Compositions and methods for treating diabetes

Abstract

This specification discloses compositions and methods comprising GLP-1 agonists for treating diabetes. The disclosed compositions are also effective for reducing body weight and improving triglyceride and cholesterol levels. This specification discloses methods for treating type 2 diabetes in subjects, methods for lowering A1C levels in subjects, methods for lowering body mass in subjects, and methods for regulating incretin hormone levels in subjects.

Description

Technical Field

[0001] In this specification, compositions and methods comprising GLP-1 agonists for treating diabetes are disclosed. The disclosed compositions are also effective for reducing body weight and improving triglyceride and cholesterol levels. In this specification, methods for treating type 2 diabetes in a subject, methods for reducing the A1C of a subject, methods for reducing the body mass of a subject, and methods for regulating the incretin hormone levels of a subject are disclosed.

Brief Description of the Drawings

[0002] [Figure 1] A plot of semaglutide levels (nmol / L) of control subjects (●) given Rybelsus™ 7 mg tablets versus study subjects (○) given the composition of Table 1 four times. [Figure 2] A plot of glucose levels (mmol / L) of control subjects (●) given Rybelsus™ 7 mg tablets versus study subjects (○) given the composition of Table 1 four times. [Figure 3] A plot of semaglutide levels (nmol / L) of combined results (first-pass and crossover studies) for subjects (●) given Rybelsus™ 7 mg tablets versus combined study subjects (○) given the composition of Table 1 four times for an effective amount of 7 mg of semaglutide. [Figure 4] A plot of glucose levels (mmol / L) of combined results (first-pass and crossover studies) for subjects (●) given Rybelsus™ 7 mg tablets versus combined study subjects (○) given the composition of Table 1 four times for an effective amount of 7 mg of semaglutide.

Best Mode for Carrying Out the Invention

[0003] The materials, compounds, compositions, articles, and methods described herein can be more readily understood by referring to the following detailed descriptions of specific embodiments of the disclosed subject matter and the examples contained herein.

[0004] Furthermore, various publications are referenced throughout this specification. In order to more fully describe the state of the art to which the disclosed subject matter belongs, the entire disclosures of these publications are incorporated into this application by reference. The disclosed references are also incorporated into this specification individually and specifically by reference, with respect to the material contained therein discussed in the texts on which the references are based.

[0005] General definition In the following specification and the subsequent claims, numerous terms are used, and these terms are defined as having the following meanings:

[0006] All percentages, ratios, and proportions in this specification are by weight unless otherwise specified. Unless otherwise specified, all temperatures are in degrees Celsius (°C).

[0007] Unless otherwise expressly required in this disclosure, the terms “a” and “an” are defined as one or more.

[0008] In this specification, a range may be expressed as "approximately" from one specific value and / or "approximately" from another specific value. When such a range is expressed, the other aspect includes from one specific value and / or from the other specific value. Similarly, when a value is expressed as an approximation by the use of the antecedent "approximately", it is understood that the specific value forms another aspect. Furthermore, it will be understood that each endpoint of a range is important both in relation to other endpoints and independently of other endpoints.

[0009] The terms “comprise” (and all forms of “comprise,” such as “comprises” and “comprising”), “have” (and all forms of “have,” such as “has” and “having”), “include” (and all forms of “include,” such as “includes” and “including”), and “contain” (and all forms of “contains,” such as “contains” and “containing”) are open-ended linking verbs. As a result, a device that “comprises,” “has,” “includes,” or “contains” one or more elements possesses, but is not limited to possessing only, those elements. Similarly, a method that "comprises," "has," "includes," or "contains" one or more processes has, but is not limited to having only, one or more of those processes.

[0010] Any embodiment of any of the disclosed methods or compositions may not merely include, contain, or have any of the described steps, elements, and / or features, but may consist of, or essentially consist of, them. Accordingly, in any claim, the scope of a given claim may be modified from the scope that would be reached using the open-ended linking verbs by replacing any of the open-ended linking verbs listed above with the terms "consisting of" or "consisting essentially of."

[0011] As used herein, the term “subject” means a human or animal that would benefit from the administration of the disclosed compositions described herein, for example, a human or animal suffering from one or more forms of diabetes, but not limited to these.

[0012] As used herein, the terms “treat,” “treating,” and “treatment” refer to reducing or relieving the disorder and / or its associated symptoms. It will be understood, though not prevented, that the treatment of epilepsy does not require the complete elimination of diabetes, diabetes-associated conditions, or symptoms.

[0013] As used herein, terms such as "prevent," "preventing," "prevention," and "prophylactic treatment" are encompassed within the scope of the term "treating," and refer to reducing the probability of developing a disorder or condition in subjects who do not have a disorder or condition but are at risk of developing one or are prone to developing one.

[0014] As used herein, “pharmaceutically acceptable” means physiologically acceptable for either human or veterinary use. Furthermore, “pharmaceutically acceptable” means that the material is not biologically or otherwise undesirable, for example, that it can be administered to a subject without causing any undesirable biological effects or adverse interactions with any other components of the pharmaceutical composition in which it is contained. Essentially, pharmaceutically acceptable materials are non-toxic to the recipient. Naturally, the carrier is selected, as is well known to those skilled in the art, to minimize any degradation of the active ingredient and to minimize any adverse side effects in the subject. For pharmaceutically acceptable carriers and other components of pharmaceutical compositions, see, for example, Remington's Pharmaceutical Sciences, 18th edition, Mack Publishing Company, 1990.

[0015] One or more features of one embodiment may be applied to other embodiments, even if not described or illustrated, unless expressly prohibited by the nature of the disclosure or the embodiment.

[0016] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art in which the invention pertains. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of the invention described herein, but preferred methods and materials are described herein. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials of which such publications are cited.

[0017] composition Incretin hormones are intestinal peptides secreted after nutrient intake that stimulate insulin secretion along with hyperglycemia. Glucagon-like peptide-1 (GLP-1) is a known incretin hormone found in the lower GI duct. Together with glucose-dependent insulinotropic polypeptide (GIP), these contribute to the incretin effect, in which the insulin secretion response to oral glucose is 2-3 times higher compared to intravenous glucose administration. In subjects with type 2 diabetes, this incretin effect is attenuated or absent. Therefore, administration of GLP-1 agonists provides a method to enhance the incretin response in type 2 diabetes.

[0018] Although not limited by theory, it has been found that pharmacological stimulation of the GLP-1 receptor significantly reduces plasma glucose and improves glycemic control. Therefore, stimulating GLP-1 activity through pharmacological agonism is the goal of incretin-based hypoglycemic agents.

[0019] Increased GLP-1 activity leads to decreased appetite and food intake, and in the long term, weight loss. Since GLP-1 secretion from the intestinal tract appears impaired in obese subjects, this may even indicate a role in the pathophysiology of obesity. Given these factors, increased GLP-1 secretion induced by the delivery of nutrients to the lower small intestine (rich in L cells) may be one factor explaining weight loss and improved blood glucose control after bariatric surgery (e.g., Roux-en-Y gastric bypass).

[0020] Currently, numerous peptide-based GLP-1 agonists are available for the control of diabetes and weight loss, including dulaglutide (Trulicity®), exenatide (Byetta®), sustained-release exenatide (Bydureon BCise®), liraglutide (Victoza®), lixisenatide (Adlyxin®), subcutaneous semaglutide (Ozempic®), semaglutide tablets (Rybelsus®), and tylzepatide (Mounjaro®, Zepbound®). All of these GLP-1 agonists must be administered by injection, and all except the semaglutide tablets are marketed under the trademark name Rybelsus®.

[0021] This specification discloses compositions and methods for the oral delivery of peptide-based GLP-1 inhibitors, thereby eliminating the need for injection delivery of these drugs and reducing side effects at any injection site. Oral delivery of these GLP-1 agonists also increases compliance levels among the treated subjects.

[0022] The disclosed composition comprises one or more GLP-1 agonists. These GLP-1 agonists increase the secretion of GLP-1, which is released in the gastrointestinal tract in response to feeding. One role of GLP-1 is to stimulate the body to produce more insulin, thereby lowering blood glucose (sugar). One important outcome of this is a way to treat diabetes. Another is a way to reduce body mass (weight loss).

[0023] The compositions disclosed below are water-free, easily flowable solids. Where present, water is an artificial product of the process of preparing the compositions and is less than 0.01% by weight of the composition. In one embodiment, the amount of water is less than 0.001% by weight of the composition.

[0024] composition In this specification, a composition for treating type 2 diabetes in a subject, a composition for reducing the A1C of a subject, a composition for reducing the body mass of a subject, and a composition for regulating the incretin hormone level of a subject, comprising: a) one or more GLP-1 agonists; and b) one or more edible oils; and c) one or more auxiliary components and carriers, is disclosed.

[0025] One aspect of the disclosed composition is a) about 0.5 wt% to about 20 wt% of one or more GLP-1 agonists; and b) about 0.5 wt% to about 40 wt% of one or more edible oils; and c) about 0.01 wt% to about 65 wt% of a bile salt extract; and d) about 35 wt% to about 65 wt% of sodium bicarbonate; and e) about 15 wt% to about 85 wt% of one or more carriers, and comprises.

[0026] In one embodiment of this aspect, the composition is a) about 0.5 wt% to about 20 wt% of one or more GLP-1 agonists selected from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, or a mixture thereof; and b) about 0.5 wt% to about 40 wt% of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or a mixture thereof; and c) about 0.01 wt% to about 65 wt% of a bile salt extract (where the bile salt extract comprises about 45 wt% to about 55 wt% of a bile salt selected from the group consisting of cholic acid, deoxycholic acid, taurocholate, glycocholic acid, or a mixture thereof); and d) about 35 wt% to about 65 wt% of sodium bicarbonate; and e) about 15 wt% to about 85 wt% of one or more carriers, and comprises.

[0027] In one iteration of this embodiment, the composition is a) Approximately 0.5% to 20% by weight of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) One or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, in an amount of approximately 0.5% to 40% by weight, c) Approximately 0.01% to approximately 65% ​​by weight of bile salt extract (wherein the bile salt extract contains approximately 45% to approximately 55% by weight of bile salts selected from the group consisting of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, or mixtures thereof), d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 15% to 85% by weight of one or more carriers selected from gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0028] In another iteration of this embodiment of this aspect, the composition is a) Approximately 0.5% to 20% by weight of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Approximately 0.01% to approximately 65% ​​by weight of bile salt extract (wherein the bile salt extract contains approximately 45% to approximately 55% by weight of bile salts selected from the group consisting of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, or mixtures thereof), d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 15% to approximately 85% by weight of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) or its derivatives, gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0029] In one further iteration of this embodiment of this aspect, the composition is a) Approximately 0.5% to 20% by weight of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Deoxycholic acid in an amount of approximately 0.01% to approximately 65% ​​by weight, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 15% to approximately 85% by weight of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC), gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0030] In another iteration of this embodiment of this aspect, the composition is a) Approximately 0.5% to 20% by weight of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Deoxycholic acid in an amount of approximately 0.01% to approximately 65% ​​by weight, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) A carrier comprising approximately 15% to 85% by weight of one or more materials selected from gum arabic, colloidal silicon dioxide, mannitol, or mixtures thereof, Includes.

[0031] In this non-limiting example of this iteration of this embodiment, the composition is: a) Approximately 0.5% to 20% by weight of semaglutide, b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Deoxycholic acid in an amount of approximately 0.01% to approximately 65% ​​by weight, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 15% to 85% by weight of gum arabic, colloidal silicon dioxide, e.g., Aeroperl® 3000, mannitol, e.g., Parteck® M 100, and mixtures thereof, Includes.

[0032] Another aspect of the disclosed composition is: a) One or more GLP-1 agonists in an amount of approximately 0.5% to approximately 5% by weight, b) Olive oil in an amount of approximately 0.5% to 10% by weight, c) Approximately 0.01% to approximately 2% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 30% to 60% by weight of gum arabic, colloidal silicon dioxide, e.g., Aeroperl® 3000, mannitol, e.g., Parteck® M 100, and mixtures thereof, Includes.

[0033] In one embodiment of this aspect, the disclosed composition is a) Approximately 0.5% to 5% by weight of semaglutide, b) Olive oil in an amount of approximately 0.5% to 15% by weight, c) Approximately 0.01% to approximately 2% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 30% to 60% by weight of colloidal silicon dioxide, e.g., Aeroperl® 3000, mannitol, e.g., Parteck® M 100, or a mixture thereof, Includes.

[0034] In one iteration of this embodiment, the composition is a) Approximately 0.5% to 5% by weight of semaglutide, b) Olive oil in an amount of approximately 0.5% to 10% by weight, c) Approximately 0.01% to approximately 2% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 30% to 60% by weight of colloidal silicon dioxide, mannitol, or a mixture thereof, Includes.

[0035] In another iteration of this embodiment, the composition is a) Approximately 0.5% to 5% by weight of semaglutide, b) Olive oil in an amount of approximately 0.5% to 10% by weight, c) Deoxycholic acid in an amount of approximately 0.01% to approximately 5% by weight, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 30% to 60% by weight of colloidal silicon dioxide, Includes.

[0036] In one further iteration of this embodiment, the composition is a) Approximately 0.5% to 5% by weight of semaglutide, b) Olive oil in an amount of approximately 0.5% to 10% by weight, c) Approximately 0.01% to 5% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 30% to 60% by weight of mannitol, Includes.

[0037] In another embodiment of this aspect, the disclosed composition is: a) Approximately 0.5% to 5% by weight of liraglutide, b) Olive oil in an amount of approximately 0.5% to 15% by weight, c) Approximately 0.01% to approximately 2% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 30% to 60% by weight of gum arabic, colloidal silicon dioxide, e.g., Aeroperl® 3000, mannitol, e.g., Parteck® M 100, or a mixture thereof, Includes.

[0038] In one iteration of this embodiment, the composition is a) Approximately 0.5% to 5% by weight of liraglutide, b) Olive oil in an amount of approximately 0.5% to 10% by weight, c) Approximately 0.01% to approximately 2% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 30% to 60% by weight of colloidal silicon dioxide, mannitol, or a mixture thereof, Includes.

[0039] In another iteration of this embodiment, the composition is a) Approximately 0.5% to 5% by weight of liraglutide, b) Olive oil in an amount of approximately 0.5% to 10% by weight, c) Approximately 0.01% to 5% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 30% to 60% by weight of colloidal silicon dioxide, Includes.

[0040] In one further iteration of this embodiment, the composition is a) Approximately 0.5% to 5% by weight of liraglutide, b) Olive oil in an amount of approximately 0.5% to 10% by weight, c) Approximately 0.01% to 5% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 30% to 60% by weight of mannitol, Includes.

[0041] The disclosed compositions may contain one or more GLP-1 agonists in an amount of about 0.5% to about 20% by weight. Non-limiting examples of GLP-1 agonists include dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, and tylzepatide. In one embodiment, the composition may contain one or more GLP-1 agonists in an amount of about 1% to about 10% by weight. In a further embodiment, the composition contains one or more GLP-1 agonists in an amount of about 0.5% to about 5% by weight. In yet another embodiment, the composition contains one or more GLP-1 agonists in an amount of about 1% to about 7% by weight. In yet another embodiment, the composition contains one or more GLP-1 agonists in an amount of about 3.5% to about 10% by weight. In yet yet another embodiment, the composition contains one or more GLP-1 agonists in an amount of about 1% to about 5% by weight.

[0042] The disclosed compositions may contain one or more GLP-1 agonists in amounts ranging from about 0.5% by weight to about 20% by weight, for example, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, or 20%, or any fractional component thereof, for example, 1.27%, 1.96%, and 2.25%.

[0043] The disclosed composition may contain about 0.5% to about 40% by weight of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof. In one embodiment, the composition may contain about 5% to about 25% by weight of one or more edible oils. In another embodiment, the composition may contain about 5% to about 20% by weight of one or more edible oils. In a further embodiment, the composition may contain about 10% to about 25% by weight of one or more edible oils. In yet another embodiment, the composition may contain about 0.5% to about 15% by weight of one or more edible oils. In yet another embodiment, the composition may contain about 1% to about 10% by weight of one or more edible oils. In yet another embodiment, the composition may contain about 0.5% to about 10% by weight of one or more edible oils.

[0044] The disclosed compositions range from about 0.5% by weight to about 40% by weight, for example, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.15%, 1.2%, 1.25%, 1.3%, 1.35%, 1.4%, 1.45%, 1.5%, 1.55%, 1.6%, 1.65%, 1.7%, 1.75%, 1.8%, 1.85%, 1.9%, 1.95%, 2%, 2.1%, 2.15%, 2.2%, 2.25%, 2.3%, 2.35%, 2.4%, 2.45%, 2.5%, 2.55%, 2.6%, 2.65%, 2.7%, 2.75%, 2.8%, 2% 0.85%, 2.9%, 2.95%, 3%, 3.1%, 3.15%, 3.2%, 3.25%, 3.3%, 3.35%, 3.4%, 3.45%, 3.5%, 3.55%, 3.6%, 3.65%, 3.7%, 3.75%, 3.8%, 3.85%, 3.9%, 3.95%, 4%, 4.1%, 4.15%, 4.2%, 4.25%, 4.3%, 4.35%, 4.4%, 4.45%, 4.5%, 4.55%, 4.6%, 4.65%, 4.7%, 4.75%, 4.8%, 4.85%, 4.9%, 4.95%, 5%, 5.1%, 5.15%, 5.2%, 5.2 5%, 5.3%, 5.35%, 5.4%, 5.45%, 5.5%, 5.55%, 5.6%, 5.65%, 5.7%, 5.75%, 5.8%, 5.85%, 5.9%, 5.95%, 6%, 6.1%, 6.15%, 6.2%, 6.25%, 6.3%, 6.35%, 6.4%, 6.45%, 6.5%, 6.55%, 6.6%, 6.65%, 6.7%, 6.75%, 6.8%, 6.85%, 6.9%, 6.95%, 7%, 7.1%, 7.15%, 7.2%, 7.25%, 7.3%, 7.35%, 7.4%, 7.45%, 7.5%, 7.55%, 7. 6%, 7.65%, 7.7%, 7.75%, 7.8%, 7.85%, 7.9%, 7.95%, 8%, 8.1%, 8.15%, 8.2%, 8.25%, 8.3%, 8.35%, 8.4%, 8.45%, 8.5%, 8.55%, 8.6%, 8.65%, 8.7%, 8.75%, 8.8%, 8.85%, 8.9%, 8.95%, 9%, 9.1%, 9.15%, 9.2%, 9.25%, 9.3%, 9.35%, 9.4%, 9.45%, 9.5%, 9.55%, 9.6%, 9.65%, 9.7%, 9.75%, 9.8%, 9.85%, 9.9%, 9.It may contain 95%, or 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, or any fractional component thereof, one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof.

[0045] The ratio of one or more GLP-1 agonists to one or more edible oils is approximately 1:1 to approximately 1:10, for example, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, or 1:10, or any small number thereof, for example, 1:1.5, 1:4.2, or 1:8.6. In one embodiment, the ratio of one or more GLP-1 agonists to one or more edible oils is 1:1. In another embodiment, the ratio of one or more GLP-1 agonists to one or more edible oils is 1:2. In yet another embodiment, the ratio of one or more GLP-1 agonists to one or more edible oils is 1:3.

[0046] The following are non-limiting examples of the compositions disclosed.

[0047] [Table 1]

[0048] [Table 2]

[0049] In a further aspect of this disclosure, the composition is a) Approximately 0.01 mg to approximately 50 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) One or more edible oils in an amount of approximately 0.01 mg to approximately 100 mg, c) Approximately 0.005 mg to approximately 250 mg of bile salt extract, d) Approximately 20 mg to approximately 250 mg of sodium bicarbonate, e) One or more carriers in an amount of approximately 0.5 mg to approximately 400 mg, Includes.

[0050] In one embodiment of this aspect of the present disclosure, a composition is a) Approximately 0.1 mg to approximately 50 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.1 mg to approximately 100 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.01 mg to approximately 250 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 20 mg to approximately 250 mg of sodium bicarbonate, e) One or more carriers in an amount of approximately 10 mg to approximately 50 mg, Includes.

[0051] In one iteration of this embodiment of this aspect of the present disclosure, the composition is a) Approximately 0.1 mg to approximately 50 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.1 mg to approximately 100 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.1 mg to approximately 250 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 20 mg to approximately 250 mg of sodium bicarbonate, e) Approximately 10 mg to approximately 50 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0052] In another aspect of this disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.01 mg to approximately 4 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.005 mg to approximately 0.5 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0053] In one embodiment of this aspect of the present disclosure, a composition is a) Approximately 0.01 mg to approximately 2 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0054] In one iteration of this embodiment of this aspect of the present disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0055] In another repeat of this embodiment of this aspect of the present disclosure, the composition is: a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0056] In one embodiment of this aspect of the present disclosure, a composition is a) Approximately 0.01 mg to approximately 2 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.01 mg to approximately 4 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.005 mg to approximately 0.5 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, silicon dioxide, colloidal silicon dioxide, or mixtures thereof, Includes.

[0057] In one iteration of this embodiment of this aspect of the present disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of one or more GLP-1 agonists selected from liraglutide, semaglutide, or mixtures thereof, b) Approximately 0.01 mg to approximately 4 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, silicon dioxide, colloidal silicon dioxide, or mixtures thereof, Includes.

[0058] In another repeat of this embodiment of this aspect of the present disclosure, the composition is: a) Approximately 0.01 mg to approximately 2 mg of one or more GLP-1 agonists selected from liraglutide, semaglutide, or mixtures thereof, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, silicon dioxide, colloidal silicon dioxide, or mixtures thereof, Includes.

[0059] In one further iteration of this embodiment of this aspect of the present disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, silicon dioxide, colloidal silicon dioxide, or mixtures thereof, Includes.

[0060] In yet another iteration of this embodiment of this aspect of the present disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of liraglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, silicon dioxide, colloidal silicon dioxide, or mixtures thereof, Includes.

[0061] In one embodiment of this aspect of the present disclosure, a composition is a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to approximately 4 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0062] In one iteration of this embodiment of this aspect of the present disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0063] In another repeat of this embodiment of this aspect of the present disclosure, the composition is: a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, silicon dioxide, colloidal silicon dioxide, or mixtures thereof, Includes.

[0064] In one further iteration of this embodiment of this aspect of the present disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to 4 mg of sunflower oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, silicon dioxide, colloidal silicon dioxide, or mixtures thereof, Includes.

[0065] In another repeat of this embodiment of this aspect of the present disclosure, the composition is: a) Approximately 0.01 mg to approximately 2 mg of liraglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, silicon dioxide, colloidal silicon dioxide, or mixtures thereof, Includes.

[0066] In one further iteration of this embodiment of this aspect of the present disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of liraglutide, b) Approximately 0.01 mg to 4 mg of sunflower oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, silicon dioxide, colloidal silicon dioxide, or mixtures thereof, Includes.

[0067] In one embodiment of this aspect of the present disclosure, a composition is a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0068] In one iteration of this embodiment of this aspect of the present disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of one or more carriers selected from mannitol, colloidal silicon dioxide, or mixtures thereof, Includes.

[0069] In a further aggravated expression of this aspect of the present disclosure, the composition is a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to 10 mg of mannitol, Includes.

[0070] In another repeat of this embodiment of this aspect of the present disclosure, the composition is: a) Approximately 0.01 mg to approximately 2 mg of semaglutide, b) Approximately 0.01 mg to 4 mg of olive oil, c) Approximately 0.005 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 0.5 mg to approximately 10 mg of sodium bicarbonate, e) Approximately 1 mg to approximately 10 mg of colloidal silicon dioxide, Includes.

[0071] In a non-limiting embodiment of this disclosure, a composition is a) Approximately 0.2 mg to approximately 25 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 50 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 5 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 460 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 480 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0072] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 25 mg of semaglutide, b) Approximately 0.4 mg to 50 mg of olive oil, c) Approximately 0.05 mg to approximately 5 mg of deoxycholic acid, d) Approximately 1 mg to approximately 460 mg of sodium bicarbonate, e) Approximately 3 mg to 480 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0073] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 25 mg of liraglutide, b) Approximately 0.4 mg to 50 mg of olive oil, c) Approximately 0.05 mg to approximately 5 mg of deoxycholic acid, d) Approximately 1 mg to approximately 460 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 480 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0074] In a further, non-limiting aspect of this disclosure, the composition is a) Approximately 0.2 mg to approximately 20 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 40 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 4 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 350 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 360 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0075] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 20 mg of semaglutide, b) Approximately 0.4 mg to 40 mg of olive oil, c) Approximately 0.05 mg to approximately 4 mg of deoxycholic acid, d) Approximately 1 mg to approximately 350 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 360 mg of one or more carriers selected from mannitol, colloidal silicon dioxide, or mixtures thereof, Includes.

[0076] In another iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 20 mg of liraglutide, b) Approximately 0.4 mg to 40 mg of olive oil, c) Approximately 0.05 mg to approximately 4 mg of deoxycholic acid, d) Approximately 1 mg to approximately 350 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 360 mg of one or more carriers selected from mannitol, colloidal silicon dioxide, or mixtures thereof, Includes.

[0077] In a further non-limiting aspect of this disclosure, the compositions are: a) Approximately 0.2 mg to approximately 20 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 40 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 4 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 350 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 360 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0078] In another non-limiting aspect of this disclosure, a composition is a) Approximately 0.2 mg to approximately 12 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 24 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 3 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 230 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 240 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0079] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 12 mg of semaglutide, b) Approximately 0.4 mg to 24 mg of olive oil, c) Approximately 0.05 mg to approximately 3 mg of deoxycholic acid, d) Approximately 1 mg to approximately 230 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 240 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0080] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 12 mg of liraglutide, b) Approximately 0.4 mg to 24 mg of olive oil, c) Approximately 0.05 mg to approximately 3 mg of deoxycholic acid, d) Approximately 1 mg to approximately 230 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 240 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0081] In another, non-limiting aspect of this disclosure, a composition is a) Approximately 0.2 mg to approximately 6 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 12 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 1.5 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 120 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 125 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0082] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 6 mg of semaglutide, b) Approximately 0.4 mg to 12 mg of olive oil, c) Approximately 0.05 mg to approximately 1.5 mg of deoxycholic acid, d) Approximately 1 mg to approximately 120 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 125 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0083] In another iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 6 mg of liraglutide, b) Approximately 0.4 mg to 12 mg of olive oil, c) Approximately 0.05 mg to approximately 1.5 mg of deoxycholic acid, d) Approximately 1 mg to approximately 120 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 125 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0084] In another non-limiting aspect of this disclosure, a composition is a) Approximately 0.2 mg to 4 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 8 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.75 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 70 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 75 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0085] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 4 mg of semaglutide, b) Approximately 0.4 mg to 8 mg of olive oil, c) Approximately 0.05 mg to approximately 0.75 mg of deoxycholic acid, d) Approximately 1 mg to approximately 70 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 75 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0086] In another iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 4 mg of liraglutide, b) Approximately 0.4 mg to 8 mg of olive oil, c) Approximately 0.05 mg to approximately 0.75 mg of deoxycholic acid, d) Approximately 1 mg to approximately 70 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 75 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0087] In yet another non-limiting aspect of this disclosure, the composition is a) Approximately 0.2 mg to approximately 2.5 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to 5 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.5 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 50 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 50 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0088] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 2.5 mg of semaglutide, b) Approximately 0.4 mg to 5 mg of olive oil, c) Approximately 0.05 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 1 mg to approximately 50 mg of sodium bicarbonate, e) Approximately 3 mg to 50 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0089] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 2.5 mg of liraglutide, b) Approximately 0.4 mg to 5 mg of olive oil, c) Approximately 0.05 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 1 mg to approximately 50 mg of sodium bicarbonate, e) Approximately 3 mg to 50 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0090] In yet another non-limiting aspect of this disclosure, the composition is a) Approximately 0.2 mg to approximately 2 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to 4 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.4 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 40 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 40 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0091] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 2 mg of semaglutide, b) Approximately 0.4 mg to 4 mg of olive oil, c) Approximately 0.05 mg to approximately 0.4 mg of deoxycholic acid, d) Approximately 1 mg to approximately 40 mg of sodium bicarbonate, e) Approximately 3 mg to 40 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0092] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 2 mg of liraglutide, b) Approximately 0.4 mg to 4 mg of olive oil, c) Approximately 0.05 mg to approximately 0.4 mg of deoxycholic acid, d) Approximately 1 mg to approximately 40 mg of sodium bicarbonate, e) Approximately 3 mg to 40 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0093] In another non-limiting aspect of this disclosure, a composition is a) Approximately 0.2 mg to approximately 1.5 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to 3 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.3 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 25 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 25 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0094] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 1.5 mg of semaglutide, b) Approximately 0.4 mg to 3 mg of olive oil, c) Approximately 0.05 mg to approximately 0.3 mg of deoxycholic acid, d) Approximately 1 mg to approximately 25 mg of sodium bicarbonate, e) Approximately 3 mg to 25 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0095] In another iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 1.5 mg of liraglutide, b) Approximately 0.4 mg to 3 mg of olive oil, c) Approximately 0.05 mg to approximately 0.3 mg of deoxycholic acid, d) Approximately 1 mg to approximately 25 mg of sodium bicarbonate, e) Approximately 3 mg to 25 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0096] In yet another non-limiting aspect of this disclosure, a composition is a) Approximately 0.2 mg to approximately 0.75 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 1.5 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.15 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to 15 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 15 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0097] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 0.75 mg of semaglutide, b) Approximately 0.4 mg to 1.5 mg of olive oil, c) Approximately 0.05 mg to approximately 0.15 mg of deoxycholic acid, d) Approximately 1 mg to 15 mg of sodium bicarbonate, e) Approximately 3 mg to 15 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0098] In another iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 0.75 mg of liraglutide, b) Approximately 0.4 mg to 1.5 mg of olive oil, c) Approximately 0.05 mg to approximately 0.15 mg of deoxycholic acid, d) Approximately 1 mg to 15 mg of sodium bicarbonate, e) Approximately 3 mg to 15 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0099] The disclosed compositions contain about 0.01 mg to about 50 mg of one or more GLP-1 agonists. In one embodiment, the composition contains about 0.1 mg to about 30 mg of one or more GLP-1 agonists. In another embodiment, the composition contains about 0.1 mg to 10 mg of semaglutide. In a further embodiment, the composition contains about 0.01 mg to 5 mg of one or more GLP-1 agonists. In yet another embodiment, the composition contains about 0.01 mg to 2 mg of one or more GLP-1 agonists. In yet another embodiment, the composition contains about 0.1 mg to 10 mg of one or more GLP-1 agonists.

[0100] The disclosed compositions range from approximately 0.01 mg to approximately 50 mg, for example, approximately 0.001 mg, 0.002 mg, 0.003 mg, 0.004 mg, 0.005 mg, 0.006 mg, 0.007 mg, 0.008 mg, 0.009 mg, 0.01 mg, 0.02 mg, 0.03 mg, 0.04 mg, 0.05 mg, 0.06 mg, 0.07 mg, 0.08 mg, 0.09 mg, 0. 1mg, 0.2mg, 0.3mg, 0.4mg, 0.5mg, 0.6mg, 0.7mg, 0.8mg, 0.9mg, 1mg, 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg , 9mg, 10mg, 11mg, 12mg, 13mg, 14mg, 15mg, 16mg, 17mg, 18mg, 19mg, 20mg, 21mg, 22mg, 23mg, 24mg, 25mg Contains one or more GLP-1 agonists in amounts of 26 mg, 27 mg, 28 mg, 29 mg, 30 mg, 31 mg, 32 mg, 33 mg, 34 mg, 35 mg, 36 mg, 37 mg, 38 mg, 39 mg, 40 mg, 41 mg, 42 mg, 43 mg, 44 mg, 45 mg, 46 mg, 47 mg, 48 mg, 49 mg, or 50 mg, or any small amount thereof, for example, 6.65 mg, 8.26 mg, or 11.33 mg.

[0101] The disclosed compositions contain one or more edible oils in an amount of about 0.01 mg to about 100 mg. Non-limiting examples of edible oils include olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof. In one embodiment, the composition contains one or more edible oils in an amount of about 0.01 mg to about 50 mg. In another embodiment, the composition contains about 0.01 mg to 10 mg of edible oil. In yet another embodiment, the composition contains one or more edible oils in an amount of about 0.01 mg to 2 mg. In yet another embodiment, the composition contains one or more edible oils in an amount of about 0.05 mg to 4 mg. In yet another embodiment, the composition contains one or more edible oils in an amount of about 0.05 mg to 1 mg.

[0102] The disclosed compositions include, for example, about 0.001 mg to about 100 mg, for example, 0.001 mg, 0.002 mg, 0.003 mg, 0.004 mg, 0.005 mg, 0.006 mg, 0.007 mg, 0.008 mg, 0.009 mg, 0.01 mg, 0.02 mg, 0.03 mg, 0.04 mg, 0.05 mg, 0.06 mg, 0.07 mg, 0.08 mg, 0.09 mg, 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5mg, 0.6mg, 0.7mg, 0.8mg, 0.9mg, 1mg, 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg, 9mg, 10mg, 11mg, 12mg, 13mg, 14mg, 15mg, 1 6mg, 17mg, 18mg, 19mg, 20mg, 21mg, 22mg, 23mg, 24mg, 25mg, 26mg, 27mg, 28mg, 29mg, 30mg, 31mg, 32mg, 33mg, 34mg, 35m g, 36mg, 37mg, 38mg, 39mg, 40mg, 41mg, 42mg, 43mg, 44mg, 45mg, 46mg, 47mg, 48mg, 49mg, 50mg, 51mg, 52mg, 53mg, 54mg , 55mg, 56mg, 57mg, 58mg, 59mg, 60mg, 61mg, 62mg, 63mg, 64mg, 65mg, 66mg, 67mg, 68mg, 69mg, 70mg, 71mg, 72mg, 73mg, 7 Contains 4 mg, 75 mg, 76 mg, 77 mg, 78 mg, 79 mg, 80 mg, 81 mg, 82 mg, 83 mg, 84 mg, 85 mg, 86 mg, 87 mg, 88 mg, 89 mg, 90 mg, 91 mg, 92 mg, 93 mg, 94 mg, 95 mg, 96 mg, 97 mg, 98 mg, 99 mg, or 100 mg, or any small amount thereof, for example, 10.2 mg, 31.35 mg, or 40.42 mg of one or more edible oils.

[0103] The ratio of one or more GLP-1 agonists to one or more edible oils is approximately 1:1 to approximately 1:10, for example, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, or 1:10, or any small number thereof, for example, 1:1.5, 1:4.2, or 1:8.6. In one embodiment, the ratio of one or more GLP-1 agonists to one or more edible oils is 1:1. In another embodiment, the ratio of one or more GLP-1 agonists to one or more edible oils is 1:2. In yet another embodiment, the ratio of one or more GLP-1 agonists to one or more edible oils is 1:3.

[0104] The table below shows non-limiting examples of compositions that can deliver the required amount of semaglutide to a person requiring treatment.

[0105] [Table 3]

[0106] [Table 4]

[0107] The table below shows non-limiting examples of compositions that can deliver the required amount of liraglutide to a person requiring treatment.

[0108] [Table 5]

[0109] [Table 6]

[0110] Bile salts The disclosed compositions comprise one or more bile salts as described herein. The source of the bile salts may be any commercially available salt.

[0111] For the purposes of this disclosure, the terms “bile salt” and “bile acid” are used interchangeably herein. Bile acids are steroid acids primarily found in the bile of mammals, such as cattle, goats, and other livestock. Bile salts are conjugated with the amino acids taurine or glycine to produce bile salts. Extracted bile salts may include unconjugated bile acids.

[0112] A non-limiting embodiment of bile salts relates to bovine bile salts. An example of bovine bile salts includes cholic acid (45-55%), the remainder being taurocholic acid deoxycholic acid salt, and glycocholic acid, all of which may be partially or completely conjugated with taurine and glycine. In some embodiments, pure acid or acid conjugates, such as deoxycholic acid, are added.

[0113] The compositions of this disclosure contain about 1.5% to about 65% by weight of bile salts. In one embodiment, the composition contains about 5% to about 55% by weight of bile salts. In one embodiment, the composition contains about 10% to about 25% by weight of bile salts. In one embodiment, the composition contains about 10% to about 20% by weight of bile salts. In one embodiment, the composition contains about 5% to about 15% by weight of bile salts.

[0114] The compositions disclosed herein are present in amounts ranging from approximately 0.01% by weight to approximately 65% ​​by weight, for example, 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, or 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%. It may contain 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, or 65%, or any small quantities thereof, for example, 39.7%, 40.23%, or 50.5% of one or more bile salts.

[0115] Cholic acid, also known as 3α,7α,12α-trihydroxy-5β-colan-24-acid, is a primary bile acid found in bile extracts. Cholic acid is insoluble in water (but soluble in alcohol and acetic acid) and is obtained as a white crystalline substance. Salts of cholic acid are called cholates. Cholic acid, along with chenodeoxycholic acid, is one of the two major bile acids produced by the mammalian liver, where it is synthesized from cholesterol. These two major bile acids are present in extracts at nearly equal concentrations. [4] Bile salts themselves are produced from coroyl-CoA, and the CoA is exchanged for either glycine or taurine to obtain glycocholic acid and taurocholic acid, respectively. Other bile salts include taurochenodeoxycholic acid and glycochenodeoxycholic acid (a derivative of chenodeoxycholic acid). These, along with glycocholic acid and taurocholic acid, constitute the main components of bile salts.

[0116] Examples of compositions containing deoxycholic acid ((4R)-4-[(1R,3aS,3bR,5aR,7R,9aS,9bS,11S,11aR)-7,11-dihydroxy-9a,11a-dimethylhexadecahydro-1H-cyclopenta[α]phenanthren-1-yl]pentanoic acid) are disclosed. The disclosed compositions may contain about 0.01% to about 65% by weight of deoxycholic acid as part of a bile salt extract or as deoxycholic acid alone. In one embodiment, the composition contains about 0.01% to about 2% by weight of deoxycholic acid, for example, 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, or 2% deoxycholic acid.

[0117] The compositions of this disclosure contain about 0.005 mg to about 250 mg of bile salts or bile salt extracts. In one embodiment, the composition contains about 0.01 mg to about 10 mg by weight of one or more bile salts. In one embodiment, the composition contains about 0.005 mg to about 0.5 mg of bile salts or bile salts. In one embodiment, the composition contains about 0.01 mg to about 0.5 mg by weight of one or more bile salts. In one embodiment, the composition contains about 0.01 mg to about 1 mg by weight of one or more bile salts. In one embodiment, the composition contains about 0.005 mg to about 0.1 mg by weight of one or more bile salts or bile salt extracts.

[0118] The compositions disclosed herein range from approximately 0.005 mg to approximately 250 mg, for example, 0.005 mg, 0.006 mg, 0.007 mg, 0.008 mg, 0.009 mg, 0.01 mg, 0.02 mg, 0.03 mg, 0.04 mg, 0.05 mg, 0.06 mg, 0.07 mg, 0.08 mg, 0.09 mg, 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, 0.9 mg, 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg mg, 9mg, 10mg, 11mg, 12mg, 13mg, 14mg, 15mg, 16mg, 17mg, 18mg, 19mg, 20mg, 21mg, 22mg, 23mg, 24mg, 25mg, 26mg, 27mg, 28mg, 29mg, 3 0mg, 31mg, 32mg, 33mg, 34mg, 35mg, 36mg, 37mg, 38mg, 39mg, 40mg, 41mg, 42mg, 43mg, 44mg, 45mg, 46mg, 47mg, 48mg, 49mg, or 50mg, 51mg, 52, mg, 53, mg, 54mg, 55mg, 56mg, 57mg, 58mg, 59mg, 60mg, 61mg, 62mg, 63mg, 64mg, 65mg, 66mg, 67mg, 68mg, 69mg, 70mg, 71mg, 7 2mg, 73mg, 74mg, 75mg, 76mg, 77mg, 78mg, 79mg, 80mg, 81mg, 82mg, 83mg, 84mg, 85mg, 86mg, 87mg, 88mg, 89mg, 90mg, 91mg, 92mg, 93mg , 94mg, 95mg, 96mg, 97mg, 98mg, 99mg, 100mg, 101mg, 102mg, 103mg, 104mg, 105mg, 106mg, 107mg, 108mg, 109mg, 110mg, 111mg, 112mg , 113mg, 114mg, 115mg, 116mg, 117mg, 118mg, 119mg, 120mg, 121mg, 122mg, 123mg, 124mg, 125mg, 126mg, 127mg, 128mg, 129mg, 130mg31mg, 132mg, 133mg, 134mg, 135mg, 136mg, 137mg, 138mg, 139mg, 140mg, 141mg, 142mg, 143mg, 144mg, 145mg, 146mg, 147 mg, 148mg, 149mg, 150mg, 151mg, 152mg, 153mg, 154mg, 155mg, 156mg, 157mg, 158mg, 159mg, 160mg, 161mg, 162mg, 163mg , 164mg, 165mg, 166mg, 167mg, 168mg, 169mg, 170mg, 171mg, 172mg, 173mg, 174mg, 175mg, 167mg, 177mg, 178mg, 179mg, 1 80mg, 181mg, 182mg, 183mg, 184mg, 185mg, 186mg, 187mg, 188mg, 189mg, 190mg, 191mg, 192mg, 193mg, 194mg, 195mg, 196m g, 197mg, 198mg, 199mg, 200mg, 201mg, 202mg, 203mg, 204mg, 205mg, 206mg, 207mg, 208mg, 209mg, 210mg, 211mg, 212mg, 213mg, 214mg, 215mg, 216mg, 217mg, 218mg, 219mg, 220mg, 221mg, 222mg, 223mg, 224mg, 225mg, 226mg, 227mg, 228mg, 22 Contains 9 mg, 230 mg, 231 mg, 232 mg, 233 mg, 234 mg, 235 mg, 236 mg, 237 mg, 238 mg, 239 mg, 240 mg, 241 mg, 242 mg, 243 mg, 244 mg, 245 mg, 246 mg, 247 mg, 248 mg, 249 mg, or 250 mg, or any small amount thereof, for example, 141.8 mg, 172.56 mg, or 202.11 mg of bile salt or bile salt extract.

[0119] In non-limiting examples of the disclosed compositions, the compositions contain about 0.01 mg to 2 mg of deoxycholic acid, for example, 0.005 mg, 0.006 mg, 0.007 mg, 0.008 mg, 0.009 mg, 0.01 mg, 0.02 mg, 0.03 mg, 0.04 mg, 0.05 mg, 0.06 mg, 0.07 mg, 0.08 mg, 0.09 mg, 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, 0.9 mg, 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, or 10 mg.

[0120] Sodium bicarbonate (NaHCO3) The compositions of this disclosure contain about 35% to about 65% by weight of sodium bicarbonate. In one embodiment, the composition contains about 35% to about 55% by weight of sodium bicarbonate. In one embodiment, the composition contains about 40% to about 65% by weight of sodium bicarbonate. In one embodiment, the composition contains about 40% to about 55% by weight of sodium bicarbonate. In one embodiment, the composition contains about 45% to about 60% by weight of sodium bicarbonate.

[0121] The compositions of this disclosure may contain about 35% to about 65% by weight of sodium bicarbonate, for example, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, or 65%, or any small amount thereof, for example, 39.7%, 40.23%, or 50.5%.

[0122] The compositions of this disclosure contain about 0.5 mg to about 250 mg of sodium bicarbonate. In one embodiment, the composition contains about 0.5 mg to about 10 mg of sodium bicarbonate. In one embodiment, the composition contains about 1 mg to about 10 mg of sodium bicarbonate.

[0123] The compositions disclosed herein range from approximately 0.5 mg to approximately 250 mg, for example, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, 0.9 mg, 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 11 mg, 12 mg, 13 mg, 14 mg, 15 mg, 16 mg, 17 mg, 18 mg, 19 mg, 20 mg, 21 mg, 22 mg, 23 mg, 24 mg, 25 mg, 26 mg, 27 mg. 28mg, 29mg, 30mg, 31mg, 32mg, 33mg, 34mg, 35mg, 36mg, 37mg, 38mg, 39mg, 40mg, 41mg, 42mg, 43mg, 44mg, 45mg, 46mg, 47mg, 48mg, 49mg, or 50mg, 51mg, 52mg, 53mg, 54mg, 55mg, 56mg, 57mg, 58mg, 59mg, 60mg, 61mg, 62mg, 63mg , 64mg, 65mg, 66mg, 67mg, 68mg, 69mg, 70mg, 71mg, 72mg, 73mg, 74mg, 75mg, 76mg, 77mg, 78mg, 79mg, 80mg, 81mg, 82mg, 83mg, 84mg, 85mg, 86mg, 87mg, 88mg, 89mg, 90mg, 91mg, 92mg, 93mg, 94mg, 95mg, 96mg, 97mg, 98mg, 99mg, 10 0mg, 101mg, 102mg, 103mg, 104mg, 105mg, 106mg, 107mg, 108mg, 109mg, 110mg, 111mg, 112mg, 113mg, 114mg, 115 mg, 116mg, 117mg, 118mg, 119mg, 120mg, 121mg, 122mg, 123mg, 124mg, 125mg, 126mg, 127mg, 128mg, 129mg, 130mg31mg, 132mg, 133mg, 134mg, 135mg, 136mg, 137mg, 138mg, 139mg, 140mg, 141mg, 142mg, 143mg, 144mg, 145mg, 146mg, 14 7mg, 148mg, 149mg, 150mg, 151mg, 152mg, 153mg, 154mg, 155mg, 156mg, 157mg, 158mg, 159mg, 160mg, 161mg, 162mg, 163m g, 164mg, 165mg, 166mg, 167mg, 168mg, 169mg, 170mg, 171mg, 172mg, 173mg, 174mg, 175mg, 167mg, 177mg, 178mg, 179mg , 180mg, 181mg, 182mg, 183mg, 184mg, 185mg, 186mg, 187mg, 188mg, 189mg, 190mg, 191mg, 192mg, 193mg, 194mg, 195mg, 1 96mg, 197mg, 198mg, 199mg, 200mg, 201mg, 202mg, 203mg, 204mg, 205mg, 206mg, 207mg, 208mg, 209mg, 210mg, 211mg, 21 2mg, 213mg, 214mg, 215mg, 216mg, 217mg, 218mg, 219mg, 220mg, 221mg, 222mg, 223mg, 224mg, 225mg, 226mg, 227mg, 228m Contains 229 mg, 230 mg, 231 mg, 232 mg, 233 mg, 234 mg, 235 mg, 236 mg, 237 mg, 238 mg, 239 mg, 240 mg, 241 mg, 242 mg, 243 mg, 244 mg, 245 mg, 246 mg, 247 mg, 248 mg, 249 mg, or 250 mg, or any fraction thereof, for example, 141.8 mg, 172.56 mg, or 202.11 mg of sodium bicarbonate.

[0124] Carrier The disclosed composition comprises one or more carriers in an amount of about 15% to about 85% by weight. In one embodiment, the composition comprises one or more carriers in an amount of about 15% to about 50% by weight. In another embodiment, the composition comprises one or more carriers in an amount of about 25% to about 50% by weight. In a further embodiment, the composition comprises one or more carriers in an amount of about 40% to about 55% by weight. In yet another embodiment, the composition comprises one or more carriers in an amount of about 35% to about 65% by weight. In yet another embodiment, the composition comprises one or more carriers in an amount of about 30% to about 50% by weight. The disclosed compositions include, for example, 15% by weight, 16% by weight, 17% by weight, 18% by weight, 19% by weight, 20% by weight, 21% by weight, 22% by weight, 23% by weight, 24% by weight, 25% by weight, 26% by weight, 27% by weight, 28% by weight, 29% by weight, 30% by weight, 31% by weight, 32% by weight, 33% by weight, 34% by weight, 35% by weight, 36% by weight, 37% by weight, 38% by weight, 39% by weight, 40% by weight, 41% by weight, 42% by weight, 43% by weight, 44% by weight, 45% by weight, 46% by weight, 47% by weight, 48% by weight, 49% by weight, 50% by weight, 51% by weight, 52% by weight, and 53% by weight. This may include amounts of %, 54% by weight, 55% by weight, 56% by weight, 57% by weight, 58% by weight, 59% by weight, 60% by weight, 61% by weight, 62% by weight, 63% by weight, 64% by weight, 65% by weight, 66% by weight, 67% by weight, 68% by weight, 69% by weight, 70% by weight, 71% by weight, 72% by weight, 73% by weight, 74% by weight, 75% by weight, 76% by weight, 77% by weight, 78% by weight, 79% by weight, 80% by weight, 81% by weight, 82% by weight, 83% by weight, 84% by weight, 85% by weight, or any small quantities thereof, for example, 2.5%, 7.66%, or 40.29% of one or more types of carriers.

[0125] The disclosed composition may contain one or more carriers in an amount of about 0.5 mg to about 400 mg. In one embodiment, the composition contains one or more carriers in an amount of about 1 mg to about 10 mg by weight. In another embodiment, the composition contains one or more carriers in an amount of about 2 mg to about 80 mg. In a further embodiment, the composition contains one or more carriers in an amount of about 1 mg to about 5 mg. In yet another embodiment, the composition contains one or more carriers in an amount of about 1.5 mg to about 5 mg.

[0126] The disclosed compositions range from approximately 0.5 mg to approximately 400 mg, for example, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, 0.9 mg, 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 11 mg, 12 mg, 13 mg, 14 mg, 15 mg, 16 mg, 17 mg, 18 mg, 19 mg, 20 mg, 21 mg, 22 mg, 23 mg, 24 mg, 25 mg, 26 mg, 27 mg. g, 28mg, 29mg, 30mg, 31mg, 32mg, 33mg, 34mg, 35mg, 36mg, 37mg, 38mg, 39mg, 40mg, 41mg, 42mg, 43mg, 44mg, 45mg , 46mg, 47mg, 48mg, 49mg, 50mg, 51mg, 52mg, 53mg, 54mg, 55mg, 56mg, 57mg, 58mg, 59mg, 60mg, 61mg, 62mg, 63mg, 64mg, 65mg, 66mg, 67mg, 68mg, 69mg, 70mg, 71mg, 72mg, 73mg, 74mg, 75mg, 76mg, 77mg, 78mg, 79mg, 80mg, 81mg, 8 2mg, 83mg, 84mg, 85mg, 86mg, 87mg, 88mg, 89mg, 90mg, 91mg, 92mg, 93mg, 94mg, 95mg, 96mg, 97mg, 98mg, 99mg, 10 0mg, 101mg, 102mg, 103mg, 104mg, 105mg, 106mg, 107mg, 108mg, 109mg, 110mg, 111mg, 112mg, 113mg, 114mg, 115 mg, 116mg, 117mg, 118mg, 119mg, 120mg, 121mg, 122mg, 123mg, 124mg, 125mg, 126mg, 127mg, 128mg, 129mg, 130mg 31mg, 132mg, 133mg, 134mg, 135mg, 136mg, 137mg, 138mg, 139mg, 140mg, 141mg, 142mg, 143mg, 144mg, 145mg, 146mg, 147mg, 148mg, 149mg, 150mg, 151mg, 152mg, 153 mg, 154mg, 155mg, 156mg, 157mg, 158mg, 159mg, 160mg, 161mg, 162mg, 163mg, 164mg, 165mg, 166mg, 167mg, 168mg, 169mg, 170mg, 171mg, 172mg, 173mg, 174mg, 175mg,167mg、177mg、178mg、179mg、180mg、181mg、182mg、183mg、184mg、185mg、186mg、187mg、188mg、189mg、190mg、191mg、192mg、193mg、194mg、195mg、196mg、197mg、198mg、199mg、200mg、201mg、202mg、203mg、204mg、205mg、206mg、207mg、208mg、209mg、210mg、211mg、212mg、213mg、214mg、215mg、216mg、217mg、218mg、219mg、220mg、221mg、222mg、223mg、224mg、225mg、226mg、227mg、228mg、229mg、230mg、231mg、232mg、233mg、234mg、235mg、236mg、237mg、238mg、239mg、240mg、241mg、242mg、243mg、244mg、245mg、246mg、247mg、248mg、249mg、250mg、251mg、252mg、253mg、254mg、255mg、256mg、257mg、258mg、259mg、260mg、261mg、262mg、263mg、264mg、265mg、266mg、267mg、268mg、269mg、270mg、271mg、272mg、273mg、274mg、275mg、276mg、277mg、278mg、279mg、280mg、281mg、282mg、283mg、284mg、285mg、286mg、287mg、288mg、289mg、290mg、290mg、291mg、292mg、293mg、294mg、295mg、296mg、297mg、298mg、299mg、300mg、301mg、302mg、303mg、304mg、305mg、306mg、307mg、308mg、309mg、310mg、311mg、312mg、313mg、314mg、315mg、316mg、317mg、318mg、319mg、320mg、321mg、322mg、323mg、324mg、325mg、326mg、327mg、328mg、329mg、330mg、331mg、332mg、333mg、334mg、335mg、336mg、337mg、338mg、339mg、340mg、341mg, 342mg, 343mg, 344mg, 345mg, 346mg, 347mg, 348mg, 349mg, 350mg, 351mg, 352mg, 353mg, 354mg, 355mg, 356mg, 357mg, 358 mg, 359mg, 360mg, 361mg, 362mg, 363mg, 364mg, 365mg, 366mg, 367mg, 368mg, 369mg, 370mg, 371mg, 372mg, 373mg, 374mg, 375mg, 3 It may contain 76 mg, 377 mg, 378 mg, 379 mg, 380 mg, 381 mg, 382 mg, 383 mg, 384 mg, 385 mg, 386 mg, 387 mg, 388 mg, 389 mg, 390 mg, 391 mg, 392 mg, 393 mg, 394 mg, 395 mg, 396 mg, 397 mg, 398 mg, 399 mg, or 400 mg, or any small quantities thereof, for example, one or more carriers of 78.65 mg, 200.7 mg, or 286.75 mg.

[0127] In one embodiment, the disclosed carrier is a polysaccharide. Non-limiting examples of polysaccharide carriers include inulin, galactogens, cellulose, chitin, pectin, psyllium, guar, hemicellulose, potato starch, and partially hydrolyzed polysaccharides. In another embodiment, the carrier is a sugar alcohol, such as sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrolyzed starch, isomaltose, or any combination thereof. In a further embodiment, the carrier component is based on any other starch, gum, or other polysaccharide, including natural or chemically modified agar, alginates, carrageenan gum, cellulose, chitosan, chitin, cyclodextrin, dextran, gellan gum, glycogen, glycosaminoglycans, karaya gum, inulin, pectin, polydextrose, xanthan gum, or functionalized derivatives, dextrin starch, hydrolyzed starch, oxidized starch, alkylated starch, hydroxyalkylated starch, acetylated starch, classified starch, and physically modified starch, as well as mixtures thereof. In some embodiments, glycerin and / or propylene glycol may be added as a carrier.

[0128] In another embodiment, the carrier is selected from gum arabic, tapioca starch, tapioca flour, silicon dioxide, mannitol, colloidal silicon dioxide, and mixtures thereof. In yet another example, the carrier is gum arabic. In yet another example, the carrier is inulin. In yet another example, the carrier is microcrystalline cellulose. In yet another example, the carrier is D-lactose monohydrate. In yet another example, the carrier is quillaja. The carrier may be a combination of gum arabic, inulin, microcrystalline cellulose, D-lactose monohydrate, or quillaja.

[0129] In one embodiment, the carrier is selected from sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC), gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or a mixture thereof.

[0130] In one embodiment, the carrier is selected from mannitol, colloidal silicon dioxide, or a mixture thereof.

[0131] In a non-limiting example, the support is mannitol, and a non-limiting example is Partek® mannitol, available from Partek Inc. In a further non-limiting example, the support is microcrystalline cellulose. In yet another example, the support is colloidal silicon dioxide. In yet another example, the support is colloidal silicon dioxide. A non-limiting example is Aeroperl® 300, available from IMCD.

[0132] method This specification discloses methods for treating diabetes, controlling and reducing body weight, and improving triglyceride and cholesterol levels. While not limited by theory, diabetes can be characterized as a chronic disease that occurs either when the pancreas does not produce enough insulin, or when the body is unable to effectively use the insulin it produces. In a normal, healthy person, most of the food eaten is broken down by the body into sugar (glucose), which is then released into the bloodstream. When blood glucose levels rise, a signal is sent to the pancreas to release insulin. Insulin acts like a key to getting the body's cells to take in glucose and use it as energy.

[0133] In diabetes, the body either doesn't produce enough insulin or can't use it properly. When there isn't enough insulin, or when cells stop responding to insulin, excessively high blood sugar levels remain in the bloodstream. Over time, this can lead to serious health problems such as heart disease, vision loss, and kidney disease. Therefore, measuring glucose levels can be key to monitoring the severity of an individual's diabetes.

[0134] Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to reduce the risk of cardiovascular adverse events in patients with diabetes. However, it is not clear whether semaglutide can reduce cardiovascular risk associated with overweight and obesity in individuals without diabetes.

[0135] In a study of 3,297 patients with established cardiovascular disease who were already receiving standard treatment, the addition of semaglutide reduced the composite outcome of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke by only 2.3 percentage points compared to placebo (6.6% compared to 8.9%, with an average of 44 patients requiring treatment over 2.1 years) (see Marso SP et al., "SUSTAIN-6 Investigators. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes," New England Journal of Medicine (N Engl J Med.), 2016, Vol. 375 (No. 19): pp. 1834-184).

[0136] The disclosed method provides for orally administering one or more GLP-1 agonists to a subject requiring treatment. Orally available compositions may exist in any form desired by the formulation manufacturer. Non-limiting examples of suitable composition forms include tablets, pills, caplets, and capsules.

[0137] The disclosed compositions can be administered to a subject to provide any desired amount of one or more GLP-1 agonists. Non-limiting examples of GLP-1 dosages include 3 mg, 7 mg, or 14 mg of semaglutide. Further non-limiting examples of GLP-1 dosages include 3 mg, 7 mg, or 14 mg of liraglutide.

[0138] The following are non-limiting examples of compositions that can deliver 3 mg of semaglutide to the required subject.

[0139] [Table 7]

[0140] The following are non-limiting examples of compositions that can deliver 7 mg of semaglutide to the required subject.

[0141] [Table 8]

[0142] The following are non-limiting examples of compositions that can deliver 14 mg of semaglutide to the required subject.

[0143] [Table 9]

[0144] In one embodiment of the disclosed method, an escalation protocol, i.e., a protocol for administering the Composition described herein to a subject in an increasing amount over time, can be utilized. For example, a subject may be administered 100 mg of the Composition described herein once daily for 7 days, followed by 200 mg per day for the next 7 days, followed by 300 mg per day for the next 7 days. The administration protocol may also follow a pattern of decreasing dosage over time. For example, 300 mg of the Composition described herein per day for 7 days, followed by 200 mg per day for the next 7 days, followed by 100 mg per day for the next 7 days. In some embodiments, the method described herein can be used in combination with a calorie restriction protocol in a subject. In certain embodiments, the Composition described herein may be administered before, after, or during meals. Furthermore, the appropriate dosage of the composition may depend, for example, on the condition being treated, its severity and course, whether the composition is administered for preventative or therapeutic purposes, past treatments, the patient's medical history and response to the composition, the type of composition used, and the discretion of the attending physician. The composition may be administered to the patient as a single dose, as part of a series of treatments, or at any time after diagnosis. The composition may be administered to the subject as a standalone composition.

[0145] In a further aspect, the disclosed composition can be administered to a subject for a number of purposes such as enhancing the effectiveness of other drugs or therapeutic agents that have been used or are currently being used in the treatment of the condition, reducing the dosage of these drugs or therapeutic agents while maintaining their effectiveness, thus reducing the potential side effects associated therewith, or gradually discontinuing these drugs or therapeutic agents by the subject to avoid the potential side effects associated therewith. Examples of these drugs or therapeutic agents include, but are not limited to, dipeptidyl peptidase-4 (DPP-4) inhibitors (sitagliptin, vildagliptin, saxagliptin, linagliptin, gemigliptin, anagliptin, teneligliptin, alogliptin, treagliptin, and omarigliptin, etc.). The composition and one or more of these drugs or therapeutic agents can be delivered simultaneously, at different times, in different frequencies, and / or by different delivery routes or forms.

[0146] The disclosed method can use any of the compositions disclosed herein. In this specification, a method for treating type 2 diabetes in a subject is disclosed. In this specification, a method for reducing A1C in a subject is disclosed. Further, a method for reducing the body mass of a subject is disclosed. Also, a method for regulating the incretin hormone level in a subject is disclosed. In one aspect, the composition of the method is a) one or more GLP-1 agonists from about 0.5% to about 20% by weight, and b) one or more edible oils from about 0.5% to about 40% by weight, and c) a bile salt extract from about 1.5% to about 65% by weight, and d) sodium bicarbonate from about 35% to about 65% by weight, and e) one or more carriers from about 15% to about 85% by weight, and comprises.

[0147] In one embodiment of this aspect, the composition of the disclosed method is a) From about 0.5% to about 20% by weight of one or more GLP-1 agonists selected from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, or mixtures thereof; b) From about 0.5% to about 40% by weight of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof; c) From about 1.5% to about 65% by weight of a bile salt extract, wherein the bile salt extract comprises from about 45% to about 55% by weight of a bile salt selected from the group consisting of cholic acid, deoxycholic acid, taurocholate, glycocholic acid, or mixtures thereof; d) From about 35% to about 65% by weight of sodium bicarbonate; e) From about 15% to about 85% by weight of one or more carriers; and comprising.

[0148] In one iteration of this embodiment of this aspect, the composition of the disclosed method is a) From about 0.5% to about 20% by weight of one or more GLP-1 agonists selected from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, or mixtures thereof; b) From about 0.5% to about 40% by weight of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof; c) From about 1.5% to about 65% by weight of a bile salt extract, wherein the bile salt extract comprises from about 45% to about 55% by weight of a bile salt selected from the group consisting of cholic acid, deoxycholic acid, taurocholate, glycocholic acid, or mixtures thereof; d) From about 35% to about 65% by weight of sodium bicarbonate; e) Approximately 15% to 85% by weight of one or more carriers selected from gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0149] In another iteration of this embodiment of this aspect, the composition of the disclosed method is: a) Approximately 0.5% to 20% by weight of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Approximately 1.5% to approximately 65% ​​by weight of bile salt extract (wherein the bile salt extract contains approximately 45% to approximately 55% by weight of bile salts selected from the group consisting of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, or mixtures thereof), d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 15% to approximately 85% by weight of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC), gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0150] In one further iteration of this embodiment of this aspect, the composition of the disclosed method is: a) Approximately 0.5% to 20% by weight of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Deoxycholic acid in an amount of approximately 1.5% to 65% by weight, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 15% to approximately 85% by weight of one or more carriers selected from carrier, Includes.

[0151] In another iteration of this embodiment of this aspect, the composition of the disclosed method is: a) Approximately 0.5% to 20% by weight of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Deoxycholic acid in an amount of approximately 1.5% to 65% by weight, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) A carrier comprising approximately 15% to 85% by weight of one or more materials selected from gum arabic, colloidal silicon dioxide, tapioca starch, or mixtures thereof, Includes.

[0152] In this non-limiting example of this iteration of this embodiment of this aspect, the composition of the disclosed method is: a) Approximately 0.5% to 20% by weight of dulaglutide, b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Deoxycholic acid in an amount of approximately 1.5% to 65% by weight, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 15% to 85% by weight of gum arabic, Includes.

[0153] In a further non-limiting example of this iteration of this embodiment of this aspect, the composition of the disclosed method is a) from about 0.5% to about 20% by weight of exenatide, and b) from about 0.5% to about 40% by weight of olive oil, and c) from about 1.5% to about 65% by weight of deoxycholic acid, and d) from about 35% to about 65% by weight of sodium bicarbonate, and e) from about 15% to about 85% by weight of gum arabic, and comprises.

[0154] In another non-limiting example of this iteration of this embodiment of this aspect, the composition of the disclosed method is a) from about 0.5% to about 20% by weight of liraglutide, and b) from about 0.5% to about 40% by weight of olive oil, and c) from about 1.5% to about 65% by weight of deoxycholic acid, and d) from about 35% to about 65% by weight of sodium bicarbonate, and e) from about 15% to about 85% by weight of gum arabic, and comprises.

[0155] In yet another non-limiting example of this iteration of this embodiment of this aspect, the composition of the disclosed method is a) from about 0.5% to about 20% by weight of lixisenatide, and b) from about 0.5% to about 40% by weight of olive oil, and <00,00979>c) from about 1.5% to about 65% by weight of deoxycholic acid, and d) from about 35% to about 65% by weight of sodium bicarbonate, and e) from about 15% to about 85% by weight of gum arabic, and comprises.

[0156] In yet still another non-limiting example of this iteration of this embodiment of this aspect, the composition of the disclosed method is a) from about 0.5% to about 20% by weight of semaglutide, and b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Deoxycholic acid in an amount of approximately 1.5% to 65% by weight, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 15% to 85% by weight of gum arabic, Includes.

[0157] In yet another, more non-limiting example of this iteration of this embodiment of this aspect, the composition of the disclosed method is: a) Approximately 0.5% to 20% by weight of tilzepatide, b) Olive oil in an amount of approximately 0.5% to 40% by weight, c) Deoxycholic acid in an amount of approximately 1.5% to 65% by weight, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) Approximately 15% to 85% by weight of gum arabic, Includes.

[0158] In another aspect of this disclosure, the composition of the disclosed method is a) Approximately 0.5% to 20% by weight of semaglutide, b) Sunflower oil in an amount of approximately 0.5% to 40% by weight, c) Approximately 1.5% to 65% by weight of bile salt extract, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) One or more carriers in an amount of approximately 15% to 65% by weight, Includes.

[0159] In one embodiment of this aspect, the composition of the disclosed method is: a) Approximately 1% to 3% by weight of semaglutide, b) Sunflower oil in an amount of approximately 1% to 25% by weight, c) Approximately 35% to 65% by weight of bile salt extract (where the bile salt is an extract containing approximately 45% to 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 35% to 65% by weight of sodium bicarbonate, e) One or more carriers in an amount of approximately 15% to 65% by weight, Includes.

[0160] In a further embodiment of this aspect, the composition of the disclosed method is: a) Approximately 1% to 3% by weight of semaglutide, b) High-oleic sunflower oil in an amount of approximately 1% to 25% by weight, c) Approximately 35% to 65% by weight of bile salt extract, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) A carrier comprising approximately 15% to 65% by weight of gum arabic, tapioca starch, tapioca flour, silicon dioxide, mannitol, colloidal silicon dioxide, and mixtures thereof, Includes.

[0161] In another embodiment of this aspect, the composition of the disclosed method is: a) Approximately 1% to 3% by weight of semaglutide, b) High-oleic sunflower oil in an amount of approximately 1% to 25% by weight, c) Approximately 35% to 65% by weight of bile salt extract (where the bile salt is an extract containing approximately 45% to 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 35% to 65% by weight of sodium bicarbonate, e) A carrier comprising approximately 15% to 65% by weight of gum arabic, tapioca starch, tapioca flour, silicon dioxide, mannitol, colloidal silicon dioxide, and mixtures thereof, Includes.

[0162] In another aspect of this disclosure, the composition of the disclosed method is a) Approximately 1% to 20% by weight of semaglutide, b) High-oleic sunflower oil in an amount of approximately 0.5% to 40% by weight, c) Approximately 1.5% to 15% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) One or more carriers in an amount of approximately 15% to 65% by weight, Includes.

[0163] In one embodiment of this aspect, the composition of the disclosed method is: a) Approximately 1% to 20% by weight of semaglutide, b) High-oleic sunflower oil in an amount of approximately 0.5% to 40% by weight, c) Approximately 1.5% to 15% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) One or more carriers in an amount of approximately 15% to 65% by weight, Includes.

[0164] In a further embodiment of this aspect, the composition of the disclosed method is: a) Approximately 1% to 20% by weight of semaglutide, b) High-oleic sunflower oil in an amount of approximately 0.5% to 40% by weight, c) Approximately 1.5% to 15% by weight of deoxycholic acid, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) A carrier comprising approximately 15% to 65% by weight of gum arabic, tapioca starch, tapioca flour, silicon dioxide, mannitol, colloidal silicon dioxide, and mixtures thereof, Includes.

[0165] In a further aspect of this disclosure, the composition of the disclosed method is: a) Approximately 0.1 mg to approximately 50 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) One or more edible oils in an amount of approximately 0.1 mg to approximately 100 mg, c) Approximately 5 mg to approximately 250 mg of bile salt extract, d) Approximately 20 mg to approximately 250 mg of sodium bicarbonate, e) One or more carriers in an amount of approximately 50 mg to approximately 400 mg, Includes.

[0166] In one embodiment of this aspect of the present disclosure, the composition of the disclosed method is a) Approximately 0.1 mg to approximately 50 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.1 mg to approximately 100 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 100 mg to approximately 250 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 20 mg to approximately 250 mg of sodium bicarbonate, e) One or more carriers in an amount of approximately 50 mg to approximately 350 mg, Includes.

[0167] In one iteration of this embodiment of this aspect of the present disclosure, the composition of the disclosed method is: a) Approximately 0.1 mg to approximately 50 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.1 mg to approximately 100 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 100 mg to approximately 250 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 20 mg to approximately 250 mg of sodium bicarbonate, e) Approximately 50 mg to approximately 350 mg of one or more carriers selected from gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0168] In another repeat of this embodiment of this aspect of the present disclosure, the composition of the disclosed method is: a) Approximately 0.1 mg to approximately 50 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.1 mg to 100 mg of olive oil, c) Approximately 100 mg to approximately 250 mg of deoxycholic acid, d) Approximately 20 mg to approximately 250 mg of sodium bicarbonate, e) Approximately 50 mg to approximately 350 mg of one or more carriers, including N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC), gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0169] In this non-limiting example of this iteration of this embodiment of this aspect of the present disclosure, the composition of the disclosed method is: a) Approximately 1 mg to 10 mg of dulaglutide, b) Approximately 1 mg to 50 mg of olive oil, c) Approximately 10 mg to 40 mg of deoxycholic acid, d) Approximately 50 mg to 100 mg of sodium bicarbonate, e) Approximately 50 mg to 350 mg of gum arabic, Includes.

[0170] In another non-limiting example of this iteration of this embodiment of this aspect of the present disclosure, the composition of the disclosed method is: a) Approximately 1 mg to 10 mg of exenatide, b) Approximately 1 mg to 50 mg of olive oil, c) Approximately 10 mg to 40 mg of deoxycholic acid, d) Approximately 50 mg to 100 mg of sodium bicarbonate, e) Approximately 50 mg to 350 mg of gum arabic, Includes.

[0171] In a further non-limiting example of this iteration of this embodiment of this aspect of the present disclosure, the composition of the disclosed method is: a) Approximately 1 mg to 10 mg of liraglutide, b) Approximately 1 mg to 50 mg of olive oil, c) Approximately 10 mg to 40 mg of deoxycholic acid, d) Approximately 50 mg to 100 mg of sodium bicarbonate, e) Approximately 50 mg to 350 mg of gum arabic, Includes.

[0172] In this iterative and further non-limiting example of this embodiment of this aspect of the present disclosure, the composition of the disclosed method is: a) Approximately 1 mg to 10 mg of lixisenatide, b) Approximately 1 mg to 50 mg of olive oil, c) Approximately 10 mg to 40 mg of deoxycholic acid, d) Approximately 50 mg to 100 mg of sodium bicarbonate, e) Approximately 50 mg to 350 mg of gum arabic, Includes.

[0173] In this iteration of this embodiment of this aspect of the present disclosure, and in yet another non-limiting example, the composition of the disclosed method is: a) Approximately 1 mg to 10 mg of semaglutide, b) Approximately 1 mg to 50 mg of olive oil, c) Approximately 10 mg to 40 mg of deoxycholic acid, d) Approximately 50 mg to 100 mg of sodium bicarbonate, e) Approximately 50 mg to 350 mg of gum arabic, Includes.

[0174] In another or further non-limiting example of this iteration of this embodiment of this aspect of the present disclosure, the composition of the disclosed method is: a) Approximately 1 mg to 10 mg of tilzepatide, b) Approximately 1 mg to 50 mg of olive oil, c) Approximately 10 mg to 40 mg of deoxycholic acid, d) Approximately 50 mg to 100 mg of sodium bicarbonate, e) Approximately 50 mg to 350 mg of gum arabic, Includes.

[0175] In another repeat of this embodiment of this aspect of the present disclosure, the composition of the disclosed method is: a) Approximately 5 mg to 10 mg of semaglutide, b) Approximately 5 mg to 30 mg of olive oil, c) Approximately 10 mg to 40 mg of deoxycholic acid, d) Approximately 25 mg to 50 mg of sodium bicarbonate, e) Approximately 50 mg to 350 mg of gum arabic, Includes.

[0176] In one further iteration of this embodiment of this aspect of the present disclosure, the composition of the disclosed method is: a) Approximately 5 mg to 10 mg of liraglutide, b) Approximately 5 mg to 30 mg of sunflower oil, c) Approximately 10 mg to 40 mg of deoxycholic acid, d) Approximately 25 mg to 50 mg of sodium bicarbonate, e) Approximately 50 mg to 350 mg of gum arabic, Includes.

[0177] In a non-limiting embodiment of this disclosure, a composition that can be administered to a subject requiring treatment is: a) Approximately 0.2 mg to approximately 25 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 50 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 5 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 460 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 480 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0178] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 25 mg of semaglutide, b) Approximately 0.4 mg to 50 mg of olive oil, c) Approximately 0.05 mg to approximately 5 mg of deoxycholic acid, d) Approximately 1 mg to approximately 460 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 480 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0179] In a further, non-limiting embodiment of this disclosure, a composition that can be administered to a subject requiring treatment is: a) Approximately 0.2 mg to approximately 20 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 40 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 4 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 350 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 360 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0180] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 20 mg of semaglutide, b) Approximately 0.4 mg to 40 mg of olive oil, c) Approximately 0.05 mg to approximately 4 mg of deoxycholic acid, d) Approximately 1 mg to approximately 350 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 360 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0181] In further non-limiting embodiments of this disclosure, compositions that can be administered to a subject requiring treatment are: a) Approximately 0.2 mg to approximately 20 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 40 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 4 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 350 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 360 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0182] In another non-limiting aspect of this disclosure, a composition that can be administered to a subject requiring treatment is: a) Approximately 0.2 mg to approximately 12 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 24 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 3 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 230 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 240 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0183] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to approximately 12 mg of semaglutide, b) Approximately 0.4 mg to 24 mg of olive oil, c) Approximately 0.05 mg to approximately 3 mg of deoxycholic acid, d) Approximately 1 mg to approximately 230 mg of sodium bicarbonate, e) Approximately 3 mg to 240 mg of mannitol, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or a mixture thereof, Includes.

[0184] In a further, non-limiting embodiment of this disclosure, a composition that can be administered to a subject requiring treatment is: a) Approximately 0.2 mg to approximately 6 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 12 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 1.5 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 120 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 125 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0185] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 6 mg of semaglutide, b) Approximately 0.4 mg to 12 mg of olive oil, c) Approximately 0.05 mg to approximately 1.5 mg of deoxycholic acid, d) Approximately 1 mg to approximately 120 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 125 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0186] In another non-limiting aspect of this disclosure, a composition that can be administered to a subject requiring treatment is: a) Approximately 0.2 mg to 4 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 8 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.75 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 70 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 75 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0187] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 4 mg of semaglutide, b) Approximately 0.4 mg to 8 mg of olive oil, c) Approximately 0.05 mg to approximately 0.75 mg of deoxycholic acid, d) Approximately 1 mg to approximately 70 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 75 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0188] In yet another non-limiting embodiment of this disclosure, a composition that can be administered to a subject requiring treatment is: a) Approximately 0.2 mg to approximately 2.5 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to 5 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.5 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 50 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 50 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0189] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 2.5 mg of semaglutide, b) Approximately 0.4 mg to 5 mg of olive oil, c) Approximately 0.05 mg to approximately 0.5 mg of deoxycholic acid, d) Approximately 1 mg to approximately 50 mg of sodium bicarbonate, e) Approximately 3 mg to 50 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0190] In yet another non-limiting embodiment of this disclosure, a composition that can be administered to a subject requiring treatment is: a) Approximately 0.2 mg to approximately 2 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to 4 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.4 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 40 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 40 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0191] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 2 mg of semaglutide, b) Approximately 0.4 mg to 4 mg of olive oil, c) Approximately 0.05 mg to approximately 0.4 mg of deoxycholic acid, d) Approximately 1 mg to approximately 40 mg of sodium bicarbonate, e) Approximately 3 mg to 40 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0192] In another non-limiting aspect of this disclosure, a composition that can be administered to a subject requiring treatment is: a) Approximately 0.2 mg to approximately 1.5 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to 3 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.3 mg of bile salt extract (where the bile salt is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to approximately 25 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 25 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0193] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 1.5 mg of semaglutide, b) Approximately 0.4 mg to 3 mg of olive oil, c) Approximately 0.05 mg to approximately 0.3 mg of deoxycholic acid, d) Approximately 1 mg to approximately 25 mg of sodium bicarbonate, e) Approximately 3 mg to 25 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0194] In yet another non-limiting aspect of this disclosure, a composition that can be administered to a subject requiring treatment is: a) Approximately 0.2 mg to approximately 0.75 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 1.5 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 0.15 mg of bile salt extract (where the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, glycocholic acid, and mixtures thereof), d) Approximately 1 mg to 15 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 15 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or mixtures thereof, Includes.

[0195] In one iteration of this aspect of the present disclosure, the composition is a) Approximately 0.2 mg to 0.75 mg of semaglutide, b) Approximately 0.4 mg to 1.5 mg of olive oil, c) Approximately 0.05 mg to approximately 0.15 mg of deoxycholic acid, d) Approximately 1 mg to 15 mg of sodium bicarbonate, e) Approximately 3 mg to 15 mg of mannitol, colloidal silicon dioxide, or a mixture thereof, Includes.

[0196] General procedure for preparing the disclosed composition study 1 The following is an outline of the procedure for preparing the disclosed composition: a) Replace 29 Rybelsus® tablets, each containing 14 mg of semaglutide, with a fine powder. b) Combine the powder from (a) with high-oleic sunflower oil at 40°C to form a mixture. c) Add the excipient and mix until homogeneous. d) The homogeneous mixture from step (c) is dried at 50°C to form a dehydrated powder. e) Let the dehydrated powder cool, f) The dehydrated powder is combined with sodium bicarbonate and bovine bile extract to form a readily flowable powder final formulation. g) Fill the capsules with the final formulation.

[0197] Method for preparing a test composition for Study 1 Semaglutide tablets (29 tablets) (each containing 14 mg of semaglutide) are crushed in a mortar and pestle, and the resulting powder is then sieved using a stainless steel mesh. High-oleic sunflower oil is heated to 40°C, and the crushed semaglutide is added while efficiently mixing. Once the oil dispersion is homogeneous, gum arabic and Aeroperl 300 are added while mixing at a low speed to completely infuse the carrier into the dispersion. Due to efficient mixing, a homogeneous powder is obtained after about 10 minutes. The powder is transferred to a stainless steel tray and spread evenly, and placed in a preheated oven at 50°C for 2 hours. The tray is removed and allowed to cool for 10 minutes. The powder is then sieved again. The cooled powder is then combined with sodium bicarbonate and bovine bile extract in a biosafety cabinet at a low to medium speed for 3 to 5 minutes. Using the readily flowable product obtained, 465.86 mg of the final product is filled into size 00 capsules.

[0198] The resulting capsules were used in the human clinical trial described in Study 1 below. Each capsule contained the amount shown in Table 1.

[0199] [Table 10]

[0200] Human Clinical Study 1 This study was conducted in two parts. In the first part of the study, three volunteers in the control group were administered Rybelsus® tablets containing 7 mg of semaglutide, while four volunteers in the study group were given four capsules containing the ingredients listed in Table 1, each containing an effective dose of 7 mg of semaglutide.

[0201] Part 2 of this study included a crossover phase, in which subjects who had taken Rybelsus® tablets in the first study were given four capsules of the research composition from Table 1 to reach an effective dose of 7 mg of semaglutide, while subjects who had taken the research composition were given Rybelsus® tablets containing 7 mg of semaglutide.

[0202] Semaglutide level Blood samples were tested 18 times over the first 10 hours of the study by a third-party laboratory using a validated bioassay, and again 24 hours after dose administration. Each subject fasted for 12 hours prior to the study. Subjects were supervised and monitored within the research facility for the entire 10 hours following drug administration, after which they were allowed to leave and resume normal activities, and returned to the research facility the following day for the 24-hour evaluation.

[0203] The first blood sample after baseline was taken 20 minutes after oral administration, at which point the study group's blood semaglutide levels were approximately 125% higher than the control group's. At every of the 19 blood sampling times, the study group's blood semaglutide levels were higher than the control group's. Furthermore, the study group reached its peak more quickly at 120 minutes (compared to 160 minutes for the control group) and had blood semaglutide levels 16% higher than the control group. The blood semaglutide levels achieved in the control group were proportional to those achieved in similar single-dose crossover Rybelsus® development-informing studies, further suggesting that the increase in blood semaglutide levels demonstrated by the study group formulation differed significantly from that of the commercially available product. Final blood sampling was performed 24 hours after the start of the study. Subjects were permitted to return to their normal schedules before the final 24-hour blood sampling.

[0204] Table 2 shows the semaglutide blood levels of subjects in Phase 1 of the study.

[0205] [Table 11]

[0206] Table 3 below shows the semaglutide blood concentrations from the Phase 1 study and the crossover study group in combination (subjects who took Rybelsus® took the compositions from Table 1, and vice versa). Figure 3 shows the combination data from Tables 2 and 3.

[0207] [Table 12]

[0208] Figure 1 plots the semaglutide levels (nmol / L) of control subjects (●) given Rybelsus® 7 mg tablets versus study subjects (○) given the compositions in Table 1 four times. As can be seen from Table 2 and Figure 1, the semaglutide levels of the study subjects were consistently 15% higher than those of the control subjects.

[0209] Table I summarizes the data plotted in Figure 1 and the observed improvements in the compositions (test compositions) listed in Table 1.

[0210] [Table 13]

[0211] Blood glucose levels In the control group, blood glucose levels decreased by 1.3% to 6.7% compared to baseline during the first 100 minutes of the study. In the study group, blood glucose levels decreased by 2.9% to 14.6% compared to baseline during the same first 100 minutes. At all time points except 20 and 240 minutes, the study's blood glucose levels decreased more than those demonstrated by the control group. Even 24 hours after dose administration, blood glucose levels decreased by 6.3% compared to baseline in the study group, compared to only 0.67% in the control group, demonstrating nearly a tenfold improvement in the study group.

[0212] These data show that after subjects were allowed to eat a standardized meal at 240 minutes and a standardized snack at 360 minutes, blood glucose levels surged by up to 22.7% in the control group. In the study group, despite consuming similar meal and snack options at the same time, blood glucose levels rose by only 5.3%.

[0213] Table 4 shows the blood glucose levels of the subjects during the first stage of the study.

[0214] [Table 14]

[0215] Table 5 below shows the glucose blood concentration data from the Phase 1 study and the crossover study group in combination (subjects who took Rybelsus® took the compositions from Table 1, and vice versa). The combination data from Tables 4 and 5 are shown in Figure 4.

[0216] [Table 15]

[0217] Figure 2 plots glucose levels (mmol / L) of control subjects (●) given Rybelsus® 7 mg tablets versus study subjects (○) given the compositions in Table 1 four times. As can be seen from Table 3 and Figure 2, the blood glucose levels of the study subjects were suppressed after a meal at 240 minutes and after a snack at 360 minutes.

[0218] Semaglutide Level Study 1 Crossover Blood samples were tested 18 times over the first 10 hours of the study by a third-party laboratory using a validated bioassay, and again 24 hours after dose administration. Each subject fasted for 12 hours prior to the study. Subjects were supervised and monitored within the research facility for the entire 10 hours after administration, after which they were allowed to leave and resume normal activities, and to return to the research facility the following day for the 24-hour evaluation point. The first blood sample after baseline was taken 20 minutes after oral administration, at which point blood semaglutide levels in the study group were approximately 125% higher than in the control group. At all 19 blood sampling points, blood semaglutide levels in the study group were higher than in the control group. Furthermore, the study group reached its peak more quickly at 120 minutes (compared to 160 minutes in the control group) and had blood semaglutide levels 16% higher than the control group. The blood semaglutide levels achieved in the control group were proportional to those achieved in a similar single-dose crossover Rybelsus® development information study, further suggesting that the increase in blood semaglutide levels demonstrated by the study group formulation differed significantly from that of the commercially available product. Final blood draws were taken 24 hours after the start of the study. Subjects were permitted to return to their normal schedules before the final 24-hour blood draw.

[0219] Figure 3 plots the semaglutide levels (nmol / L) of subjects administered Rybelsus® 7 mg tablets (●) versus subjects in a combination study (○) who were given four doses of the compositions from Table 1 for an effective dose of 7 mg of semaglutide (Phase 1 and crossover study). As can be seen from Figure 3, the peak blood semaglutide levels were 43% higher in volunteers who took the compositions from Table 1 compared to the Rybelsus® control, with values ​​of 8.80 nmol / mL compared to 6.15 nmol / mL (p=0.0123). Furthermore, over the 10-hour period during which subjects were studied in the clinic, the geometric least squares mean AUC0-10 (area under the curve from 0 to 10 hours) from the compositions in Table 1 was 47% higher than that of Rybelsus® administered alone, with values ​​of 71.93 h·nmol / mL compared to 49.00 h·nm / mL (p=0.0114).

[0220] Figure 4 plots glucose levels (mmol / L) for subjects administered Rybelsus® 7 mg tablets (●) versus subjects in a combination study (○) who were given four doses of the compositions in Table 1 for an effective dose of 7 mg semaglutide (Phase 1 and crossover study). As can be seen from Figure 4, the control group (7 mg of Rybelsus®) demonstrated an inconsistent reduction in blood glucose that did not interfere with the postprandial surge in blood glucose. In volunteers who took the compositions from Table 1, blood glucose decreased to lower levels and was significantly more effective in consistently maintaining the reduction in blood glucose levels, even after eating a standardized meal at 240 minutes and a standardized snack at 360 minutes.

[0221] animal research 2 Rybelsus® is the only semaglutide-containing composition approved for oral administration in humans. While not limited by theory, the presence of the carrier sodium salcaproate (SNAC) is considered an important osmotic enhancer enabling oral delivery of semaglutide. This disclosure provides animal studies of the disclosed composition against Rybelsus®, serving as a prior art control: 1. Reformulated Rybelsus™ OTC formulations (Tables 9-11). 2. Reformulated Rybelsus® OTC products based on the disclosed compositions (Tables 12-14). 3. Disclosed formulations containing semaglutide (Tables 15-17). 4. Disclosed formulations containing liraglutide (Tables 18-20).

[0222] The following is an overview of the compositions tested in the four cohorts of Animal Study 2.

[0223] Rybelsus® is used as a control in the prior art, as shown in Tables 6 to 8. The control animals in the prior art are administered Rybelsus® tablets containing 14 mg of semaglutide. Each tablet has a mass of approximately 306 mg.

[0224] The composition of Cohort 1 tested below contains semaglutide obtained from crushed Rybelsus® tablets containing sodium salcaproate incorporated into the test composition. Cohort 1 further contains, as an auxiliary bile salt substance, bovine bile salts comprising a mixture of cholic acid, deoxycholic acid, taurocholic acid, and glycocholic acid in an amount of 45% to 55% by weight.

[0225] The composition of Cohort 2 tested below contains semaglutide obtained from crushed Rybelsus® tablets containing sodium salcaproate incorporated into the test composition. Cohort 2 further contains bovine bile salts as an auxiliary bile salt substance, comprising a mixture of cholic acid, deoxycholic acid, taurocholic acid, and glycocholic acid in an amount of 45% to 55% by weight. Cohort 2 has a semaglutide to olive oil ratio of 1:2.

[0226] The composition of Cohort 3 contains semaglutide in the disclosed composition.

[0227] The composition of Cohort 4 contains liraglutide in the disclosed composition.

[0228] Conventional control technology - RYBELSUS (trademark)

[0229] [Table 16]

[0230] Administer animals a sufficient amount of Rybelsus™ to achieve the indicated semaglutide dose per unit. Each Rybelsus tablet contains 14 mg of semaglutide.

[0231] Conventional control technology - RYBELSUS (trademark)

[0232] [Table 17]

[0233] Administer animals a sufficient amount of Rybelsus® to achieve the indicated semaglutide dose per unit. Each Rybelsus® tablet contains 14 mg of semaglutide.

[0234] Conventional control technology - RYBELSUS (trademark)

[0235] [Table 18]

[0236] Administer animals a sufficient amount of Rybelsus® to achieve the indicated semaglutide dose per unit. Each Rybelsus® tablet contains 14 mg of semaglutide.

[0237] Cohort 1: Re-formulated Rybelsus OTC preparations

[0238] [Table 19]

[0239] [Table 20]

[0240] [Table 21]

[0241] Cohort 2: Reformulated Rybelsus OTC formulations based on the disclosed compositions

[0242] [Table 22]

[0243] [Table 23]

[0244] [Table 24]

[0245] Cohort 3: Disclosed composition containing semaglutide

[0246] [Table 25]

[0247] [Table 26]

[0248] [Table 27]

[0249] Cohort 4: Disclosed composition containing liraglutide

[0250] [Table 28]

[0251] [Table 29]

[0252] [Table 30]

[0253] animal research 2 design The following is an overview of the design for animal experiment 2.

[0254] [Table 31]

[0255] Research Procedure Rearing and acclimatization In this study, 72 three-month-old male Zucker obese rats (ZDF fa / fa, CRL strain code 370) from Charles River Laboratories were used as test subjects. The Zucker obese rats were specially bred to carry a pair of recessive fat genes (fa / fa). The animals were acclimated to the new environment for at least three days prior to the experiment. The subjects were maintained in a 12-hour / 12-hour light / dark cycle. All experimental activities were performed during the animals' light cycles.

[0256] Feeding and watering Purina's LabDiet® 5008 was freely provided to all research subjects. Water was freely provided in glass bottles with stainless steel swivels. The control group was given water only during the study period.

[0257] Treatment group This study was conducted on 24 Zucker obese rats.

[0258] [Table 32]

[0259] Validation phase The validation phase spanned from day 0 to day 14 of the study. Throughout the entire study, animals were sustained by being given LabDiet 5008.

[0260] Blood glucose measurement Blood glucose levels were measured on days 6 and 12 of the study by puncturing the saphenous vein and measuring one drop of blood via an Accu-Chek glucose monitor.

[0261] Group assignment On day 14 of the study, the animals were randomly assigned to one of four treatment groups, balanced based on their body weight and blood glucose levels since day 12.

[0262] Treatment stage This study has three treatment phases. Treatment phase 1 spans from day 15 to day 42 of the study. A one-day washout period is provided between each treatment phase to facilitate the decision-making process regarding subsequent doses in subsequent treatment phases. Treatment phase 2 will be conducted from day 44 to day 71 of the study. Treatment phase 3 will be conducted from day 73 to day 101 of the study. The decision to perform treatment phase 3 will be based on a Go / NoGo decision after reviewing the data from treatment phases 1 and 2.

[0263] Administration of the test substance Animals were administered either the test substance, Rybelsus®, or the vehicle once daily for 28 consecutive days. The test substance and Rybelsus® were administered in the late afternoon, close to the animals' natural feeding time.

[0264] Blood collection and analysis On the first and last days of each treatment phase, blood (0.3 mL) was collected in a K2EDTA blood collection tube via saphenous vein puncture, and plasma was separated. Blood was collected 1 hour, 4 hours, 24 hours, and before administration on the first day of administration, and 1 hour, 4 hours, and 24 hours after administration on the last day of administration in each treatment cycle. Blood glucose was measured via an Accu-Chek glucose monitor at the time of the initial puncture. The samples were centrifuged (at 3200 RCF for 5 minutes at 4°C) to separate the plasma, and sent to an external bioanalysis laboratory for analysis. Blood glucose was measured on days 7, 14, and 28 of each treatment phase by puncturing the saphenous vein and measuring one drop of blood via an Accu-Chek glucose monitor.

[0265] The table below lists the changes in animal mass for cohorts 1 through 4 over an 84-day study period.

[0266] [Table 33]

[0267] The table below lists the changes in blood glucose levels (mmol / L) of animals in cohorts 1 through 4 over an 84-day study period.

[0268] [Table 34]

[0269] As demonstrated by the data in Tables 23 and 24, the compositions disclosed herein can deliver semaglutide and liraglutide to the plasma of test animals in the absence of N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC), thereby affecting not only body mass but also blood glucose levels. Notably, all of the compositions disclosed herein achieved better weight management than the Rybelsus® positive control group. On day 84, compared to the Rybelsus® positive control group, Cohort 1 showed a 5.97% improvement (p=0.0016), Cohort 2 showed a 6.43% improvement (p<0.0001), Cohort 3 showed a 5.67% improvement (p=0.0007), and Cohort 4 showed an 11.53% improvement (p<0.0001).

[0270] Other advantages that are obvious and unique to this disclosure will be apparent to those skilled in the art. Certain features and subcombinations are useful and can be adopted without reference to other features and subcombinations. This is assumed to be within the scope of the claims and is within the scope of the claims. Since many possible embodiments relating to this disclosure can be made without departing from the scope of this disclosure, all things shown herein or in the accompanying drawings should be understood to be illustrative and not restrictive.

Claims

1. a) One or more GLP-1 agonists in an amount of approximately 0.5% to approximately 20% by weight, b) One or more edible oils in an amount of approximately 0.5% to approximately 40% by weight, c) Approximately 1.5% to approximately 65% ​​by weight of bile salt extract, d) Approximately 35% to 65% by weight of sodium bicarbonate, e) One or more carriers in an amount of approximately 15% to approximately 85% by weight, A composition containing the following:

2. The composition according to claim 1, wherein the GLP-1 agonist is selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, and tylzepatide, or a mixture thereof.

3. The composition according to claim 1, wherein the GLP-1 agonist is liraglutide.

4. The composition according to claim 1, wherein the GLP-1 agonist is a semaglutide.

5. The composition according to claim 1, wherein the one or more edible oils are selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil, or mixtures thereof.

6. The composition according to claim 1, wherein the edible oil is olive oil.

7. The composition according to claim 1, wherein the bile salt extract comprises about 45% to about 55% by weight of a bile salt selected from the group consisting of cholic acid, deoxycholic acid, taurocholic acid, and glycocholic acid, or a mixture thereof.

8. The composition according to claim 1, wherein the bile salt is deoxycholic acid.

9. The composition according to claim 1, wherein the one or more carriers are selected from sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC), gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, and quillaja, or mixtures thereof.

10. The composition according to claim 1, wherein the carrier is selected from mannitol, colloidal silicon dioxide, or a mixture thereof.

11. a) Approximately 0.2 mg to approximately 25 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 50 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 5 mg of bile salt extract (wherein the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, and glycocholic acid, or a mixture thereof), d) Approximately 1 mg to approximately 460 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 480 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, and quillaja, or mixtures thereof, A composition containing the following:

12. The composition according to claim 11, wherein the GLP-1 agonist is selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, and tilzepatide, or a mixture thereof.

13. The composition according to claim 11, wherein the GLP-1 agonist is liraglutide.

14. The composition according to claim 11, wherein the GLP-1 agonist is a semaglutide.

15. The composition according to claim 11, wherein the one or more edible oils are selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil, or mixtures thereof.

16. The composition according to claim 11, wherein the edible oil is olive oil.

17. The composition according to claim 11, wherein the bile salt extract comprises about 45% to about 55% by weight of a bile salt selected from the group consisting of cholic acid, deoxycholic acid, taurocholic acid, and glycocholic acid, or a mixture thereof.

18. The composition according to claim 11, wherein the bile salt is deoxycholic acid.

19. The composition according to claim 11, wherein the one or more carriers are selected from sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC), gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, and quillaja, or mixtures thereof.

20. The composition according to claim 11, wherein the carrier is selected from mannitol, colloidal silicon dioxide, or a mixture thereof.

21. A method for treating type 2 diabetes in a subject, wherein the subject in question is required to a) Approximately 0.2 mg to approximately 25 mg of one or more GLP-1 agonists selected from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tylzepatide, or mixtures thereof, b) Approximately 0.4 mg to approximately 50 mg of one or more edible oils selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil, or mixtures thereof, c) Approximately 0.05 mg to approximately 5 mg of bile salt extract (wherein the bile salt extract is an extract containing approximately 45% to approximately 55% by weight of cholic acid, deoxycholic acid, taurocholic acid, and glycocholic acid, or a mixture thereof), d) Approximately 1 mg to approximately 460 mg of sodium bicarbonate, e) Approximately 3 mg to approximately 480 mg of one or more carriers selected from N-[8-(2-hydroxybenzoyl)amino]caprylate sodium (SNAC) gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, and quillaja, or mixtures thereof, A method comprising administering a composition containing [a certain substance].

22. The method according to claim 21, wherein the GLP-1 agonist is selected from dulaglutide, exenatide, lilaglutide, lixisenatide, semaglutide, and tylzepatide, or a mixture thereof.

23. The method according to claim 21, wherein the GLP-1 agonist is liraglutide.

24. The method according to claim 21, wherein the GLP-1 agonist is semaglutide.

25. The method according to claim 21, wherein the one or more edible oils are selected from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil, or mixtures thereof.

26. The method according to claim 21, wherein the edible oil is olive oil.

27. The method according to claim 21, wherein the bile salt extract comprises about 45% to about 55% by weight of a bile salt selected from the group consisting of cholic acid, deoxycholic acid, taurocholic acid, and glycocholic acid, or a mixture thereof.

28. The method according to claim 21, wherein the bile salt is deoxycholic acid.

29. The method according to claim 21, wherein the one or more carriers are selected from sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC), gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, and quillaja, or mixtures thereof.

30. The method according to claim 21, wherein the carrier is selected from mannitol, colloidal silicon dioxide, or a mixture thereof.

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