Claims for Patent: 12,171,742

Summary for Patent: 12,171,742

Title:	Duloxetine sprinkles
Abstract:	The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.
Inventor(s):	Ravindra Agarwal, Tarun Singhal, Ravi Kochhar
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US17/519,388
Patent Claims:	1. A multiparticulate sprinkle dosage form comprising a drug core comprising duloxetine or a pharmaceutically acceptable salt thereof; and an enteric coating layer surrounding the drug core; wherein the dosage form has higher acid resistance, wherein the higher acid resistance is characterized by not more than 15% of 1-naphthol impurity is released from the dosage form after 6 hours when placed in 0.1 N HCl dissolution media. 2. A multiparticulate sprinkle dosage form comprising a drug core of an acid labile drug; and an enteric coating surrounding the acid labile drug: wherein the dosage form has a higher acid resistance and the acid resistance is characterized by not more than 15% of acid hydrolysis impurity is released from the dosage form after 6 hours when placed in 0.1 N HCl dissolution media; or wherein the sprinkle dosage form exhibits dissolution of not more than 75% of the acid labile drug within 75 minutes, when placed in a dissolution media comprising 0.1N HCl and 20% alcohol; or wherein the multiparticulate sprinkle dosage form can be placed in contact with soft food for at least 60 minutes before administration without affecting the stability of the enteric coating. 3. A multiparticulate sprinkle dosage form comprising a plurality of discrete units, wherein each unit comprises: (a) a drug core comprising an acid labile drug or a pharmaceutically acceptable salt thereof; and (b) an enteric coating layer surrounding the drug core; wherein not more than 90% of acid labile drug is released from the dosage form after 1 or 2 hours when placed in a 40% ethanol dissolution media. 4. A multiparticulate sprinkle dosage form comprising a plurality of discrete units, wherein each unit comprises: an inert core, and a drug layer surrounding the inert core; wherein the drug layer comprises an acid labile drug or a pharmaceutically acceptable salt thereof; an enteric coating layer surrounding the drug core; wherein not more than 90% of the acid labile drug is release from the dosage form after 1 or 2 hours when placed in 40% ethanol dissolution media. 5. The multiparticulate sprinkle dosage form as claimed in claim 4, wherein the acid labile drug is duloxetine or a pharmaceutically acceptable salt thereof. 6. The multiparticulate sprinkle dosage form as claimed in claim 4, wherein the multiparticulates when sprinkled on soft food having pH more than 5 are stable for about 60 minutes. 7. The multiparticulate sprinkle dosage form as claimed in claim 4, wherein the multiparticulates when sprinkled on soft food having pH less than or equal to 5 are stable for about 90 minutes. 8. A multiparticulate sprinkle dosage form comprising a plurality of discrete units, wherein each unit comprises a drug core of an acid labile drug; and an enteric coating surrounding the acid labile drug; wherein the discrete units, after 90 minutes of contact with soft food having a pH less than or equal to 5 release not more than 2% of 1-naphthol after 2 hours when placed in 1000 mL of 0.1N HCl in USP apparatus I. 9. A multiparticulate sprinkle dosage form comprising a plurality of discrete units, wherein each unit comprises a drug core of an acid labile drug; and an enteric coating surrounding the acid labile drug; wherein the discrete units, after 60 minutes contact with soft food having a pH more than 5 release not more than 4% of the 1-naphthol impurity after 2 hours, when placed in 1000 mL of 0.1N HCl in USP apparatus I. 10. The multiparticulate sprinkle dosage form of claim 9, wherein the acid labile drug is duloxetine or a pharmaceutically acceptable salt thereof. 11. The multiparticulate sprinkle dosage form of claim 1, wherein the multiparticulate sprinkle dosage form is suitable for administration to a patient via a feeding tube. 12. The multiparticulate sprinkle dosage form of claim 3, wherein the size of discrete units suitable to be sprinkled on soft food is less than 2 mm. 13. The multiparticulate sprinkle dosage form of claim 1, wherein the multiparticulate sprinkle dosage form is suitable for administration in intact form. 14. The multiparticulate sprinkle dosage form of claim 1, wherein the enteric coating comprises a polymer present in an amount of about 75% to about 99% by weight based on the weight of the enteric coating. 15. The multiparticulate sprinkle dosage form of claim 14, wherein the enteric coating layer comprises a polymer selected from methacrylic acid copolymers, cellulose acetate phthalate, cellulose acetate succinate, polymethacrylic acid, hydroxypropyl methyl cellulose, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate, hydroxyethyl ethyl cellulose phthalate, cellulose acetate tetrahydrophthalate, acrylic resin, and mixtures thereof. 16. The multiparticulate sprinkle dosage form of claim 1, wherein the dosage form further comprises a finishing layer containing a cushioning agent selected from the group consisting of polyethylene glycols, polyoxyethylenes, colloidal and/or amorphous silicon dioxide, microcrystalline cellulose, polyvinyl acetate, waxes, fats, lipids, gums, and mixtures thereof, surrounding the enteric coating. 17. The multiparticulate sprinkle dosage form of claim 16, wherein the cushioning agent is present in an amount of about 2% to about 20% based on the total weight of the dosage form. 18. The multiparticulate sprinkle dosage form of claim 1, wherein the dosage form contains duloxetine or pharmaceutically acceptable salts thereof in an amount of about 20% by weight of the dosage form. 19. The multiparticulate sprinkle dosage form of claim 1, wherein the discrete units are pellets, beads, particles, granules, or minitablets.