Pharmaceutical composition comprising dual GIP and GLP-1 receptor agonist

Abstract

The invention pertains to pharmaceutical compositions containing a GIP (glucose-dependent insulino-tropic polypeptide) and GLP-1 (Glucagon-like peptide-1) receptor agonist. In particular, the invention provides pharmaceutical compositions containing tirzepatide. The pharmaceutical compositions according to the invention are physically and chemically stable, are easy to manufacture and suitable for parenteral administration. The invention further provides methods for making the same as specified in the claims.

Description

PHARMACEUTICAL COMPOSITION COMPRISING DUAL GIP AND GLP-1 RECEPTOR AGONIST

[0001] Priority is claimed of Slovenian patent application no. SI P-202400036 that was filed on 15.3.2024.

[0002] The invention pertains to new pharmaceutical compositions containing a GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (Glucagon-like peptide- 1) receptor agonist. In particular, the invention provides pharmaceutical compositions containing tirzepatide. The pharmaceutical compositions according to the invention are physically and chemically stable, are easy to manufacture and suitable for parenteral administration. The invention further provides methods for making the same.

[0003] GLP-1 and GIP are hormones involved in blood-sugar control. After a meal, these hormones are secreted by cells of the intestines, and they cause the secretion of insulin from the pancreas.

[0004] Tirzepatide is a long-acting GIP / GLP analogue that activates both the GLP-1 and GIP receptors, leading to improved blood-sugar control. It has a greater affinity to GIP receptors than to GLP-1 receptors, and this dual agonist behavior has been shown to produce greater reductions of hyperglycemia compared to a selective GLP-1 receptor agonist. Tirzepatide mimics the actions of natural GIP at the GIP receptor. At the GLP-1 receptor tirzepatide shows bias towards cAMP (a messenger associated with regulation of glycogen, sugar, and lipid metabolism) generation, rather than [3-arrestin recruitment. This combination of preference towards GIP receptor and distinct signaling properties at GLP-1 suggest this biased agonism increases insulin secretion. Tirzepatide has also been reported to increase levels of adi- ponectin, an adipokine involved in the regulation of both glucose and lipid metabolism.

[0005] Tirzepatide (CAS 2023788-19-2, ATC A10BX16) is a linear polypeptide of 39 amino acids that has been chemically modified by lipidation (fatty-diacid section (eicosanedioic acid) is linked via a glutamic acid and two (2-(2-aminoethoxy)ethoxy)acetic acid units to the side chain of the lysine residue.), which improves its uptake into cells and also enables a much longer half-life (because of its high affinity to albumin), thereby extending the time between doses.

[0006] Tirzepatide, sold under the brand name Mounjaro® among others, is an antidiabetic medication used for the treatment of type 2 diabetes and for weight loss. It is administered once a week through subcutaneous injections.

[0007] Tirzepatide was first described in WO 2016 / 111971 Al. The same document also describes a method of synthesis of tirzepatide. WO 2019 / 245893 A2 describes formulations of tirzepatide. One composition comprises tirzepatide, NaCl, and dibasic sodium phosphate. An alternative composition comprises tirzepatide, propylene glycol, and dibasic sodium phosphate. Compositions which further comprise a preservative (metacresol or phenol) are described as well.

[0008] There remains a need for pharmaceutical compositions exhibiting a desired physical and chemical stability. Further, there is an unmet need for formulating GIP / GLP analogue peptides with alternative excipients, e.g. to provide suitable treatment options for patients with allergies against specific excipients. The accomplishment of this objective is hampered by the need to maintain excellent performance characteristics with respect to stability.

[0009] Zapadka KL et al., 2017 Factors affecting the physical stability (aggregation) of peptide therapeutics. Interface Focus 7: 20170030. http: / / dx.doi.org / 10.1098 / rsfs.2017.0030 relates to factors affecting the physical stability (aggregation) of peptide therapeutics. The aggregation of peptides is one of the most common and troubling processes encountered in almost all phases of biological drug development. It can take several different forms during a number of different processes where peptide molecules associate into larger species consisting of multiple polypeptide chains. Aggregates can be amorphous or highly structured, e.g. amyloid fibrils, and can form in solution or on surfaces due to adsorption. They can arise as a result of the non-covalent association of polypeptide chains, or from covalent linkage of chains. In some cases, aggregation is reversible while in others it is effectively irreversible. In either case, it reduces the physical stability of the peptide in question, not only leading to a loss in activity but also other critical problems such as toxicity and immunogenicity.

[0010] Predicting a long-term stability of therapeutic peptides during development of the drug product (formulation) is of major interest. There are different approaches for long-term stability predictions of therapeutic proteins and peptides in solution.

[0011] A more traditional approach is based on results from accelerated stability studies and Arrheniusbased kinetics. Using the Arrhenius equation, accelerated degradation rate of a peptide can be used to extrapolate it to estimate the degradation of a drug under normal conditions.

[0012] A more recent approach is based on an assessment of colloidal stability of the peptide molecule in solution. Colloidal stability in peptide formulation refers to the ability of peptide particles to remain uniformly dispersed in a solution without aggregating or precipitating over time. It is expressed as diffusion interaction parameter (kD) or second virial coefficient (A2) determined respectively by dynamic light scattering (DLS) and static light scattering (SLS) analysis of the liquid peptide formulation (Dauer K et al., High-Throughput Screening for Colloidal Stability of Peptide Formulations Using Dynamic and Static Light Scattering. Mol Pharm. 2021 May 3;18(5): 1939-1955. doi: 10.1021 / acs.molpharma- ceut.0c01028. Epub 2021 Mar 31. PMID: 33789055).

[0013] Formulation assessment based on (kD) or (A2) obtained by high throughput (HT) methods offers important insights into the optimization of colloidal stability during the development of peptide- based liquid formulations.

[0014] Concerning colloidal stability, weak peptide to peptide interactions (PPIs) are an indicator of the colloidal stability of protein liquid formulations (Sorret, L. L. et al., Challenges in Predicting Protein- Protein Interactions from Measurements of Molecular Diffusivity. Biophys. J. 2016, 111, 1831-1842;Thiagarajan, G. et al., Comparison of biophysical characterization techniques in predicting monoclonal antibody stability. mAbs 2016, 8, 1088-1097; Saito, S. et al., Effects of Ionic Strength and Sugars on the Aggregation Propensity of Monoclonal Antibodies: Influence of Colloidal and Conformational Stabilities. Pharm. Res. 2013, 30, 1263-1280; Kumar, V. et al., Impact of short range hydrophobic interactions and long range electrostatic forces on the aggregation kinetics of a monoclonal antibody and a dual-variable domain immunoglobulin at low and high concentrations. Int. J. Pharm. 2011, 421, 82-93; Wills, P. R. et al., The osmotic second virial coefficient for protein self-interaction: Use and misuse to describe thermodynamic nonideality. Anal. Biochem. 2015, 490, 55-65).

[0015] Protein-protein interactions (PPIs) generally arise from several contributions including hard- sphere repulsion, electrostatic interactions, attractive van der Waals forces, osmotic attraction, and specific interaction such as hydrophobic attraction, hydrogen bonding, and the formation of salt bridges. Accordingly, the peptide of defined concentrations can be stabilized against attractive intermolecular forces by optimal formulation conditions such as buffer composition, specific ion types, ionic strength, solution pH, and further excipients.

[0016] Peptides possess a lower molecular weight and much smaller surface compared to larger proteins. These factors increase the impact of a net charge on diffusion and colloidal stability while simultaneously lowering the impact of charge distribution. The tirzepatide drug molecules in proposed formulations maintained a significant net charge at pH values 6.5-7.5. Additionally, they exhibited sufficiently low ionic strength, due to low buffer molarity and non-ionic tonicity agents. As the net charge of the peptide was sufficiently high, optimization of colloidal stability could have been supported by the SLS method to determine A2 (

[0017] Hofmann, M. et al., Predictive Screening Tools Used in High-Concentration Protein Formulation Development. J. Pharm. Sci. 2018, 107, 772-777. h concentration protein formulations. Pharm. Dev. Technol. 2015, 20, 367-374; Garidel, P. et al., Prediction of colloidal stability of high concentration protein formulations. Pharm. Dev. Technol. 2015, 20, 367-374; Valente, J. et al., Colloidal Behavior of Proteins: Effects of the Second Virial Coefficient on Solubility, Crystallization and Aggregation of Proteins in Aqueous Solution. Curr. Pharm. Biotechnol. 2005, 6, 427-436; Garripelli VK et al., Developability assessment for monoclonal antibody drug candidates: a case study. Pharm Dev Technol. 2021 Jan;26(l): 11-20. doi: 10.1080 / 10837450.2020.1829641. Epub 2020 Oct 14. PMID: 32986499; Webster S., Predicting Long-Term Storage Stability of Therapeutic Proteins. Pharmaceutical Technology l l-02-2013;Volume 37; Issue 11; WP5003: Automated dynamic and static light scattering in microwell plates for fast, productive development of biologies Daniel Some, Ph.D, 2024. Wyatt Technology White paper).

[0018] The second virial coefficient (A2) provides crucial thermodynamic insights into the interactions and aggregation behavior of peptides in solution and their long-term stability. However, for acomprehensive prediction of long-term stability, it should be considered that stability is influenced by a combination of factors, including chemical degradation, structural changes and environmental conditions.

[0019] The invention pertains to pharmaceutical compositions containing a GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (Glucagon-like peptide- 1) receptor agonist (GIP / GLP analogue). In particular, the invention provides pharmaceutical compositions containing tirzepatide. The pharmaceutical compositions according to the invention are physically and chemically stable, are easy to manufacture and suitable for parenteral administration. The invention further provides methods for making the same as specified in the claims.

[0020] The pharmaceutical composition of the invention comprises a GIP / GLP analogue, one or more buffering agents, one or more tonicity agents, and optionally other pharmaceutically acceptable excipients, preferably selected from the group consisting of but not limited to one or more preservatives, one or more solvents, one or more chelating agents, one or more stabilizers, one or more pH adjusting agents, one or more antioxidants, and one or more surfactants.

[0021] The pharmaceutical composition of the invention is preferably in the form of a solution, more preferably in the form of an injectable solution.

[0022] The pharmaceutical composition of the invention have increased stability in terms of the formation of undesired high molecular weight impurities (HMW), related substances and aggregates, after exposure to stress, accelerated- or in-use conditions.

[0023] It has been surprisingly found that suitable materials can be used without compromising performance of the GIP / GLP analogue formulations. The invention has been made on the basis of these findings. The invention has been completed based on these findings.

[0024] According to the invention and unless specified, all amount indications are provided on a weight basis.

[0025] Measurement of pH is performed according to the Ph. Eur. test 2.2.3. Potentiometric determination of pH, where determination of pH is made by measuring the potential difference between the reference electrode and the electrode, sensitive to hydrogen ions.

[0026] Measurement of osmolality is performed according to the Ph. Eur. test 2.2.35. Osmolality, where osmolality is determined by measurement of depression of freezing point.

[0027] Clarity of solution is measured according to the Ph. Eur. test 2.2.1. Clarity and degree of opalescence of liquids, where clarity can be determined by a visual or an instrumental method.

[0028] According to a preferred embodiment, the above tests are carried out as specified in the 9th Edition of Ph. Eur.

[0029] If no temperature is specified, the temperature for carrying out the described methods is not particularly restricted. Unless the context dictates otherwise, the described operations may for instance be carried out at any temperature within the normal room temperature range, i.e. 15-30°C, such as 20- 25 °C and more specifically 21-23 °C.

[0030] The term “final volume” is meant to characterize the volume that is obtained when adding sufficient water for injections to reach the intended concentration of the GIP / GLP analogue, such as, in embodiments of the invention, the concentrations specified in Section 5.

[0031] In a preferred embodiment of the invention the GIP / GLP analogue is tirzepatide. Tirzepatide was first described in WO 2016 / 111971 Al. The term tirzepatide as used in the invention denotes tirzepatide and all pharmaceutically acceptable salts, hydrates, solvates, prodrugs, chelates and complexes thereof.

[0032] In a preferred embodiment the concentration of tirzepatide present in the pharmaceutical composition according to the invention is from 4-30 mg / ml.

[0033] Tirzepatide used in the pharmaceutical composition according to the invention may be prepared according to any manufacturing process known from the state art such as for example WO 2016 / 111971 Al.

[0034] The pharmaceutical composition of the invention is designated by the use of at least one buffering agent. The term buffering agent as used in the invention denotes a compound used to maintain the pH near a desired value. A suitable buffering agent can be any compound known to the person skilled in the art as described e.g. in Remington: The Science and Practice of Pharmacy, 22nd Edition, 2013, to maintain the pH in basic environment, e.g. in one of the pH ranges specified in the pharmaceutical composition section below, and which is suitable for using in pharmaceutical compositions. The buffering agent can include, but it is not limited to, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium phosphate, sodium acetate, sodium carbonate, sodium citrate, meglumine, glycine, histidine, lysine, arginine, asparagine, glutamic acid, sodium glutamate, TRIS (hydroxymethyl)-amino- methane, methionine, Hepes, maleic acid, malic acid, lactate or any combinations thereof. Each one of these specific buffering agents and combinations thereof constitutes an alternative embodiment of the invention.

[0035] The buffering agent to be used according to a preferred embodiment of the invention is selected from the group consisting of TRIS, sodium citrate, histidine and disodium hydrogen phosphate or any combination thereof.

[0036] The buffering agent to be used according to a preferred embodiment of the invention is selected from the group consisting of TRIS, sodium citrate and histidine or any combination thereof.

[0037] In a preferred embodiment the concentration of buffering agent used in the pharmaceutical composition of the invention is in the range of 0.30-1.70 mg / ml.

[0038] In a preferred embodiment the concentration of buffering agent used in the pharmaceutical composition of the invention is in the range of 0.55-1.20 mg / ml.

[0039] In a preferred embodiment the buffering agent used in the pharmaceutical composition of the invention is TRIS.

[0040] In a preferred embodiment the concentration of TRIS used in the pharmaceutical composition of the invention is in the range of 0.30-0.90 mg / ml.

[0041] In a preferred embodiment the concentration of TRIS used in the pharmaceutical composition of the invention is in the range of 0.45-0.75 mg / ml.

[0042] In a preferred embodiment the concentration of TRIS used in the pharmaceutical composition of the invention is in the range of 0.50-0.70 mg / ml.

[0043] In a preferred embodiment the buffering agent used in the pharmaceutical composition of the invention is Na-citrate.

[0044] In a preferred embodiment the concentration of Na-citrate used in the pharmaceutical composition of the invention is in the range of 0.55-1.65 mg / ml.

[0045] In a preferred embodiment the concentration of Na-citrate used in the pharmaceutical composition of the invention is in the range of 0.75-1.45 mg / ml.

[0046] In a preferred embodiment the concentration of Na-citrate used in the pharmaceutical composition of the invention is in the range of 0.90-1.30 mg / ml.

[0047] In a preferred embodiment the buffering agent used in the pharmaceutical composition of the invention is histidine.

[0048] In a preferred embodiment the concentration of histidine used in the pharmaceutical composition of the invention is in the range of 0.40-1.20 mg / ml.

[0049] In a preferred embodiment the concentration of histidine used in the pharmaceutical composition of the invention is in the range of 0.55-1.05 mg / ml.

[0050] In a preferred embodiment the concentration of histidine used in the pharmaceutical composition of the invention is in the range of 0.70-0.90 mg / ml.

[0051] In a preferred embodiment the buffering agent used in the pharmaceutical composition of the invention is disodium hydrogen phosphate.

[0052] In a preferred embodiment the concentration of disodium hydrogen phosphate used in the pharmaceutical composition of the invention is in the range of 0.67-1.65 mg / ml.

[0053] In a preferred embodiment the concentration of disodium hydrogen phosphate used in the pharmaceutical composition of the invention is in the range of 1-1.55 mg / ml.

[0054] In a preferred embodiment the concentration of disodium hydrogen phosphate used in the pharmaceutical composition of the invention is in the range of 1.20-1.50 mg / ml.

[0055] The pharmaceutical composition of the invention is designated by the use of at least one tonicity agent. The term tonicity agent as used in the invention denotes any pharmaceutically acceptable excipient known to the person skilled in the art as described e.g. in Remington: The Science and Practice of Pharmacy, 22nd Edition, 2013, to provide the effective osmolality i.e. to adjust the osmolality of the solution to that which is almost isotonic to blood plasma, for instance the osmolality ranges indicated in the pharmaceutical composition section below.

[0056] The tonicity agent can include, but it is not limited to xylitol, sorbitol, PEG 400, sucrose, glucose, lactose, maltose, sodium chloride (NaCl), glycerol, mannitol, trehalose, glycine, myo-inositol, L- arginine, dimethylsulfone, mannitol, dextrose, potassium chloride (KC1), any hydrate thereof and / or any combinations thereof. Each one of these specific tonicity agents and combinations thereof constitutes an alternative embodiment of the invention. The tonicity agents can be used in an anhydrous form or as a hydrate. Preferred hydrates include but are not limited to glucose monohydrate, lactose monohydrate, maltose monohydrate, and dextrose monohydrate.

[0057] The tonicity agent to be used according to a preferred embodiment of the invention is selected from the group consisting of sodium chloride (NaCl), xylitol, sorbitol, PEG 400, sucrose, glucose, glucose monohydrate, lactose, lactose monohydrate, maltose, maltose monohydrate, glycerol, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, dextrose monohydrate, potassium chloride (KC1) or any combinations thereof.

[0058] The tonicity agent to be used according to a preferred embodiment of the invention is selected from the group consisting of sodium chloride (NaCl), xylitol, sorbitol, PEG 400, sucrose, glucose, lactose, maltose, glycerol, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, potassium chloride (KC1), any hydrate thereof and / or any combinations thereof.

[0059] The tonicity agent to be used according to a preferred embodiment of the invention is selected from the group consisting of sodium chloride (NaCl), xylitol, sorbitol, PEG 400, sucrose, glucose, glucose monohydrate, lactose, lactose monohydrate, maltose, maltose monohydrate, glycerol, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, dextrose monohydrate, potassium chloride (KC1) or any combinations thereof.

[0060] The tonicity agent to be used according to a preferred embodiment of the invention is selected from the group consisting of xylitol, sorbitol, PEG 400, sucrose, glucose, lactose, maltose, glycerol, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, potassium chloride (KC1), any hydrate thereof and / or any combinations thereof.

[0061] The tonicity agent to be used according to a preferred embodiment of the invention is selected from the group consisting of xylitol, sorbitol, PEG 400, sucrose, glucose, glucose monohydrate, lactose,lactose monohydrate, maltose, maltose monohydrate, glycerol, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, dextrose monohydrate, potassium chloride (KC1) or any combinations thereof.

[0062] In a preferred embodiments, the tonicity agent comprises a combination of glycerol as a first tonicity agent with a second tonicity agent, wherein said second tonicity agent is preferably selected from the group consisting of sodium chloride (NaCl), xylitol, sorbitol, PEG 400, sucrose, glucose, glucose monohydrate, lactose, lactose monohydrate, maltose, maltose monohydrate, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, dextrose monohydrate, potassium chloride (KC1).

[0063] In a preferred embodiment the concentration of tonicity agent used in the pharmaceutical composition of the invention is in the range of 4-192 mg / ml.

[0064] In a preferred embodiment the concentration of tonicity agent used in the pharmaceutical composition of the invention is in the range of 9-128 mg / ml.

[0065] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is glucose or a hydrate thereof, preferably glucose or glucose monohydrate, more preferably glucose.

[0066] In a preferred embodiment the concentration of glucose used in the pharmaceutical composition of the invention is in the range of 20-90 mg / ml.

[0067] In a preferred embodiment the concentration of glucose used in the pharmaceutical composition of the invention is in the range of 30-65 mg / ml.

[0068] In a preferred embodiment the concentration of glucose used in the pharmaceutical composition of the invention is in the range of 39-58 mg / ml.

[0069] In a preferred embodiment the concentration of glucose used in the pharmaceutical composition of the invention is in the range of 39-48 mg / ml.

[0070] In a preferred embodiment the concentration of glucose used in the pharmaceutical composition of the invention is in the range of 49-58 mg / ml.

[0071] In a preferred embodiment the concentration of glucose used in the pharmaceutical composition of the invention is in the range of 45-55 mg / ml.

[0072] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is glucose monohydrate.

[0073] In a preferred embodiment the concentration of glucose monohydrate used in the pharmaceutical composition of the invention is in the range of 20-39 mg / ml.

[0074] In a preferred embodiment the concentration of glucose monohydrate used in the pharmaceutical composition of the invention is in the range of 20-31 mg / ml.

[0075] In a preferred embodiment the concentration of glucose monohydrate used in the pharmaceutical composition of the invention is in the range of 25-36 mg / ml.

[0076] In a preferred embodiment the concentration of glucose monohydrate used in the pharmaceutical composition of the invention is in the range of 35-43 mg / ml.

[0077] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is lactose or a hydrate thereof, preferably lactose or lactose monohydrate, more preferably lactose.

[0078] In a preferred embodiment the concentration of lactose used in the pharmaceutical composition of the invention is in the range of 44-165 mg / ml.

[0079] In a preferred embodiment the concentration of lactose used in the pharmaceutical composition of the invention is in the range of 60-125 mg / ml.

[0080] In a preferred embodiment the concentration of lactose used in the pharmaceutical composition of the invention is in the range of 88-110 mg / ml.

[0081] In a preferred embodiment the concentration of lactose used in the pharmaceutical composition of the invention is in the range of 90-100 mg / ml.

[0082] In a preferred embodiment the concentration of lactose used in the pharmaceutical composition of the invention is in the range of 100-110 mg / ml.

[0083] In a preferred embodiment the concentration of lactose used in the pharmaceutical composition of the invention is in the range of 95-100 mg / ml.

[0084] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is lactose monohydrate.

[0085] In a preferred embodiment the concentration of lactose monohydrate used in the pharmaceutical composition of the invention is in the range of 50-70 mg / ml.

[0086] In a preferred embodiment the concentration of lactose monohydrate used in the pharmaceutical composition of the invention is in the range of 43-63 mg / ml.

[0087] In a preferred embodiment the concentration of lactose monohydrate used in the pharmaceutical composition of the invention is in the range of 45-65 mg / ml.

[0088] In a preferred embodiment the concentration of lactose monohydrate used in the pharmaceutical composition of the invention is in the range of 37-57 mg / ml.

[0089] In a preferred embodiment the concentration of lactose monohydrate used in the pharmaceutical composition of the invention is in the range of 49-69 mg / ml.

[0090] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is maltose or a hydrate thereof, preferably maltose or maltose monohydrate, more preferably maltose.

[0091] In a preferred embodiment the concentration of maltose used in the pharmaceutical composition of the invention is in the range of 44-165 mg / ml.

[0092] In a preferred embodiment the concentration of maltose used in the pharmaceutical composition of the invention is in the range of 60-125 mg / ml.

[0093] In a preferred embodiment the concentration of maltose used in the pharmaceutical composition of the invention is in the range of 88-110 mg / ml.

[0094] In a preferred embodiment the concentration of maltose used in the pharmaceutical composition of the invention is in the range of 90-100 mg / ml.

[0095] In a preferred embodiment the concentration of maltose used in the pharmaceutical composition of the invention is in the range of 100-110 mg / ml.

[0096] In a preferred embodiment the concentration of maltose used in the pharmaceutical composition of the invention is in the range of 95-100 mg / ml.

[0097] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is maltose monohydrate.

[0098] In a preferred embodiment the concentration of maltose monohydrate used in the pharmaceutical composition of the invention is in the range of 50-100 mg / ml.

[0099] In a preferred embodiment the concentration of maltose monohydrate used in the pharmaceutical composition of the invention is in the range of 43-63 mg / ml.

[0100] In a preferred embodiment the concentration of maltose monohydrate used in the pharmaceutical composition of the invention is in the range of 45-65 mg / ml.

[0101] In a preferred embodiment the concentration of maltose monohydrate used in the pharmaceutical composition of the invention is in the range of 49-69 mg / ml.

[0102] In a preferred embodiment the concentration of maltose monohydrate used in the pharmaceutical composition of the invention is in the range of 37-57 mg / ml.

[0103] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is glycine.

[0104] In a preferred embodiment the concentration of glycine used in the pharmaceutical composition of the invention is in the range of 10-36 mg / ml.

[0105] In a preferred embodiment the concentration of glycine used in the pharmaceutical composition of the invention is in the range of 15-30 mg / ml.

[0106] In a preferred embodiment the concentration of glycine used in the pharmaceutical composition of the invention is in the range of 19-24 mg / ml.

[0107] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is PEG 400.

[0108] In a preferred embodiment the concentration of PEG 400 used in the pharmaceutical composition of the invention is in the range of 50-192 mg / ml.

[0109] In a preferred embodiment the concentration of PEG 400 used in the pharmaceutical composition of the invention is in the range of 75-165 mg / ml.

[0110] In a preferred embodiment the concentration of PEG 400 used in the pharmaceutical composition of the invention is in the range of 104-128 mg / ml.

[0111] In a preferred embodiment the concentration of PEG 400 used in the pharmaceutical composition of the invention is in the range of 104-116 mg / ml.

[0112] In a preferred embodiment the concentration of PEG 400 used in the pharmaceutical composition of the invention is in the range of 116-128 mg / ml.

[0113] In a preferred embodiment the concentration of PEG 400 used in the pharmaceutical composition of the invention is in the range of 110-120 mg / ml.

[0114] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is myo-inositol.

[0115] In a preferred embodiment the concentration of myo-inositol used in the pharmaceutical composition of the invention is in the range of 20-90 mg / ml.

[0116] In a preferred embodiment the concentration of myo-inositol used in the pharmaceutical composition of the invention is in the range of 30-65 mg / ml.

[0117] In a preferred embodiment the concentration of myo-inositol used in the pharmaceutical composition of the invention is in the range of 39-58 mg / ml.

[0118] In a preferred embodiment the concentration of myo-inositol used in the pharmaceutical composition of the invention is in the range of 39-48 mg / ml.

[0119] In a preferred embodiment the concentration of myo-inositol used in the pharmaceutical composition of the invention is in the range of 49-58 mg / ml.

[0120] In a preferred embodiment the concentration of myo-inositol used in the pharmaceutical composition of the invention is in the range of 45-55 mg / ml.

[0121] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is L-arginine.

[0122] In a preferred embodiment the concentration of L-arginine used in the pharmaceutical composition of the invention is in the range of 23-70 mg / ml.

[0123] In a preferred embodiment the concentration of L-arginine used in the pharmaceutical composition of the invention is in the range of 38-66 mg / ml.

[0124] In a preferred embodiment the concentration of L-arginine used in the pharmaceutical composition of the invention is in the range of 45-56 mg / ml.

[0125] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is dimethylsulfone.

[0126] In a preferred embodiment the concentration of dimethylsulfone used in the pharmaceutical composition of the invention is in the range of 10-45 mg / ml.

[0127] In a preferred embodiment the concentration of dimethylsulfone used in the pharmaceutical composition of the invention is in the range of 15-35 mg / ml.

[0128] In a preferred embodiment the concentration of dimethylsulfone used in the pharmaceutical composition of the invention is in the range of 20-30 mg / ml.

[0129] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is sorbitol.

[0130] In a preferred embodiment the concentration of sorbitol used in the pharmaceutical composition of the invention is in the range of 20-90 mg / ml.

[0131] In a preferred embodiment the concentration of sorbitol used in the pharmaceutical composition of the invention is in the range of 30-65 mg / ml.

[0132] In a preferred embodiment the concentration of sorbitol used in the pharmaceutical composition of the invention is in the range of 39-58 mg / ml.

[0133] In a preferred embodiment the concentration of sorbitol used in the pharmaceutical composition of the invention is in the range of 39-48 mg / ml.

[0134] In a preferred embodiment the concentration of sorbitol used in the pharmaceutical composition of the invention is in the range of 49-58 mg / ml.

[0135] In a preferred embodiment the concentration of sorbitol used in the pharmaceutical composition of the invention is in the range of 45-55 mg / ml.

[0136] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is xylitol.

[0137] In a preferred embodiment the concentration of xylitol used in the pharmaceutical composition of the invention is in the range of 20-75 mg / ml.

[0138] In a preferred embodiment the concentration of xylitol used in the pharmaceutical composition of the invention is in the range of 30-60 mg / ml.

[0139] In a preferred embodiment the concentration of xylitol used in the pharmaceutical composition of the invention is in the range of 39-49 mg / ml.

[0140] In a preferred embodiment the concentration of xylitol used in the pharmaceutical composition of the invention is in the range of 39-48 mg / ml.

[0141] In a preferred embodiment the concentration of xylitol used in the pharmaceutical composition of the invention is in the range of 49-58 mg / ml.

[0142] In a preferred embodiment the concentration of xylitol used in the pharmaceutical composition of the invention is in the range of 45-55 mg / ml.

[0143] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is sucrose.

[0144] In a preferred embodiment the concentration of sucrose used in the pharmaceutical composition of the invention is in the range of 44-165 mg / ml.

[0145] In a preferred embodiment the concentration of sucrose used in the pharmaceutical composition of the invention is in the range of 60-125 mg / ml.

[0146] In a preferred embodiment the concentration of sucrose used in the pharmaceutical composition of the invention is in the range of 88-110 mg / ml.

[0147] In a preferred embodiment the concentration of sucrose used in the pharmaceutical composition of the invention is in the range of 90-100 mg / ml.

[0148] In a preferred embodiment the concentration of sucrose used in the pharmaceutical composition of the invention is in the range of 100-110 mg / ml.

[0149] In a preferred embodiment the concentration of sucrose used in the pharmaceutical composition of the invention is in the range of 95-100 mg / ml.

[0150] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is mannitol.

[0151] In a preferred embodiment the concentration of mannitol used in the pharmaceutical composition of the invention is in the range of 20-90 mg / ml.

[0152] In a preferred embodiment the concentration of mannitol used in the pharmaceutical composition of the invention is in the range of 30-65 mg / ml.

[0153] In a preferred embodiment the concentration of mannitol used in the pharmaceutical composition of the invention is in the range of 39-58 mg / ml.

[0154] In a preferred embodiment the concentration of mannitol used in the pharmaceutical composition of the invention is in the range of 39-48 mg / ml.

[0155] In a preferred embodiment the concentration of mannitol used in the pharmaceutical composition of the invention is in the range of 49-58 mg / ml.

[0156] In a preferred embodiment the concentration of mannitol used in the pharmaceutical composition of the invention is in the range of 45-55 mg / ml.

[0157] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is glycerol.

[0158] In a preferred embodiment the concentration of glycerol used in the pharmaceutical composition of the invention is in the range of 8-45 mg / ml.

[0159] In a preferred embodiment the concentration of glycerol used in the pharmaceutical composition of the invention is in the range of 8-22 mg / ml.

[0160] In a preferred embodiment the concentration of glycerol used in the pharmaceutical composition of the invention is in the range of 12-45 mg / ml.

[0161] In a preferred embodiment the concentration of glycerol used in the pharmaceutical composition of the invention is in the range of 18-40 mg / ml.

[0162] In a preferred embodiment the concentration of glycerol used in the pharmaceutical composition of the invention is in the range of 24-29 mg / ml.

[0163] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is dextrose or a hydrate thereof, preferably dextrose or dextrose monohydrate, more preferably dextrose.

[0164] In a preferred embodiment the concentration of dextrose used in the pharmaceutical composition of the invention is in the range of 20-90 mg / ml.

[0165] In a preferred embodiment the concentration of dextrose used in the pharmaceutical composition of the invention is in the range of 30-65 mg / ml.

[0166] In a preferred embodiment the concentration of dextrose used in the pharmaceutical composition of the invention is in the range of 39-58 mg / ml.

[0167] In a preferred embodiment the concentration of dextrose used in the pharmaceutical composition of the invention is in the range of 39-48 mg / ml.

[0168] In a preferred embodiment the concentration of dextrose used in the pharmaceutical composition of the invention is in the range of 49-58 mg / ml.

[0169] In a preferred embodiment the concentration of dextrose used in the pharmaceutical composition of the invention is in the range of 45-55 mg / ml.

[0170] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is dextrose monohydrate.

[0171] In a preferred embodiment the concentration of dextrose monohydrate used in the pharmaceutical composition of the invention is in the range of 20-39 mg / ml.

[0172] In a preferred embodiment the concentration of dextrose monohydrate used in the pharmaceutical composition of the invention is in the range of 20-31 mg / ml.

[0173] In a preferred embodiment the concentration of dextrose monohydrate used in the pharmaceutical composition of the invention is in the range of 23-42 mg / ml.

[0174] In a preferred embodiment the concentration of dextrose monohydrate used in the pharmaceutical composition of the invention is in the range of 25-36 mg / ml.

[0175] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is KC1.

[0176] In a preferred embodiment the concentration of KC1 used in the pharmaceutical composition of the invention is in the range of 4.5-18 mg / ml.

[0177] In a preferred embodiment the concentration of KC1 used in the pharmaceutical composition of the invention is in the range of 6-14 mg / ml.

[0178] In a preferred embodiment the concentration of KC1 used in the pharmaceutical composition of the invention is in the range of 9-12 mg / ml.

[0179] In a preferred embodiment the tonicity agent used in the pharmaceutical composition of the invention is sodium chloride.

[0180] In a preferred embodiment the concentration of sodium chloride used in the pharmaceutical composition of the invention is in the range of 1-12 mg / ml.

[0181] In a preferred embodiment the concentration of sodium chloride used in the pharmaceutical composition of the invention is in the range of 4-12 mg / ml.

[0182] In a preferred embodiment the concentration of sodium chloride used in the pharmaceutical composition of the invention is in the range of 5-11 mg / ml.

[0183] In a preferred embodiment the concentration of sodium chloride used in the pharmaceutical composition of the invention is in the range of 6-10 mg / ml.

[0184] The pharmaceutical composition of the invention is designated by the use of at least one preservative. The term preservative as used in the invention denotes any pharmaceutically acceptable excipient known to the person skilled in the art as described e.g. in Remington: The Science and Practice of Pharmacy, 22nd Edition, 2013, used to prevent microbial growth. Multidose aqueous preparations provide excellent growth media for microorganisms, such as molds, yeast and bacteria and thereforerequire the presence of an antimicrobial preservative to maintain aseptic conditions throughout their shelf life.

[0185] The preservative can include, but it is not limited to phenol, m-cresol (metacresol), methyl p- hydroxybenzoate, propyl p-hydroxybenzoate, benzoic acid, benzyl alcohol, benzyl benzoate, 2-phenox- yethanol, butyl p-hydroxybenzoate, 2-phenylethanol, chlorobutanol, acetone sodium bisulfite, benzalkonium chloride, benzethonium chloride and thiomerosal, or any combinations thereof. Preferred preservatives are phenol, metacresol, benzyl alcohol, and any combinations thereof, preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol. Each one of these specific preservatives and combinations thereof constitutes an alternative embodiment of the invention.

[0186] The preservative to be used according to a preferred embodiment of the invention is selected from the group consisting of phenol and metacresol.

[0187] In a preferred embodiment the concentration of preservative used in the pharmaceutical composition of the invention is in the range of 0.5-20 mg / ml.

[0188] In a preferred embodiment the concentration of preservative used in the pharmaceutical composition of the invention is in the range of 1-10 mg / ml.

[0189] In a preferred embodiment the preservative used in the pharmaceutical composition of the invention is phenol.

[0190] In a preferred embodiment the concentration of phenol used in the pharmaceutical composition of the invention is in the range of 1-10 mg / ml.

[0191] In a preferred embodiment the concentration of phenol used in the pharmaceutical composition of the invention is in the range of 2.5-10 mg / ml.

[0192] In a preferred embodiment the concentration of phenol used in the pharmaceutical composition of the invention is in the range of 3.5-8.5 mg / ml.

[0193] In a preferred embodiment the concentration of phenol used in the pharmaceutical composition of the invention is in the range of 4-7 mg / ml.

[0194] In a preferred embodiment the preservative used in the pharmaceutical composition of the invention is metacresol.

[0195] In a preferred embodiment the concentration of metacresol used in the pharmaceutical composition of the invention is in the range of 1.75-7 mg / ml.

[0196] In a preferred embodiment the concentration of metacresol used in the pharmaceutical composition of the invention is in the range of 2.5-5.5 mg / ml.

[0197] In a preferred embodiment the concentration of metacresol used in the pharmaceutical composition of the invention is in the range of 3-4.5 mg / ml.

[0198] In a preferred embodiment the preservative used in the pharmaceutical composition of the invention is benzyl alcohol.

[0199] In a preferred embodiment the concentration of benzyl alcohol used in the pharmaceutical composition of the invention is in the range of 5-13 mg / ml.

[0200] The pharmaceutical composition according to the invention optionally further comprises other pharmaceutically acceptable excipients selected among any known state of the art for pharmaceutical ingredients used in liquid dosage forms, as described e.g. in Remington: The Science and Practice of Pharmacy, 22nd Edition, 2013.

[0201] Particularly, other pharmaceutically acceptable excipients present in the pharmaceutical composition according to the invention can be selected from the group consisting of, but not limited to, one or more solvents, one or more chelating agents, one or more stabilizers, one or more pH adjusting agents, one or more antioxidants, one or more surfactants or any combinations thereof.

[0202] In a preferred embodiment the pharmaceutical composition of the invention is in the form of a solution.

[0203] In a preferred embodiment the pharmaceutical composition of the invention is in the form of a suspension.

[0204] In a preferred embodiment the pharmaceutical composition of the invention is a solid to which a reconstitution solvent is added prior to use. The reconstitution solvent may be any suitable solvent, particularly water for injection. For this embodiment, the amount indications provided elsewhere in the specification apply only indirectly to the solid composition insofar as it must allow fulfilment of the amount indications after reconstitution. Similar considerations apply also with respect to other characteristics like the pH of the composition.

[0205] The pharmaceutical composition according to the invention is preferably a clear solution with no visible particles.

[0206] In a preferred embodiment the pH of the pharmaceutical composition according to the invention is in the range of 6-8.

[0207] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, b) a buffering agent, c) a tonicity agent or a combination of two or more tonicity agents, d) a preservative and, e) optionally, other pharmaceutically acceptable excipients.

[0208] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof,b) a buffering agent, c) a tonicity agent or a combination of two or more tonicity agents, d) optionally, other pharmaceutically acceptable excipients.

[0209] In a preferred embodiment the pharmaceutical composition of the invention comprises tir- zepatide or a pharmaceutically acceptable salt thereof; a buffering agent, selected from the group consisting of TRIS, sodium citrate, histidine and disodium hydrogen phosphate or any combination thereof; a tonicity agent, selected from the group consisting of xylitol, sorbitol, PEG 400, sucrose, glucose, lactose, maltose, glycerol, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, potassium chloride (KC1), sodium chloride (NaCl), any hydrate thereof and / or any combinations thereof; and a preservative, selected from the group consisting of phenol and metacresol.

[0210] In a preferred embodiment the pharmaceutical composition of the invention comprises tir- zepatide or a pharmaceutically acceptable salt thereof; a buffering agent, selected from the group consisting of TRIS, sodium citrate, histidine or any combination thereof; a tonicity agent, selected from the group consisting of xylitol, sorbitol, PEG 400, sucrose, glucose, lactose, maltose, glycerol, glycine, myoinositol, L-arginine, dimethylsulfone, mannitol, dextrose, potassium chloride (KC1), any hydrate thereof and / or any combinations thereof; and a preservative, selected from the group consisting of phenol and metacresol.

[0211] In a preferred embodiment the pharmaceutical composition of the invention comprises tir- zepatide or a pharmaceutically acceptable salt thereof, wherein the concentration of tirzepatide or a pharmaceutically acceptable salt thereof is from about 4 to about 30 mg / ml; a buffering agent, selected from the group consisting of TRIS, sodium citrate, histidine and disodium hydrogen phosphate or any combination thereof, wherein the concentration of a buffer is from about 0.30 to about 1.70 mg / ml; a tonicity agent, selected from the group consisting of xylitol, sorbitol, PEG 400, sucrose, glucose, lactose, maltose, glycerol, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, KC1, sodium chloride (NaCl), any hydrate thereof and / or any combinations thereof, wherein the concentration of a tonicity agent is from about 4 to about 192 mg / ml; and a preservative, selected from the group consisting of phenol and metacresol, wherein the concentration of a preservative is from about 0.5 to about 20 mg / ml.

[0212] In a preferred embodiment the pharmaceutical composition of the invention comprises tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration of tirzepatide or a pharmaceutically acceptable salt thereof is from about 4 to about 30 mg / ml; a buffering agent, selected from the group consisting of TRIS, sodium citrate and histidine or any combination thereof, wherein the concentration of a buffer is from about 0.30 to about 1.70 mg / ml; a tonicity agent, selected from the group consisting of xylitol, sorbitol, PEG 400, sucrose, glucose, lactose, maltose, glycerol, glycine, myoinositol, L-arginine, dimethylsulfone, mannitol, dextrose, potassium chloride (KC1), any hydrate thereof and / or any combinations thereof, wherein the concentration of a tonicity agent is from about 4 to about192 mg / ml; and a preservative, selected from the group consisting of phenol and metacresol, wherein the concentration of a preservative is from about 0.5 to about 20 mg / ml.

[0213] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glucose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0214] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) lactose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0215] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) maltose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0216] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glycine, wherein the concentration is 10-36 mg / ml, preferably 15-30 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0217] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) PEG 400, wherein the concentration is 50-192 mg / ml, preferably 75-165 mg / ml, most preferably 104-128 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0218] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) myo-inositol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0219] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) L-arginine, wherein the concentration is 23-70 mg / ml, preferably 38-60 mg / ml, most preferably 45-56 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0220] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) dimethylsulfone, wherein the concentration is 10-45 mg / ml, preferably 15-35 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0221] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sorbitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0222] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) xylitol, wherein the concentration is 20-75 mg / ml, preferably 30-60 mg / ml, most preferably 39-49 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0223] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sucrose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml;d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0224] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) mannitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0225] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glycerol, wherein the concentration is 8-45 mg / ml, preferably 18-40 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0226] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) dextrose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0227] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) KC1, wherein the concentration is 4.5-18 mg / ml, preferably 6-14 mg / ml, most preferably 9-12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0228] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sodium chloride, wherein the concentration is 1-12 mg / ml, preferably 4-12 mg / ml, most preferably 5-11 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0229] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) glucose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0230] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) lactose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0231] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) maltose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0232] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) glycine, wherein the concentration is 10-36 mg / ml, preferably 15-30 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0233] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) PEG 400, wherein the concentration is 50-192 mg / ml, preferably 75-165 mg / ml, most preferably 104-128 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0234] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) myo-inositol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml;d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0235] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) L-arginine, wherein the concentration is 23-70 mg / ml, preferably 38-60 mg / ml, most preferably 45-56 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0236] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) dimethylsulfone, wherein the concentration is 10-45 mg / ml, preferably 15-35 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0237] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) sorbitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0238] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) xylitol, wherein the concentration is 20-75 mg / ml, preferably 30-60 mg / ml, most preferably 39-49 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0239] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) sucrose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0240] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) mannitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0241] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) glycerol, wherein the concentration is 8-45 mg / ml, preferably 18-40 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0242] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) dextrose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0243] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) KC1, wherein the concentration is 4.5-18 mg / ml, preferably 6-14 mg / ml, most preferably 9-12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0244] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) sodium chloride, wherein the concentration is 1-12 mg / ml, preferably 4-12 mg / ml, most preferably 5-11 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0245] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glucose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml;d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0246] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) lactose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0247] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) maltose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0248] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glycine, wherein the concentration is 10-36 mg / ml, preferably 15-30 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0249] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) PEG 400, wherein the concentration is 50-192 mg / ml, preferably 75-165 mg / ml, most preferably 104-128 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0250] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) myo-inositol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0251] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) L-arginine, wherein the concentration is 23-70 mg / ml, preferably 38-60 mg / ml, most preferably 45-56 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0252] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) dimethylsulfone, wherein the concentration is 10-45 mg / ml, preferably 15-35 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0253] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sorbitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0254] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) xylitol, wherein the concentration is 20-75 mg / ml, preferably 30-60 mg / ml, most preferably 39-49 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0255] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sucrose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0256] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) mannitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml;d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0257] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glycerol, wherein the concentration is 8-45 mg / ml, preferably 18-40 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0258] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) dextrose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0259] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) KC1, wherein the concentration is 4.5-18 mg / ml, preferably 6-14 mg / ml, most preferably 9-12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0260] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sodium chloride, wherein the concentration is 1-12 mg / ml, preferably 4-12 mg / ml, most preferably 5-11 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0261] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) glucose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0262] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) lactose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0263] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) maltose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0264] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) glycine, wherein the concentration is 10-36 mg / ml, preferably 15-30 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0265] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) PEG 400, wherein the concentration is 50-192 mg / ml, preferably 75-165 mg / ml, most preferably 104-128 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0266] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1. 1.20-1.50 mg / ml; c) myo-inositol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0267] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) L-arginine, wherein the concentration is 23-70 mg / ml, preferably 38-60 mg / ml, most preferably 45-56 mg / ml;d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0268] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) dimethylsulfone, wherein the concentration is 10-45 mg / ml, preferably 15-35 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0269] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) sorbitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0270] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) xylitol, wherein the concentration is 20-75 mg / ml, preferably 30-60 mg / ml, most preferably 39-49 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0271] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) sucrose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88- 110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0272] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) mannitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0273] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) glycerol, wherein the concentration is 8-45 mg / ml, preferably 18-40 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0274] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) dextrose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39- 58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0275] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) KC1, wherein the concentration is 4.5-18 mg / ml, preferably 6-14 mg / ml, most preferably 9-12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0276] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glucose monohydrate, wherein the concentration is 20-39 mg / ml, preferably 20-31 mg / ml, most preferably 25-36 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0277] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) lactose monohydrate, wherein the concentration is 50-70 mg / ml, preferably 49-69 mg / ml, most preferably 45-65 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0278] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) maltose monohydrate, wherein the concentration is 50-100 mg / ml, preferably 45-65 mg / ml, most preferably 37-57 mg / ml;d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0279] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glycine, wherein the concentration is 10-15 mg / ml, preferably 8-13 mg / ml, most preferably 7-12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0280] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) PEG 400, wherein the concentration is 41-64 mg / ml, preferably 54-78 mg / ml, most preferably 47- 71 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0281] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) myo-inositol, wherein the concentration is 20-39 mg / ml, preferably 18-37 mg / ml, most preferably 18-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0282] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) L-arginine, wherein the concentration is 20-31 mg / ml, preferably 23-34 mg / ml, most preferably 17-27 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0283] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sorbitol, wherein the concentration is 25-44 mg / ml, preferably 20-39 mg / ml, most preferably 19- 29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0284] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) xylitol, wherein the concentration is 20-30 mg / ml, preferably 17-27 mg / ml, most preferably 15-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0285] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sucrose, wherein the concentration is 40-60 mg / ml, preferably 35-55 mg / ml, most preferably 46- 66 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0286] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) mannitol, wherein the concentration is 19-38 mg / ml, preferably 20-39 mg / ml, most preferably 19- 29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0287] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glycerol, wherein the concentration is 8-29 mg / ml, preferably 18-23 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0288] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) dextrose monohydrate, wherein the concentration is 25-36 mg / ml, preferably 20-31 mg / ml, most preferably 23-42 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0289] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) glucose monohydrate, wherein the concentration is 25-36 mg / ml, preferably 20-31 mg / ml, most preferably 23-42 mg / ml;d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0290] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) lactose monohydrate, wherein the concentration is 45-65 mg / ml, preferably 37-57 mg / ml, most preferably 49-69 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0291] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) maltose monohydrate, wherein the concentration is 45-65 mg / ml, preferably 37-57 mg / ml, most preferably 49-69 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0292] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) glycine, wherein the concentration is 8-13 mg / ml, preferably 7-12 mg / ml, most preferably 9-14 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0293] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) PEG 400, wherein the concentration is 50-74 mg / ml, preferably 41-64 mg / ml, most preferably 54- 78 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0294] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) myo-inositol, wherein the concentration is 20-39 mg / ml, preferably 18-29 mg / ml, most preferably 18-37 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0295] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) L-arginine, wherein the concentration is 20-31 mg / ml, preferably 17-27 mg / ml, most preferably 23-34 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0296] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) sorbitol, wherein the concentration is 20-39 mg / ml, preferably 19-29 mg / ml, most preferably 21- 40 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0297] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) xylitol, wherein the concentration is 17-27 mg / ml, preferably 15-24 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0298] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) sucrose, wherein the concentration is 40-60 mg / ml, preferably 35-55 mg / ml, most preferably 46- 66 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0299] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) mannitol, wherein the concentration is 20-39 mg / ml, preferably 19-29 mg / ml, most preferably 21- 40 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0300] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) glycerol, wherein the concentration is 8-39 mg / ml, preferably 18-23 mg / ml, most preferably 19-24 mg / ml;d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0301] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) dextrose monohydrate, wherein the concentration is 25-36 mg / ml, preferably 20-31 mg / ml, most preferably 20-39 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0302] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glucose monohydrate, wherein the concentration is 23-42 mg / ml, preferably 20-39 mg / ml, most preferably 25-36 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0303] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) lactose monohydrate, wherein the concentration is 49-69 mg / ml, preferably 43-63 mg / ml, most preferably 50-70 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0304] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) maltose monohydrate, wherein the concentration is 49-69 mg / ml, preferably 43-63 mg / ml, most preferably 45-65 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0305] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glycine, wherein the concentration is 9-14 mg / ml, preferably 8-13 mg / ml, most preferably 10-15 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0306] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) PEG 400, wherein the concentration is 54-78 mg / ml, preferably 47-71 mg / ml, most preferably SO- 74 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0307] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) myo-inositol, wherein the concentration is 20-39 mg / ml, preferably 18-37 mg / ml, most preferably 18-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0308] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) L-arginine, wherein the concentration is 23-34 mg / ml, preferably 25-31 mg / ml, most preferably 20-31 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0309] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sorbitol, wherein the concentration is 21-40 mg / ml, preferably 20-39 mg / ml, most preferably 25- 44 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0310] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) xylitol, wherein the concentration is 20-30 mg / ml, preferably 18-28 mg / ml, most preferably 17-27 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0311] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sucrose, wherein the concentration is 46-66 mg / ml, preferably 40-60 mg / ml, most preferably 35- 55 mg / ml;d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0312] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) mannitol, wherein the concentration is 21-40 mg / ml, preferably 20-39 mg / ml, most preferably 19- 29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0313] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glycerol, wherein the concentration is 8-23 mg / ml, preferably 19-24 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

[0314] In a preferred embodiment the pharmaceutical composition of the invention comprises: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) dextrose monohydrate, wherein the concentration is 23-42 mg / ml, preferably 20-39 mg / ml, most preferably 25-36 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

[0315] In a preferred embodiment the processes of the invention comprises the following steps: a) dissolving the preservative, the buffering agent and the tonicity agent in water for injections (WFI), b) adjusting the pH of the solution,c) adding the GIP / GLP analogue, d) adjusting the pH of solution, e) adding WFI up to the final volume.

[0316] In a preferred embodiment the processes of the invention comprises the following steps: a) dissolving the buffering agent and the tonicity agent in water for injections (WFI), b) adjusting the pH of the solution, c) adding the GIP / GLP analogue, d) adjusting the pH of solution, e) adding WFI up to the final volume.

[0317] The above-mentioned components may be present in amounts as shown in the following table. Amount indications may be understood as indications of absolute weight, the unit being mass concentration.

[0318] The pharmaceutical compositions of the invention can be manufactured by means of any processes known from the state of the art, as for example disclosed in e.g. in Remington: The Science and Practice of Pharmacy, 22nd Edition, 2013.

[0319] In particular, the processes of the invention comprises the following steps:

[0320] Method A: a) dissolving the preservative, the buffering agent and the tonicity agent in water for injections (WFI), b) adjusting the pH of the solution, c) adding the GIP / GLP analogue, d) adjusting the pH of solution, e) adding WFI up to the final volume.

[0321] Method B: a) dissolving the buffering agent and the tonicity agent in water for injections (WFI), b) adjusting the pH of the solution, c) adding the GIP / GLP analogue, d) adjusting the pH of solution, e) adding WFI up to the final volume.

[0322] The invention also pertains to the pharmaceutical compositions obtainable by any one of the methods specified herein. Any specific product characteristic obtainable by the specified methods is to be understood as a characteristic of pharmaceutical compositions of certain embodiments of the invention. These process-derived characteristics may also be present in combination with any one of the further features described elsewhere in the specification.

[0323] Preferred specific embodiments of the invention are described in the following examples. It is, however, to be understood that the invention is not limited to these examples.

[0324] Various pharmaceutical compositions according to the invention were prepared.

[0325] Examples Fl to F98:

[0326] Buffering agent, isotonicity agent and preservative were dissolved in water for injections. The pH of the solution was adjusted to around 6-8. Tirzepatide was added to the solution while stirring slowly. The pH was then adjusted to 6.5-7.5. Water for injection was added up to the final volume. The solution was stirred.

[0327] The nature and individual concentrations of tirzepatide and the excipients are compiled in Tables 1-7 below:

[0328] Table 1:

[0329] Table 2:

[0330] The compositions F16-F30 are prepared by the same process as disclosed in Table 1

[0331] Table 3:

[0332] The compositions F31-F45 are prepared by the same process as disclosed in Table 1.

[0333] Table 4:

[0334] The compositions F46-F60 are prepared by the same process as disclosed in Table 1.

[0335] Table 5:

[0336] The compositions F61-F75 are prepared by the same process as disclosed in Table 1.

[0337] Table 6:

[0338] The compositions F76-F90 are prepared by the same process as disclosed in Table 1.

[0339] Table ?:

[0340] Examples F1P to F83P:

[0341] Buffering agent, isotonicity agent and preservative were dissolved in water for injections. The pH of the solution was adjusted to around 6-8. Tirzepatide was added to the solution while stirring slowly. The pH was then adjusted to 6.5-7.5. Water for injection was added up to the final volume. The solution was stirred and filtered through a 0.2pm filter.

[0342] The nature and individual concentrations of tirzepatide and the excipients are compiled in Tables 8-14 below:

[0344] Table 8:

[0345] Table 9:

[0346] The compositions F13P-F25P are prepared by the same process as disclosed in Table 8.

[0347] Table 10:

[0348] The compositions F26P-F37P are prepared by the same process as disclosed in Table 8.

[0349] Table 11:

[0350] The compositions F38P-F50P are prepared by the same process as disclosed in Table 8.

[0351] Table 12:

[0352] The compositions F51P-F62P are prepared by the same process as disclosed in Table 8.

[0353] Table 13:

[0354] The compositions F63P-F75P are prepared by the same process as disclosed in Table 8.

[0355] Table 14:

[0356] Formulation assessment based on (kD) or (A2)

[0357] An extensive study and analysis was performed that is necessary for a reliable prediction of peptide stability in formulations. The testing comprised of measurement of the second virial coefficient (A2), chemical degradation monitoring, aggregation testing, and biological activity assays after accelerated conditions.

[0358] The approach included the following:

[0359] Accelerated stability testing: Subject the peptide formulation to elevated temperatures, thermal cycling, light exposure and extreme pH conditions to observe degradation, aggregation, and loss of activity. Techniques like HPLC, mass spectrometry, and size-exclusion chromatography (SEC) are used to monitor aggregation, oxidation, and other degradation pathways.

[0360] Thermal stability analysis: Differential scanning calorimetry (DSC) or thermal shift assays provide insight into the thermal stability of peptides in formulations and help predict how they will behave under prolonged storage at different temperatures.

[0361] Chemical degradation pathways: Mass spectrometry are used to monitor for oxidation, deamidation, fragmentation, that may occur over time, and help identify weak points in the peptide structure that may lead to degradation.

[0362] Aggregation monitoring: Techniques like dynamic light scattering (DLS), static light scattering (SLS), and size-exclusion chromatography (SEC) measure aggregation over time and give a clearer picture of stability during storage.

[0363] In vivo or in vitro bioactivity assays: Bioactivity testing is essential to ensure that the peptide retains its therapeutic efficacy.

[0364] The study was carried out with the compositions F1P to F75P, where they were compared to the reference formulation Mounjaro® through high throughput screening, measuring the second virial coefficient A2.

[0365] The results are shown in Figure 1.

[0366] The results predict an increased long-term stability of the F1P to F75P formulations (the factor between A2 of the formulation and A2 of the reference product formulation is > 1) with some exceptions: F7P, F19P, F32P, F44P, F57P, F69P, F72P and F73P.

[0367] Formulations F7P, F19P, F32P, F44P, F57P and F69P contain L-arginine as the isotonicity agent, which causes aggregation in the proposed compositions. In order to achieve the lowest possible aggregation in subcutaneous formulations, the formulations with L-arginine are disadvantageous. Because of high aggregate content, the A2 second virial coefficient could not be measured in formulations with L-arginine.

[0368] Additionally, formulations F72P and F73P demonstrate negative A2, which also points to low longterm stability.

[0369] Apart from these 8 exceptions, all the other proposed formulations of the invention demonstrate increased A2 values. These formulations are therefore candidates for the development of tirzepatide solutions, which demonstrate increased physically stability on long-term conditions.

Claims

Claims:

1. A pharmaceutical composition comprising a) a GIP / GLP analogue and: b) a buffering agent; c) a tonicity agent; d) optionally, a preservative; and e) optionally, other pharmaceutically acceptable excipients.

2. The pharmaceutical composition according to claim 1, wherein the buffering agent is selected from sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium phosphate, sodium acetate, sodium carbonate, sodium citrate, meglumine, glycine, histidine, lysine, arginine, asparagine, glutamic acid, sodium glutamate, TRIS (hydroxymethyl) -aminomethane, methionine, Hepes, maleic acid, malic acid, lactate or any combinations thereof.

3. The pharmaceutical composition according to claim 1 or 2. wherein the tonicity agent is selected from the group consisting of xylitol, sorbitol, PEG 400, sucrose, glucose, lactose, maltose, sodium chloride (NaCl), glycerol, mannitol, trehalose, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, potassium chloride (KC1), any hydrate thereof and / or any combinations thereof.

4. The pharmaceutical composition according to any of the preceding claims, comprising a) tirzepatide or a pharmaceutically acceptable salt thereof; b) a buffering agent selected from the group consisting of TRIS, sodium citrate, histidine and disodium hydrogen phosphate or any combination thereof; c) a tonicity agent selected from the group consisting of xylitol, sorbitol, PEG 400, sucrose, glucose, lactose, maltose, glycerol, glycine, myo-inositol, L-arginine, dimethylsulfone, mannitol, dextrose, potassium chloride (KC1), sodium chloride (NaCl), any hydrate thereof and / or any combinations thereof; and d) optionally, a preservative selected from the group consisting of phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol.

5. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glucose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

6. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) lactose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

7. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) maltose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

8. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glycine, wherein the concentration is 10-36 mg / ml, preferably 15-30 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

9. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) PEG 400, wherein the concentration is 50-192 mg / ml, preferably 75-165 mg / ml, most preferably 104-128 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

10. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) myo-inositol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

11. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) L-arginine, wherein the concentration is 23-70 mg / ml, preferably 38-60 mg / ml, most preferably 45-56 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

12. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) dimethylsulfone, wherein the concentration is 10-45 mg / ml, preferably 15-35 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

13. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sorbitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

14. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) xylitol, wherein the concentration is 20-75 mg / ml, preferably 30-60 mg / ml, most preferably 39-49 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

15. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sucrose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

16. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) mannitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

17. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glycerol, wherein the concentration is 8-45 mg / ml, preferably 18-40 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

18. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) dextrose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

19. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) KC1, wherein the concentration is 4.5-18 mg / ml, preferably 6-14 mg / ml, most preferably 9- 12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

20. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sodium chloride, wherein the concentration is 1-12 mg / ml, preferably 4-12 mg / ml, mostpref- erably 5-11 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

21. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) glucose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

22. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) lactose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

23. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) maltose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

24. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) glycine, wherein the concentration is 10-36 mg / ml, preferably 15-30 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

25. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) PEG 400, wherein the concentration is 50-192 mg / ml, preferably 75-165 mg / ml, most preferably 104-128 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

26. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) myo-inositol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

27. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) L-arginine, wherein the concentration is 23-70 mg / ml, preferably 38-60 mg / ml, most preferably 45-56 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

28. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) dimethylsulfone, wherein the concentration is 10-45 mg / ml, preferably 15-35 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

29. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) sorbitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

30. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) xylitol, wherein the concentration is 20-75 mg / ml, preferably 30-60 mg / ml, most preferably 39-49 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

31. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) sucrose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

32. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) mannitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

33. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) glycerol, wherein the concentration is 8-45 mg / ml, preferably 18-40 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

34. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) dextrose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

35. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) KC1, wherein the concentration is 4.5-18 mg / ml, preferably 6-14 mg / ml, most preferably 9- 12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

36. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.30 mg / ml; c) sodium chloride, wherein the concentration is 1-12 mg / ml, preferably 4-12 mg / ml, mostpref- erably 5-11 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

37. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glucose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

38. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) lactose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

39. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) maltose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

40. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glycine, wherein the concentration is 10-36 mg / ml, preferably 15-30 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

41. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) PEG 400, wherein the concentration is 50-192 mg / ml, preferably 75-165 mg / ml, most preferably 104-128 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

42. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) myo-inositol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

43. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) L-arginine, wherein the concentration is 23-70 mg / ml, preferably 38-60 mg / ml, most preferably 45-56 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

44. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) dimethylsulfone, wherein the concentration is 10-45 mg / ml, preferably 15-35 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

45. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sorbitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

46. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) xylitol, wherein the concentration is 20-75 mg / ml, preferably 30-60 mg / ml, most preferably 39-49 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

47. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sucrose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

48. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) mannitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

49. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glycerol, wherein the concentration is 8-45 mg / ml, preferably 18-40 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

50. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) dextrose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

51. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) KC1, wherein the concentration is 4.5-18 mg / ml, preferably 6-14 mg / ml, most preferably 9- 12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

52. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sodium chloride, wherein the concentration is 1-12 mg / ml, preferably 4-12 mg / ml, mostpref- erably 5-11 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

53. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) glucose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

54. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) lactose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

55. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) maltose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

56. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) glycine, wherein the concentration is 10-36 mg / ml, preferably 15-30 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

57. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) PEG 400, wherein the concentration is 50-192 mg / ml, preferably 75-165 mg / ml, most preferably 104-128 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

58. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) myo-inositol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

59. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) L-arginine, wherein the concentration is 23-70 mg / ml, preferably 38-60 mg / ml, most preferably 45-56 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

60. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) dimethylsulfone, wherein the concentration is 10-45 mg / ml, preferably 15-35 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

61. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) sorbitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

62. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) xylitol, wherein the concentration is 20-75 mg / ml, preferably 30-60 mg / ml, most preferably 39-49 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

63. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) sucrose, wherein the concentration is 44-165 mg / ml, preferably 60-125 mg / ml, most preferably 88-110 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

64. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) mannitol, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

65. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) glycerol, wherein the concentration is 8-45 mg / ml, preferably 18-40 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

66. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) dextrose, wherein the concentration is 20-90 mg / ml, preferably 30-65 mg / ml, most preferably 39-58 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

67. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) disodium hydrogen phosphate, wherein the concentration is 0.67-1.65 mg / ml, preferably 1-1.55 mg / ml, most preferably 1.20-1.50 mg / ml; c) KC1, wherein the concentration is 4.5-18 mg / ml, preferably 6-14 mg / ml, most preferably 9- 12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

68. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glucose monohydrate, wherein the concentration is 20-39 mg / ml, preferably 20-31 mg / ml, most preferably 25-36 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

69. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) lactose monohydrate, wherein the concentration is 50-70 mg / ml, preferably 49-69 mg / ml, most preferably 45-65 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

70. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) maltose monohydrate, wherein the concentration is 50-100 mg / ml, preferably 45-65 mg / ml, most preferably 37-57 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

71. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glycine, wherein the concentration is 10-15 mg / ml, preferably 8-13 mg / ml, most preferably 7-12 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

72. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) PEG 400, wherein the concentration is 41-64 mg / ml, preferably 54-78 mg / ml, most preferably 47-71 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

73. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) myo-inositol, wherein the concentration is 20-39 mg / ml, preferably 18-37 mg / ml, most preferably 18-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

74. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) L-arginine, wherein the concentration is 20-31 mg / ml, preferably 23-34 mg / ml, most preferably 17-27 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

75. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sorbitol, wherein the concentration is 25-44 mg / ml, preferably 20-39 mg / ml, most preferably 19-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

76. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) xylitol, wherein the concentration is 20-30 mg / ml, preferably 17-27 mg / ml, most preferably 15-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

77. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) sucrose, wherein the concentration is 40-60 mg / ml, preferably 35-55 mg / ml, most preferably 46-66 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

78. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) mannitol, wherein the concentration is 19-38 mg / ml, preferably 20-39 mg / ml, most preferably 19-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

79. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) glycerol, wherein the concentration is 8-29 mg / ml, preferably 18-23 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

80. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) TRIS, wherein the concentration is 0.30-0.90 mg / ml, preferably 0.45-0.75 mg / ml, most preferably 0.50-0.70 mg / ml; c) dextrose monohydrate, wherein the concentration is 25-36 mg / ml, preferably 20-31 mg / ml, most preferably 23-42 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

81. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) glucose monohydrate, wherein the concentration is 25-36 mg / ml, preferably 20-31 mg / ml, most preferably 23-42 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

82. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) lactose monohydrate, wherein the concentration is 45-65 mg / ml, preferably 37-57 mg / ml, most preferably 49-69 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

83. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) maltose monohydrate, wherein the concentration is 45-65 mg / ml, preferably 37-57 mg / ml, most preferably 49-69 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

84. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) glycine, wherein the concentration is 8-13 mg / ml, preferably 7-12 mg / ml, most preferably 9-14 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

85. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) PEG 400, wherein the concentration is 50-74 mg / ml, preferably 41-64 mg / ml, most preferably 54-78 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

86. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) myo-inositol, wherein the concentration is 20-39 mg / ml, preferably 18-29 mg / ml, most preferably 18-37 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

87. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) L-arginine, wherein the concentration is 20-31 mg / ml, preferably 17-27 mg / ml, most preferably 23-34 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

88. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) sorbitol, wherein the concentration is 20-39 mg / ml, preferably 19-29 mg / ml, most preferably 21-40 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

89. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) xylitol, wherein the concentration is 17-27 mg / ml, preferably 15-24 mg / ml, most preferably 20-30 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

90. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) sucrose, wherein the concentration is 40-60 mg / ml, preferably 35-55 mg / ml, most preferably 46-66 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

91. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) mannitol, wherein the concentration is 20-39 mg / ml, preferably 19-29 mg / ml, most preferably 21-40 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

92. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) glycerol, wherein the concentration is 8-39 mg / ml, preferably 18-23 mg / ml, most preferably 19-24 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

93. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) Na-citrate, wherein the concentration is 0.55-1.65 mg / ml, preferably 0.75-1.45 mg / ml, most preferably 0.90-1.40 mg / ml; c) dextrose monohydrate, wherein the concentration is 25-36 mg / ml, preferably 20-31 mg / ml, most preferably 20-39 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

94. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glucose monohydrate, wherein the concentration is 23-42 mg / ml, preferably 20-39 mg / ml, most preferably 25-36 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

95. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) lactose monohydrate, wherein the concentration is 49-69 mg / ml, preferably 43-63 mg / ml, most preferably 50-70 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

96. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) maltose monohydrate, wherein the concentration is 49-69 mg / ml, preferably 43-63 mg / ml, most preferably 45-65 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

97. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glycine, wherein the concentration is 9-14 mg / ml, preferably 8-13 mg / ml, most preferably 10-15 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

98. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) PEG 400, wherein the concentration is 54-78 mg / ml, preferably 47-71 mg / ml, most preferably 50-74 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

99. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) myo-inositol, wherein the concentration is 20-39 mg / ml, preferably 18-37 mg / ml, most preferably 18-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

100. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) L-arginine, wherein the concentration is 23-34 mg / ml, preferably 25-31 mg / ml, most preferably 20-31 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

101. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sorbitol, wherein the concentration is 21-40 mg / ml, preferably 20-39 mg / ml, most preferably 25-44 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

102. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) xylitol, wherein the concentration is 20-30 mg / ml, preferably 18-28 mg / ml, most preferably 17-27 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

103. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) sucrose, wherein the concentration is 46-66 mg / ml, preferably 40-60 mg / ml, most preferably 35-55 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

104. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml;b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) mannitol, wherein the concentration is 21-40 mg / ml, preferably 20-39 mg / ml, most preferably 19-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

105. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) glycerol, wherein the concentration is 8-23 mg / ml, preferably 19-24 mg / ml, most preferably 24-29 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients.

106. The pharmaceutical composition according to claim 4, comprising: a) tirzepatide or a pharmaceutically acceptable salt thereof, wherein the concentration is 2.5-60 mg / ml, preferably 5-45 mg / ml, most preferably 4-30 mg / ml; b) histidine, wherein the concentration is 0.40-1.20 mg / ml, preferably 0.55-1.05 mg / ml, most preferably 0.70-0.90 mg / ml; c) dextrose monohydrate, wherein the concentration is 23-42 mg / ml, preferably 20-39 mg / ml, most preferably 25-36 mg / ml; d) optionally, a preservative, preferably phenol, metacresol, benzyl alcohol, or any combinations thereof; more preferably phenol, or metacresol, or a combination of phenol with benzyl alcohol; e) optionally, other pharmaceutically acceptable excipients; preferably glycerol.

107. The pharmaceutical composition according to any of the preceding claims, which is a liquid; preferably a solution.

108. The pharmaceutical composition according to any of the preceding claims, which is for injection.

109. A method for the preparation of pharmaceutical composition according to any of the preceding claims 1-4, which comprises the following steps: a) dissolving the preservative, the buffering agent and the tonicity agent in water for injections (WFI), b) adjusting the pH of solution, c) adding the GIP / GLP analogue, d) adjusting the pH of solution, e) adding WFI up to the final volume.

110. A method for the preparation of pharmaceutical composition according to any one of claims 1- 108, which comprises the following steps: a) dissolving the buffering agent and the tonicity agent in water for injections (WFI), b) adjusting the pH of solution, c) adding the GIP / GLP analogue, d) adjusting the pH of solution, e) adding WFI up to the final volume.

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