Claims for Patent: 10,507,165

Summary for Patent: 10,507,165

Title:	Multi chamber flexible bag and methods of using 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:	16/249,347
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 a third chamber, wherein the first chamber and the second chamber are separated by a first breakable seal, wherein the third chamber is separated from one of the first and the second chambers by a second 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, wherein the reconstituting solution is a 0.9% saline solution. 4. 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. 5. The method according to claim 1, further comprising applying a predetermined amount of pressure to the flexible bag to break the first breakable seal between the first chamber and the second chamber; and mixing a reconstituting solution with the lyophilized pharmaceutical product in the first chamber to create a reconstituted pharmaceutical product. 6. The method according to claim 5, further comprising administering the reconstituted pharmaceutical product to a patient through an administration port disposed in the flexible bag. 7. The method according to claim 1, wherein the first 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 to claim 7, wherein the first breakable seal comprises a weak point where the first breakable seal is not as wide as the rest of the first breakable seal, and wherein the breaking of the first breakable seal initiates at the weak point when pressure is applied to the flexible bag. 9. The method according to claim 1, wherein the pharmaceutical product is an antineoplastic or an immunomodulating agent. 10. The method according to claim 1, wherein the pharmaceutical product is selected from the group consisting of: azacytidine, belinostat, bendamustine, brentuximab vedotin, bleomycin, bortezomib, busulfan, carboplatin, carmustine, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, daunorubicin, decitabine, deferoxamine, doxorubicin, epirubicin hydrochloride, fludarabine, fotemustine, fulvestrant, gemcitabine, idarubicin, ifosfamide, irinotecan hydrochloride, ixabepilone, melphalan, methotrexate, oxaliplatin, paclitaxel, pemetrexed, 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.

Details for Patent 10,507,165

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2037-05-31
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2037-05-31
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	08/19/2011		2037-05-31
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2037-05-31