28 results about "INSULIN PREPARATIONS" patented technology

Embodiments of the present disclosure provide insulin formulations having a near neutral pH and improved pharmacokinetic / pharmacodynamic properties, and uses in insulin infusion devices that may provide extended infusion period up to 7-14 days. Also provided are systems for administering insulin, the system may include a first reservoir, a second reservoir, an insulin pump configured to administer contents of the first reservoir or the second reservoir, and one or more hardware processors in communication with the insulin pump.

A method may comprise (a) inserting an insulin delivery device subcutaneously into a body of a subject, which comprises an amperometric glucose sensor comprising an electrode layer comprising an indicating electrode and underlying a redox-catalytic layer comprising a redox mediator; (b) using said insulin delivery device to deliver an insulin formulation (e.g., comprising a phenol or cresol excipient) subcutaneously to said subject; and (c) using said amperometric glucose sensor to measure a subcutaneous glucose concentration, which comprises using said redox-catalytic layer to allow electron transfer from subcutaneous glucose to said indicating electrode sufficient to cause a response of said amperometric glucose sensor at an applied bias potential of no more than +250 millivolts, wherein (b) and (c) are performed at the same time for at least one hour, while maintaining a sensor sensitivity of at least 50% of an initial sensor sensitivity for up to one hour.

The present invention provides an aggregate, a preparation method thereof, and an oral insulin formulation. Specifically, an aggregate formed by the assembly of a chalcogen heterocyclic compound and insulin is provided. The aggregate can be further prepared into an oral insulin formulation. The oral formulation can be used to lower the blood glucose level of mammals and is used as part of a diabetes treatment regimen. The chalcogen heterocyclic compound in the oral insulin formulation prepared by this method can effectively protect insulin from overcoming the three major physiological barriers of the oral intake route, is stable in the gastrointestinal environment, and undergoes a dynamic chemical exchange reaction with the sulfhydryl groups of intestinal mucin in intestinal fluid and the proteins on the inner and outer sides of the epithelial cell membrane through the surface poly-chalcogen molecular bond, entering the circulatory system from intestinal epithelial cells and playing a role in lowering blood glucose. When the oral insulin formulation is administered orally, it has high bioavailability and good blood glucose lowering effect in mammals and can be used for the treatment of diabetes.

The invention provides a high-stability high-concentration zinc-containing insulin preparation, and belongs to the field of pharmaceutical preparations, the concentration of human insulin in the preparation is greater than 500 IU / mL, the preparation further contains zinc ions, a preservative, an isotonic agent and a buffer agent, the pH value of the preparation is 7.0-7.8, and the content of the zinc ions in the preparation is greater than 1%. Compared with similar products known in the field, the preparation has great physical stability, the volume of injection liquid medicine can be reduced under the condition that the required amount of insulin is the same, the hardening and caking phenomena of tissues at an injection part are effectively relieved, and the preparation still can be kept in a basically non-aggregated state in a heat or mechanical pressure environment; the method is suitable for continuous infusion systems.

An insulin formulation and a method of preparing and using same. The insulin preparation includes insulin, oligosaccharide and sodium chloride at a ratio of 1:A:B (w:w:w respectively) with ranges of A and B are 1000-5000 and 10-50, respectively.

A method may comprise (a) inserting an insulin delivery device subcutaneously into a body of a subject, which comprises an amperometric glucose sensor comprising an electrode layer comprising an indicating electrode and underlying a redox-catalytic layer comprising a redox mediator; (b) using said insulin delivery device to deliver an insulin formulation (e.g., comprising a phenol or cresol excipient) subcutaneously to said subject; and (c) using said amperometric glucose sensor to measure a subcutaneous glucose concentration, which comprises using said redox-catalytic layer to allow electron transfer from subcutaneous glucose to said indicating electrode sufficient to cause a response of said amperometric glucose sensor at an applied bias potential of no more than +250 millivolts, wherein (b) and (c) are performed at the same time for at least one hour, while maintaining a sensor sensitivity of at least 50% of an initial sensor sensitivity for up to one hour.

Disclosed in the present invention is an acylated insulin preparation, a pharmaceutical composition of an acylated insulin and a long-acting GLP-1 compound, and a medical use of the preparation and the pharmaceutical composition.

The present invention relates to insulin formulations comprising polysorbate 80. The present invention provides, inter alia, aqueous liquid pharmaceutical formulations comprising insulin or an insulin analogue, ionic zinc, a chelating agent, and polysorbate 80.

Provided are an acylated insulin preparation, a pharmaceutical composition of acylated insulin and a long-acting GLP-1 compound, and the medical use thereof. The preparation and the pharmaceutical composition have satisfactory physical stability, chemical stability, and safety.

Providing modified insulin and glucokinase nucleic acids for treating diabetes SOLUTION: Reducing hyperglycaemia and maintaining euglycaemia are the goals of all therapeutic approaches to the T1DM and T2DM. Current therapy for most diabetics is based on regular subcutaneous injections of both short-acting and long-acting insulin preparations. The present disclosure relates to modified nucleic acid sequences encoding insulin and glucokinase, expression cassettes and delivery vectors comprising the same, and methods for their delivery to treat diabetes.SELECTED DRAWING: None

The invention provides an insulin aspart 50 injection and a preparation method thereof, and belongs to the field of pharmaceutical preparations, the insulin aspart 50 injection comprises the following components: insulin aspart: protamine sulfate: glycerol: m-cresol: phenol: sodium chloride: disodium hydrogen phosphate = 100,000 IU: (0.21-0.42 g): (16-20 g): (1.5-2 g): (1-2 g): (0.8-1 g): (1-1.5 g), and the pH value is 7.0-7.8. The preparation method is simple in preparation process, scientific and reasonable, and the preparation method is suitable for industrial production. The preparation method is simple and easy to operate, the prepared insulin aspart 50 injection has the advantages of high stability and good drug effect, the insulin aspart in the injection exists in two forms, one form is in a solution and plays a quick-acting role, and the other form is in a solution. One of the two insulin preparations is combined with protamine sulfate to form a precipitate, and has the time phase characteristic of medium-efficiency insulin, so that the insulin preparation has the action characteristics of two insulin preparations, great convenience is brought to diabetics, and the injection frequency and the pain and inconvenience caused by the injection frequency are reduced.

The present invention relates to the field of pharmacy and medicine, i.e. To compositions of quick-acting, injectable insulin formulations. More specifically, the present invention relates to a composition comprising insulin aspart, a nicotinic acid compound, a surfactant selected from poloxamer 188, polysorbate 20, polysorbate 80, or a combination thereof, and an amino acid selected from lysine, arginine, and / or a salt thereof, and / or a combination thereof. The compositions of the present invention are useful for reducing blood glucose levels in subjects, particularly suitable for insulin formulations requiring high stability against thermal and / or physical and mechanical stresses.

The invention relates to a preparation method and application of sugar-responsive protamine insulin, which comprises the following steps: modifying a chemical group on cysteine of protamine, connecting with a phenylboronic acid compound to form a compound, and mixing with insulin to prepare the sugar-responsive protamine insulin. The sugar-responsive insulin preparation can realize an intelligent sugar-responsive regulation mechanism. Specifically, the insulin can be slowly released at a normal blood glucose level and is accelerated to be released at a hyperglycemia state, so that the blood glucose is effectively regulated and controlled, and the occurrence of hypoglycemia is avoided.

The invention relates to the technical field of medical instruments, and discloses a portable insulin intelligent constant-temperature protection device and method based on a phase-change material, the portable insulin intelligent constant-temperature protection device based on the phase-change material comprises a shell, a phase-change material layer, a vacuum heat insulation layer and an insulin constant-temperature control circuit; a storage cavity capable of accommodating an insulin preparation is formed in the middle of the shell; a phase change material layer and a vacuum heat insulation layer are sequentially arranged on the outer side of the storage cavity from inside to outside; the phase-change material layer is used for maintaining the temperature of the storage cavity within the optimal storage temperature range of the insulin preparation; the vacuum heat insulation layer is used for preventing external environment heat from being transferred into the storage cavity; the insulin constant-temperature control circuit is arranged on the shell to monitor the temperature in the storage cavity in real time. The temperature in the storage cavity can be kept stable for a long time under the condition that external power supply is not needed, and real-time monitoring and abnormity alarming of the storage temperature are achieved.

This invention relates to a method for preparing glucose-responsive protamine insulin and its application. The method involves modifying chemical groups on the cysteine ​​residues of protamine and linking them with phenylboronic acid compounds to form a complex, which is then mixed with insulin to prepare glucose-responsive protamine insulin. This glucose-responsive insulin formulation achieves an intelligent glucose response regulation mechanism. Specifically, under normal blood glucose levels, the insulin is released slowly, while under hyperglycemic conditions, its release is accelerated, thereby achieving effective blood glucose control and preventing hypoglycemia.

The invention concerns a soluble insulin preparation comprising NϵB29-hexadecandioyl-γ-Glu-(desB30) human insulin in a concentration from 1800 nmol / ml to 4200 nmol / ml, Zinc ions in a concentration from 4.0 Zn / 6Ins to 7.0 Zn / 6Ins, Niacinamide in a concentration from 110 mM to 220 mM or treprostinil in a concentration from 0.02 μg / ml to 1 μg / ml, Citrate in a concentration from 6 mM to 40 mM, and pH in the range from 7.0 to 8.0. The invention further comprises a method for using the soluble insulin preparation for reducing the blood glucose level in a mammal and a process for preparing the soluble insulin preparations.

An insulin formulation and a method of preparing and using same. The insulin preparation includes insulin, oligosaccharide and sodium chloride at a ratio of 1:A:B (w:w:w respectively) with ranges of A and B are 1000-5000 and 10-50, respectively.

The invention belongs to the technical field of biological materials, and particularly relates to an injectable insulin hydrogel with glucose responsiveness and a preparation method and application thereof. The invention develops an injectable hydrogel which has glucose responsiveness and is easy to degrade, and the injectable hydrogel is used for precisely controlled release of insulin. The hydrogel is prepared by combining silk fibroin and phenylboronic acid, based on the self-adjusting response of phenylboronic acid to glucose, the hydrogel shows specific response to the concentration of glucose in blood, and long-acting release can be achieved. Moreover, the hydrogel can be completely metabolized in vivo within a short time, has no adverse reaction in animal experiments, and shows good in-vivo applicability. Besides, the silk fibroin-phenylboronic acid-based hydrogel is simple to prepare and low in production cost, and a new method is provided for developing long-acting intelligent insulin preparations and using injectable hydrogel for glucose metabolism or / and clinical treatment of insulin dysfunction diseases.

The invention relates to an aqueous pharmaceutical formulation having insulin, an insulin analog, or an insulin derivative, and methionine; and to the production thereof, to the use thereof for treating diabetes mellitus, and to a medication for treating diabetes mellitus.

Describe a pharmaceutical preparation for the transdermal administration of insulin by topical application to the skin of humans or other animals. A methodology for formulating such a preparation that provides very rapid uptake of insulin, as well as migration to the skin and transdermal migration to either adipose tissue or the vasculature, while minimizing skin irritation and / or immune response, is based on a transdermal delivery system in which insulin forms a true solution in the form of a complex formed from a specific solvent in combination with a skin stabilizer and solvent and solute modifiers. Uptake of the therapeutic agent is further facilitated and made more rapid by including forskolin or other cellular energy sources, i.e., by induction of cAMP or cGMP.

The invention relates to the field of pharmaceutical science and medicine, in particular to a composition of a quick-acting insulin preparation. More specifically, the present invention relates to a composition comprising quick-acting insulin and an amino acid as a stabilizer wherein the amino acid may be selected from lysine and / or a salt thereof, or a combination of lysine and / or a salt thereof and arginine and / or a salt thereof. Compared with the closest prior art, the composition disclosed by the invention shows better chemical and physical stability.

The invention discloses a method and equipment for optimizing the initial four-time injection dosage of a weekly insulin preparation, and the method comprises the steps: obtaining corresponding information used for calculating the first injection dosage W1 before the first injection of the weekly insulin preparation; determining W1 according to the acquired corresponding information; determining a second injection regulation coefficient k2 and a second injection dosage W2 according to the fasting blood glucose gear and W1 after the first injection of the periinsulin preparation and before the second injection of the periinsulin preparation; determining a third injection regulation coefficient k3 and a third injection dosage W3 according to fasting blood glucose gears, W1, k2 and W2 after the second injection of the periinsulin preparation and before the third injection of the periinsulin preparation; and determining a third injection regulation coefficient k4 and a third injection dosage W4 according to fasting blood glucose gears, W1, k2, W2, k3 and W3 after the third injection of the periinsulin preparation and before the fourth injection of the periinsulin preparation. According to the invention, a more scientific basis can be provided for the initial four-time injection dosage of the weekly preparation.

The invention discloses an oral insulin preparation, a preparation method and a preparation device. The oral insulin preparation comprises a machine body, an air heater is fixedly installed on the right side of the machine body, a material collector is fixedly installed on the left side of the machine body, a bent pipe is fixedly communicated between the material collector and the machine body, and a material pump is fixedly installed in the middle of the top end of the machine body. Through the arrangement of the rack, the frame, the square pipe and the spray head, during use, hot air generated by the hot air blower is conveyed into the square pipe through the hose and finally sprayed out through the spray head, the driving mechanism can enable the straight gear to drive the frame to reciprocate up and down, and meanwhile due to the design of the rack, the straight gear and the frame can rotate in a small range when moving up and down; and under the action of the shaking mechanism, the spray head can swing left and right, so that the spray head sprays hot air to different positions, and disordered airflow is formed in the machine body. The insulin premixing liquid drying device has the advantage that the drying effect on the insulin premixing liquid is improved by spraying hot air to different positions.

It is provided an insulin formulation comprising insulin and antimicrobial excipients for use in insulin pumps, connected to subcutaneous tissue via a catheter, a method also known as continuous subcutaneous insulin infusion, wherein the antimicrobial excipient inhibits growth of bacteria in insulin formulations and biofilm bacterial population formation on the internal surfaces of a catheter, allowing extending the time of use of the catheter.

The invention relates to the field of pharmaceutical analysis, in particular to a method for determining the content of phenol and m-cresol in an insulin preparation based on GC-MS / MS (Gas Chromatography-Mass Spectrometry / Mass Spectrometry). The method comprises the following steps: (1) precisely measuring human insulin injection or insulin glargine injection, putting into a measuring flask, diluting by 100 times with a methanol aqueous solution, uniformly shaking, precisely measuring, putting into the measuring flask, diluting by 10 times with the methanol aqueous solution, and taking as a test solution; (2) a quartz capillary column is adopted, the column temperature is kept at 200 DEG C for 5 min, the sample size is 1 microliter, the split ratio is 10: 1, and carrier gas is inert gas; (3) an ionization source is an electron bombardment ion source, the energy is 70 eV, the temperature of the ion source is 200 DEG C, the interface temperature is 250 DEG C, the solvent delay is 1 min, the mass scanning range is 45-500 m / z, the electron multiplication voltage is 3.0 kV, the collision gas is inert gas, and multi-reaction monitoring MRM and full scanning Scan are collected at the same time. The specificity, the linear range, the accuracy, the repeatability, the stability and the durability of the method are superior to those of the prior art.

The invention discloses a solid-phase synthesis insulin glargine preparation process, which belongs to the technical field of biological pharmacy, and comprises the following steps: S1, carrying out solid-phase synthesis on an insulin A chain through Wang resin, removing a protecting group, and then oxidizing by using NCS to form a first pair of disulfide bonds: sequentially inoculating amino acids according to an Fmoc solid-phase synthesis method by using NCS as an oxidizing agent and Wang resin as a solid-phase carrier, so as to obtain a second pair of disulfide bonds; constructing an A chain sequence; s2, performing solid-phase synthesis of insulin B chain by Wang resin, grafting DTDP after cutting, and purifying; s3, butting the A chain solution and the B chain solution to form a second pair of disulfide bonds; and S4, constructing a third pair of disulfide bonds by adopting an iodine oxidation method. According to the method, disulfide bonds can be directionally formed and constructed in three steps, non-specific crosslinking is avoided through selective oxidation of NCS, DTDP and iodine, correct folding of molecules is ensured, the total yield of the three-step disulfide bond forming process reaches 28% and is increased by 13% compared with one-pot oxidation, and the yield is increased; the process is controllable, and the industrial adaptability is high.