Ondansetron Extendable Release Injectable Suspension and Methods of Use
OwnerVeerendra Kumar PANUGANTIinventor
Life of this patent
Estimating the term…
Abstract
The present disclosure provides an extended release suspension comprising ondansetron and methods of treating or preventing nausea in a subject using the same. The extended release suspension is suitable for intramuscular injection wherein a single dose provides a plasma concentration of ondansetron, or a metabolite thereof, of above about 10 ng/ml or more for a period of at least four days after administration to a subject.
Claims21
An extended release suspension comprising:
- about 100 mg of ondansetron;
- about 0.0001 ml to about 0.2 ml ethanol;
- about 5 mg carboxymethyl cellulose sodium salt;
- about 10 mg egg phosphatidylcholine;
- and
- quantum satis (q.s.) water to one milliliter total final volume,
- wherein the suspension is suitable for intramuscular injection;
- and
- wherein the suspension provides a plasma concentration of ondansetron, or a metabolite thereof, of above about 10 ng/ml or more for a period of at least four days after administration to a subject.
A method of treating or preventing nausea in a subject receiving chemotherapy for cancer, the method comprising administering to the subject by intramuscular injection an extended release ondansetron suspension,
- wherein 1 ml of the suspension comprises 100 mg ondansetron;
- about 0.0001 ml to about 0.2 ml ethanol;
- about 5 mg carboxymethyl cellulose sodium salt;
- about 10 mg egg phosphatidylcholine;
- and q.s. water;
- wherein a single dose of the suspension comprises from about 70 mg to about 100 mg of ondansetron, and wherein the single dose provides a plasma concentration of ondansetron, or a metabolite thereof, in the subject of about 10 ng/ml or more for a period of at least three days following administration.
(canceled)
A method of treating or preventing nausea in a subject, the method comprising:
- i) administering to the subject an extended release ondansetron suspension, wherein 1 ml of the suspension comprises 100 mg ondansetron;
- about 0.0001 ml to about 0.2 ml ethanol;
- about 5 mg carboxymethyl cellulose sodium salt;
- about 10 mg egg phosphatidylcholine;
- and q.s. water;
- wherein a single dose of the suspension comprises from about 70 mg to about 100 mg of ondansetron;
- and wherein the single dose provides:
- a) a plasma concentration of ondansetron, or a metabolite thereof, in the subject of about 10 ng/ml or more;
- or
- b) an AUC for ondansetron, or a metabolite thereof, in the subject of about 180 (ng/mL)*(hr) or more;
- or
- c) a plasma concentration of ondansetron, or a metabolite thereof, in the subject of about 10 ng/ml or more and an AUC for ondansetron, or a metabolite thereof, in the subject of about 180 (ng/mL)*(hr) or more;
- over at least three consecutive 24 hour periods following administration;
- ii) administering one or more additional active agents selected from the group consisting of steroids, corticosteroids, anti-nausea agents, and combinations thereof, and
- iii) administering to the subject chemotherapy.
Dependencies are inferred from the claim text.