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|Title:||Oral drug delivery system|
|Abstract:||An oral drug delivery system comprising a coated tablet having one or more surfaces. The coated tablet further comprises a core and a coating surrounding the core. The core comprises an active ingredient composition comprising at least one active ingredient and a pharmaceutically acceptable excipient and a composition selected from a swellable composition and a reactive composition located in an immediate vicinity of one or more preselected surfaces. The coating comprising water insoluble polymer(s) and leachable component(s) is operable to be reliably removed fully from the one or more of the preselected surfaces of the tablet upon contact with an aqueous environment, but not removed from at least one of the surfaces.|
|Inventor(s):||Bhalachandra Dharmadhikari; Nitin (Mumbai, IN), Rupsinh Zala; Yashoraj (Mumbai, IN), Singh; Amarjit (Mumbai, IN)|
|Assignee:||Sun Pharma Advanced Research Company Ltd. (Andheri (E), Mumbai, unknown)|
1. A coated tablet comprising: a) a core comprising a first layer comprising active ingredient and a rate controlling excipient and a second layer comprising a swellable composition;
b) a water insoluble coating surrounding the core, the coating comprising one or more water insoluble polymers and one or more water leachable components; wherein the water insoluble coating allows permeation of water after contact with an aqueous
environment causing the second layer to swell and exert pressure on the coating, thereby removing only the coating that is in the immediate vicinity of the swellable composition but not the remaining portion, thereby exposing a defined surface area for
release of the active ingredient for controlled release of active ingredient.
2. The coated tablet of claim 1, wherein the water insoluble coating is impermeable to the active ingredient.
3. The coated tablet of claim 1, wherein the swellable composition comprises a swelling agent.
4. The coated tablet of claim 3, wherein the swelling agent is selected from a swellable excipient, a gas generating agent and mixtures thereof.
5. The coated tablet of claim 1, wherein the swellable composition comprises wicking agents.
6. The coated tablet of claim 1, wherein the swellable composition comprises osmogents.
7. The coated tablet of claim 1, wherein the active ingredient is released without a substantial delay after the tablet contacts an aqueous environment.
8. The coated tablet of claim 1 further comprising an outer coating comprising a pH-dependent polymer.
9. The coated tablet of claim 1, wherein the swellable composition is in the form of an in-lay.
10. The coated tablet of claim 1, wherein the ratio of water insoluble polymer to leachable component varies from about 70: 30 to about 95:5.
11. The coated tablet of claim 10, wherein the leachable component is selected from the group consisting essentially of: inorganic water soluble compounds, organic water soluble compounds and mixtures thereof.
12. The coated tablet of claim 1, wherein the water insoluble polymer in the coating is ethyl cellulose.
13. The coated tablet of claim 12, wherein the water insoluble coating further comprises a mixture of hydrophobic and hydrophilic plasticizers.
14. The coated tablet of claim 13, wherein the hydrophobic plasticizer is selected from the group consisting of dibutyl sebacate, diethyl sebacate, diethyl phthalate, vegetable and mineral oils and mixtures thereof.
15. The coated tablet of claim 14, wherein the ratio of dibutyl sebacate to triethyl citrate is about 5:1.
16. The coated tablet of claim 13, wherein the hydrophilic plasticizer is selected from the group consisting of triethyl citrate, triethyl acetyl citrate, triacetin, tributyl citrate, polyethylene glycol, glycerol and mixtures thereof.