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Post by mnholdem on Sept 8, 2017 12:05:33 GMT -5
"Insulin preparations mimicking early phase kinetics in this manner are referred to herein as ultrarapid acting insulins."
Perhaps that may become the FDA's definition of Ultra Rapid Acting insulin as well... 
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Post by mango on Sept 8, 2017 17:35:05 GMT -5
I know we have all seen this patent before, but mnholdem did you notice the date of the patent application? This is almost a decade old and just think how long it has taken for the Endo community and the FDA to catch on. Not to mention, this way of thinking via Al Mann and Co. is older than a decade. Amazing. This is the patent that mentions the 24 week Phase 3 open label clinical trial with Metformin and illustrates Technosphere insulin superiority and safety. There is also a wealth of scientific information on why first phase insulin response is important and the physiology is described as well as in relation to Technosphere insulin. This is a great patent and Al Mann is one of the inventors. |
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Post by agedhippie on Sept 8, 2017 17:45:18 GMT -5
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Post by mnholdem on Sept 8, 2017 18:55:06 GMT -5
When you're right you're right, mango ! I just wonder if MannKind is dusting off some patents / patent applications that explain the significance of mimicking first phase insulin release...in preparation for a new URAI label? |
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Post by mango on Sept 8, 2017 19:18:35 GMT -5
When you're right you're right, mango ! I just wonder if MannKind is dusting off some patents / patent applications that explain the significance of mimicking first phase insulin release...in preparation for a new URAI label? Yep. |
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Post by peppy on Sept 8, 2017 19:31:22 GMT -5
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Post by itellthefuture777 on Sept 12, 2017 12:59:02 GMT -5
I know we have all seen this patent before, but mnholdem did you notice the date of the patent application? This is almost a decade old and just think how long it has taken for the Endo community and the FDA to catch on. Not to mention, this way of thinking via Al Mann and Co. is older than a decade. Amazing. This is the patent that mentions the 24 week Phase 3 open label clinical trial with Metformin and illustrates Technosphere insulin superiority and safety. There is also a wealth of scientific information on why first phase insulin response is important and the physiology is described as well as in relation to Technosphere insulin. This is a great patent and Al Mann is one of the inventors. Superior....to frontline therapy...Superior glucose..ultra rapid acting..and no hypos when used alone..64% less hypos when used with a basal..and the basal is to blame for those...why this stock is under 1000 is beyond me.. |
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Post by mango on Sept 26, 2017 14:56:42 GMT -5
New MannKind Granted Patent 9/26/2017 Powder dispensing and sensing apparatus and methodsAbstract: Powder dispensing and sensing apparatus and methods are provided. The powder dispensing and sensing apparatus includes a tray support structure to receive a cartridge tray holding cartridges, a powder dispenser assembly including powder dispenser modules to dispense powder into respective cartridges of a batch of cartridges in the cartridge tray, a powder transport system to deliver powder to the powder dispenser modules, a sensor module including sensor cells to sense respective fill states, such as the weights, of each of the cartridges in the batch of cartridges, and a control system to control the powder dispenser modules in response to the respective sensed fill states of each of the cartridges of the batch of cartridges. Type: Grant Filed: July 15, 2014 Date of Patent: September 26, 2017 Assignee: MannKind Corporation Inventors: Trent A. Poole, David F. Bonneau, Per B. Fog Powder dispensing and sensing apparatus and methods |
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Post by mango on Sept 29, 2017 15:17:25 GMT -5
New International MannKind Patent Application Published 9/28/2017 Application Date: 09.06.2017 Publication Date: 28.09.2017 Applicants: MannKind Corporation Inventors: Andrea Leone-Bay Destardi Moye-Sherman Bryan R. Wilson Title: (EN) Diketopiperazine salts for drug delivery and related methods Abstract: (EN)Drug delivery systems have been developed based on the formation of diketopiperazine carboxylate salts and microparticles containing the same. The systems may further comprise a bioactive agent. Related methods for making and using the biologically active agent delivery compositions are also provided. In certain embodiments, the pharmaceutically acceptable salts described can be formed by removal of solvent by methods including distillation, evaporation, spray drying or lyophilization. • Example 10. Preparation of an Oral Dosage Form Spray-dried disodium FDKP/insulin powder as described in Examples 6 or 7 is packed into hard gelatin capsules. The capsules can contain approximately 50-100 mg of powder. The FDKP salt/insulin powders prepared in Examples 6 and 7 were 25% insulin by weight and insulin activity was about 26 units/mg. Thus, 50 mg would be on the order of 1300 units, significantly larger than a typical dose. About 2-30 mg of the FDKP salt/insulin powder is mixed with methyl cellulose (other bulking agents are well known in the art) to make up the balance of the desired mass. • Example 11. Oral Administration of Disodium FDKP-Insulin Capsules containing the FDKP salt and insulin are taken before a meal. The exact dosage is patient-specific, but generally on the order of approximately 10-150 units of insulin is administered per dose. The subsequent insulin absorption attenuates post-prandial blood glucose excursions. This oral insulin formulation is used to replace pre-meal insulin injections in patients with diabetes. Additionally, insulin absorbed through the gastrointestinal tract mimics endogenous insulin secretion. Endogenous insulin is secreted by the pancreas into the portal circulation. Insulin absorbed following oral administration also goes directly to the portal circulation. Thus, the oral route of insulin administration delivers insulin to its site of action in the liver, offering the potential to control glucose levels while limiting systemic exposure to insulin. Oral insulin delivery using a combination of insulin and the diacid form of FDKP is hindered by the poor solubility of the FDKP diacid in the low pH environment of the gastrointestinal tract. The FDKP salts, however, provide a local buffering effect that facilitates their dissolution in low pH. patentscope.wipo.int/search/en/detail.jsf?docId=US204148335 |
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Post by itellthefuture777 on Sept 29, 2017 15:50:09 GMT -5
Needed for International expansion..hmm nice find!
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Post by dreamboatcruise on Sept 29, 2017 16:03:06 GMT -5
New International MannKind Patent Application Published 9/28/2017 Application Date: 09.06.2017 Publication Date: 28.09.2017 Applicants: MannKind Corporation Inventors: Andrea Leone-Bay Destardi Moye-Sherman Bryan R. Wilson Title: (EN) Diketopiperazine salts for drug delivery and related methods Abstract: (EN)Drug delivery systems have been developed based on the formation of diketopiperazine carboxylate salts and microparticles containing the same. The systems may further comprise a bioactive agent. Related methods for making and using the biologically active agent delivery compositions are also provided. In certain embodiments, the pharmaceutically acceptable salts described can be formed by removal of solvent by methods including distillation, evaporation, spray drying or lyophilization. • Example 10. Preparation of an Oral Dosage Form Spray-dried disodium FDKP/insulin powder as described in Examples 6 or 7 is packed into hard gelatin capsules. The capsules can contain approximately 50-100 mg of powder. The FDKP salt/insulin powders prepared in Examples 6 and 7 were 25% insulin by weight and insulin activity was about 26 units/mg. Thus, 50 mg would be on the order of 1300 units, significantly larger than a typical dose. About 2-30 mg of the FDKP salt/insulin powder is mixed with methyl cellulose (other bulking agents are well known in the art) to make up the balance of the desired mass. • Example 11. Oral Administration of Disodium FDKP-Insulin Capsules containing the FDKP salt and insulin are taken before a meal. The exact dosage is patient-specific, but generally on the order of approximately 10-150 units of insulin is administered per dose. The subsequent insulin absorption attenuates post-prandial blood glucose excursions. This oral insulin formulation is used to replace pre-meal insulin injections in patients with diabetes. Additionally, insulin absorbed through the gastrointestinal tract mimics endogenous insulin secretion. Endogenous insulin is secreted by the pancreas into the portal circulation. Insulin absorbed following oral administration also goes directly to the portal circulation. Thus, the oral route of insulin administration delivers insulin to its site of action in the liver, offering the potential to control glucose levels while limiting systemic exposure to insulin. Oral insulin delivery using a combination of insulin and the diacid form of FDKP is hindered by the poor solubility of the FDKP diacid in the low pH environment of the gastrointestinal tract. The FDKP salts, however, provide a local buffering effect that facilitates their dissolution in low pH. patentscope.wipo.int/search/en/detail.jsf?docId=US204148335Hmmm... does anyone know if MNKD has performed any clinical work towards this oral insulin formulation? Seems like bioavailability is pretty low. |
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Post by mango on Oct 10, 2017 14:02:09 GMT -5
New International MannKind Patent Application Published 10/5/2017 Application Date: 21.06.2017 Publication Date: 05.10.2017 Applicants:MannKind Corporation Inventors:Keith A. Oberg Joseph Sulner Marshall L. Grant Title: (EN) METHOD OF DRUG FORMULATION BASED ON INCREASING THE AFFINITY OF CRYSTALLINE MICROPARTICLE SURFACES FOR ACTIVE AGENTS Abstract: (EN)Methods are provided for coating crystalline microparticles with an active agent by altering the surface properties of the microparticles in order to facilitate favorable association on the microparticle by the active agent. Types of surface properties that are altered by the disclosed methods include electrostatic properties, hydrophobic properties, and hydrogen bonding properties. patentscope.wipo.int/search/en/detail.jsf?docId=US204579015 |
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Post by mango on Oct 24, 2017 3:48:47 GMT -5
New MannKind Patent Application Published 10/19/2017 Application Date: 03.09.2004 Publication Date: 19.10.2017 Applicants: MannKind Corporation Inventors: STEINER, Solomon, S. POOLE, Trent, A. FOG, Per, B. POHL, Roderike CRICK, Michael FELDSTEIN, Robert Title: (ES) Cartucho de dosis unitaria e inhalador de polvo seco (Unit Dose Cartridge and Dry Powder Inhaler) patentscope.wipo.int/search/en/detail.jsf?docId=ES205306955 |
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Post by mango on Oct 27, 2017 3:34:06 GMT -5
New Granted MannKind Patent Published 10/24/2017 Catalysis of diketopiperazine synthesisAbstract:Provided is a method for the synthesis of N-protected bis-3,6-[4-aminobutyl]-2,5-diketopiperazine including the step of heating a solution of ?-amino protected lysine in the presence of a catalyst selected from the group consisting of sulfuric acid, phosphoric acid, and phosphorus pentoxide. Type: Grant Filed: April 12, 2016 Date of Patent: October 24, 2017 Assignee: MannKind Corporation Inventors: John J. Stevenson, Destardi Moye-Sherman patents.justia.com/patent/9796688 |
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Post by mnholdem on Oct 27, 2017 6:59:59 GMT -5
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides methods for the synthesis of diketopiperazines using catalysts such that faster reaction times and higher yields are achieved compared to conventional step(s)/method(s). Utilizing the catalyst of the present invention, phosphorus pentoxide, in a cyclocondensation reaction, provides for the synthesis of diketopiperazines of higher yield and higher purity in shorter reaction times over that of conventional step(s)/method(s).
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The rest of the document is over my head, but I can appreciate the $ value associated with getting better results in a shorter time.
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