# US 10,369,077 B2 · Multi chamber flexible bag and methods of using the same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,369,077 B2 - Document ID: US10369077B2 - Status: Granted - Kind: B2 - Application number: 15/609,870 - Filed: 2017-05-31 - Published: 2018-12-06 - Granted: 2019-08-06 - Earliest claimed: 2017-05-31 - Assignees: ADIENNE Pharma & Biotech SA - Applicants: ADIENNE Pharma & Biotech SA - Inventors: Antonio Francesco Di Naro - Web page: https://patentgrep.com/patent/US10369077B2 ## CPC - A61J 1/2024: {having peelable seals} - A61J 1/10: Bag-type containers - A61J 1/2093: {Containers having several compartments for products to be mixed} - A61M 5/1407: {Infusion of two or more substances} - A61M 5/1411: {Drip chambers (A61M5/1689, A61M5/40 take precedence)} - A61M 5/1413: {Modular systems comprising interconnecting elements} - B65D 81/3266: {separated by a common rupturable seal, a clip or other removable fastening device} - B65D 81/3272: {formed by arranging one flexible container within another} - F26B 5/06: the process involving freezing - F26B 25/063: {Movable containers or receptacles, e.g. carts, trolleys, pallet-boxes (for use in freeze-drying apparatus F26B5/06; in general B62D)} - A61M 2205/3606: cooled - B65D 77/04: Articles or materials enclosed in two or more containers disposed one within another - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES - F26B: DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM (drying devices for combines A01D41/133; racks for drying fruit or vegetables A01F25/12; drying foodstuffs A23; drying hair A45D20/00; body-drying implements A47K10/00; drying household articles A47L; drying gases or vapours B01D; chemical or physical processes for dewatering or like separating liquids from solids B01D43/00; centrifugal apparatus B04; drying ceramics C04B33/30; drying yarns or fabrics in association with some other form of treatment D06C; drying frames for laundry without heating or positive air circulation, domestic laundry-or spin-driers, wringing or hot pressing laundry D06F; furnaces, kilns, ovens F27) ## 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) The method according to claim 1, further comprising introducing a reconstituting solution into the second chamber of the flexible bag. ### Claim 3 (depends on 2) 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. ### Claim 4 (depends on 3) 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. ### Claim 5 (depends on 2) The bag according to claim 2, wherein the reconstituting solution is a 0.9% saline solution. ### Claim 6 (depends on 1) 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. ### Claim 7 (depends on 1) 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. ### Claim 8 (depends on 7) 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. ### Claim 9 (depends on 1) The bag according to claim 1, wherein the pharmaceutical product is an antineoplastic or an immunomodulating agent. ### Claim 10 (depends on 1) 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. ### Claim 11 (depends on 1) The method according to claim 1, wherein the flexible bag is fabricated from a polyolefine/styrene-block copolymer based film. ### Claim 12 (depends on 1) The method of claim 1, wherein the flexible bag does not contain rigid inserts during lyophilization. ### Claim 13 (depends on 1) The method of claim 1, wherein the flexible bag is not restrained by a structure during lyophilization. ### Claim 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. ### Claim 15 (depends on 14) The method according to claim 14, further comprising introducing a gas into the first chamber. ### Claim 16 (depends on 14) 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. ### Claim 17 (depends on 16) 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. ### Claim 18 (depends on 14) 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. ### Claim 19 (depends on 18) 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. ### Claim 20 (depends on 14) The bag according to claim 14, wherein the pharmaceutical product is an antineoplastic or an immunomodulating agent. ### Claim 21 (depends on 14) 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. ### Claim 22 (depends on 14) The method according to claim 14, wherein the flexible bag is fabricated from a polyolefine/styrene-block copolymer based film.