Claims for Patent: 9,474,688

Summary for Patent: 9,474,688

Title:	Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
Abstract:	The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient.
Inventor(s):	Weeks; Wendell Porter (Corning, NY), Schaut; Robert Anthony (Painted Post, NY), DeMartino; Steven Edward (Painted Post, NY), Peanasky; John Stephen (Big Flats, NY)
Assignee:	Corning Incorporated (Corning, NY)
Application Number:	13/660,680
Patent Claims:	1. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising: SiO.sub.2 in a concentration greater than about 74 mol. %; alkaline earth oxide comprising MgO and CaO, wherein CaO is present in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1.0 mol. % relative to the glass composition, and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5; and Y mol. % alkali oxide, wherein the alkali oxide comprises Na.sub.2O in an amount greater than about 8 mol. %, wherein the glass composition is free of boron and compounds of boron, and wherein the pharmaceutical composition comprises one of: an antidiabetic, an anti-neoplastic Mab, an antirheumatic, an antibacterial, a cytostatic, a vaccine, an immunosuppressant, an anti-fibrinolytic, an eye preparation, a MS therapeutic, a bone calcium regulator, an anti-coagulant, an anti-psychotic, an anti-metabolite, a radiopharmaceutical, an immunostimulant, a cytotoxic antibiotic, a cerebral and peripheral vasotherapeutic, a muscoskeletal agent, a nootropic, a CNS drug, a dermatological, an angiotensin II antagonist, a serelaxin, an anti-spasmodic, an anti-cholinergic, an interferon, an anti-anaemic, an anti-psoriasis agent, an anti-hyperlipidaemic, a cardiac therapeutic, an alkylating agent, a bronchodilator, a gastro-intestinal anti-inflammatory, a growth hormone, a hormone preparation, a non-narcotic analgesic, a diagnostic imaging agent, a haematological, a peripheral muscle relaxant, a growth hormone (human), or an immune globulin. 2. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising: from about 74 mol. % to about 78 mol. % SiO.sub.2; from about 4 mol. % to about 8 mol. % alkaline earth oxide, wherein the alkaline earth oxide comprises both MgO and CaO and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5; X mol. % Al.sub.2O.sub.3, wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %.; and Y mol. % alkali oxide, wherein the alkali oxide comprises Na.sub.2O in an amount greater than or equal to about 9 mol. % and less than or equal to about 15 mol. %, a ratio of Y:X is greater than 1, and the glass composition is free of boron and compounds of boron, and wherein the pharmaceutical composition comprises one of: of an antidiabetic, an anti-neoplastic Mab, an antirheumatic, an antibacterial, a cytostatic, a vaccine, an immunosuppressant, an anti-fibrinolytic, an eye preparation, a MS therapeutic, a bone calcium regulator, an anti-coagulant, an anti-psychotic, an anti-metabolite, a radiopharmaceutical, an immunostimulant, a cytotoxic antibiotic, a cerebral and peripheral vasotherapeutic, a muscoskeletal agent, a nootropic, a CNS drug, a dermatological, an angiotensin II antagonist, a serelaxin, an anti-spasmodic, an anti-cholinergic, an interferon, an anti-anaemic, an anti-psoriasis agent, an anti-hyperlipidaemic, a cardiac therapeutic, an alkylating agent, a bronchodilator, a gastro-intestinal anti-inflammatory, a growth hormone, a hormone preparation, a non-narcotic analgesic, a diagnostic imaging agent, a haematological, a peripheral muscle relaxant, a growth hormone (human) or an immune globulin. 3. A delamination resistant pharmaceutical container comprising a pharmaceutical composition stored within the container, wherein the pharmaceutical container comprises a glass composition comprising: from about 74 mol. % to about 78 mol. % SiO.sub.2; alkaline earth oxide comprising both CaO and MgO, wherein the alkaline earth oxide comprises CaO in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1.0 mol. % relative to the glass composition, and a ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.5; X mol. % Al.sub.2O.sub.3, wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %; and Y mol. % alkali oxide, wherein the alkali oxide comprises from about 0.01 mol. % to about 1.0 mol. % K.sub.2O and a ratio of Y:X is greater than 1, and the glass composition is free of boron and compounds of boron, and wherein the pharmaceutical composition comprises one of: an antidiabetic, an anti-neoplastic Mab, an antirheumatic, an antibacterial, a cytostatic, a vaccine, an immunosuppressant, an anti-fibrinolytic, an eye preparation, a MS therapeutic, a bone calcium regulator, an anti-coagulant, an anti-psychotic, an anti-metabolite, a radiopharmaceutical, an immunostimulant, a cytotoxic antibiotic, a cerebral and peripheral vasotherapeutic, a muscoskeletal agent, a nootropic, a CNS drug, a dermatological, an angiotensin II antagonist, a serelaxin, an anti-spasmodic, an anti-cholinergic, an interferon, an anti-anaemic, an anti-psoriasis agent, an anti-hyperlipidaemic, a cardiac therapeutic, an alkylating agent, a bronchodilator, a gastro-intestinal anti-inflammatory, a growth hormone, a hormone preparation, a non-narcotic analgesic, a diagnostic imaging agent, a haematological, a peripheral muscle relaxant, a growth hormone (human) or an immune globulin. 4. The pharmaceutical container of claim 1, wherein the container comprises a vial, cartridge, syringe, ampoule, bottle, flask, or vacutainer. 5. The pharmaceutical container of claim 1, wherein the container is delamination resistant. 6. The pharmaceutical container of claim 1, wherein the container has a delamination factor of 1. 7. The pharmaceutical container of any one of 1, 2, and 3, wherein (i) the antidiabetic is selected from the group consisting of insulin aspart; insulin degludec; insulin glargine recombinant; dulaglutide; lixisenatide; hyaluronidase (human); insulin; liraglutide; insulin glargine; albiglutide; insulin lispro recombinant; insulin (human); insulin detemir; exenatide synthetic; insulin aspart and insulin aspart protamine; insulin aspart and insulin degludec; hyaluronidase (human) and insulin lispro/insulin aspart; insulin glargine and lixisenatide; and insulin degludec and liraglutide; (ii) the antineoplastic is selected from the group consisting of Bavituximab, Onartuzumab, yttrium Y-90 clivatuzumab tetraxetan, obinutuzumab, cixutumumab, necitumumab, pertuzumab, brentuximab vedotin, nivolumab, trastuzumab emtansine, siltuximab, elotuzumab, ramucirumab, Ipilimumab, Rituximab, Trastuzumab, and bevacizumab; (iii) the antirheumatic is selected from the group consisting of tabalumab, sarilumab, Tocilizumab, Infliximab, Etanercept, Abatacept, certolizumab pegol, Golimumab, and Adalimumab; (iv) the antibacterial is selected from the group consisting of ceftolozane sulfate, and tazobactam sodium, ceftaroline fosamil, brilacidin, and tedizolid phosphate; (v) the cytostatic is selected from the group consisting of CT-107, ganetespib, CUDC-101, Reolysin, AEZS-108, velimogene aliplasmid, imetelstat sodium, algenpantucel-L, retaspimycin hydrochloride, astuprotimut-R, vosaroxin, BiovaxID, iniparib, Bortezomib, and carfilzomib; (vi) the vaccine is selected from the group consisting of meningococcal B vaccine; herpes zoster vaccine; hepatitis B vaccine; human papillomavirus (HPV) vaccine; pneumococcal vaccine; DTPw; influenza vaccine; hepatitis A and B vaccine; DTP, hepatitis B, and polio vaccine; and PENTAct-H1B; (vii) the immunosuppressant is selected from the group consisting of epratuzumab, eritoran tetrasodium, blisibimod, and ustekinumab; (viii) the anti-fibrinolytic is selected from the group consisting of turoctocog alfa, vonicog alfa, factor VIII, eptacog alfa, and octocog alfa; (ix) the eye preparation is selected from the group consisting of Ocriplasmin, Aflibercept, and Ranibizumab; (x) the MS therapeutic is selected from the group consisting of Alemtuzumab, ocrelizumab, daclizumab, peginterferon beta-1a, Natalizumab, glatiramer acetate, and interferon beta-1a; (xi) the bone calcium regulator is selected from the group consisting of romosozumab, Denosumab, and recombinant human teriparatide; (xii) the anti-coagulant is selected from the group consisting of semuloparin sodium, otamixaban, and enoxaparin sodium (xiii) the anti-psychotic is aripiprazole; (xiv) the anti-metabolite is gemcitabine elaidate; (xv) the radiopharmaceutical is radium Ra-223 chloride; (xvi) the immunostimulant is Pegfilgrastim; (xvii) the cytotoxic antibiotic is doxorubicin hydrochloride; (xviii) the cerebral and peripheral vasotherapeutic is defibrotide; (xix) the musculoskeletal agent is selected from the group consisting of Drisapersen, eteplirsen, and asfotase alfa; (xx) the nootropic is solanezumab; (xxi) the CNS drug is neural stem cells; (xxii) the dermatological is secukinumab; (xxiii) the angiotensin II antagonist is serelaxin; (xxiv) the anti-spasmodic or anti-cholinergic is teduglutide; (xxv) the interferon is peginterferon lambda-1a or peginterferon alfa-2a; (xxvi) the anti-anaemic is ferric pyrophosphate or darbepoetin alfa; (xxvii) the anti-psoriasis agent is ixekizumab; (xxviii) the anti-hyperlipidaemic is alirocumab; (xxix) the cardiac therapeutic is cenderitide; (xxx) the alkylating agent is palifosfamide; (xxxi) the bronchodilator is lebrikizumab; (xxxii) the gastro-intestinal anti-inflammatory is vedolizumab; (xxxiii) the hormone preparation is parathyroid hormone 1-84; (xxxiv) the non-narcotic analgesic is fulranumab; (xxxv) the diagnostic imaging agent is Minretumomab; (xxxvi) the haematological is Eculizumab (xxxvii) the peripheral muscle relaxant is botulinum toxin type A; and (xxxviii) the pharmaceutical composition comprises an agent selected from the group consisting of elosulfase alfa, Protectan CBLB502, HGT-1410, HGT 1110, and sebelipase alfa. 8. The pharmaceutical container of claim 1, wherein the pharmaceutical composition comprises a citrate buffer or a phosphate buffer. 9. The pharmaceutical container of claim 8, wherein the buffer is selected from the group consisting of sodium citrate, saline-sodium citrate (SSC), monosodium phosphate and disodium phosphate. 10. The pharmaceutical container of claim 1, wherein the pharmaceutical composition is a solution having a pH between about 7 and about 11. 11. The pharmaceutical container of claim 1, wherein the concentration of SiO.sub.2 is less than or equal to about 80 mol. %. 12. The pharmaceutical container of claim 1, wherein the glass composition is free from phosphorous and compounds of phosphorous. 13. The pharmaceutical container of claim 1, further comprising X mol. % Al.sub.2O.sub.3, wherein a ratio of Y:X is greater than 1. 14. The pharmaceutical container of claim 13, wherein the ratio of Y:X is less than or equal to 2. 15. The pharmaceutical container of claim 13, wherein X is greater than or equal to about 2 mol. % and less than or equal to about 10 mol. %. 16. The pharmaceutical container of claim 1, wherein the alkaline earth oxide is present in an amount from about 3 mol. % to about 13 mol. %. 17. The pharmaceutical container of claim 13, wherein the ratio of Y:X is greater than or equal 1.3 and less than or equal to 2. 18. The pharmaceutical container of claim 13, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %. 19. The pharmaceutical container of claim 1, wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.3. 20. The pharmaceutical container of claim 1, further comprising SnO.sub.2. 21. The pharmaceutical container of claim 2, wherein the ratio of Y:X is less than or equal to about 2. 22. The pharmaceutical container of claim 2, wherein the ratio of Y:X is greater than or equal to about 1.3 and less than or equal to about 2.0. 23. The pharmaceutical container of claim 2, wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.1. 24. The pharmaceutical container of claim 2, wherein the alkaline earth oxide comprises from about 3 mol. % to about 7 mol. % MgO. 25. The pharmaceutical container of claim 2, wherein the alkaline earth oxide comprises CaO in an amount greater than or equal to about 0.1 mol. % and less than or equal to about 1.0 mol. %. 26. The pharmaceutical container of claim 2, wherein the alkali oxide further comprises K.sub.2O in an amount greater than or equal to about 0.01 mol. % and less than or equal to about 1.0 mol. %. 27. The pharmaceutical container of claim 2, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %. 28. The pharmaceutical container of claim 3, wherein the ratio of Y:X is less than or equal to 2. 29. The pharmaceutical container of claim 3, wherein the ratio of Y:X is greater than or equal to 1.3 and less than or equal to 2.0. 30. The pharmaceutical container of claim 3, wherein the ratio (CaO (mol. %)/(CaO (mol. %)+MgO (mol. %))) is less than or equal to 0.1. 31. The pharmaceutical container of claim 3, wherein the glass composition is free of phosphorous and compounds of phosphorous. 32. The pharmaceutical container of claim 3, wherein the alkali oxide further comprises Na.sub.2O in an amount greater than about 8 mol. %. 33. The pharmaceutical container of claim 3, wherein the alkali oxide further comprises Na.sub.2O in an amount greater than or equal to about 2 mol. % and less than or equal to about 15 mol. %. 34. The pharmaceutical container of claim 3, wherein the alkali oxide further comprises from about 9 mol. % to about 13 mol. % Na.sub.2O. 35. The pharmaceutical container of claim 3, wherein X is greater than or equal to about 5 mol. % and less than or equal to about 7 mol. %.

Details for Patent 9,474,688

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10/28/1982		2031-10-25
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2031-10-25
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2031-10-25
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	03/31/1994		2031-10-25
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	05/25/2018		2031-10-25