Encapsulation apparatus and process

• US 5,735,105 A
• Filed: 10/02/1995
• Issued: 04/07/1998
• Est. Priority Date: 12/16/1992
• Status: Expired due to Term

• Current Assignee: Catalent Pharma Solutions Incorporated (Catalent, Inc.), Catalent Pharma Solutions Limited (Catalent, Inc.), Catalent USA Packaging LLC (Catalent, Inc.), Catalent USA Paintball, Inc. (Catalent, Inc.), Catalent USA Woodstock, Inc. (Catalent, Inc.)
• Original Assignee: R.P. Scherer Corporation (Cardinal Health, Inc.)
• Inventors: Walker, David J., Garnett, Kelvin R., Wood, Anthony J., Burnett, Arthur J., Stroud, Norman S.
• Primary Examiner(s): YEUNG, GEORGE CHAN PUI
• Application Number:
  US08/481,411
• Time in Patent Office: 918 Days
• Field of Search: 426/576, 53/560, 53/141, 53/411, 53/452, 53/454, 264/4, 264/DIG. 37, 425/804, 425/5, 206/484, 156/291, 156/298
• US Class Current: 53/411
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• CPC Class Codes: Y10S 264/37 Processes and molds for making capsules
• CPC Class Codes: Y10S 425/804 Capsule making
• CPC Class Codes: Y10T 156/109 Embedding of laminae within face of additional laminae

Abstract

A continuous solvent free gelatin encapsulation apparatus and process includes an oil roll back assembly (20) for applying a controlled amount of a food-approved lubricant to a first side of the gelatin ribbon and an applicator guide bar assembly (40) for applying a controlled amount of food-approved lubricant to a second side of the gelatin ribbon. Two opposing food-approved lubricant coated gelatin ribbons are then united in a die assembly (50) to form gelatin capsules which are then dried and recovered.

Claims

1. A gelatin encapsulation process comprising the steps of:

a. casting a continuous first gelatin ribbon and a continuous second gelatin ribbon;

b. applying food-approved lubricant to a first side of the first gelatin ribbon and to a first side of the second gelatin ribbon;

c. applying food approved lubricant to a second side of the first gelatin ribbon and to a second side of the second gelatin ribbon to give a lubricated first gelatin ribbon and a lubricated second gelatin ribbon;

d. uniting the lubricated first gelatin ribbon and the lubricated second gelatin ribbon to form gel pockets and injecting fill material into the gel pockets to give freshly formed gelatin capsules;

e. cooling the freshly formed gelatin capsules to assist their separation from a net formed by the remainder of the gelatin ribbons;

f. finishing the freshly formed gelatin capsules by drying them to give finished gelatin capsules; and

g. recovering the finished gelatin capsules;

wherein the steps of applying food-approved lubricant to the first and second gelatin ribbons comprise controlling the amount of food-approved lubricant applied to the first and second gelatin ribbons so that the finished gelatin capsules do not require a solvent wash step to remove lubricant, whereby the gelatin encapsulation process is a solvent-free process.

2. A solvent-free gelatin encapsulation process as claimed in claim 1, wherein the amount of food-approved lubricant applied to the first side and second side of the first and second gelatin ribbons is controlled with a lubricant pump.

3. A solvent-free gelatin encapsulation process as claimed in claim 1 or 2, wherein the food-approved lubricant applied to the first side of the first and second gelatin ribbons is fractionated coconut oil or a similar medium chain triglyceride.

4. A solvent-free gelatin encapsulation process as claimed in claim 1, wherein the freshly formed gelatin capsules are finished by the steps of conveying the freshly formed gelatin capsules to a dryer, and drying the freshly formed gelatin capsules to define finished gelatin capsules.

5. A solvent free gelatin encapsulation process as claimed in claim 1, wherein the amount of food-approved lubricant applied to the first and second gelatin ribbons is controlled to give freshly formed gelatin capsules coated with less than 600 micrograms/gram of a food-approved lubricant.

6. A solvent free gelatin encapsulation process as claimed in claim 1, wherein the amount of food-approved lubricant applied to the first and second gelatin ribbons is controlled so that the finished gelatin capsules are coated with less than 400 micrograms/gram of food-approved lubricant.

7. A solvent free encapsulation process as claimed in claim 1, wherein cooling air is directed onto the freshly formed gelatin capsules.

8. A solvent free encapsulation process as claimed in claim 7, wherein the air temperature in the region of the freshly formed gelatin capsules is 13-18°

C.

9. A soft gelatin encapsulation apparatus comprising:

two opposing gelatin ribbon casting apparatuses for casting a first and second continuous ribbon of gelatin;

a first pair of applicator means respectively for applying a food-approved lubricant to a first side of the first gelatin ribbon and a first side of the second gelatin ribbon;

a second pair of applicator means respectively for applying a food-approved lubricant to a second side of the first gelatin ribbon and a second side of the second gelatin ribbon;

a die assembly;

cooling means for cooling the gelatin capsules when they are freshly formed by the die assembly, in order to assist separation of the gelatin capsules from a net formed by the remainder of the gelatin ribbons; and

means for controlling the amount of food-approved lubricant applied to the first and second gelatin ribbons so that finished gelatin capsules do not require a solvent wash step to remove lubricant.

10. Apparatus as claimed in claim 9 wherein each applicator means of said first pair thereof comprises an oil roll bank assembly including a lower roller, one or more intermediate rollers, and a first sintered roller for applying a food-approved lubricant to the first side of the gelatin ribbon.

11. Apparatus as claimed in claim 10, wherein the first sintered roller includes a perforated roller shaft surrounded by a sintered sleeve.

12. Apparatus as claimed in claim 10 or 11, wherein the rate of food-approved lubricant delivered to the first sintered roller is controlled with a first lubricant pump.

13. Apparatus as claimed in claim 12, wherein the first lubricant pump rate is controlled by the rotation of a roller associated with the oil roll bank assembly.

14. Apparatus as claimed in claim 13, wherein each applicator means of said second pair thereof comprises an applicator guide bar assembly.

15. Apparatus as claimed in claim 14, wherein the applicator guide bar assembly includes a stationary bar and a second sintered roller for applying food-approved lubricant to the second side of the gelatin ribbon.

16. Apparatus as claimed in claim 15, wherein the stationary bar is tapered.

17. Apparatus as claimed in claim 16, wherein the second sintered roller includes a perforated sparge tube and a sintered sleeve.

18. Apparatus as claimed in claim 17, wherein the sintered sleeve is a sintered high-density polyethylene sleeve.

19. Apparatus as claimed in claim 15, wherein the rate of food-approved lubricant delivered to the second sintered roller is controlled by a second lubricant pump.

20. Apparatus as claimed in claim 19 wherein the pump rate of the second lubricant pump is controlled by the rotation of a roller associated with the oil roll bank assembly.

21. Apparatus as claimed in claim 9, wherein the cooling means is arranged to direct cooling air or other gaseous coolant onto the freshly formed gelatin capsules.

22. Soft gelatin encapsulation apparatus comprising:

lubricant applying apparatus, said lubricant applying apparatus compromising first applicator means for applying a food-approved lubricant to a first side of a gelatin ribbon, second applicator means for applying a food-approved lubricant to a second side of the gelatin ribbon, and means for controlling the amount of food-approved lubricant applied to the gelatin ribbon so that finished gelatin capsules do not require a solvent wash step to remove lubricant;

a die assembly for forming gelatin capsules using the gelatin ribbon; and

cooling means for cooling freshly formed gelatin capsules to assist their separation from the remainder of the gelatin ribbon.