SMALL VOLUME ORAL TRANSMUCOSAL DOSAGE FORMS CONTAINING SUFENTANIL FOR TREATMENT OF PAIN
First Claim
Patent Images
1. A tablet comprising:
- about 5 to about 200 μ
g sufentanil or pharmaceutically acceptable salts thereof (expressed as the free base of sufentanil),60-95 wt % of one or more bulking agents,1-5 wt % of one or more hydrogel forming excipients, and1-10 wt % of one or more lubricants,wherein;
said tablet has a volume less than about 30 μ
L, and when said tablet is adhered to the oral mucosa of a patient during the period of drug delivery;
a) at least 55% of the total amount of sufentanil in the tablet is delivered via the oral transmucosal route;
b) at least 90% of the total amount of sufentanil delivered to the patient, as measured by plasma concentration, is delivered via the oral transmucosal route;
c) said tablet provides a mean Tmax of about 15 minutes to about 80 minutes;
d) said tablet provides a mean Tmax with a coefficient of variation of less than 40%; and
e) said tablet provides a dose-normalized mean Cmax of about 1.59-2.75 μ
g/mL per meg dosed.
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Accused Products
Abstract
Compositions, systems and methods for administration of small volume sufentanil drug dosage forms via the oral transmucosal route of a subject for treatment of pain.
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Citations
25 Claims
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1. A tablet comprising:
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about 5 to about 200 μ
g sufentanil or pharmaceutically acceptable salts thereof (expressed as the free base of sufentanil),60-95 wt % of one or more bulking agents, 1-5 wt % of one or more hydrogel forming excipients, and 1-10 wt % of one or more lubricants, wherein;
said tablet has a volume less than about 30 μ
L, and when said tablet is adhered to the oral mucosa of a patient during the period of drug delivery;a) at least 55% of the total amount of sufentanil in the tablet is delivered via the oral transmucosal route; b) at least 90% of the total amount of sufentanil delivered to the patient, as measured by plasma concentration, is delivered via the oral transmucosal route; c) said tablet provides a mean Tmax of about 15 minutes to about 80 minutes; d) said tablet provides a mean Tmax with a coefficient of variation of less than 40%; and e) said tablet provides a dose-normalized mean Cmax of about 1.59-2.75 μ
g/mL per meg dosed. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 22, 23, 24, 25)
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- 18. A method of treating pain, comprising administering the tablet of claim to a patient in need thereof.
Specification