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 29, 2024

Claims for Patent: 7,968,351


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 7,968,351
Title:Method for dissolution testing of pharmaceutical products
Abstract: The present invention relates to the field of dissolution measurement and, more particularly to methods for reproducible dissolution testing of pharmaceutical products such as allergen vaccines.
Inventor(s): Sorensen; Lise Smith (Helsinge, DK), Schwartz; Anne Piechowicz (Hellerup, DK), Sondergaard-Andersen; Jan (Hillerod, DK)
Assignee: ALK-Abello A/S (Horsholm, DK)
Application Number:12/158,913
Patent Claims:1. A method for determining the amount of active ingredient released from a pharmaceutical solid dosage form wherein the active ingredient is one or more proteins, said method comprising the steps of: (a) allowing said solid dosage form to release the active ingredient in a dissolution medium comprising from 0.05 to 2.0% (w/v) casein and from 0.005 to 1.0 M phosphate buffered saline, and having a pH in the range of 6 to 8.5; and (b) determining the amount of active ingredient in the solution.

2. The method according to claim 1, wherein the dissolution medium has a pH in the range of 6.2 to 7.6.

3. The method according to claim 2, wherein the dissolution medium has a pH in the range of 6.6 to 7.3.

4. The method according to claim 3, wherein the dissolution medium has a pH in the range of 6.7 to 6.9.

5. The method according to claim 1, wherein the dissolution medium comprises from 0.1 to 1.0% (w/v) casein.

6. The method according to claim 5, wherein the dissolution medium comprises from 0.3 to 0.7% (w/v) casein.

7. The method according to claim 6, wherein the dissolution medium comprises about 0.5% (w/v) casein.

8. The method according to claim 1, wherein the phosphate buffered saline is from 0.005 to 0.5 M phosphate buffered saline.

9. The method according to claim 8, wherein the phosphate buffered saline is from 0.005 to 0.1 M phosphate buffered saline.

10. The method according to claim 9, wherein the phosphate buffered saline is about 0.01M phosphate buffered saline.

11. The method according to claim 1, wherein the dissolution medium further comprises a non-ionic detergent such as a non-ionic detergent selected from the group consisting of Tween-20, Tween-80, Span 20 or Span 80.

12. The method according to claim 11, wherein the solid dosage form is a fast dispersing solid dosage form.

13. The method according to claim 12, wherein the solid dosage form is a fast dispersing solid dosage form for oromucosal administration.

14. The method according to claim 11, wherein the solid dosage form disperses in less than about 90 seconds, after being received in the oral cavity.

15. The method according to claim 1, wherein the active ingredient is one or more allergen extract(s).

16. The method according to claim 15, wherein the allergen extract comprise one or more allergens from the group consisting of grass group 1 and 5 and 6 allergens, dust mite group 1 and 2 allergens, tree pollen allergens 1 and 2, ragweed pollen allergens 1 and 2, and cat allergen 1.

17. The method according to claim 1, wherein the active ingredient is an extract of Phleum pratense.

18. The method according to claim 1, wherein the active ingredient is an extract of Dermatophagoides pteronyssinus and Dermatophagoides farinae.

19. The method according to claim 1, wherein the method for determining the amount of active ingredient is an ELISA method.

20. The method according to claim 1, wherein the release of active ingredient is carried out in a dissolution apparatus.

21. The method according to claim 20, wherein the rpm in the dissolution apparatus is 50-150 rpm.

22. The method according to claim 1, wherein the solid dosage form comprises one or more ingredients selected from the group consisting of mannitol, cellulose, croscarmellose sodium, silica and/or magnesium stearate.

23. The method according to claim 1, wherein the solid dosage form comprises one or more ingredients selected from the group consisting of mannitol and fish gelatine.

24. The method according to claim 1, wherein the dissolution testing is used for assessing batch-to-batch quality of a solid dosage form.

25. The method according to claim 1, wherein the dissolution testing is used for testing of the shelf life of a solid dosage form.

26. The method according to claim 1, wherein the amount of active ingredient in the solution is determined within 15 min of placing the solid dosage form in the dissolution medium.

27. The method according to claim 1, wherein the amount of active ingredient in the solution is determined within 10 min of placing the solid dosage form in the dissolution medium.

28. The method according to claim 1, wherein the amount of active ingredient in the solution is determined within 5 min of placing the solid dosage form in the dissolution medium.

29. The method according to claim 1, wherein the amount of active ingredient in the solution is determined within 3 min of placing the solid dosage form in the dissolution medium.

30. The method according to claim 1, wherein the amount of active ingredient in the solution is determined within 1 min of placing the solid dosage form in the dissolution medium.

Details for Patent 7,968,351

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Greer Laboratories, Inc. N/A insects (whole body), mite dermatophagoides farinae Injection 101834 09/15/1958 ⤷  Try a Trial 2025-12-23
Greer Laboratories, Inc. N/A insects (whole body), mite dermatophagoides pteronyssinus Injection 101835 09/15/1958 ⤷  Try a Trial 2025-12-23
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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.