Encased-pellet tablets

1. An encased-pellet tablet for an active pharmaceutical ingredient, comprising:

an inner core including an excipient matrix and a plurality of individually coated pellets containing at least one active pharmaceutical ingredient coated with a pellet coating, and

an excipient layer completely surrounding the inner core including all of the coated pellets of the inner core,

wherein the excipient layer contains from about 1 wt. % to about 20 wt. % of at least one cushioning agent selected from polyhydroxyl compounds, based on the total weight of the excipient layer.

2. The encased-pellet tablet of claim 1 , wherein the inner core comprises two or more different coated pellets.

3. The encased-pellet tablet of claim 2 , wherein the two or more different coated pellets have different pellet coatings that provide different active pharmaceutical ingredient release profiles to the coated pellets.

4. The encased-pellet tablet of claim 2 , wherein the two or more different types of coated pellets comprise pellets with different active pharmaceutical ingredients.

5. The encased-pellet tablet of claim 1 , wherein the pellet coating has at least one function selected from the group consisting of taste masking, odor masking, stabilization of the active pharmaceutical ingredient, improving processability of the active pharmaceutical ingredient, improving the flow behavior of the active pharmaceutical ingredient, decreasing the hygroscopicity of the active pharmaceutical ingredient, guaranteeing and improving the chemical and/or mechanical stability of the active pharmaceutical ingredient, modifying the release of the active pharmaceutical ingredient from the coated pellet, modifying the API bioavailability, and coloring.

6. The encased-pellet tablet of claim 1 , wherein the at least one cushioning agent comprises from about 2 wt. % to about 18 wt. % of the excipient layer.

7. The encased-pellet tablet of claim 1 , wherein the at least one cushioning agent comprises from about 4 wt. % to about 18 wt. % of the excipient layer.

8. The encased-pellet tablet of claim 1 , wherein the at least one cushioning agent comprises from about 5 wt. % to about 15 wt. %, or from about 7 wt. % to about 12 wt. % , or from about 4 wt. % to about 11 wt. %, of the excipient layer.

9. The encased-pellet tablet of claim 1 , wherein the excipient matrix of the inner core comprises at least one component selected from cushioning agents, disintegrants, plasticizers, binders, diluents, and antistatic agents.

10. The encased-pellet tablet of claim 1 , wherein the at least one cushioning agent is selected from polyethylene glycols, polypropylene glycols, polytetramethylene glycols, polybutylene glycols, polybutadiene diols and triols, low molecular weight hydroxy-containing polyesters, hydroxy-containing polyester amides, polyalkylene ether glycol compounds, and hydroxy-containing oils.

11. The encased-pellet tablet of claim 1 , wherein the at least one cushioning agent comprises polyethylene glycol.

12. The encased-pellet tablet of claim 1 , wherein the excipient layer comprises a polymer selected from ethylcellulose, methylcellulose, hydroxypropylmethyl cellulose, cellulose acetate phthalate, polymers of methacrylic acid and methacrylic acid esters, microcrystalline cellulose, polysaccharides such as lactose, and combinations thereof.

13. The encased-pellet tablet of claim 1 , wherein the excipient layer comprises one or more excipients selected from the group consisting of a disintegrant, a swelling agent, a diluent, a lubricant, an antistatic agent or a glidant, a permeabilizer, a sweetener, a flavoring agent, and a colorant.

14. The encased-pellet tablet of claim 1 , wherein the excipient matrix of the inner core comprises at least one cushioning agent selected from polyhydroxyl compounds.

15. The encased-pellet tablet of claim 14 , wherein the at least one cushioning agent in the excipient matrix of the inner core comprises a cushioning agent selected from polyethylene glycols, polypropylene glycols, polytetramethylene glycols, polybutylene glycols, polybutadiene diols and triols, low molecular weight hydroxy-containing polyesters, hydroxy-containing polyester amides, polyalkylene ether glycol compounds, and hydroxy-containing oils.

16. The encased-pellet tablet of claim 14 , wherein the at least one cushioning agent in the excipient matrix of the inner core comprises polyethylene glycol.

17. The encased-pellet tablet of claim 1 , wherein the at least one cushioning agent in the excipient matrix of the inner core has a weight percentage of from about 1% to about 20%, or from about 2% to about 18%, or from 4% to about 18%, or from 5% to about 15%, or from 7% to about 12%, or from 4% to about 11% of the total weight of the inner core.

18. A method for manufacturing an encased-pellet tablet, comprising the steps of:

(i) compressing an excipient material with a compression force from about 0.1 kN to 3 kN to form a first layer of excipient material;

(ii) compressing a excipient matrix and a plurality of individually coated pellets containing an active pharmaceutical ingredient on said first layer with a compression force from about 0.1 kN to 3 kN to form an inner core of said excipient matrix and said coated pellets on said first layer; and

(iii) compressing additional excipient material with a compression force from 2 kN to 20 kN around an exposed portion of said inner core thereby completely surrounding said inner core including all of the coated pellets of the inner core with said excipient material from steps (i) and (iii).

19. The method of claim 18 , wherein the compression force for step (iii) is from about 4 kN to about 15 kN.

20. The method of claim 18 , wherein the compression force for step (iii) is from about 5 kN to about 12 kN.

21. The encased-pellet table of claim 1 , wherein the excipient layer comprises at least 40 wt. %, based on the total weight of the encased pellet-tablet.