JP-2026514413-A - therapeutic liquid composition

Abstract

A therapeutic liquid composition useful for treating various conditions, containing a bulk sweetener derived from grain or fruit sources.

Inventors

• コル・グレゴリー・イー
• ゼショタースキ・ジョナサン
• ホジャ・ゲルシ

Assignees

• ケンビュー・ブランズ・エルエルシー

Dates

Publication Date

20260511

Application Date

20240327

Priority Date

20240325

Claims (20)

1. A liquid composition comprising at least one therapeutic ingredient and at least one natural bulk sweetener, wherein the fructose content of the total amount of natural bulk sweeteners in the composition is less than 75 percent.
2. The liquid composition according to claim 1, wherein the natural bulk sweetener is selected from glycerin, allulose syrup, rice syrup, brown rice syrup, tapioca syrup, apple syrup, carob syrup, and combinations thereof.
3. The liquid composition according to claim 1, wherein the liquid composition has a total fructose level of less than 0.7 g/mL.
4. The liquid composition according to claim 1, wherein the therapeutic component is a pharmaceutically active ingredient.
5. The liquid composition according to claim 1, wherein the therapeutic component is a homeopathic active ingredient.
6. The liquid composition according to claim 1, wherein the therapeutic component is a nutritional supplement.
7. The liquid composition according to claim 1, wherein the liquid composition is in the form of a suspension.
8. The liquid composition according to claim 1, wherein the liquid composition is in the form of a solution.
9. The liquid composition according to claim 4, wherein the pharmaceutically active ingredient is selected from acetaminophen, diphenhydramine, dextromethorphan, guaifenesin, ibuprofen, cetirizine, loperamide, and phenylephrine.
10. The liquid composition according to claim 1, wherein the therapeutic component is an antihistamine.
11. The liquid composition according to claim 1, further comprising a sensory stimulant.
12. The liquid composition according to claim 1, further comprising a second natural bulk sweetener.
13. The liquid composition according to claim 12, wherein the natural bulk sweetener is glycerin, and the second natural bulk sweetener is tapioca syrup.
14. The liquid composition according to claim 12, wherein the natural bulk sweetener is glycerin, and the second natural bulk sweetener is brown rice syrup.
15. The liquid composition according to claim 12, wherein the natural bulk sweetener is glycerin, and the second natural bulk sweetener is allulose syrup.
16. The liquid composition according to claim 12, wherein the natural bulk sweetener is glycerin, and the second natural bulk sweetener is a combination of apple syrup and carob syrup.
17. The liquid composition according to claim 16, wherein the ratio of the aforementioned combination of apple syrup and carob syrup to glycerin is approximately 3.30:1.
18. The liquid composition according to claim 1, wherein the liquid composition substantially does not contain agave syrup.
19. The liquid composition according to claim 1, wherein the liquid composition substantially does not contain any component having a fructose content of more than 15 percent.
20. A method for alleviating symptoms selected from pain, fever, cough, nasal congestion, diarrhea, allergic rhinitis, and pharyngitis in a subject, comprising administering the composition described in claim 1.

Description

(Cross-reference to related applications) This application claims the interests of U.S. Provisional Patent Application No. 63/493395, filed on 31 March 2023, the full disclosure of which is incorporated herein by reference for all purposes. (Field of invention) The present invention relates to liquid compositions, more specifically to therapeutic liquid compositions. The present invention also relates to a process for producing liquid compositions and a method for alleviating symptoms in human subjects upon administration of the liquid compositions. Liquid compositions, which may contain one or more therapeutic agents, are particularly useful for treating allergic symptoms, pain symptoms, and cough and cold symptoms (including, but not limited to, pain, cough, nasal congestion, rhinitis, and pharyngitis). Orally administered pharmaceuticals or medicines are given to patients in many forms, including solid forms such as capsules, caplets, gel caps, or tablets, and liquid forms such as solutions, syrups, elixirs, emulsions, or suspensions. Many other patients, including children, elderly patients, and patients with physical disabilities or incapacity, have difficulty swallowing solid forms, such as whole tablets and even capsules. Therefore, when the dose to be administered cannot be made into very small tablets or capsules, it is desirable to provide the medicine in either a chewable solid or liquid form. For many patients, including pediatric patients and elderly patients, liquid oral dosage forms are preferred over chewable dosage forms because they can be easily swallowed without chewing. A suspension is a two-phase system having solid, substantially water-insoluble active drug particles dispersed throughout a liquid medium. A suspension does not include emulsions, meaning it describes a liquid suspended in a liquid carrier or syrup formulation containing only substantially completely dissolved pharmaceutically active agents. As used herein, “particles” may be crystals, granules, aggregates, or any undissolved solid material. The particles of the present invention preferably have a median particle size (d50%) of about 2 to about 150 microns, more preferably about 10 to about 100 microns. The challenges of keeping substantially water-insoluble active agents suspended, ensuring the stability of substantially water-insoluble active agents, and maintaining dose uniformity over long periods have been addressed previously. See, for example, U.S. Patents 5,409,907 and 5,374,659. In pharmaceutical suspensions, typically, at least one active agent exists in the form of substantially undissolved solid particles, i.e., substantially water-insoluble active agents. However, in any such system, a portion of such active agents may be in a soluble state. When formulating such systems, it is advantageous to minimize the amount of drug present in a soluble state. Minimizing the amount of active agent in the solution is advantageous for both the taste of the product and its chemical and/or physical stability. Liquid dosage forms may exist in the form of a solution, in which case the therapeutic component(s) are substantially dissolved in the liquid blend. If the dose of the therapeutic component is less than 50 g/5 mL, the therapeutic component may be dissolved in the form of a solution. A common problem associated with liquid dosage forms is often the unpleasant taste of the active ingredient that develops during the time the liquid dosage form is in the mouth before swallowing. While suspensions typically offer better taste masking than other liquid forms, those skilled in the art recognize the considerable technical difficulties in producing stable, sensory-tolerant suspensions. Furthermore, when over-the-counter ("OTC") oral solutions or oral suspension products are formulated or reformulated to use reduced or naturally derived ingredients, solutions to such challenges must be re-evaluated. The terms "clean" or "clean medicine" represent a newly emerging trend in OTC medicines. While there is no generally accepted definition of "clean," consumers generally understand it to mean one of the following: free from artificial flavors, dyes, preservatives, or sweeteners; derived from natural sources; and/or free from artificial, chemical, or unnecessary ingredients. Formulating a “clean” oral solution or suspension product may involve limiting or eliminating certain components conventionally used in pharmaceutical suspensions to overcome the challenges of keeping substantially water-insoluble active agents suspended, ensuring the stability of substantially water-insoluble active agents, and maintaining dose uniformity over long periods. New components that meet the definition of “clean” must be identified and evaluated to ensure that such newly formulated pharmaceutical solutions or suspension products meet the safety and efficacy standards required for all over-the-counter (OTC) medicines. Dyes have traditionally been added t