PRE-FILLED, READY-TO-USE SYRINGE FORMULATION CONTAINING SEMAGGLUTIDE

Abstract

The invention relates to sterile, injectable, aqueous pharmaceutical formulations containing semagglutide. More specifically, the invention describes pre-filled, ready-to-use formulations for single-dose administration. The invention relates to ready-to-use semaglutide formulations presented in syringes, suitable for subcutaneous administration. It also relates to single-dose pre-filled ready-to-use syringes containing the said semaglutide formulation and kits containing these syringes.

Description

PRE-FILLED, READY-TO-USE CONTAINING SEMAGGLUTIDE. SYRINGE FORMULATION Technical Area The invention relates to sterile, injectable, aqueous pharmaceutical formulations containing semagglutide. More specifically, the invention is a pre-filled syringe for single-dose administration. presented within, ready-to-use semaglutide suitable for subcutaneous administration. It relates to their formulations. The invention also includes a single-dose pre-filled container with the aforementioned semaglutide formulation. This relates to pre-filled syringes and kits containing these syringes. State of the Art Semagglutide is a GLP-1 receptor agonist used for the management of type 2 diabetes and weight loss. It is a compound belonging to the class. The compound semaglutide is described in patent EP1863839B1. Semagglutide has the molecular formula CHNO and a molecular weight of 4113.58 g / mol. 187 291 45 59 The structure of the semaglutide compound is shown as Compound 1 below. (https: / / www.rxlist.com / ozempic-drug.htm) Compound 1 Semagglutide and similar GLP-1 analogs injectable pharmaceutical formulations. Its preparation in this form has been the subject of various patent documents under the prior art. These documents specifically address the stability of peptide-structured active substances in aqueous solutions. Selection of excipients, pH range, isotonicity-providing components, preservatives, and Technical issues such as compatibility with injection molding devices are discussed. In this context, European patent number EP1687019B1 concerns a peptide containing propylene glycol. It relates to formulations. The patent in question involves a peptide with a GLP-1 analog structure. Pharmaceutical formulations containing propylene glycol are described. However, EP1687019B1... A single-dose, pre-filled, ready-to-use syringe containing semagglutide as the focus. These are not formulations. The document in question generally refers to peptides containing propylene glycol. This relates to their formulations and suitability for use in injection devices. 1 The document contains a single dose of semagglutide in each pre-filled syringe, for specific purposes. available in dose / volume combinations, without histidine and / or sodium chloride, for use It does not explicitly reveal the ready-made semagglutide formulation. The present invention describes a single-dose sterile, injectable, aqueous formulation containing semagglutide. presented in a pre-filled, ready-to-use syringe for administration. It is related. Within the scope of the present invention, the formulation includes semagglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and / or sodium hydroxide as pH adjusters, and It contains water for injection. In some formulations of the invention, the formulation does not contain histidine; Some formulations do not contain sodium chloride; however, their preferred formulations contain histidine and sodium chloride. It does not contain chloride. Furthermore, the present invention applies to each pre-filled, ready-to-use unit. the syringe contains a single dose of semaglutide and specific dose / volume combinations It focuses on providing it in a single-dose syringe. Therefore, in the current state of the art, semaglutide and similar GLP-1 analogs are used with propylene formulated with glycol, phosphate buffer, phenol, histidine and various injection devices. Although it is known that it can be done, the present invention involves a single-dose pre-filled syringe. available, ready-to-use, with specific dose / volume combinations and containing histidine and / or The technique is known for providing a sodium chloride-free semagglutide formulation. It is deviating from its current state. In the current state of the art, injectable products containing semagglutide can be used in different devices. It is known that it is presented with packaging systems. However, in the current systems The following technical and practical needs remain: Firstly, it is suitable for single-dose use, administered directly to the patient or healthcare professional. A viable semaglutide formulation needs to be provided. Secondly, each packaging unit contains components that reduce or eliminate the need for dose adjustment. Systems containing only a single applicable dose of semaglutide are needed. Thirdly, unlike pen or cartridge systems, it has a simpler application structure. This results in a reduced risk of dosage errors and minimized device-related malfunctions. It offers advantages. It also features a simpler packaging system (glass syringe + limited elastomer contact). (surface), potential leakage and protein-packaging compared to multi-component pen systems It reduces their interaction. Fourth, semaglutide-containing and subcutaneous administration in specific dose / volume combinations. pharmaceutical formulations that can be prepared in injection volumes suitable for the application are needed. there are. Fifth, an alternative semagglutide that does not contain histidine and / or sodium chloride. Providing 35 formulations would be pharmaceutically beneficial. Sixth, the formulation in question will be suitable for storage at a temperature range of 2°C to 8°C. It needs to be designed in this way. Seventh, in multi-dose pen systems, the product demonstrates “in-use stability” after the first use. It is evaluated within this scope, and the shelf life of unused doses is between 6 weeks. 40 is the limit. In contrast, single-dose pre-filled, ready-to-use syringes are available. 2 Since each dose in the system is a separate and sealed unit, unused doses can be stored for 24–36 months. Shelf life stability is maintained. Therefore, semagglutide-containing syringes, in single-dose pre-filled containers, a sterile, injectable, aqueous, and ready-to-use pharmaceutical formulation is needed It is located. Advantages of the Invention The formulation described in this invention is a sterile, injectable, and aqueous pharmaceutical containing semagglutide. The solution is ready for use in a single-dose, pre-filled syringe. This allows the formulation to be reconstituted before application. by being diluted, mixed with another solvent, or transferred from a separate container to a syringe. There is no need for extraction. This structure provides ease of application and benefits the patient or healthcare professional. It reduces the preparation tasks that can be performed by the staff. A key advantage of the invention is that each pre-filled, ready-to-use syringe is a single unit. It contains semagglutide. Thanks to this feature, the dose to be administered is determined during the production phase. This is predetermined. The user can select the dose, measure the volume, or administer a multi-dose regimen. No specific dose adjustment may be required from the system. This reduces the risk of dosing errors. And in each application, a predetermined amount of semagglutide can be administered. The subject of the invention is a pre-filled, ready-to-use syringe, multi-dose pen or cartridge. It provides an alternative product offering to existing systems. The formulation is in a single-dose syringe. Its inclusion creates an independent dose unit for each application. This structure allows for multiple applications. It can provide a simpler mode of use compared to dose reservoir or cartridge systems, and It can offer a practical solution, especially in cases where a single dose is preferred. Another advantage of the invention is that the formulation contains semaglutide, disodium phosphate dihydrate, and propylene. glycol, phenol, hydrochloric acid and / or sodium hydroxide as pH adjusters, and for injection. It is prepared as an aqueous solution containing water. This excipient system contains semagglutide. the ready-to-use injection solution is presented in a pre-filled syringe. It provides opportunities. In some formulations of the invention, the absence of histidine and the presence of semagglutide are the issues addressed. an alternative adjunct for pre-filled, ready-to-use syringe formulations The system provides a material. In some components of the invention, the formulation uses sodium chloride. Its absence also offers an alternative formulation approach. In preferential configurations The formulation does not contain either histidine or sodium chloride, unlike the aqueous formulation containing semagglutide. This allows formulations to be prepared with different auxiliary substance compositions. Another advantage of the invention is that the pH of the formulation can be preferably between 7.0 and 8.5. The pH can be adjusted to between 7.2 and 7.8. This pH range is suitable for aqueous solutions containing semagglutide. the solution as a sterile injection formulation suitable for subcutaneous administration It contributes to the preparation. The pH value is adjusted with hydrochloric acid and / or sodium hydroxide. Its adjustability allows the formulation to be prepared within the target pH range. It is also important that the formulation described in the invention can be prepared in different dose / volume combinations. 40 is an advantage. Approximately 0.25 mg / 0.19 mL, approximately 0.5 mg / 0.37 mL, approximately 1 mg / 0.74 mL, approximately 1.7 mg / 0.75 mL, approximately 2 mg / 0.74 mL and approximately 2.4 mg / 0.75 mL dose / volume Thanks to the combinations, different semagglutide doses are available in single-dose pre-filled packages. 3 It is possible to present it in a ready-to-use syringe. This design allows each dose to be... This allows the level to be prepared as a single application unit with a suitable injection volume. provides. Another advantage of the invention is that the formulation is ready to use in a pre-filled glass container. It can be presented in a syringe. Glass syringe for sterile aqueous formulation containing semagglutide. It can be used as a primary packaging system. The syringe is pre-filled and sealed. This presentation contributes to the proper preservation of the formulation until use. It is found. An additional advantage is that the formulation in question is suitable for storage at 2°C to 8°C. This feature ensures that the sterile aqueous formulation containing semagglutide can withstand the cold chain. under these conditions, it should be stored in a pre-filled, ready-to-use syringe. It allows. The invention also includes two or more pre-filled, ready-to-use units, preferably four. They can provide a kit containing a syringe. This kit setup corresponds to one month's treatment. This allows for the single-dose syringes to be presented together. Thus, the product is delivered to the user... The required semagglutide doses for a specific treatment period are presented in a regular and practical packaging structure. It can provide this within. In conclusion, the invention relates to a sterile, aqueous, and injectable pharmaceutical containing semagglutide. The formulation is in a single-dose, ready-to-use, pre-filled syringe. by providing ease of use, pre-determining the dose, and eliminating dosing errors. risk reduction, provision of an alternative excipient system, within the appropriate pH range. It can be prepared in various dose / volume combinations and is available as a kit. It offers advantages such as the ability to be packaged. Description of the Invention The invention relates to a pre-filled, ready-to-use syringe for single-dose administration. This relates to a pharmaceutical formulation in the form of a sterile, injectable aqueous solution. The subject matter of the invention is a pharmaceutical formulation containing semaglutide, disodium phosphate dihydrate, and propylene glycol. It contains phenol, hydrochloric acid and / or sodium hydroxide as pH adjusters, and water for injection. In one design of the invention, the formulation is suitable for subcutaneous administration. The invention consists of a pre-filled, ready-to-use syringe containing a single semaglutide. includes the dose. In a formulation of the invention, one of the following dose / volume combinations may be used. Includes: approximately 0.25 mg semaglutide / 0.19 mL, 35 approximately 0.5 mg semaglutide / 0.37 mL, approximately 1 mg semaglutide / 0.74 mL, approximately 1.7 mg semaglutide / 0.75 mL, approximately 2 mg semaglutide / 0.74 mL, 4 approximately 2.4 mg semaglutide / 0.75 mL. In one configuration of the invention, the semagglutide concentration in the formulation is approximately 1.34 mg / mL is approximately 2.27 mg / mL, approximately 2.68 mg / mL, or approximately 3.2 mg / mL. In one aspect of the invention, the formulation does not contain histidine. In one aspect of the invention, the formulation does not contain sodium chloride. In a preferential configuration of the invention, the formulation does not contain histidine or sodium chloride. In one formulation of the invention, the pH value of the formulation is between 7.0 and 8.5. In a preferred formulation of the invention, the pH of the formulation is between 7.2 and 7.8. In one aspect of the invention, the pre-filled, ready-to-use syringe is a glass syringe. In one aspect of the invention, the formulation is a ready-to-use, single-dose injection solution. The invention consists of a formulation in a pre-filled, ready-to-use syringe. It is suitable for storage at temperatures between 2°C and 8°C. The invention also relates to a kit containing the pharmaceutical formulation in question. This kit is a Two or more units, preferably four, in advance, corresponding to monthly treatment. Includes a pre-filled, ready-to-use syringe. Detailed Description of the Invention The present invention is a pre-filled, ready-to-use syringe for single-dose administration. in the form of a sterile, injectable aqueous solution containing semagglutide. It relates to a pharmaceutical formulation. The formulation that is the subject of the invention is a ready-to-use injection. It has been developed as a solution, and reconstitution, dilution, and dose reduction are required prior to application. or suitable for direct subcutaneous administration without requiring any other preparation procedure. It is prepared in this way. The term "pre-filled ready-to-use syringe" used within the scope of the invention, where the pharmaceutical formulation is filled into the syringe during the production or filling stage, a primary packaging that is properly sealed and presented to the user ready for use It refers to the system. In this system, the formulation is in a separate vial, cartridge, or multi-dose form. Instead of being drawn from the reservoir, a predetermined volume is injected directly into the syringe. This allows the user or healthcare professional to make additional dose selections or Administering a single dose without the need to draw up a specific volume of formulation. It becomes possible. The formulation described in this invention contains semaglutide as the active ingredient. Semaglutide is a peptide-structured substance. It is an active ingredient in pharmaceutical formulations suitable for subcutaneous administration. available. Within the scope of the invention, semaglutide, each pre-filled and ready for use. Each syringe contains a single, administerable dose. Therefore, each one... 35 syringes, as self-administered units containing a specific dose of semagglutide. It has been improved. The formulation subject to the invention is in the form of an aqueous solution. Within this scope, the formulation is a suspension. It is not in emulsion or lyophilized powder form. The formulation is in aqueous solution form. finding, adding solvent before application, dissolving the powder product or This eliminates the need to mix the formulation with another carrier. Thus, the invention... The formulation in question is supplied as a ready-to-use, single-dose injection solution. The pharmaceutical formulation that is the subject of the invention contains semaglutide in addition to disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and / or sodium hydroxide as pH adjusters, and Contains water for injection. Disodium phosphate dihydrate is included in the formulation within the appropriate pH range. It is used as an auxiliary substance that can contribute to its preparation and preservation. Propylene glycol is an excipient that can be used in aqueous injection formulations, The invention may contribute to ensuring the pharmaceutical properties of the formulation. Phenol, as an excipient that can be used in injectable pharmaceutical formulations It is included in the formulation. Hydrochloric acid and / or sodium hydroxide are part of the formulation. It is used to adjust the pH value to the target range. Water for injection, It forms the aqueous carrier phase of the formulation and the final volume is obtained by dissolving the components. It is used for the purpose of completion. A preferred configuration of the invention is the formulation of disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and / or sodium hydroxide as pH adjusters, and water for injection. It contains no other excipients. In one formulation of the invention, the pH value of the formulation is between 7.0 and 8.5. The invention further... In its preferred formulation, the pH value of the formulation is between 7.2 and 7.8. The formulation... The pH value being within this range indicates that the aqueous solution containing semagglutide can be administered subcutaneously. It contributes to the preparation of a suitable injection formulation for the application. pH This pH value can be adjusted using hydrochloric acid and / or sodium hydroxide. The amount of adjusters ensures that the final pH of the formulation is within the desired range. It is determined in a way that will provide In some formulations of the invention, the formulation does not contain histidine. In these formulations, semagglutide Histidine is not used in the preparation of the formulation containing and the formulation is histidine-free. It is prepared with an alternative auxiliary substance system. In some components of the invention, the formulation... It does not contain sodium chloride. In these formulations, sodium chloride is not added to the mixture. In preferential configurations of the invention, the formulation does not contain histidine or sodium chloride. This In preferred formulations, semagglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and / or sodium hydroxide as pH adjusters, and water for injection. It is prepared as an aqueous solution that is formed or primarily contains these components. The formulation subject to the invention is a pre-filled, ready-to-use system with varying doses of semagglutide. It allows for presentation in a single-dose syringe. In a structure of the invention The formulation contains approximately 0.25 mg semaglutide / 0.19 mL dose / volume combination. 35. In one configuration of the invention, the formulation contains approximately 0.5 mg semaglutide / 0.37 mL dose / volume. It includes the combination. In one configuration of the invention, the formulation contains approximately 1 mg of semaglutide / It contains a dose / volume combination of 0.74 mL. In one configuration of the invention, the formulation is approximately It contains a dose / volume combination of 1.7 mg semaglutide / 0.75 mL. In a structure of the invention. The formulation contains approximately 2 mg semaglutide / 0.74 mL dose / volume combination. The invention In another formulation, the dose / volume is approximately 2.4 mg semaglutide / 0.75 mL. It includes a combination. Thanks to these dose / volume combinations, each pre-treatment The pre-filled, ready-to-use syringe contains a specific dose of semagglutide as a single unit of administration. includes. 6 In the formulation subject to this invention, the semagglutide concentration depends on the selected dose / volume combination. It is determined depending on the formulation of semaglutide in one aspect of the invention. The concentration is approximately 1.34 mg / mL. In a design of the invention, the formulation contains... The semagglutide concentration is approximately 2.27 mg / mL. In a construct of the invention The semagglutide concentration in the formulation is approximately 2.68 mg / mL. The invention is a In this formulation, the semagglutide concentration is approximately 3.2 mg / mL. Concentration values ​​for different semagglutide doses in volumes suitable for subcutaneous administration. and allows for preparation in a single-dose, pre-filled, ready-to-use syringe format. It gives. The invention involves the formulation being contained in a pre-filled syringe. the formulation is presented as a single-dose, ready-to-use and practical application system. It provides. Each pre-filled, ready-to-use syringe contains a single dose of semaglutide. Therefore, the syringe is suitable for multi-dose use. This allows the same syringe to be used for multiple applications. The primary packaging may not need to be reused. This reduces the risk of dosing errors. contributes to reducing and predetermining the volume to be applied by the user. provides. In one aspect of the invention, the pre-filled, ready-to-use syringe is a glass syringe. A glass syringe can be used as the primary packaging for the aqueous solution containing semagglutide. The syringe, The volume can be selected to match the dosage / volume combination of the formulation. Pre-filled. pre-filled syringe, syringe body, plunger, stopper, end cap, needle, needle guard or needle holder. It may include components such as a connection structure. The syringe can be filled under aseptic conditions and is suitable. By sealing with closure elements, it can be kept sterile and sealed until use. The formulation that is the subject of this invention is a ready-to-use, single-dose injection solution. Therefore... The formulation must not be mixed, diluted, or mixed with another solution prior to application. It does not need to be reconstituted. Each pre-filled, ready-to-use syringe contains one It includes the required amount of semaglutide for the application and the corresponding formulation volume. This structure allows the user to directly administer a predetermined dose. Thus The formulation is a single-dose injection solution suitable for subcutaneous administration. available. In one aspect of the invention, the formulation is a pre-filled, ready-to-use syringe. It is suitable for storage at 2°C to 8°C. This storage condition applies to sterile containers containing semaglutide. It allows the aqueous formulation to be stored under cold chain conditions. The formulation is suitable for storage in pre-filled syringes at 2°C to 8°C. This ensures that the product is stored in a ready-to-use condition and remains suitable until it is applied. It supports preservation under 35 conditions. Storage suitability of the formulation. When evaluated, appearance, pH, semagglutide content, relevant impurities, particle presence, and sterility are considered. Parameters such as primary packaging compatibility are taken into consideration. The formulation described in this invention can be prepared using appropriate pharmaceutical manufacturing techniques. In one example preparation method, the water for injection is placed in a suitable mixing container. 40 Disodium phosphate dihydrate, propylene glycol, and phenol are added to water for injection and dissolved. It is stirred until dissolved. Then semagglutide is added to the solution and stirred until dissolution is complete. Stirring is continued for this period. The pH value of the resulting solution is adjusted according to the hydrochloric acid and / or sodium. The pH is adjusted to the desired range using hydroxide. After pH adjustment, the solution is ready for injection. The solution is diluted with water to the final volume. The prepared solution is sterilized using appropriate sterilization methods. 7 It can be brought in. In one setup, the solution is subjected to sterile filtration. After sterile filtration... The solution is filled into ready-to-use syringes under aseptic conditions. The filled syringes are then placed in appropriate containers. They are sealed with closing elements and the final packaging processes are carried out. The invention also relates to a kit containing the pharmaceutical formulation described above. The invention is a In its formulation, the kit includes two or more, preferably four, kits corresponding to a one-month treatment. Each pre-filled, ready-to-use syringe contains... The pre-filled syringe contains a single dose of semagglutide. The kit also includes instructions for use, outer packaging, blister packs, carrier trays, labels, protective packaging elements, or storage conditions. It may include informational elements. Thus, the kit provides the single dose required for a specific treatment period. It allows for the simultaneous delivery of semaglutide syringes. The invention describes a formulation and kit that is a ready-to-use, single-dose injection containing semagglutide. It has been developed to provide a solution. The formulation is pre-filled and ready to use. Having it in a syringe allows for pre-determining the dose, ease of administration, and a single dose. It contributes to the dosage regimen. The invention does not contain histidine and / or sodium chloride. formulations, pre-filled ready-to-use syringes containing semagglutide It provides an alternative excipient system for formulations. The formulation has a specific pH. Suitable for storage within specific dose / volume combinations and at 2°C to 8°C. The design of the invention involves a sterile, aqueous, and injectable pharmaceutical containing semagglutide. This enables the creation of a viable solution in the field of formulations. The formulation subject to this invention is based on known pharmaceutical production techniques, given the appropriate art. It can be prepared using [method]. In a sample preparation method, the water for injection is placed in a suitable mixing container. Disodium phosphate dihydrate, propylene glycol, and phenol are added to the water for injection and dissolved. It is mixed until... Next, semagglutide is added to the solution and stirred until dissolution is complete. It is continued. The pH of the solution can be adjusted to the desired pH using hydrochloric acid and / or sodium hydroxide. It is adjusted to the range. In one configuration of the invention, the pH value is adjusted to between 7.0 and 8.5. In a preferred configuration of the invention, the pH value is adjusted to between 7.2 and 7.8. After pH adjustment, the solution is diluted to its final volume with water for injection. The prepared solution can be sterilized using an appropriate sterilization method. In a structure The solution is subjected to sterile filtration. After sterile filtration, the solution is stored under aseptic conditions. It is filled into ready-to-use syringes. 35. The filled syringes are sealed with suitable closure elements and subjected to final packaging procedures. is carried out. Examples The following examples are given to illustrate the invention. These examples illustrate the scope of the invention. It is not restrictive. Example 1: Pre-filled, ready-to-use sachet containing approximately 0.25 mg of semagglutide. Syringe In this example, a sterile, injectable aqueous solution with a semagglutide concentration of approximately 1.34 mg / mL was used. The formulation has been prepared in solution form. The formulation contains semaglutide, disodium phosphate dihydrate, propylene glycol, phenol, and a pH adjuster. It contains hydrochloric acid and / or sodium hydroxide and water for injection. The prepared solution is adjusted to the appropriate pH range and, after sterile filtration, administered as a single dose. The syringe is aseptically filled with 0.19 mL of the product. Example 2: Pre-filled, ready-to-use sachet containing approximately 0.5 mg of semagglutide. Syringe In this example, a sterile, injectable aqueous solution with a semagglutide concentration of approximately 1.34 mg / mL was used. The formulation has been prepared in solution form. The formulation contains semaglutide, disodium phosphate dihydrate, propylene glycol, phenol, and a pH adjuster. It contains hydrochloric acid and / or sodium hydroxide and water for injection. The prepared solution is adjusted to the appropriate pH range and, after sterile filtration, administered as a single dose. The syringe is aseptically filled with 0.37 mL of the product. Example 3: Pre-filled, ready-to-use sachet containing approximately 1 mg of semagglutide. Syringe In this example, a sterile, injectable aqueous solution with a semagglutide concentration of approximately 1.34 mg / mL was used. The formulation has been prepared in solution form. The formulation contains semaglutide, disodium phosphate dihydrate, propylene glycol, phenol, and a pH adjuster. It contains hydrochloric acid and / or sodium hydroxide and water for injection. The prepared solution is adjusted to the appropriate pH range and, after sterile filtration, administered as a single dose. The syringe is aseptically filled with 0.74 mL of the product. Example 4: Pre-filled, ready-to-use sachet containing approximately 1.7 mg of semagglutide. Syringe In this example, a sterile, injectable aqueous solution with a semagglutide concentration of approximately 2.27 mg / mL was used. The formulation has been prepared in solution form. The formulation contains semaglutide, disodium phosphate dihydrate, propylene glycol, phenol, and a pH adjuster. It contains hydrochloric acid and / or sodium hydroxide and water for injection. The prepared solution is adjusted to the appropriate pH range and, after sterile filtration, administered as a single dose. The syringe is aseptically filled with 0.75 mL of the product. Example 5: Pre-filled, ready-to-use sachet containing approximately 2 mg of semagglutide. Syringe 35 In this example, a sterile, injectable aqueous solution with a semagglutide concentration of approximately 2.68 mg / mL was used. The formulation has been prepared in solution form. 9 The formulation contains semaglutide, disodium phosphate dihydrate, propylene glycol, phenol, and a pH adjuster. It contains hydrochloric acid and / or sodium hydroxide and water for injection. The prepared solution is adjusted to the appropriate pH range and, after sterile filtration, administered as a single dose. The syringe is aseptically filled with 0.74 mL of the product. Example 6: Pre-filled, ready-to-use sachet containing approximately 2.4 mg of semagglutide. Syringe In this example, a sterile, injectable aqueous solution with a semagglutide concentration of approximately 3.2 mg / mL was used. The formulation has been prepared in solution form. The formulation contains semaglutide, disodium phosphate dihydrate, propylene glycol, phenol, and a pH adjuster. It contains hydrochloric acid and / or sodium hydroxide and water for injection. The prepared solution is adjusted to the appropriate pH range and, after sterile filtration, administered as a single dose. The syringe is aseptically filled with 0.75 mL of the product. Example 7: Formulation Free of Histidine and Sodium Chloride In this example, semagglutide, disodium phosphate dihydrate, propylene glycol, phenol, and pH adjuster are used. in the form of an aqueous solution containing hydrochloric acid and / or sodium hydroxide and water for injection The formulation has been prepared. Histidine is not added to the formulation. Sodium chloride is not added to the formulation. The prepared formulation is filled into a single-dose, ready-to-use syringe. Example 8: Pre-filled, ready-to-use, suitable for storage at 2°C to 8°C. Syringe In this example, a sterile aqueous formulation containing semagglutide is aseptically injected into a glass syringe. It is filled in. The filled syringes are packaged for storage at 2°C to 8°C.

Claims

1. Contains a pre-filled, ready-to-use syringe for single-dose administration. It is a sterile, injectable pharmaceutical formulation, characterized by the fact that the formulation... • semaglutide, • disodium phosphate dihydrate, • propylene glycol, • phenol, • Hydrochloric acid and / or sodium hydroxide as pH adjusters, and • water for injection, It is an aqueous solution containing.

2. According to Claim 1, it is a pharmaceutical formulation, characterized by its subcutaneous administration. It is the implementation.

3. A pharmaceutical formulation according to Claim 1 or 2, whose characteristics are pre-filled. The ready-to-use syringe contains a single dose of semagglutide.

4. A pharmaceutical formulation according to any of the previous requirements, and its characteristics The formulation must contain one of the following dose / volume combinations: • approximately 0.25 mg semaglutide / 0.19 mL, • approximately 0.5 mg semaglutide / 0.37 mL, • approximately 1 mg semaglutide / 0.74 mL, • approximately 1.7 mg semaglutide / 0.75 mL, • approximately 2 mg semaglutide / 0.74 mL or • Approximately 2.4 mg semaglutide / 0.75 mL.

5. A pharmaceutical formulation according to any of the previous requirements, and its characteristics The semagglutide concentration in the formulation is approximately 1.34 mg / mL, approximately 2.27 mg / mL, This is approximately 2.68 mg / mL or approximately 3.2 mg / mL.

6. A pharmaceutical formulation according to any of the previous requirements, and its characteristics The formulation does not contain histidine.

7. A pharmaceutical formulation according to any of the previous requirements, and its characteristics The formulation does not contain sodium chloride.

8. A pharmaceutical formulation according to any of the previous requirements, and its characteristics The formulation does not contain histidine or sodium chloride.

9. A pharmaceutical formulation according to any of the previous requirements, and its characteristics The pH value of the formulation should be between 7.0 and 8.

5.

10. A pharmaceutical formulation according to any of the previous requirements, and its characteristics The pH value of the 35 formulations should be between 7.2 and 7.

8. 11 11. A pharmaceutical formulation according to any of the previous requirements, whose characteristics are predetermined. The pre-filled, ready-to-use syringe is a glass syringe.

12. A pharmaceutical formulation according to any of the previous requirements, and its characteristics The formulation is a ready-to-use, single-dose injection solution.

13. A pharmaceutical formulation according to any of the previous requirements, and its characteristics The formulation is stored in a pre-filled, ready-to-use syringe at 2°C to 8°C. It is suitable for concealment.

14. A kit containing a pharmaceutical formulation according to any of the previous requirements, and its characteristics The kit contains four pre-filled syringes, enough for one month's treatment. It includes. 12