You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Claims for Patent: 5,344,658


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 5,344,658
Title: Process and composition using ondansetron
Abstract:The invention relates to a process for reducing the crystal size of ondansetron hydrochloride dihydrate produced by crystallisation from solvent to a size which is suitable for effective distribution in a tablet blend, in particular 100% less that 250 .mu.m. The ondansetron hydrochloride dihydrate is desolvated by drying at elevated temperature and reduced or atmospheric pressure and is then rehydrated.
Inventor(s): Collin; David T. (Ware, GB2)
Assignee: Glaxo Group Limited (London, GB2)
Application Number:08/005,736
Patent Claims: 1. A process for reducing the crystal size of ondansetron hydrochloride dihydrate produced by crystallisation from solvent, in which said ondansetron hydrochloride dihydrate is desolvated by drying at elevated temperature and reduced or atmospheric pressure and is then rehydrated, wherein the resulting crystals are suitable for homogeneous distribution in a tablet blend, and wherein 100% of the resulting crystals have a size of less than 250 .mu.m and at least about 80% by weight of the crystals have a size of less than 63 .mu.m.

2. A process according to claim 1, in which said ondansetron hydrochloride dihydrate is prepared by crystallisation from an aqueous solvent mixture.

3. A process according to claim 1, in which said ondansetron hydrochloride dihydrate is desolvated by heating at a temperature greater than 40.degree. C. and at reduced pressure for more than 8 hours.

4. A process according to claim 3, in which said ondansetron hydrochloride dihydrate is desolvated by heating at a temperature of about 50.degree. C. at a pressure of about 100 torr for about 24 hours.

5. A process according to claim 1, in which said ondansetron hydrochloride dihydrate is desolvated by heating at a temperature of 50.degree. C. or above at ambient pressure.

6. A process according to claim 5, in which said temperature is about 100.degree. C.

7. A process according to claim 1, in which said ondansetron hydrochloride dihydrate is rehydrated in a humidified atmosphere at ambient temperature.

8. Crystalline ondansetron hydrochloride dihydrate in which 100% of the crystals have a size of less than 250 .mu.m and at least about 80% by weight of the crystals have a size of less than 63 .mu.m.

9. A pharmaceutical composition in the form of tablets containing crystalline ondansetron hydrochloride dihydrate as active ingredient, in which 100% of said ondansetron hydrochloride dihydrate crystals have a size less than 250 .mu.m and at least about 80% by weight of said crystals have a size less than 63 .mu.m.

10. A pharmaceutical composition according to claim 9, in which each tablet has a nominal content of active ingredient which is 5 mg or 10 mg.

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.