Psyllium tablet composition, method of manufacture and method of use

• US 4,999,200 A
• Filed: 12/09/1987
• Issued: 03/12/1991
• Est. Priority Date: 12/09/1987
• Status: Expired due to Fees

• Current Assignee: Marion Laboratories Incorporated Kansas City Missouri
• Original Assignee: Marion Laboratories (Sanofi )
• Inventors: Casillan, Angel
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Catchpole, W.
• Application Number:
  US07/130,021
• Time in Patent Office: 1,189 Days
• Field of Search: 424/195.1, 424/464, 424/465, 424/474, 424/480, 514/892
• US Class Current: 424/480
• CPC Class Codes: A61K 36/68 Plantaginaceae (Plantain Family)
• CPC Class Codes: A61K 9/2004 Excipients; Inactive ingredients

Abstract

A psyllium composition in tablet form is provided having a wetting agent, a disintegrant and a binding agent. In one embodiment, the wetting agent is polysorbate 80, the binding agent is polyvinyl pyrrolidone and the dry binding agent and disintegrant is microcrystalline cellulose. Calcium carbonate may also be added to serve as a disintegrant in HCL. The tablets are manufactured by mixing the psyllium powder with a solution of povidone and polysorbate 80. Microcrystalline cellulose may be added either during or after granulation. After mixing, the composition is compressed into tablet form. The mixing of the ingredients in specific quantities allows a tablet to be manufactured that is both resistant to fracture and at the same time disintegrates easily and quickly in the gastrointestinal tract of the patient.

Claims

1. A bulk laxative composition in tablet form consisting essentially of:

50 parts of psyllium powder ±

10;

1.5 parts of a wetting agent ±

1.0;

100 parts of a binding agent ±

10; and

2.5 parts of a disintegrating agent ±

0.5, to provide a tablet which resists fracture in commercial production but disintegrates easily in water or stomach acid.

4. The composition of claim 1 wherein said tablets are coated with an hydroxypropyl methylcellulose film.

2. A bulk laxative composition in tablet form consisting essentially of:

50 parts of psyllium powder ±

10;

1.5 parts of polysorbate 80 ±

1.0;

15 parts of polyvinyl pyrrolidone ±

1.0; and

100 parts of microcrystalline cellulose ±

10.

3. The composition of claim 2 and further including calcium carbonate as a disintegrant in stomach acid.

5. A method of treating constipation in a patient comprising:

administering to the patient an effective amount of a bulk laxative in tablet form consisting essentially of, the composition of 50 parts of psyllium powder ±

10, 1.5 parts of polysorbate 80 ±

1.0, 100 parts of microcrystalline cellulose ±

10, 2.5 parts of calcium carbonate ±

0.5 and 15 parts of polyvinyl pyrrolidone ±

1.0, said tablet being formulated so as to disintegrate rapidly and thoroughly in the patient'"'"'s gastrointestinal tract.

6. The method of claim 5 wherein the total daily dosage of said psyllium is approximately 2.4 to 3.6 grams.

7. The method of claim 5 and further comprising:

administering one to four of said tablets to the patient wherein each tablet has 600-900 mg psyllium.

8. A method of preparing a bulk laxative composition in tablet form, said method comprising the steps of:

granulating psyllium powder with povidone-polysorbate solution in water;

adding microcrystalline cellulose;

drying the mixture of said granulated psyllium powder with povidone-polysorbate solution in water and said microcrystalline cellulose; and

compressing the resulting composition into tablets.

9. The method of claim 8, wherein said tablets are coated with hydroxypropyl methylcellulose.

10. The method of claim 8 and further comprising the steps of:

adding a portion of said microcrystalline cellulose during wet granulation.