. A soft capsule according to claim 34, wherein the fill material comprises a drug.

54. A soft capsule according to claim 53, wherein the content of the drug is 60% or less with respect to the total weight of the fill material.

55. A soft capsule according to claim 54, wherein the drug is selected from the group consisting of an antipyretic analgesic drug component, a rhinitis drug component, an antitussive expectorant drug component and a vitamin component as well as a combination thereof.

56. A soft capsule according to claim 34, wherein the fill material comprises a food.

57. A method for producing a soft capsule according to claim 34, comprising the step of:

filling the shell with the fill material.

58. A method according to claim 57, wherein the fill material comprises cacao butter and the method further comprises the step of:

subjecting the fill material filling in the shell to aging at a temperature of 30 to 40°

C.

59. A method according to claim 58, wherein the aging is conducted for 10 hours to 64 hours.

60. A soft capsule according to claim 39, wherein the second ingredient is lard.

61. A soft capsule according to claim 39, wherein the second ingredient is coconut oil.

62. A soft capsule according to claim 39, wherein the second ingredient is polyethylene glycol.

63. A soft capsule according to claim 34, wherein the melting point of the low melting point additive is about 20 to 50°

C. and wherein the low melting point additive further comprises lard, coconut oil, polyethylene glycol, or combinations thereof.

64. The soft capsule of claim 34, wherein the soft capsule has been subjected to aging for 5 hours to 16 hours at a temperature of about 35°

C.

65. A soft capsule comprising a fill material filling a shell:

wherein the fill material is in a solid or semi-solid form at room temperature;

wherein the fill material comprises (i) a chocolate base comprising cacao butter and bitter chocolate, and (ii) a drug;

wherein said soft capsule has been subjected to aging for 5 hours to 64 hours at a temperature of 30 to 40°

C. so that a major amount of V-type cacao butter crystals and minor amount of VI-type cacao butter crystals are formed such that the shell and fill material are homogenized with each other; and

wherein the soft capsule is a chewable capsule.

66. A soft capsule produced by:

melting a chocolate base comprising cacao butter to produce a fill material;

producing a shell;

filling the shell with the fill material; and

drying the fill material in a drying chamber at a temperature of 30 to 40°

C. for 5 hours to 64 hours so that a major amount of V-type cacao butter crystals and minor amount of VI-type cacao butter crystals are formed such that the shell and fill material are homogenized with each other to produce the soft capsule.