Claims for Patent: 10,369,077

Summary for Patent: 10,369,077

Title:	Multi chamber flexible bag and methods of using the same
Abstract:	A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient.
Inventor(s):	Di Naro; Antonio Francesco (Morcote, CH)
Assignee:	ADIENNE PHARMA & BIOTECH SA (Lugano, CH)
Application Number:	15/609,870
Patent Claims:	1. A method of preparing a pharmaceutical product in a multiple chamber flexible bag, the method comprising: introducing the pharmaceutical product in a liquid state into a first chamber of the flexible bag through a first port; and lyophilizing the pharmaceutical product within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product, wherein the flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal, and wherein the pharmaceutical product is a cytotoxic drug. 2. The method according to claim 1, further comprising introducing a reconstituting solution into the second chamber of the flexible bag. 3. The method according to claim 2, further comprising applying a predetermined amount of pressure to the flexible bag to break the breakable seal between the first chamber and the second chamber; and mixing the reconstituting solution with the lyophilized pharmaceutical product in the first chamber to create a reconstituted pharmaceutical product. 4. The method according to claim 3, further comprising administering the reconstituted pharmaceutical product to a patient through an administration port disposed in the flexible bag. 5. The bag according to claim 2, wherein the reconstituting solution is a 0.9% saline solution. 6. The method according to claim 1, further comprising introducing a gas into the first chamber and sealing the first port after the pharmaceutical product in the first chamber has been lyophilized. 7. The method according to claim 1, wherein the breakable seal is formed between the first chamber and the second chamber by joining a front surface of the flexible bag and a back surface of the flexible bag. 8. The method according claim 7, wherein the breakable seal comprises a weak point where the breakable seal is not as wide as the rest of the breakable seal, and wherein the breakable seal breaks at the weak point when pressure is applied to the flexible bag. 9. The bag according to claim 1, wherein the pharmaceutical product is an antineoplastic or an immunomodulating agent. 10. The bag according to claim 1, wherein the pharmaceutical product is selected from the group consisting of: azacytidine, belinostat, bendamustine, brentuximab vedotin, bleomycin, bortezomib, busulfan, carboplatin, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, daunorubicin, decitabine, deferoxamine, doxorubicin, epirubicin hydrochloride, fludarabine, fotemustine, fulvestrant, gemcitabine, idarubicin, ifosfamide, irinotecan hydrochloride, ixabepilone, melphalan, methotrexate, oxaliplatin, paclitaxel, pemeterxed, pentostatin, raltitrexed, romidepsin, temozolomide, thiotepa, topotecan, trabectedin, trastuzumab, and vinblastine. 11. The method according to claim 1, wherein the flexible bag is fabricated from a polyolefine/styrene-block copolymer based film. 12. The method of claim 1, wherein the flexible bag does not contain rigid inserts during lyophilization. 13. The method of claim 1, wherein the flexible bag is not restrained by a structure during lyophilization. 14. A method of preparing a pharmaceutical product in a multiple chamber flexible bag, the method comprising: introducing the pharmaceutical product in a liquid state into a first chamber of the flexible bag through a first port; lyophilizing the pharmaceutical product within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product; and sealing the first port after the pharmaceutical product in the first chamber has been lyophilized, wherein the pharmaceutical product is a cytotoxic drug, and wherein the flexible bag has a second chamber for introducing a reconstituting solution and wherein the first chamber and the second chamber are separated by a breakable seal. 15. The method according to claim 14, further comprising introducing a gas into the first chamber. 16. The method according to claim 14, further comprising applying a predetermined amount of pressure to the flexible bag to break the breakable seal between the first chamber and the second chamber; and mixing the reconstituting solution with the lyophilized pharmaceutical product in the first chamber to create a reconstituted pharmaceutical product. 17. The method according to claim 16, further comprising administering the reconstituted pharmaceutical product to a patient through an administration port disposed in the flexible bag. 18. The method according to claim 14, wherein the breakable seal is formed between the first chamber and the second chamber by joining a front surface of the flexible bag and a back surface of the flexible bag. 19. The method according claim 18, wherein the breakable seal comprises a weak point where the breakable seal is not as wide as the rest of the breakable seal, and wherein the breaking of the breakable seal initiates at the weak point when pressure is applied to the flexible bag. 20. The bag according to claim 14, wherein the pharmaceutical product is an antineoplastic or an immunomodulating agent. 21. The bag according to claim 14, wherein the pharmaceutical product is selected from the group consisting of: azacytidine, belinostat, bendamustine, brentuximab vedotin, bleomycin, bortezomib, busulfan, carboplatin, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, daunorubicin, decitabine, deferoxamine, doxorubicin, epirubicin hydrochloride, fludarabine, fotemustine, fulvestrant, gemcitabine, idarubicin, ifosfamide, irinotecan hydrochloride, ixabepilone, melphalan, methotrexate, oxaliplatin, paclitaxel, pemeterxed, pentostatin, raltitrexed, romidepsin, temozolomide, thiotepa, topotecan, trabectedin, trastuzumab, and vinblastine. 22. The method according to claim 14, wherein the flexible bag is fabricated from a polyolefine/styrene-block copolymer based film.

Details for Patent 10,369,077

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2039-08-20
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2039-08-20
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	08/19/2011		2039-08-20
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2039-08-20