Fast-dissolve tablet technology

• US 20040161459A1
• Filed: 08/01/2003
• Published: 08/19/2004
• Est. Priority Date: 12/31/2002
• Status: Abandoned Application

• Current Assignee: Cheng Der Tony Yu, Larry Augsburger, Ngoc Do
• Original Assignee: Cheng Der Tony Yu, Larry Augsburger, Ngoc Do
• Inventors: Do, Ngoc, Augsburger, Larry, Yu, Cheng Der Tony
• Application Number:
  US10/633,445
• Publication Number:
  US 20040161459A1
• Time in Patent Office: Days
• US Class Current: 424/465
• 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 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/2081 with microcapsules or coated microparticles according to A61K9/50
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: A61K 9/5078 with drug-free core

Abstract

The current invention relies on a process already provided in great detail in U.S. Pat. No. 60/437,507 and an associated CIP filed on May 23, 2003 and hereby incorporated by reference. However, it was noted during additional studies that if the Cushioning Beads™ were milled to a particle size between about 10 mesh and about 50 mesh and to a most preferred size of 30-40 mesh, the Cushioning Beads™ did not loose their ability to protect coated particles during compression, as would be expected because of the fine milling. Moreover, it was also discovered that tablets compressed from the milled Cushioning Beads™ immediately disperse in the mouth. A final advantage of the current invention is the improved hardness and friability. The invention produces a tablet of 2Kp or 20N hardness. A vast improvement because it allows for use of conventional manufacturing and packaging equipment.

Claims

1. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of highly-compactable filler in combination with a highly water-absorbing material and;

b) adding purified water to the mixture of highly compactable filler and highly water-absorbing material until granules are formed by visual inspection thus creating the cushioning component; and

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and milled cushioning component with or without said extrusion and spheronization to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

2. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of Avicel®

PH101 and Ac-Di-Sol® and

;

b) adding purified water to the mixture of Avicel®

PH101 and Ac-Di-Sol®

until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and milled cushioning component with or without said extrusion and spheronization to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

3. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of Avicel®

PH101 and Ac-Di-Sol®

in a ratio that the mixture will have Ac-Di-Sol ranging from 5 to 90% by weight and;

b) adding of purified water to the mixture of Avicel®

PH101 and Ac-Di-Sol®

until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and the milled cushioning component with or without said extrusion and spheronization to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

4. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of a highly-compactable filler in combination with a highly water-absorbing material and;

b) adding of purified water to the mixture of highly-compactable filler and highly water-absorbing material until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including nonactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and the milled cushioning component with or without said extrusion and spheronization until a LOD of 2-15% is achieved to create the Cushioning Beads™

followed by an optional step of extrusion and spheronization of the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

5. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of Avicel®

PH 101 and Ac-Di-Sol® and

;

b) adding purified water to the mixture of Avicel®

PH101 and Ac-Di-Sol®

until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and milled cushioning component with or without said extrusion and spheronization until a LOD of 2-15% is achieved to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast tablet for treatment of a patient in need of said treatment.

6. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of Avicel®

PH101 and Ac-Di-Sol®

in a ratio that the mixture will have Ac-Di-Sol ranging from 5 to 90% by weight;

b) adding of purified water to the mixture of Avicel®

PH101 and Ac-Di-Sol®

until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and milled cushioning component with or without said extrusion and spheronization until a LOD of 2-15% is achieved to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

7. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of a highly-compactable filler in combination with a highly water-absorbing material and;

b) adding purified water to the mixture of highly-compactable filler and highly water-absorbing material until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding more than one type of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and milled cushioning component with or without said extrusion and spheronization to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

8. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of Avicel®

PH101 and Ac-Di-Sol® and

;

b) adding purified water to the mixture of Avicel®

PH101 and Ac-Di-Sol®

until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of more than one type of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and milled cushioning component with or without said extrusion and spheronization to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

9. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of Avicel®

PH101 and Ac-Di-Sol®

in a ratio that the mixture will have Ac-Di-Sol ranging from 5 to 90% by weight and;

b) adding of purified water to the mixture of Avicel®

PH101 and Ac-Di-Sol®

until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of more than one type of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and the milled cushioning component with or without said extrusion and spheronization to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

10. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of a highly-compactable filler in combination with a highly water-absorbing material and;

b) adding of purified water to the mixture of highly-compactable filler and highly water-absorbing material until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of more than one type of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and the milled cushioning component with or without said extrusion and spheronization until a LOD of 2-15% is achieved to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

11. A method for the of manufacture of a fast dissolve tablet that includes:

a) blending of Avicel®

PH101 and Ac-Di-Sol® and

;

b) adding purified water to the mixture of Avicel®

PH101 and Ac-Di-Sol®

until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of more than one type of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and milled cushioning component with or without said extrusion and spheronization until a LOD of 2-15% is achieved to create the Cushioning Beads™

; and

f) and compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.

12. A method for the manufacture of a fast dissolve tablet that includes:

a) blending of Avicel®

PH101 and Ac-Di-Sol®

in a ratio that the mixture will have Ac-Di-Sol ranging from 5 to 90% by weight and;

b) adding of purified water to the mixture of Avicel®

PH101 and Ac-Di-Sol®

until granules are formed by visual inspection thus creating the cushioning component and;

c) the cushioning component is milled to a particle size of between 10-325 mesh (2000-45 micron); and

d) adding of more than one type of active-loaded beads to the milled cushioning component to create a mixture followed by an optional step of extrusion and spheronization and the option of including inactive ingredients to improve patient compliance, functionality or manufacturability; and

e) freeze-drying of the mixture of active-loaded beads and milled cushioning component with or without said extrusion and spheronization until a LOD of 2-15% is achieved to create the Cushioning Beads™

; and

f) compressing the Cushioning Beads™

into a fast dissolve tablet for treatment of a patient in need of said treatment.