Multilayered dosage form
The present invention relates to a multilayered coated tablet comprising at least three layers, i.e., first, second and third layer wherein the first and third layers contain at least one active pharmaceutical ingredient and the second layer is either a placebo or an immediate-release drug layer. Further, the tablet has a delayed-release coating, wherein the coating may contain one or more pore-forming agents and/or orifices on one or both sides. Furthermore, it may contain an immediate-release layer of the drug over the delayed-release coating layer. The present invention further relates to processes for preparing such a multilayered coated tablet.
1. A tri-layered tablet having a coating, comprising three layers wherein:
a) a first layer and a third layer contain at least one active pharmaceutical ingredient; and
b) a second layer is either a placebo layer or contains an active pharmaceutical ingredient;
wherein the orientation of the layers is stacked such that the first layer and the third layer constitute the top and bottom layers respectively, and the second layer is the middle layer of the tri-layered tablet and the coating on the tablet is a delayed release coating;
wherein after reaching the intestine the delayed release coating and the second layer dissolve immediately thereby separating the first and the third layers.
2. The tri-layered coated tablet according to claim 1 , wherein the first layer and the third layer contain the same drug.
3. The tri-layered coated tablet according to claim 1 , wherein the first layer and the third layer contain different drugs.
4. The tri-layered coated tablet according to claim 1 , wherein the first layer and the third layer provide an extended-release of the drug contained therein.
5. The tri-layered coated tablet according to claim 1 , wherein the first layer provides an immediate-release of the drug and the third layer provides an extended-release of the drug contained therein after reaching the intestine and dissolution of the delayed release coating.
6. The tri-layered coated tablet according to claim 1 , wherein the second layer comprises lactose and optionally a drug.
7. The tri-layered coated tablet according to claim 6 , wherein the first layer, the second layer and the third layer contain the same drug.
8. The tri-layered coated tablet according to claim 6 , wherein the first layer, the second layer and the third layers contain different drugs.
9. The tri-layered coated tablet according to claim 6 , wherein the first layer and the second layer contain the same drug and the third layer contains a different drug.
10. The tri-layered coated tablet according to claim 6 , wherein the first layer provides an immediate-release of the drug and the third layer provides an extended-release of the drug after reaching the intestine and dissolution of the delayed release coating, provided that the drugs in the first layer and the second layers are different.
11. The tri-layered coated tablet according to claim 1 , wherein the delayed-release coating contains an orifice on either the top or the bottom layer of the tablet.
12. The tri-layered coated tablet according to claim 1 , wherein the delayed-release coating contains orifices on both the top and the bottom layers of the tablet.
13. The tri-layered coated tablet according to claim 1 , wherein the delayed-release coating contains one or more pore-forming agents.
14. The tri-layered coated tablet according to claim 1 , wherein the delayed-release coating contains an orifice on either the top or the bottom layer of the tablet and a pore-forming agent.
15. The tri-layered coated tablet according to claim 1 , wherein the delayed-release coating contains orifices on both the top and the bottom layers of the tablet and a pore-forming agent.
16. The tri-layered coated tablet according to claim 13 or 14 , wherein the pore-forming agent used in the delayed-release coating is a hydrophilic substance, and is selected from the group consisting of sodium chloride, potassium chloride, and magnesium salts, lactose, sucrose, sorbitol, and mannitol, polyethylene glycol and propylene glycol; hydroxypropyl cellulose, hydroxy propyl methylcellulose; methacrylic acid copolymers; sodium starch glycolate, polyvinylpyrrolidones, carbopol, xanthan gum; and mixtures thereof.
17. The tri-layered coated tablet according to claim 1 , wherein the delayed-release polymer used in the delayed-release coating is selected from the group consisting of cellulose acetate phthalate (CAP), cellulose acetate trimelletate (CAT), poly(vinyl acetate)phthalate (PVAP), hydroxypropyl methylcellulose phthalate (HPMCP), poly(methacrylate ethylacrylate) (1:1) copolymer (MA-EA), poly(methacrylate methylmethacrylate) (1:1) copolymer (MA-MMA), poly(methacrylate methylmethacrylate) (1:2) copolymer, Poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) 7:3:1, hydroxypropyl methylcellulose acetate succinate (HPMCAS), and combinations thereof.
18. The tri-layered coated tablet according to claim 1 , wherein the delayed-release coating further comprises an immediate-release drug layer over it.
19. The tri-layered coated tablet according to claim 18 , wherein the immediate-release drug layer over the delayed-release coating layer contains the same drug as that of one of the first layer, the second layer, or the third layer of the tablet.
20. The tri-layered coated tablet according to claim 18 , wherein the immediate-release layer over the delayed-release coating layer contains a drug different than that of one of the first layer, the second layer, or the third layer of the tablet.
21. The tri-layered coated tablet according to claim 1 , wherein the tablet further comprises pharmaceutically acceptable excipients selected from the group consisting of adsorbents, antioxidants, acidifying agents, alkalizing agents, buffering agents, colorants, flavorants, sweetening agents, antiadherents, binders, diluents, direct compression excipients, disintegrants, glidants, lubricants, opaquants, and polishing agents.