Chewable dosage forms

• US 5,637,313 A
• Filed: 12/16/1994
• Issued: 06/10/1997
• Est. Priority Date: 12/16/1994
• Status: Expired due to Term

• Current Assignee: Watson Laboratories, Inc. (Connecticut) (Abbvie Incorporated)
• Original Assignee: Watson Laboratories, Inc. (Connecticut) (Abbvie Incorporated)
• Inventors: Chau, Tommy L., La Bella, Nicholas A. Jr.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): HOWARD, SHARON LEE
• Application Number:
  US08/357,506
• Time in Patent Office: 907 Days
• Field of Search: 424/440, 424/469, 424/488, 514/819, 514/820, 425/3-6
• US Class Current: 424/440
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/07 Retinol compounds, e.g. vitamin A retinoic acids A61K31/203
• CPC Class Codes: A61K 31/52 Purines, e.g. adenine
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61K 31/714 Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
• CPC Class Codes: A61K 31/80 Polymers containing hetero atoms not provided for in groups A61K31/755 - A61K31/795
• CPC Class Codes: A61K 33/08 Oxides; Hydroxides
• 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

Abstract

Disclosed is a soft, chewable dosage form, including a matrix of hydrogenated starch hydrolysate, a water soluble bulking agent, and a water insoluble bulking agent. The present invention also includes a method of preparing a soft, chewable dosage form, including the steps of mixing under high shear force, a hydrogenated starch hydrolysate, a water soluble bulking agent, and a water insoluble bulking agent until a uniformly blended matrix is obtained. Active ingredients may optionally be incorporated in the matrix.

Claims

1. A soft, chewable dosage form, comprising:

a matrix comprising between 7 and 45% by weight hydrogenated starch hydrolysate, up to 90% by weight of a water soluble bulking agent, and up to 65% by weight of a water insoluble bulking agent.

2. The soft, chewable dosage form of claim 1, further comprising an active ingredient supported by said matrix.

3. The dosage form of claim 1, wherein said matrix comprising between about 14 and 27% by weight hydrogenated starch hydrolysate, between about 30 and 60% by weight of a water soluble bulking agent, and between about 15 and 40% of a water insoluble bulking agent.

4. The dosage form of claim 1, wherein said water soluble bulking agent is selected from the group consisting of sorbitol, xylitol, sucrose, fructose, dextrose, mannitol, starch, maltodextrin, corn syrup solids and mixtures thereof.

5. The dosage form of claim 1, wherein said water insoluble bulking agent is selected from the group consisting of aluminum hydroxide, calcium carbonate, magnesium carbonate, magnesium hydroxide and mixtures thereof.

6. The dosage form of claim 1, wherein said water soluble bulking agent is sorbitol and said water insoluble bulking agent is calcium carbonate.

7. The dosage form of claim 1, wherein the dosage form is selected from the group consisting of tablets, caplets and pills.

8. The dosage form of claim 1, further comprising a flavoring agent.

9. The dosage form of claim 1, further comprising a colorant.

10. The dosage form of claim 1, further comprising a humectant.

11. The dosage form of claim 10, wherein said humectant is glycerin.

12. The dosage form of claim 2, wherein said active ingredient is selected from the group consisting of magnesium hydroxide, aluminum hydroxide, caffeine, simethicone, vitamin A, vitamin B₁₂, vitamin D₃ and mixtures thereof.

21. The dosage form of claim 1, wherein the matrix is non-compressed.

22. The dosage form of claim 2, wherein the matrix is non-compressed.

26. The dosage form of claim 2, wherein said active ingredient is microencapsulated.

27. The dosage form of claim 22, wherein said active ingredient is microencapsulated.

28. The dosage form of claim 1 further comprising an emulsifier.

29. The dosage form of claim 1 wherein said dosage form is a comestible.

13. A soft, chewable calcium tablet, comprising a matrix comprising between 7 and 45% by weight hydrogenated starch hydrolysate, up to 90% by weight of sorbitol and up to 65% by weight of calcium carbonate.

14. The tablet of claim 13, wherein said tablet is formed from a matrix comprising between about 20 and 25% by weight hydrogenated starch hydrolysate, between about 35 and 45% by weight of sorbitol and between about 30 and 40% of calcium carbonate.

23. The tablet of claim 13, wherein said matrix is non-compressed.

15. A method of preparing a soft, chewable dosage form, comprising the steps of:

mixing under high shear force, between 7 and 45% by weight hydrogenated starch hydrolysate, up to 90% by weight of a water soluble bulking agent, and up to 65% by weight of a water insoluble bulking agent until a uniformly blended matrix is obtained; and

forming said matrix into said dosage form.

16. The method of claim 15, wherein said high shear force is provided by a sigma-bladed mixer.

17. The method of claim 15, further comprising the step of adding an active ingredient during the mixing step.

18. The method of claim 15, wherein said mixing takes place in the absence of added heat.

19. The method of claim 15, wherein said matrix is rolled to a predetermined thickness and cut into tablets of predetermined size.

24. The method of claim 15, wherein said matrix is formed into said dosage form without compression.

25. The method of claim 17, wherein said active ingredient is microencapsulated.

20. A soft, chewable antacid tablet, comprising a matrix comprising between 14 and 27% by weight hydrogenated starch hydrolysate, between 30 and 60% by weight sorbitol, aluminum hydroxide, magnesium hydroxide and simethicone.