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Summary for Patent: 10,076,494
|Title:||Stable orally disintegrating pharmaceutical compositions|
|Abstract:||Described herein are stable orally disintegrating tablets containing a proton pump inhibitor, methods for making the same, and methods for treating subjects in need thereof. In particular, the orally disintegrating tablets are composed of a plurality of coated units admixed with a disintegrant that demonstrate decreased friability and increased hardness.|
|Inventor(s):||Pevzner; Victor (Hadera, IL), Moses-Heller; Sheera (Atlit, IL)|
|Assignee:||DEXCEL PHARMA TECHNOLOGIES LTD. (Or-Akiva, IL)|
1. A compressed orally disintegrating tablet comprising a disintegrant and a plurality of units comprising: i) a plurality of cores comprising a therapeutically effective
amount of a proton pump inhibitor; ii) an enteric coating in an amount of 10% to 30% by weight of a total tablet weight over the cores, wherein the enteric coating comprises hydroxypropyl methylcellulose phthalate (HPMCP); and iii) a coating comprising
a reverse enteric polymer in an amount of 5% to 15% by weight of a total tablet weight over the enteric coating, wherein the reverse enteric polymer comprises a methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer; wherein a
friability of the compressed tablet is 0.75% or less when 10 kN to 50 kN of a compression force is applied during manufacturing of the tablet.
2. The tablet of claim 1, wherein each core comprises an inert seed coated with an active ingredient coating comprising a proton pump inhibitor.
3. The tablet of claim 2, wherein the inert seed comprises a granule, a pellet, a bead, or a powder.
4. The tablet of claim 1, wherein the proton pump inhibitor comprises omeprazole, lansoprazole, pantoprazole, rabeprazole, tenatoprazole, ilaprazole or a mixture or combination thereof.
5. The tablet of claim 1, wherein each unit further comprises a subcoating between the plurality of cores and the enteric coating.
6. The tablet of claim 5, wherein the subcoating comprises one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, polyethylene glycol, polyvinyl alcohol or a mixture or combination thereof.
7. The tablet of claim 1, wherein the reverse enteric polymer is in an amount of 70% to 100% of the total reverse enteric coating mass.
8. The tablet of claim 1, wherein the weight percentage ratio of the coating comprising a reverse enteric polymer to the enteric coating is about 0.4:1.
9. The tablet of claim 1, wherein the disintegrant comprises one or more of crospovidone, croscarmellose sodium, a cellulose derivative, cross-linked derivatives of starch, pregelatinized starch, crosslinked sodium carboxymethyl cellulose, low substituted hydroxypropylcellulose or a mixture or combination thereof.
10. The tablet of claim 1, further comprising one or more pharmaceutically acceptable excipients selected from a binder, a filler, a diluent, a surfactant, a glidant, a lubricant, a plasticizer, an anti-tacking agent, an alkaline substance, a tonicity enhancing agent, a wetting agent, a buffering substance, a preservative, a sweetener, an opacifier, a colorant, and a mixture or combination thereof.
11. The tablet of claim 1 having a hardness of 20 N to 100 N.
12. The tablet of claim 1, which substantially disintegrates in an oral cavity of a subject within less than 60 seconds after administration.
13. The tablet of claim 1, wherein the disintegrant is in an amount of 2% to 25% by weight of a total tablet weight.
14. The tablet of claim 5, wherein the subcoating is in an amount of 2% to 15% by weight of a total tablet weight.
15. A compressed orally disintegrating tablet prepared by a process comprising the following steps: a) generating a plurality of cores comprising a therapeutically effective amount of a proton pump inhibitor; b) applying an enteric coating solution or dispersion comprising hydroxypropyl methylcellulose phthalate (HPMCP) to the plurality of cores of step (a) thereby obtaining a plurality of enteric coated cores; c) applying a reverse enteric polymer solution or dispersion comprising methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer to the enteric coated cores of step (b) thereby obtaining a plurality of units; d) mixing the plurality of units of step (c) with at least one tablet excipient comprising a disintegrant thereby obtaining a blend; and e) compressing the blend of step (d) using a compression force of from 10 kN to 50 kN thereby obtaining the compressed orally disintegrating tablet having a friability of 0.75% or less, wherein the orally disintegrating tablet comprises an enteric coating in an amount of 10% to 30% by weight of a total tablet weight and a coating comprising a reverse enteric polymer in an amount of 5% to 15% by weight of a total tablet weight.
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