.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 9,095,577

« Back to Dashboard

Claims for Patent: 9,095,577

Title:Stabilized amine-containing actives in oral film compositions
Abstract: The present invention relates to compositions relating to films containing active pharmaceutical agents. In particular, the present invention relates to methods and systems useful for stabilizing amine-containing actives for dispersion in a film product.
Inventor(s): Myers; Garry L. (Kingsport, TN), Hariharan; Madhu Sudan (Munster, IN), Davidson; Kevin (Valparaiso, IN), Sanghvi; Pradeep (Dyer, IN)
Assignee: MONOSOL RX, LLC (Warren, NJ)
Application Number:14/635,851
Patent Claims: 1. An edible film dosage composition consisting of: a. ondansetron; b. a polymeric carrier matrix consisting of: i. hydroxypropylmethyl cellulose, and ii. polyethylene oxide; c. erythritol; d. peppermint flavor; e. calcium carbonate; f. sucralose; g. sodium bicarbonate; h. fumed silica; i. titanium dioxide; j. monoammonium glycyrrhizinate; k. xanthan gum; and l. butylated hydroxytoluene.

2. The edible film dosage composition of claim 1, wherein said polyethylene oxide is present in an amount of from about 20% to about 70% by weight and said hydroxypropylmethyl cellulose is present in an amount of from about 20% to about 70% by weight based on the total weight of the polymeric carrier matrix.

3. The edible film dosage composition of claim 1, wherein said polyethylene oxide is present in an amount of from about 20% to about 60% by weight and said hydroxypropylmethyl cellulose is present in an amount of from about 20% to about 60% by weight based on the total weight of the polymeric carrier matrix.

4. The edible film dosage composition of claim 1, wherein said titanium dioxide is present in an amount of from about 0.02 to about 3% by weight based on the total weight of the edible film dosage composition.

5. The edible film dosage composition of claim 1, wherein said titanium dioxide is present in an amount of from about 0.02 to about 1% by weight based on the total weight of the edible film dosage composition.

6. An edible film dosage composition consisting of: a. ondansetron; b. a polymeric carrier matrix consisting of: i. hydroxypropylmethyl cellulose; c. erythritol; d. peppermint flavor; e. calcium carbonate; f. sucralose; g. sodium bicarbonate; h. fumed silica; i. titanium dioxide; j. monoammonium glycyrrhizinate; k. xanthan gum; and l. butylated hydroxytoluene, wherein the amount of monoammonium glycyrrhizinate is sufficient to prevent the strong electrophilic interaction of the alkyl chloride groups of the sucralose with the amine groups of the ondansetron and thereby prevent the agglomeration of the ondansetron and sucralose.

7. The edible film dosage composition of claim 6, wherein said titanium dioxide is present in an amount of from about 0.02 to about 3% by weight based on the total weight of the edible film dosage composition.

8. The edible film dosage composition of claim 6, wherein said titanium dioxide is present in an amount of from about 0.02 to about 1% by weight based on the total weight of the edible film dosage composition.

9. An edible film dosage composition consisting of: a. ondansetron; b. a polymeric carrier matrix consisting of: i. hydroxypropylmethyl cellulose; c. erythritol; d. peppermint flavor; e. calcium carbonate; f. sucralose; g. sodium bicarbonate; h. fumed silica; i. titanium dioxide; j. monoammonium glycyrrhizinate; k. xanthan gum; and l. butylated hydroxytoluene, wherein the amounts of ondansetron and monoammonium glycyrrhizinate are sufficient for the amines groups of the ondansetron to form an equilibrium with the ammonium ions of the monoammonium glycyrrhizinate.

10. The edible film dosage composition of claim 8, wherein said titanium dioxide is present in an amount of from about 0.02 to about 3% by weight based on the total weight of the edible film dosage composition.

11. The edible film dosage composition of claim 8, wherein said titanium dioxide is present in an amount of from about 0.02 to about 1% by weight based on the total weight of the edible film dosage composition.

12. An edible film dosage composition consisting of: a. ondansetron; b. a polymeric carrier matrix consisting of: i. hydroxypropylmethyl cellulose, and ii. polyethylene oxide; c. erythritol; d. peppermint flavor; e. calcium carbonate; f. sucralose; g. sodium bicarbonate; h. fumed silica; i. titanium dioxide; j. monoammonium glycyrrhizinate; k. xanthan gum; and l. butylated hydroxytoluene, wherein the amount of monoammonium glycyrrhizinate is sufficient to prevent the strong electrophilic interaction of the alkyl chloride groups of the sucralose with the amine groups of the ondansetron and thereby prevent the agglomeration of the ondansetron and sucralose, and/or wherein the amounts of ondansetron and monoammonium glycyrrhizinate are sufficient for the amines groups of the ondansetron to form an equilibrium with the ammonium ions of the monoammonium glycyrrhizinate.

13. The edible film dosage composition of claim 12, wherein said polyethylene oxide is present in an amount of from about 20% to about 70% by weight and said hydroxypropylmethyl cellulose is present in an amount of from about 20% to about 70% by weight based on the total weight of the polymeric carrier matrix.

14. The edible film dosage composition of claim 12, wherein said polyethylene oxide is present in an amount of from about 20% to about 60% by weight and said hydroxypropylmethyl cellulose is present in an amount of from about 20% to about 60% by weight based on the total weight of the polymeric carrier matrix.

15. The edible film dosage composition of claim 12, wherein said titanium dioxide is present in an amount of from about 0.02 to about 3% by weight based on the total weight of the edible film dosage composition.

16. The edible film dosage composition of claim 12, wherein said titanium dioxide is present in an amount of from about 0.02 to about 1% by weight based on the total weight of the edible film dosage composition.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc