Manage your formulary budget
Find generic entry opportunities
Deep knowledge on
small-molecule drugs and
the 110,000 global patents
Anticipate generic drug launch
Proactively manage your pharmacy inventory
Drug patents …
… from Kazakhstan to Kalamazoo
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|Title:||Oral suspension of prednisolone acetate|
|Abstract:||The present invention relates to novel oral suspension formulation comprising prednisolone acetate, a pharmaceutically acceptable vehicle and a thickening agent. The present invention further provides a method of treating patients in need of prednisolone with the novel formulation.|
|Inventor(s):||Asotra; Satish (Brampton, CA), Gao; Shen (Bolton, CA), Yacobi; Avraham (Englewood, NJ)|
|Assignee:||Taro Pharmaceuticals North America, Inc. (Grand Cayman, KY)|
|Filing Date:||Aug 27, 2010|
|Claims:||1. A pharmaceutical composition for oral delivery, comprising a pharmaceutically effective amount of prednisolone acetate particles in suspension in the composition, wherein the prednisolone acetate has a median particle size in the range of about 1 .mu.m to about 30 .mu.m and wherein the composition, when administered to humans, exhibits pharmacokinetic parameters within the 80-125% confidence interval, with a statistical power of at least 80%, of one or more of the following values: a. C.sub.max of 176.27 ng/mL; b. T.sub.max of 1.00 hour; c. AUC.sub.T of 812.39 ngh/mL; d. AUC.sub..infin. of 846.53 ngh/mL; e. K.sub.el of 0.2629 hr.sup.-1; and f. T.sub.1/2 el of 2.66 hours; and wherein the composition is suitable for oral delivery. |
2. The pharmaceutical composition of claim 1, wherein the composition is bioequivalent to a 5 mg tablet of prednisolone.
3. The pharmaceutical composition of claim 1, comprising from about 0.5 mg/mL to about 5 mg/mL of prednisolone acetate.
4. The pharmaceutical composition of claim 1, further comprising a thickening agent.
5. The pharmaceutical composition of claim 4, wherein the thickening agent is a carbomer.
6. The pharmaceutical composition of claim 1, further comprising a wetting agent.
7. The pharmaceutical composition of claim 6, wherein the wetting agent is poloxamer.
8. The pharmaceutical composition of claim 1, comprising carbomer and poloxamer.
9. The pharmaceutical composition of claim 1, wherein the pH is between about 4.0 to about 5.9.
10. The pharmaceutical composition of claim 1, wherein the pH is between about 4.8 to about 5.2.
11. The pharmaceutical composition of claim 1, comprising from about 0.5 mg/mL to about 5 mg/mL of prednisolone acetate, water, glycerin, sorbitol in an amount up to about 20% (w/w), propylene glycol in an amount up to about 20% (w/w), wetting agent in an amount up to about 3% (w/w) and a thickening agent in an amount up to about 1% (w/w).
12. The pharmaceutical composition of claim 1, comprising: a. from about 5 mg/5 mL to about 15 mg/5 mL prednisolone acetate in suspension in the composition; b. 0.1% poloxamer 188; c. 50% glycerin; d. 5% sorbitol crystalline; e. 5% propylene glycol; f. 0.065% edetate disodium; g. 0.2% sucralose; h. carbomer in an amount up to about 1%; i. 0.04% butylparaben; and j. sodium hydroxide.
13. The pharmaceutical composition of claim 1, wherein the composition exhibits an in vitro dissolution profile of about 82% to about 85% released after about 15 minutes, about 93% to about 95% released after about 30 minutes, about 95% to about 97% released after about 45 minutes and about 96% to about 97% released after about 60 minutes.
14. A method for treating a patient in need of prednisolone, comprising the step of orally administering a therapeutically effective amount of the pharmaceutical composition of claim 1.
15. The method of claim 14, wherein the patient is suffering from a medical condition selected from the group consisting of endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, respiratory diseases, hemaologic disorders, neoplastic diseases, edema, gastrointestinal diseases and nervous diseases.
16. The pharmaceutical composition of claim 1, comprising carbomer and a wetting agent.
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.