Oral formulation of clonidine and midazolam for sedation in dental procedures

11826,371

17/542651

December 06, 2021

A drug composition in solid drug matrix formulation comprising clonidine, midazolam, and fentanyl. The amounts of the drug contained in the solid drug matrix are sufficient to induce sedation in preparation for a clinical procedure. When administered in the mouth, the drug ingredients are absorbed by transmucosal passage. This solid drug matrix formulation may be particularly useful in pediatric dentistry practice. Also disclosed is a method of inducing sedation in a patient by administering the solid drug matrix formulation to the patient prior to performing a clinical procedure.

Transdermal Sedation Solutions, LLC (Little Rock, AR, US)

Therapeutic Sedation Solutions, LLC (Rogers, AR, US)

1. A solid drug matrix formulation comprising: clonidine in an amount ranging from 10-300 μg; midazolam in an amount ranging from 1-40 mg; fentanyl in an amount ranging from 10-300 μg.

2. The drug formulation of claim 1 , wherein the amount of fentanyl is at least 10 μg, but less than 190 μg.

3. The drug formulation of claim 2 , wherein the amount of fentanyl is at least 10 μg, but less than 175 μg.

4. The drug formulation of claim 3 , wherein the amount of fentanyl is at least 10 μg, but less than 150 μg.

5. The drug formulation of claim 1 , being in the form of a lozenge or lollipop.

6. The drug formulation of claim 1 , having a size of at least 1.0 cm along its widest dimension.

7. The drug formulation of claim 6 , having a size of at least 1.5 cm along its widest dimension.

8. The drug formulation of claim 6 , having a size of at least 1.0 cm, but less than 3.5 cm along its widest dimension.

9. The drug formulation of claim 1 , having a total weight in the range of 2.0-25 grams.

10. The drug formulation of claim 9 , having a total weight of at least 2.0 grams, but less than 15 grams.

11. The drug formulation of claim 10 , having a total weight of at least 2.0 grams, but less than 10 grams.

12. The drug formulation of claim 1 , further comprising a sweetener or flavor enhancer.

13. A method of inducing sedation in a patient, comprising: having a solid drug matrix formulation of claim 1 ; administering the solid drug matrix formulation to the patient orally and letting dwell in patient's mouth for a duration of time; allowing time for transmucosal absorption of the clonidine, midazolam, and fentanyl in the patient's mouth.

14. The method of claim 13 , wherein the time allowed for transmucosal absorption is 5-60 minutes duration.

15. The method of claim 14 , wherein the time allowed for transmucosal absorption is 10-45 minutes duration.

16. The method of claim 13 , wherein the sedation is in preparation for a clinical procedure.

17. The method of claim 16 , wherein the clinical procedure is performed after waiting a duration of 10-45 minutes duration from administering the solid drug matrix formulation to the patient.

18. The method of claim 16 , wherein the sedation and the clinical procedure are performed together in a non-hospital setting.

19. The method of claim 16 , wherein the clinical procedure is a dental procedure and the sedation is performed by a dental practitioner who is also performing the dental procedure.

20. The method of claim 16 , wherein the sedation is not performed by an anesthesiology specialist.

Trevor et al, “A comparison of midazolam and clonidine as an oral premedicationin pediatric patients” (2012) Saudi J Anaesth. 6(1):8-11. cited by applicant
Salem et al, “Two Oral Midazolam Preparations in Pediatric Dental Patients: A Prospective Randomised Clinical Trial” (2015) International Journal of Pediatrics, article ID 349795. cited by applicant
International Search Report by the USPTO dated Feb. 23, 2022, for PCT/US21/61960. cited by applicant
Written Opinion by the USPTO dated Feb. 23, 2022, for PCT/US21/61960. cited by applicant

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