Chewable soft capsules having improved administration properties and process for producing the same

• US 7,763,276 B1
• Filed: 02/23/2000
• Issued: 07/27/2010
• Est. Priority Date: 02/26/1999
• Status: Expired due to Fees

• Current Assignee: Shionogi & Co., Ltd.
• Original Assignee: Shionogi & Co., Ltd.
• Inventors: Okada, Yuka, Toyoda, Toshitada, Nagafuji, Noboru, Shodai, Hidekazu
• Primary Examiner(s): TRAN, SUSAN T
• Application Number:
  US09/914,340
• Time in Patent Office: 3,807 Days
• Field of Search: 424/451
• US Class Current: 424/456
• 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. A method for producing a soft capsule comprising:

melting a low melting point additive comprising a chocolate base comprising cacao butter to produce a fill material, wherein the fill material has a hardness of no greater than 47 kgs;

producing a shell;

filling the shell with the fill material; and

drying the filled material in a drying chamber at a temperature of 30°

C. to 40°

C. for 5 hours to 64 hours so that a major amount of V-type cacao butter crystals and a 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.

2. A method for producing a soft capsule according to claim 1, wherein the content of the low melting point additive is 10% or more with respect to the total weight of the fill material.

3. A method for producing a soft capsule according to claim 2, wherein the content of the low melting point additive is 30% or more with respect to the total weight of the fill material.

4. A method for producing a soft capsule according to claim 3, wherein the content of the low melting point additive is 50% or more with respect to the total weight of the fill material.

5. A method for producing a soft capsule according to any one of claims 1, 2, 3, or 4, wherein the melting point of the low melting point additive is about 20 to 50°

C.

6. A method for producing a soft capsule according to any one of claims 1, 2, 3, or 4, wherein the low melting point additive further comprises a second ingredient selected from lard, coconut oil, polyethylene glycol, or combinations thereof.

7. A method for producing a soft capsule according to claim 1, wherein the chocolate base further comprises bitter chocolate.

8. A method for producing a soft capsule according to claim 1, wherein the fill material further comprises a sweetening agent.

9. A method for producing a soft capsule according to claim 8, 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.

10. A method for producing a soft capsule according to claim 9, wherein the fill material comprises cacao butter and aspartame.

11. A method for producing a soft capsule according to claim 8, wherein the fill material further comprises a saccharide.

12. A method for producing a soft capsule according to claim 11, 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.

13. A method for producing a soft capsule according to claim 8, wherein the fill material further comprises an aromatic.

14. A method for producing a soft capsule according to claim 13, wherein the aromatic is chocolate flavor.

15. A method for producing a soft capsule according to claim 1, 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.

16. A method for producing a soft capsule according to claim 15, wherein the plasticizers (B) include the glycerin (b1).

17. A method for producing a soft capsule according to claim 15, 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.

18. A method for producing a soft capsule according to claim 15, wherein the shell further comprises (D) a sweetener.

19. A method for producing a soft capsule according to claim 18, wherein the sweetener (D) is selected from the group consisting of saccharin sodium, stevia and thaumatin as well as a combination thereof.

20. A method for producing a soft capsule according to claim 1, wherein the fill material further comprises a drug.

21. A method for producing a soft capsule according to claim 20, wherein the content of the drug is 60% or less with respect to the total weight of the fill material.

22. A method for producing a soft capsule according to claim 21, 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.

23. A method for producing a soft capsule according to claim 1, wherein the fill material further comprises a food.

24. A method according to claim 1, wherein the drying is conducted for 10 hours to 64 hours.

25. A method for producing a soft capsule according to claim 6, wherein the second ingredient is lard.

26. A method for producing a soft capsule according to claim 6, wherein the second ingredient is coconut oil.

27. A method for producing a soft capsule according to claim 6, wherein the second ingredient is polyethylene glycol.

28. A method for producing a soft capsule according to any one of claims 1, 2, 3, or 4, 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.

29. A method for producing a soft capsule of claim 1, wherein the drying is conducted for 5 hours to 16 hours at a temperature of about 35°

C.