Biopolymer formulations for drug delivery

Abstract

Described herein are formulations for drug delivery of active molecules comprising a homogeneous biopolymer suspension. In embodiments, the biopolymer is selected from the group consisting of chitin, chitosan, cellulose, hemicellulose, lignin, amylose, actin, fibrin, collagen, silk, fibroin, keratin, wool, alginic acid, and mixtures thereof. In embodiments, the biopolymer has been machined with the API under high shear conditions and / or high mechanical energy. The formulations may have particular uses in drug delivery systems, including carrying and releasing beneficial compounds or molecules, such as pharmaceuticals, pharmaceutical substances, cosmetics, and the like.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to provisional patent application US 63 / 356,703 (filed on June 29, 2022), the contents of which are incorporated herein in their entirety. Technical Field

[0003] The present invention relates to the field of therapy and cosmetology, and more particularly to novel formulations for drug delivery of active molecules comprising a homogeneous biopolymer suspension. Background Art

[0004] Drug delivery systems (DDS) are used to control the release rate and location of a drug in the body. In this regard, there is a constant need for new methods, formulations, manufacturing techniques, storage systems, and technologies that can better deliver drug compounds to their target sites to achieve the desired therapeutic effect.

[0005] Natural polymers or biopolymers have been widely used as carriers for drug delivery because they offer many advantages over conventional polymers. Biopolymers are non-toxic and biocompatible, making them a versatile carrier. They offer economic advantages by being relatively cheap. Biopolymers also offer environmental advantages by being biodegradable. However, the most abundant biopolymers such as cellulose and chitin are insoluble, which limits and complicates their use. Advantageously, the applicant describes in WO 2022 / 137184 a novel homogeneous biopolymer suspension that is homogeneous and stable and can have many applications in DDS.

[0006] Therefore, there remains a need for novel approaches to include biopolymers in DDS.

[0007] Furthermore, there remains a need for drug delivery compositions comprising natural, biocompatible, biodegradable and non-toxic components (eg, cellulose, chitin, etc.).

[0008] The present invention addresses these needs and other needs, which will become apparent from a review of the following disclosure and description of the features of the invention. Summary of the invention

[0009] According to one aspect, the present invention relates to a composition for delivering an active pharmaceutical ingredient (API), comprising: a biopolymer and at least one API.

[0010] According to another aspect, the present invention relates to a method for delivering an active pharmaceutical ingredient (API) to a subject in need thereof, comprising: (i) providing a composition for delivery as defined herein; and (ii) administering said composition to a subject.

[0011] According to another aspect, the present invention relates to a method for local delivery of an active pharmaceutical ingredient (API) to a subject in need thereof, comprising: (i) providing a composition for delivery as defined herein, said composition comprising a biopolymer and at least one API; and (ii) administering said composition to the body of said subject.

[0012] According to another aspect, the present invention relates to a method for oral delivery of an active pharmaceutical ingredient (API) to a subject in need thereof, comprising: (i) providing a mixture comprising the API mixed in a biopolymer composition; (ii) drying the mixture to obtain a dry product; and (iii) orally administering the dry product to the subject.

[0013] According to another aspect, the present invention relates to a method for manufacturing a composition for delivery as defined herein, said method comprising mechanically processing an API together with a biopolymer under high shear conditions and / or high mechanical energy to obtain a stable homogeneous aqueous composition.

[0014] Other aspects, advantages and features of the present invention will become more apparent upon reading the following non-limiting description of preferred embodiments, which are exemplary and should not be construed as limiting the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order that the invention may be readily understood, embodiments of the invention are shown by way of example in the accompanying drawings.

[0016] Figure 1 is a line graph showing the release time of acetaminophen from chitosan according to Example 1.

[0017] Figure 2 is a line graph showing the release time of acetaminophen from chitosan according to Example 2.

[0018] Figure 3 is a line graph showing the release time of acetylsalicylic acid from chitosan according to Example 3.

[0019] Further details of the present invention and its advantages will become apparent from the detailed description included below. DETAILED DESCRIPTION

[0020] In the following description of the embodiments, examples in which the present invention can be practiced are described with reference to the accompanying drawings. It should be understood that other embodiments may be formed without departing from the scope of the disclosed invention. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention belongs.

[0021] General Overview

[0022] In PCT publication WO 2022 / 137184, entitled “HOMOGENEOUSBIOPOLYMER SUSPENSIONS, PROCESSES FOR MAKING SAME AND USES THEREOF” (the contents of which are incorporated herein by reference in their entirety), applicants describe the preparation of stable homogeneous suspensions of insoluble and / or semi-soluble biopolymers.

[0023] The inventors have shown that the biopolymer suspensions according to the present invention have the ability to retain hydrophilic and hydrophobic molecules, making these suspensions useful as drug delivery vehicles for transporting and releasing beneficial molecules (e.g., active pharmaceutical ingredients (API) and / or other molecules) in drug delivery systems (DDS). The biopolymer suspensions of the present invention can be particularly useful when considering the minimum components required in the suspension and thereby reducing the possibility of undesirable interactions between the carrier (i.e., suspension components) and the API. The present invention includes general compositions and specific compositions described in WO 2022 / 137184, but is not limited thereto.

[0024] Therefore, the present invention generally relates to the use of homogeneous biopolymer suspensions for drug delivery. As used herein, the term "drug delivery" generally refers to carrying and releasing beneficial compounds or molecules, such as drugs, pharmaceutical substances, cosmetics, etc. In this article, the terms "composition for drug delivery" and "drug delivery composition" are used interchangeably.

[0025] Biopolymers

[0026] Compositions for drug delivery according to the present invention require biopolymers minimally. As used herein, the term "biopolymer" refers to a natural polymer produced by the cells of a living organism. Biopolymers are composed of monomeric units that are covalently bonded to form larger molecules. The present invention includes polypeptides, polysaccharides and polynucleotide biopolymers. Other examples of biopolymers include natural rubber (polymers of isoprene), suberin and lignin (composite polyphenol polymers), cutin and horn carbon (cutan) (composite polymers of long-chain fatty acids) and melanin. In embodiments, the biopolymers used as starting materials and obtained in a suspension mode are substantially pure, i.e., they are only composed of purified natural polymers.

[0027] Preferably, the biopolymer used in the drug delivery composition is substantially free of chemical residues, and any such chemical residues are absent or present in undetectable amounts or trace amounts. As used herein, "substantially free of chemical residues" means such as acids, bases, reactive chemicals, organic and / or inorganic salts, surfactants, dispersants (e.g., Tween 80 TM ), silanizing agents, acrylamide, etc. are completely absent or only present in undetectable or trace amounts in the final composition or final suspension. In embodiments, the biopolymer may constitute at least 98 wt % or at least 99 wt % or at least 99.9 wt % or at least 99.99 wt % of the organic compounds in the biopolymer composition or suspension, i.e., the biopolymer composition or suspension may contain less than 2 wt % or less than 1 wt %, less than 0.1 wt % or less than 0.01 wt % or less than 0.001 wt % of organic components other than the biopolymer or degradation products.

[0028] In embodiments, the biopolymer comprises or consists of biopolymer molecules that have been mechanically processed into a stable homogeneous aqueous suspension (eg, a suspension of insoluble and / or semi-soluble biopolymer particles stably dispersed in a polar solvent).

[0029] According to the present invention, biopolymers can be insoluble in water or semi-soluble in water. As used herein, the term "insoluble biopolymer" refers to a biopolymer that is "insoluble" in a polar solvent (particularly water), and the term includes equivalent terms such as "water-insoluble", "water-insoluble", "water-insoluble" or "insoluble". Insolubility can usually be observed by separation, i.e., there are two separated phases in an aqueous mixture, such as biopolymers depositing / precipitating at the bottom of an aqueous mixture or floating on the top of an aqueous mixture. According to the present invention, examples of insoluble biopolymers include chitin, chitosan, cellulose, hemicellulose, lignin, amylose, actin, fibrin, collagen, silk, silk protein, keratin, wool, alginic acid and mixtures thereof, but are not limited thereto. As used herein, the term "semi-soluble (semi-soluble) biopolymer" refers to a biopolymer that can be dissolved in a polar solvent (e.g., water) only under certain conditions (e.g., molecular weight, heat, added chemicals (e.g., acid, alcohol, surfactant, etc.)). According to the present invention, examples of semi-soluble biopolymers include gelatin, pectin, starch, pullulan, agarose, hyaluronic acid, RNA, DNA, xanthan gum, latex, polymannan, suberin, keratin, horny carbon and mixtures thereof, but are not limited thereto.

[0030] In an embodiment, the insoluble biopolymer is selected from the group consisting of chitin, chitosan, cellulose, hemicellulose, lignin, amylose, actin, fibrin, collagen, silk, silk protein, keratin, wool, and mixtures thereof. In an embodiment, the semi-soluble biopolymer is selected from the group consisting of gelatin, pectin, starch, pullulan, agarose, alginic acid, alginate, hyaluronic acid, RNA, DNA, xanthan gum, guar gum, carrageenan, latex, polymannos, suberin, keratin, horny carbon, and mixtures thereof.

[0031] Biopolymers from various sources can be used, and the present invention is not limited to specific material sources. For example, suitable sources of chitin can include green plants, algae and fungi, but are not limited thereto. Suitable sources of chitin and chitosan can include fungi, crustaceans (such as crabs and shrimps) and insects, but are not limited thereto. In an embodiment, insoluble or semi-soluble biopolymers are obtained from fungi and mushrooms. In an embodiment, insoluble or semi-soluble biopolymers are obtained from plant materials, and the plant materials include roots, tubers, leaves, petals, seeds, fruits, etc., but are not limited thereto. Preferred sources are non-animal sources.

[0032] In an embodiment, the biopolymer is a 100% natural biopolymer, such as SunSpheres Bio TM (microcrystalline cellulose, Dow Chemical), Chemjac TM (konjac root extract and xanthan gum, Chemspire), Kelset TM (sodium alginate, Dupont), Instant Pure Flo F TM (Corn starch, Ingredion), Gelcarin TM GP 379 (carrageenan, iota type, Dupont), Betafib TM MCF (cellulose (and) water-microfibrillated cellulose, Cosun Biobased Products), Betafib TM ETD (cellulose and cellulose gum-microfibrillated cellulose, Cosun Biobased Products), Exilva TM FM02-V,L (cellulose-microfibrillated cellulose, Borregard), Naturesoft TM 800 (cellulose-micro powder), Kelcogel TMCG-HA (Gelan gum-CP, Kelco), agar, agarose, mushroom chitosan (e.g., GBS003, Qingdao Chibio Biotech), fungal chitosan (e.g., GBS010, Qingdao Chibio Biotech; or from Kraeber & Co), chitosan derived from fungi (e.g., Kiosmetine-CS TM , Kitozyme).

[0033] In an embodiment, the biopolymer is a naturally derived biopolymer, such as Natrathix TM Biocellulose (cellulose gum, Ashland), Aquasorb TM A500 (cellulose gum, Ashland), Polysurf TM CS 67 / Natrosol TM CS plus 330 (cetyl hydroxyethyl cellulose, Ashland), Structure XL TM (hydroxypropyl starch phosphate, Nouryon), CD-58 (chitosan succinimide, Onlystar Bio-Technology Ltd), carboxymethyl chitosan derivative (GBS010, Qingdao Chibio Biotech), Makimousse TM 7 / 400 (sodium polyacrylate starch-kobo product, Daito Kasei Kogyo), Salanjul / Sanfresh TM 1000 / 300sp (sodium polyacrylate starch, IwaseCosfa USA Inc. / Sanyo), Antaron ECoT ethylcellulose (ethylcellulose, Ashland).

[0034] In embodiments, the biopolymer comprises a synergistic biopolymer combination, such as Chemjac TM (konjac root extract and xanthan gum, Chemspire), PemuPur TM start (microcrystalline cellulose (and) Sphingomonas ferment extract (and) cellulose gum, Lubrizol), Nomcort CG (xanthan gum, carob gum, Ikeda).

[0035] Biopolymers can also include other biopolymer active substances, such as B-CAN TM 55% (oat beta glucan, Adams Food Ingredients) and / or beta glucan from mushrooms.

[0036] The present invention includes a mixture of two, three, four, five or more insoluble biopolymers, including chitin + chitosan, chitin + cellulose, chitin + collagen, chitin + silk, chitosan + silk, chitosan + cellulose, chitosan + collagen, cellulose + collagen, cellulose + silk, collagen + silk, etc., but not limited thereto. The present invention also includes a mixture of two, three, four, five or more semi-soluble biopolymers, including agarose + DNA, xanthan gum + starch, latex + alginate, xanthan gum + DNA, guar gum + horn carbon, etc., but not limited thereto. It is also conceivable to mix two, three, four, five or more insoluble biopolymers and semi-soluble biopolymers together, wherein the insoluble biopolymers and semi-soluble biopolymers include chitin + agarose, chitosan + agarose, chitosan + gelatin, chitosan + xanthan gum, chitosan + xanthan gum, chitosan + sodium hyaluronate, chitosan + sodium hyaluronate, cellulose + sodium hyaluronate, chitosan + agarose, chitosan + agarose, cellulose + agarose, but are not limited thereto.

[0037] The present invention also includes combinations of hydrophobically modified biopolymers and unmodified biopolymers that can form stable viscous oil-in-water emulsions when dispersed using high shear processes and / or mechanical energy (with or without emulsifiers). Examples of hydrophobically modified biopolymers include Natrosol TM CS Plus 330 / Polysurf TM CS 67 (cetyl hydroxyethyl cellulose, Ashland), StarDesign Ultra TM (Sodium starch octenylsuccinate, Cargill Beauty), Inutec TM SP1 (inulin dodecyl carbamate, Beneo), Texturlux Stabil TM (Hydrolyzed corn starch hydroxyethyl ether, Primient).

[0038] In embodiments, biopolymer is made up of biopolymer composition, and the biopolymer composition comprises biopolymer molecules that have been mechanically processed into stable uniform aqueous biopolymer suspension. As used herein, the term "uniform" generally refers to the appearance of suspension under the naked eye (for example, uniform color, uniform texture, etc.). As used herein, uniformity does not exclude the possibility that suspension is "non-uniform" on the molecular level (for example, the presence of various particle sizes, aggregates, etc.). As used herein, the term "stable uniform aqueous biopolymer suspension" or similar terms used interchangeably herein such as "uniform biopolymer suspension" or "stable biopolymer suspension" or simply "biopolymer suspension" all refer to the suspension of insoluble and / or semi-soluble biopolymer particles that have been stably dispersed in polar solvents. Polar solvents can be polar protic solvents or polar aprotic solvents. Polar solvents can be aqueous solvents. Insoluble and / or semi-soluble biopolymer particles present in biopolymer suspensions can be shaped as similar to fibers and / or similar to agglomerated spheres or agglomerates. The stability of biopolymer suspensions can be assessed by any suitable method. In a preferred embodiment, stability is measured or observed by the absence of separation, i.e., there is a single phase rather than two separate phases in the aqueous mixture, e.g., no biopolymer sedimentation / precipitation at the bottom of the aqueous mixture or floating on the top of the aqueous mixture. Preferably, the biopolymer suspension according to the present invention is stable (e.g., does not separate) for at least 1 day, or at least 1 week, or at least one month, or at least one year, or longer.

[0039] Notwithstanding the above, it will be appreciated by those skilled in the art that insoluble and / or semi-soluble biopolymers may never completely dissolve. Instead, they become "swellable" and bind water, which is why the biopolymers become viscous suspensions in accordance with the present invention when subjected to high shear conditions and / or mechanical energy. Thus, the present invention includes "swellable biopolymers" and "non-swellable biopolymers" because non-swellable polymers may be swellable using high shear and / or mechanical energy. As used herein, swellable biopolymers include biopolymers that absorb and bind water such that their particle size and aqueous dispersion viscosity increases.

[0040] In embodiments, the biopolymer may be swollen by wet ball milling. This may include, but is not limited to, chitin, chitosan, hemicellulose, and pregelatinized corn starch.

[0041] In embodiments, the biopolymer may be swollen by a high shear process other than ball milling. This may include, but is not limited to, microcrystalline cellulose, microfibrillated cellulose, nanocellulose, hairy nanocellulose, konjac glucomannan, hydroxypropyl starch phosphate, high acyl gellan gum, gellan gum, carboxymethyl starch, carboxymethyl cellulose (low ds type), agar, and agarose.

[0042] According to the present invention, it is also contemplated to use soluble biopolymers including, but not limited to, xanthan gum, diutangum, sodium alginate, sclerotium gum.

[0043] In embodiments, biopolymer molecules or particles as part of a composition for drug delivery have been mechanically processed into a stable uniform aqueous biopolymer suspension. In embodiments, mechanical processing involves high shear conditions and / or high mechanical energy. In embodiments, high shear conditions and / or high mechanical energy are obtained by processes including: mechanical shearing, shear thinning, planetary ball milling, rolling milling, vibrating ball milling, tumbling agitation ball milling, horizontal media grinding, colloid milling, but not limited thereto. As described below, high shear conditions and / or high mechanical energy can be continued for a period of time under parameters, suitable conditions, etc., until a desired state change is obtained, such as color change, viscosity change, from a slurry to a paste, ointment, cream, lotion, gel or emulsion, etc.

[0044] Without wishing to be bound by theory, subjecting the biopolymer to high shear conditions and / or high mechanical energy can improve biopolymer properties that cannot be ensured using conventional methods, including improved rheological properties (e.g., viscosity), shear thinning properties, and high yield values. Biopolymers dispersed using a high shear process can contain a lamellar crystalline gel network (LGN), which can synergistically increase the viscosity of the biopolymer dispersion. The oil + water biopolymer dispersion according to the present invention can also contain a Pickering emulsion, wherein a water-in-oil or oil-in-water emulsion is stabilized by a biopolymer.

[0045] In an embodiment, high shear conditions and / or high mechanical energy require the use of suitable devices or equipment, including ball mills (e.g., planetary ball mills, rolling mills, vibrating ball mills, tumbling agitated ball mills, horizontal media mills, colloid mills, magnetic mills), twin screw extruders, high pressure homogenizers, blade homogenizers, stirring homogenizers, dispersers, rotor-stator homogenizers, high shear mixers, plowshare mixers, dynamic mixers, plowshare mixers, turbine mixers, speed mixers, friction mills, ultrasonic instruments (e.g., high shear ultrasonic processes), tissue tearers, cell lysers, homogenizers (polytrons), ribbon stirrers, microfluidizers, high pressure homogenizers, and combinations thereof, but are not limited thereto. In a preferred embodiment, the present invention uses ball milling under wet conditions. Specific examples of ball mills include vertical planetary mills (e.g., Tencan XQM-2A) with a 100 mL capacity zirconia jar and 10 mm diameter zirconia balls. TM ), Flacktek with 40mL zirconia canister and 5mm diameter zirconia ball or ring TM Speed ​​mixer (DAC 330-11SE), 1.5L Supermill Plus with 1.4 to 1.7 mm zirconium oxide beads TM and Netzsch mills Labstar with beads from 0.6 to 0.8 mm or beads from 1.4 to 1.7 mm TM , but not limited to this.

[0046] In a particular embodiment, the biopolymer compositions and suspensions according to the invention are obtained using a particular protocol referred to herein as the "10+1 Alt method". The method comprises grinding the biopolymer for a certain period of time (e.g. 10 minutes), followed by a short pause (e.g. 1 minute), and then grinding in the opposite direction for a certain period of time (e.g. 10 minutes), for a total of 1 hour or 2 hours or 3 hours or 5 hours, 10 hours or 12 hours.

[0047] Advantageously, the viscosity of the composition / suspension can be changed by changing the high shear conditions and / or mechanical energy experienced by the biopolymer. These conditions can be adjusted to obtain a stable uniform suspension (e.g., a stable colloid uniform suspension) with a desired viscosity. Typically, providing more mechanical energy will increase shearing and correspondingly reduce the viscosity of the final product. The biopolymer itself and / or the final composition for drug delivery can be formulated as a paste, ointment, cream, lotion, gel or emulsion.

[0048] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules or particles is a colloidally homogeneous biopolymer suspension. In embodiments, the colloidally homogeneous suspension comprises colloids ranging from about 1 nm to about 1 μm.

[0049] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules comprises a biopolymer fiber. In embodiments, the width of the fiber is from about 1 nm to about 5 μm, or from about 5 nm to about 5 μm, from about 7 nm to about 5 μm, or from about 10 nm to about 5 μm, or from about 20 nm to about 5 μm, or from about 25 nm to about 5 μm, or from about 30 nm to about 5 μm, or from about 35 nm to about 5 μm, or from about 35 nm to about 3 μm. In embodiments, the width of the fiber is at least 1 nm, or at least 5 nm, or at least 10 nm, or at least 20 nm, or at least 30 nm, or at least 40 nm, or at least 50 nm, or at least 75 nm, or at least 100 nm, or at least 250 nm, or at least 500 nm, or at least 750 nm, or at least 1 μm, or at least 2 μm, or at least 3 μm, or at least 4 μm, or at least 5 μm, or wider.

[0050] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules comprises biopolymer fibers having a length of about 1 nm to about 200 μm, about 10 nm to about 100 μm, or about 50 nm to about 10 μm, or about 100 nm to about 10 μm, or about 500 nm to about 10 μm, or about 750 nm to about 10 μm, or about 800 nm to about 10 μm, or about 900 nm to about 5 μm, or about 1 μm to about 10 μm, or about 1 μm to about 5 μm, or about 1 μm to about 3 μm. In embodiments, the length of the fiber is at least 1 nm or at least 10 nm, at least 50 nm or at least 100 nm or at least 250 nm or at least 500 nm or at least 750 nm or at least 800 nm or at least about 900 nm or at least 1 μm or at least 2 μm or at least 3 μm or at least 4 μm or at least 5 μm or at least 6 μm or at least 7 μm or at least 8 μm or at least 9 μm or at least 10 μm or at least 25 μm or at least 50 μm or at least 75 μm or at least 100 μm or at least 150 μm or at least 200 μm or longer. In embodiments, the dry particle size may range from about 1 nm to about 1 μm or up to 10 μm, and the wet particle size may range from about 200 nm to about 20 μm or up to 200 μm.

[0051] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules comprises a biopolymer fiber having: (i) a width greater than 20 nm (e.g., at least 25 nm or at least 40 nm or at least 50 nm) and a length greater than 50 nm (e.g., at least 100 nm or at least 500 nm or at least 1 μm or at least 2 μm); or (ii) a width greater than 32 nm (e.g., at least 35 nm or at least 40 nm or at least 50 nm) and a length greater than 50 nm (e.g., at least 100 nm or at least 500 nm) or (iii) a width greater than 20 nm (e.g., at least 25 nm, at least 40 nm, or at least 50 nm) and a length greater than 500 nm (e.g., at least 600 nm, or at least 750 nm, or at least 1 μm, or at least 2 μm); or (iv) a width greater than 30 nm (e.g., at least 35 nm, or at least 40 nm, or at least 50 nm) and a length greater than 800 nm (e.g., at least 900 nm, or at least 1 μm, or at least 2 μm); or (v) a width greater than 8 nm (e.g., at least 10 nm, or at least 20 nm); or (vi) a width of greater than 11 nm (e.g., at least 15 nm, at least 25 nm, or at least 35 nm, or at least 40 nm, or at least 50 nm) and a length of greater than 166 nm (e.g., at least 200 nm, or at least 350 nm, or at least 500 nm, or at least 750 nm, or at least 900 nm) or at least 1 μm or at least 2 μm; or (vii) a width of greater than 11 nm (e.g., at least 15 nm, or at least 25 nm, or at least 35 nm, or at least 40 nm, or at least 50 nm) and a length of greater than 166 nm (e.g., at least 200 nm, or at least 350 nm, or at least 500 nm, or at least 750 nm, or at least 900 nm) or at least 1 μm or at least 2 μm. or (viii) a width greater than 32 nm (e.g., at least 35 nm, or at least 40 nm, or at least 50 nm) and a length greater than 800 nm (e.g., at least 900 nm, or at least 1 μm, or at least 2 μm, or at least 3 μm, or at least 4 μm, or at least 5 μm, or at least 6 μm, or at least 7 μm, or at least 8 μm, or at least 9 μm, or at least 10 μm, or at least 25 μm, or at least 50 μm, or at least 75 μm, or at least 100 μm, or at least 150 μm, or at least 200 μm, or longer).

[0052] In an embodiment, the biopolymer and / or biopolymer composition comprising biopolymer molecules comprises biopolymer fibers, wherein the average width and average length of the fibers in the composition are as defined above, e.g., the average width is greater than 20 nm (e.g., at least 25 nm or at least 40 nm or at least 50 nm) and the average length is greater than 50 nm (e.g., at least 60 nm, at least 75 nm, or at least 100 nm, or at least 500 nm, at least 750 nm, or at least 1 μm, or at least 2 μm, or at least 3 μm, or at least 4 μm, or at least 5 μm, or at least 6 μm, or at least 7 μm, or at least 8 μm, or at least 9 μm, or at least 10 μm, or at least 25 μm, or at least 50 μm, or at least 75 μm, or at least 100 μm, or at least 150 μm, or at least 200 μm, or more).

[0053] In embodiments, the biopolymer suspension and / or biopolymer composition comprising biopolymer molecules has a pH between about 6.5 and about 8.5. In specific embodiments, the biopolymer suspension is a chitosan suspension having a pH between about 7.8 and about 8.1.

[0054] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules comprises biopolymer fibers of both crystalline regions and amorphous regions. In embodiments, the stable homogenous suspension comprises biopolymer fibers having a spherical shape. In embodiments, the stable homogenous suspension consists primarily of or consists solely of suspended biopolymer nanofibrils.

[0055] Those skilled in the art will appreciate that particle size measurements will vary depending on the measurement method and the state of the particles (e.g., particles in a wet state are generally larger than the same particles in a dry state). Typically, particles are in a wet or suspended state when measured by dynamic light scattering (DLS), and particles are in a dry state when measured by scanning electron microscopy (SEM).

[0056] In embodiments, biopolymers and / or biopolymer compositions comprising biopolymer molecules comprise agglomerated spheres of alginic acid having an average size of about 40 nm to about 80 nm or about 45 nm to about 75 nm when measured by scanning electron microscopy (SEM). In embodiments, stable homogeneous suspensions comprise agglomerated spheres of alginic acid having a median size of about 30 nm to about 70 nm or about 35 nm to about 65 nm, an average size of about 40 nm to about 80 nm or about 45 nm to about 75 nm when measured by scanning electron microscopy (SEM).

[0057] In an embodiment, the biopolymer and / or biopolymer composition comprising the biopolymer molecules comprises agglomerated spheres of cellulose having an average size of about 50 nm to about 80 nm or about 55 nm to about 75 nm, an average size of about 40 nm to about 80 nm or about 45 nm to about 75 nm, when measured by scanning electron microscopy (SEM). In an embodiment, the stable homogenous biopolymer suspension comprises agglomerated spheres of cellulose having a median size of about 35 nm to about 75 nm or about 40 nm to about 65 nm, an average size of about 40 nm to about 80 nm or about 45 nm to about 75 nm, when measured by scanning electron microscopy (SEM).

[0058] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules comprises agglomerated spheres of chitosan having an average size of about 45 nm to about 85 nm or about 50 nm to about 80 nm. In embodiments, the stable homogenous biopolymer suspension comprises agglomerated spheres of cellulose having a median size of about 45 nm to about 80 nm or about 50 nm to about 75 nm when measured by scanning electron microscopy (SEM).

[0059] In embodiments, the biopolymer and / or biopolymer composition comprising the biopolymer molecules comprises agglomerated spheres of chitosan having an average size of about 75 nm to about 120 nm, or about 80 nm to about 115 nm, or about 85 nm to about 110 nm when measured by scanning electron microscopy (SEM). In embodiments, the stable homogeneous suspension comprises agglomerated spheres of chitosan having a median size of about 70 nm to about 100 nm, or about 75 nm to about 95 nm when measured by scanning electron microscopy (SEM).

[0060] In an embodiment, the biopolymer and / or biopolymer composition comprising the biopolymer molecules comprises agglomerated spheres of silk having an average size of about 40 nm to about 165 nm or about 45 nm to about 160 nm when measured by a scanning electron microscope (SEM). In an embodiment, the stable homogenous biopolymer suspension comprises agglomerated spheres of silk having a median size of about 40 nm to about 150 nm or about 45 nm to about 140 nm when measured by a scanning electron microscope (SEM).

[0061] In an embodiment, the biopolymer and / or biopolymer composition comprising biopolymer molecules comprises particles of one or more of alginate, cellulose, chitin, chitosan and silk, wherein the particle size range when measured by SEM is as defined in the tables and figures of WO 2022 / 137184.

[0062] In embodiments, the biopolymer and / or biopolymer composition comprising the biopolymer molecules is characterized by those visual properties as shown by the SEM images shown in the figures of WO 2022 / 137184.

[0063] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules is characterized by a Fourier transform infrared spectroscopy (FTIR) spectrum as shown in the figures of WO 2022 / 137184.

[0064] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules is characterized by solid state nuclear magnetic resonance (SSNMR) characterization as shown in the figures of WO 2022 / 137184.

[0065] In an embodiment, the biopolymer and / or biopolymer composition comprising the biopolymer molecules is characterized by a Power X-Ray Diffraction (PXRD) pattern as shown in the figures of WO 2022 / 137184.

[0066] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules is characterized by dynamic light scattering (DLS) measurements as those described in WO 2022 / 137184.

[0067] In embodiments, the biopolymer and / or biopolymer composition comprising biopolymer molecules is characterized by a transmission spectrum as shown in the Figures of WO 2022 / 137184.

[0068] In an embodiment, the biopolymer and / or biopolymer composition comprising biopolymer molecules is characterized by the Glance Suspension Test as described in WO 2022 / 137184.

[0069] In embodiments, the biopolymer and / or biopolymer composition comprising the biopolymer molecules is characterized by rheological behavior as shown in the figures of WO 2022 / 137184.

[0070] Active pharmaceutical ingredients

[0071] The present invention is particularly aimed at carrying, transporting and / or providing a vehicle for carrying, delivering and releasing beneficial compounds.

[0072] In an embodiment, the beneficial compound is an "active pharmaceutical ingredient" or "API". As used herein, the term active pharmaceutical ingredient or API includes any substance or compound that is capable of providing at least one favorable health benefit to a subject. For example, an API can be a cosmetic compound, a pharmaceutical compound, or a drug substance, etc.

[0073] As used herein, the term "subject" includes living organisms to which beneficial compounds are to be delivered. The term "subject" includes animals (e.g., mammals (e.g., cats, dogs, horses, pigs, cows, goats, sheep, rodents (e.g., mice or rats), rabbits, squirrels, bears, primates (e.g., chimpanzees, monkeys, gorillas, and humans)) and birds (e.g., chickens, ducks, Peking ducks, geese) and transgenic species thereof. Preferably, the subject is a human or non-human primate (e.g., chimpanzee, monkey, macaque, gorilla). More preferably, the subject is a human. Even more preferably, the subject is a person who needs treatment and has or may have one or more adverse health problems and / or symptoms. In an embodiment, the subject is a person who can benefit from the delivery and release of a drug or cosmetic (e.g., on his skin or skin layer).

[0074] The pharmaceutical compound may be any compound having pharmaceutical activity, including analgesics, anesthetics, anti-addiction agents, antibacterial agents, anticonvulsants, antidementia agents, antidepressants, antiemetics, antifungals, antigout agents, anti-inflammatory agents, anti-migraine agents, anti-myasthenia gravis agents, anti-mycobacterial agents, anti-tumor agents, anti-obesity agents, anti-parasitic agents, anti-Parkinson's agents, antipsychotic agents, anticonvulsants, antivirals, antianxiety agents, bipolar disorder agents, agents), blood glucose regulators, blood products, cardiovascular agents, central nervous system agents, contraceptive agents, dental and oral agents, dermatological agents, electrolytes, minerals, metals, vitamins, gastrointestinal agents, genitourinary agents, hormone agents (adrenal), hormone agents (pituitary), hormone agents (prostaglandins), hormone agents (sex hormones), hormone agents (thyroid), hormone inhibitors (adrenal), hormone inhibitors (pituitary), hormone inhibitors (thyroid), immunology agents, infertility agents, inflammatory bowel disease agents, metabolic bone disease agents, ophthalmic agents, otic agents, respiratory agents, sexual disorder agents, skeletal muscle relaxants, sleep disorder agents, but are not limited to these.

[0075] In an embodiment, the drug compound is selected from acetaminophen, acetylsalicylic acid, acyclovir, acrivastine, adalimumab, alendronic acid, allopurinol, alogliptin, amitriptyline for depression, amitriptyline for pain and migraine, amlodipine, amoxicillin, anastrozole, apixaban, atenolol, atorvastatin, azathioprine, azithromycin, baclofen, benzylpezil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, tadalafil, beclometasone inhaler, beclomethasone nasal spray, beclomethasone skin cream, bendroflumethiazide, benzoyl peroxide, benzydamine, betahistine, betamethasone for eyes, ears, and nose, betamethasone for skin application, bimatoprost, bisacodyl, bisoprolol, brinzolamide, budesonide inhaler, budesonide nasal spray, budesonide rectal foam and enema, bumetanide, buprenorphine for pain, buscopan (hyoscine butylbromide), butylbromide), candesartan, carbamazepine, carbimazole, carbocisteine, carmellose sodium, carvedilol, cefalexin, cetirizine, varenicline, chloramphenicol, chlorhexidine, chlorphenamine, cinnarizine, ciprofloxacin, citalopram, clarithromycin,Clobetasol, clobetasone, clonazepam, clopidogrel, clotrimazole, clotrimazole, co-amoxiclav, co-beneldopa, co-careldopa, co-codeine-acetaminophen for adults, co-codeine-acetaminophen for children, co-codeine-aspirin prin (aspirin and codeine), co-dydramol, codeine, colchicine, cyanocobalamin, cyclizine, dabigatran, dapagliflozin, dexamethasone tablets and liquid, diazepam, diclofenac, digoxin, dihydrocodeine, diltiazem azem), diphenhydramine, dipyridamole, docusate, domperidone, donepezil, dosulepin, doxazosin, doxycycline, duloxetine, edoxaban, empagliflozin, enalapril, eplerenone, erythromycin, escitalopram, citalopram, esomeprazole, ezetimibe, felodipine, fentanyl, ferrous fumarate, ferrous sulfate, fexofenadine, finasteride, flucloxacillin, fluconazole, fluoxetine, fluticasone inhaler, fluticasone nasal spray and drops, fluticasone skin cream, folic acid, furosemide,fusidic acid, fybogel (ispaghula husk), gabapentin, gliclazide, glimepiride, glyceryl trinitrate, heparinoid, hydrocortisone, hydrocortisone lozenges, hydrocortisone for hemorrhoids and itchy buttocks, hydrocortisone for skin, hydrocortisone injection, hydrocortisone rectal foam, hydrocortisone tablets, hydroxocobalamin, hyoscine hydrobromide, ibuprofen, indapamide, irbesartan, isosorbide mononitrate, isosorbide dinitrate dinitrate), isotretinoin capsules, isotretinoin gel, ketoconazole, labetalol, lactulose, lamotrigine, lansoprazole, latanoprost, lercanidipine, letrozole, levetiracetam, levothyroxine, lidocaine, linagliptin, lisinopril, lithium, loperamide, loratadine, lorazepam m), losartan, low-dose aspirin, lymecycline, macrogol, mebendazole, mebeverine, melatonin, mesalazine, metformin, methadone, methotrexate, methylphenidate, metoclopramide, metoprolol, metronidazole, mirabegron, mirtazapine, molnupiravir,mometasone, montelukast, morphine, naproxen, nefopam, nicorandil, nifedipine, nitrofurantoin, nortriptyline, nystatin, olanzapine, olmesartan, omeprazole, oxybutynin, oxycodone, pantoprazole oprazole, paroxetine, nirmatrelvir, peppermint oil, perindopril, phenoxymethylpenicillin, phenytoin, pioglitazone, pravastatin, prednisolone tablets and liquid, pregabalin, prochlorperazine, promethazine, propranolol, olol), pseudoephedrine, rabeprazole, ramipril, ranitidine, remdesivir, risedronate, risperidone, rivaroxaban, ropinirole, rosuvastatin, salbutamol inhaler, saxagliptin, senna, sertraline ne), sildenafil, simeticone, simvastatin, sitagliptin, sodium valproate, solifenacin, sotalol, sotrovimab, sulfasalazine, sumatriptan, tadalafil, tamsulosin, temazepam, terbinafine, thiamine (vitamin B1),Ticagrelor, tolterodine, topiramate, tramadol, tranexamic acid, trazodone, trimethoprim, valproic acid, valsartan, varenicline, venlafaxine, verapamil, zolpidem, and zopiclone.

[0076] In an embodiment, the pharmaceutical compound is a compound for treating and / or preventing a medical condition selected from the group consisting of acne, acute cholecystitis, acute lymphocytic leukemia, acute myeloid leukemia, acute pancreatitis, Addison's disease, alcohol-related liver disease, allergic rhinitis, allergies, Alzheimer's disease, anal cancer, anaphylaxis, angioedema, ankylosing spondylitis, anxiety, anxiety disorders, appendicitis, arthritis, asthma, atopic eczema, attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), bacterial vaginosis, benign prostatic hyperplasia, biliary cancer (cholangiocarcinoma), binge eating, bipolar disorder, bladder cancer, sepsis (sepsis), bone cancer, intestinal cancer, incontinence (Bowel incontinence), intestinal polyps, brain tumors, breast cancer, bronchiectasis, bronchitis, bulimia, bunions, carcinoid syndrome and carcinoid tumors, mucositis, cellulitis, cervical cancer, chest infections, chest pain, chickenpox, frostbite, chlamydia, chronic fatigue syndrome, chronic kidney disease, chronic lymphocytic leukemia, chronic myeloid leukemia, chronic obstructive pulmonary disease, chronic pancreatitis, cirrhosis of the liver, Clostridium difficile disease, celiac disease, cold sores, sore), coma, common cold, common heart disease, congenital heart disease, conjunctivitis, constipation, coronavirus (COVID-19), cough, Crohn's disease, croup, cystic fibrosis, cystitis, blindness and deafness, deep vein thrombosis, dehydration, dementia, Lewy body dementia, dental abscess, depression, dermatitis herpetiformis, diabetes, diarrhea, discoid eczema, diverticulosis and diverticulitis, vertigo (dizziness), Down syndrome, dry mouth, dysphagia (swallowing problems), dystonia, earache, earwax accumulation, Ebola virus disease, ectopic pregnancy, endometriosis, epilepsy, erectile dysfunction (impotence), E. coli (E. coli) O157 disease, Ewing's sarcoma, childhood Ewing's sarcoma (Ewing sarcoma:Children), eye cancer, febrile seizures, fever in adults, fever in children, fibroids, fibromyalgia, flatulence, influenza, fetal alcohol syndrome, food poisoning, fungal nail infections, gallbladder cancer, gallstones, ganglion cysts, gastroenteritis, gastroesophageal reflux disease (GORD), genital herpes, genital warts, germ cell tumors, glandular fever, gonorrhea, gout, gum disease, hemorrhoids (piles), hairy cell leukemia, hand, foot and mouth disease, hay fever, head and neck cancer, head lice and nits, headaches, hearing loss, heart failure, hepatitis A, hepatitis B, hepatitis C, hiatal hernia, high cholesterol, HIV, Hodgkin lymphoma, childhood Hodgkin lymphomalymphoma: children, Hodgkin lymphoma: teenagers and young adults, Huntington's disease, polysaccharidosis (high blood sugar), hyperhidrosis, hypoglycemia (low blood sugar), idiopathic pulmonary fibrosis, impetigo, indigestion, ingrown toenails, hereditary heart disease, insomnia, iron deficiency anemia, irritable bowel syndrome (IBS), irritable hip, itching, itchy bottom, Kaposi's sarcoma, kidney cancer, kidney infection, kidney stones, inner ear inflammation, lactose intolerance, Langerhans cell histiocytosis, laryngeal (throat) cancer, laryngitis, leg cramps, lichen planus, liver cancer, liver disease, liver tumors, loss of libido, lung cancer, lupus, Lyme disease, lymphedema, lymphogranuloma venereum venereum, LGV), malaria, malignant brain tumor (cancer), malnutrition, measles, meningitis, menopause, mesothelioma, middle ear infection (otitis media), migraine, motor neuron disease (MND), oral cancer, mouth ulcers, multiple myeloma, multiple sclerosis (MS), mumps, Meniere's disease, sinus cancer, nasopharyngeal cancer, neuroblastoma, neuroendocrine tumors, non-alcoholic fatty liver disease (NAFLD), non-Hodgkin lymphoma, childhood non-Hodgkin lymphoma (Non-Hodgkin lymphoma: Children), Norwalk virus (Norovirus) disease, epistaxis, obesity, obsessive-compulsive disorder (OCD), sleep apnea, esophageal cancer, thrush in adults, osteoarthritis, osteoporosis, osteosarcoma, otitis externa, ovarian cancer, ovarian cancer in teenagers and young people (Ovarian cancer: Teenagers and young adults), ovarian cysts, hyperthyroidism, Paget's disease of the nipple, pancreatic cancer, panic disorder, Parkinson's disease, pelvic inflammatory disease, pelvic organ prolapse, penile cancer, peripheral neuropathy, personality disorders, pleurisy, pleurisy, polymyalgia rheumatica, post-traumatic stress disorder (PTSD), postpartum depression, pregnancy and infants, pressure sores, prostate cancer, psoriasis, psoriatic arthritis, mental illness, pubic lice, rare tumors, Raynaud's phenomenon, reactive arthritis, restless legs syndrome, retinoblastoma, retinoblastoma: children, rhabdomyosarcoma, rheumatoid arthritis, ringworm and other fungal infections, rosacea, scabies, scarlet fever, schizophrenia, scoliosis, septic shock, herpes zoster, breathing difficulties, sickle cell disease, sinusitis, Sjogren's syndrome, skin cancer (melanoma), skin cancer (non-melanoma), slapped cheek syndromesyndrome), Soft tissue sarcomas: Teenagers and young adults, Sore throat, Spleen problems and splenectomy, Stillbirth, Stomach and abdominal pain, Stomach cancer, Stomach ulcers, Stress, anxiety and depression, Stroke, Sudden Infant Death Syndrome (SIDS), Suicidal behavior, Sunburn, Swollen glands, Syphilis, Testicular cancer: Teenagers and young adults adults), testicular lumps and swelling, thirst, threadworms, thrush, thyroid cancer, thyroid cancer, tinnitus, tonsillitis, tooth decay, toothache, transient ischemic attack (TIA), trigeminal neuralgia, tuberculosis (TB), type 1 diabetes, type 2 diabetes, Trichomonas infection, ulcerative colitis, hypothyroidism, urinary incontinence, urinary tract infection (UTI), urinary tract infection (UTI) in children, urticaria (urticaria), vaginal cancer, vaginal thrush, varicose eczema, venous leg ulcers, vertigo, vitamin B12 or folate deficiency anemia, vomiting in adults, vulvar cancer, warts and warts, whooping cough, Wilms' tumor, Womb (uterus) cancer, yellow fever.

[0077] The API may be any compound that can be used in cosmetics, including compounds for moisturizing the skin, compounds for improving the appearance of the skin, compounds for protecting against environmental damage, compounds for combating the effects of aging, compounds for removing wrinkles and / or sun spots, and / or compounds for preventing any of the following skin conditions, but not limited to: acne, acne / folliculitis, acne scars, aging skin, blemishes, broken blood vessels, brown spots or other discolored skin, cellulite, wrinkles around the mouth or nose, hollows or hollows around the cheeks, temples, lips and eyes, dull and discolored skin , excess facial or body hair, enlarged pores, a tired or fatigued appearance, fine lines and wrinkles, flaking and cracked skin, a reddish appearance, freckles, furrows or wrinkles on the forehead, hair loss, hair loss, hirsutism and hypertrichosis, hyperpigmentation, melasma, rosacea, sagging or volume loss, skin scarring, skin cancer, spider veins on the legs and face, sun damaged skin, sun spots, tattoo removal, changes in texture and tone, fine lines near the eyes or mouth, visible facial blood vessels, wrinkles and fine lines, etc.

[0078] The API may also be any compound that can be used in hygiene products such as anti-acne products, toothpaste and anti-caries products, antiperspirants, astringents, corn and callus removers, anti-dandruff products, hair growth / anti-hair loss products, anti-nail biting products, and wart removers. The API may also be any compound that can be used in other skin products such as skin bleaching agents, sunscreens, topical analgesics, topical antifungal products, and antimicrobial products.

[0079] In an embodiment, the cosmetic compound is selected from antioxidants (e.g., resveratrol, vitamin C), alpha hydroxy acids (AHA), hyaluronic acid, retinoids (e.g., retinol), vitamins (e.g., vitamin A, vitamin E), resorcinol, benzoyl peroxide, salicylic acid, ceramide, niacinamide, sulfur, sodium fluoride, sodium monophosphate, clioquinol, haloprogin, miconazole nitrate, povidone-iodine, tolnaftate, undecylenic acid, calcium undecylenate, copper undecylenate, zinc undecylenate, clotrimazole bacitracin, chlortetracycline, neomycin sulfate, tetracycline hydrochloride, aluminum chloride, aluminum chlorohydrate, aluminum chlorohydrex polyethylene glycol. polyethylene glycol), aluminum chlorohydrex propylene glycol, aluminum dichlorohydrate, aluminum dichlorohydrex polyethylene glycol, aluminum dichlorohydrex propylene glycol, aluminum sesquichlorohydrate, aluminum sesquichlorohydrate polyethylene glycol, aluminum sesquichlorohydrate propylene glycol, aluminum zirconium octachlorohydrate, aluminum zirconium octachlorohydrate glycine gly), aluminum zirconium pentachlorohydrate, aluminum zirconium pentachlorohydrate glycine, aluminum zirconium tetrachlorohydrate, aluminum zirconium tetrachlorohydrate glycine, aluminum zirconium trichlorohydrate, aluminum zirconium trichlorohydrate glycine, allantoin, aluminum hydroxide gel, calamine, cocoa butter, cod liver oil, dimethicone, glycerin, kaolin, lanolin, mineral oil, sodium bicarbonate, zinc acetate, zinc carbonate, zinc oxide, aluminum acetate, aluminum sulfate, witch hazel, selenium sulfide, pyrithione zinc, selenium sulfide, coal tar, hydroquinone, benzocaine, lidocaine.

[0080] manufacture

[0081] Any suitable methods and conditions may be used to produce the composition for drug delivery according to the present invention.

[0082] In an embodiment, obtaining a composition for drug delivery comprises mixing the API into a stable homogeneous aqueous solution comprising insoluble and / or semi-soluble particles.

[0083] In an embodiment, manufacturing a composition for drug delivery comprises: mechanically processing the API with a biopolymer under high shear conditions and / or under high mechanical energy to obtain a stable homogeneous aqueous composition as defined herein, the composition comprising insoluble and / or semi-soluble particles in which the API is dispersed. Some examples of such manufacturing are provided in the Examples section below.

[0084] The composition for drug delivery according to the present invention is preferably stable. Stable means at least that the biopolymer (e.g., fiber, spheroid) or any other component of the composition will not settle to the bottom. In embodiments, the insoluble and / or semi-soluble biopolymer is kept in suspension for at least 1 week or at least 1 month or at least 6 months or at least 12 months or at least 18 months or at least two years or at least three years or longer.

[0085] Preferably, the composition for drug delivery according to the present invention also provides a stable environment for the API contained in the composition. Those skilled in the art can easily confirm and provide such a stable environment to the API, for example, by selecting a suitable biopolymer or a combination thereof, confirming the appropriate concentration or ratio of the biopolymer and / or API, adding additional compounds (e.g., stabilizers, pH regulators, adhesives, salts, cross-linking agents, cosolvents, softeners, etc.).

[0086] Compositions for drug delivery according to the present invention can be formulated as pastes, ointments, creams, lotions, gels or emulsions. In embodiments, the desired preparation is obtained by obtaining a composition with a desired viscosity. In embodiments, the viscosity of the composition / suspension can be changed by changing the high shear conditions and / or mechanical energy experienced by the biopolymer. In embodiments, stable uniform suspensions have a viscosity of about 25mPa to about 85000mPa. Table 1 below provides non-limiting examples of the desired viscosity of compositions / suspensions according to the present invention.

[0087] Table 1 : Example of required viscosity

[0088] Required viscosity Exemplary viscosity (mPa·s) Paste About 40,000 to about 300,000 or more ointment About 20,000 to about 50,000 Cream About 1500 to about 30000 lotion About 800 to about 4000 gel About 1,000 to about 40,000 Lotion About 20 to about 2000

[0089] In an embodiment, the viscosity of the composition for drug delivery according to the present invention may be varied by selecting the biopolymer and / or API included in the composition accordingly.

[0090] In addition to the biopolymer, the viscosity of the composition for drug delivery according to the present invention can also be changed according to the ratio or concentration of each compound entering the composition. In an embodiment, the weight ratio of biopolymer:API is about 0.1:20 to about 10:20, or about 0.5:20 to about 3:20, or about 0.75:20, or about 1.0:20, 1.25:20, or about 1.5:20.

[0091] In embodiments, the composition for drug delivery according to the present invention comprises about 0.01% w / w to 10% w / w of biopolymer or 0.01% w / w to 5% w / w of biopolymer or 0.01% w / w to 2% w / w of biopolymer or 0.01% w / w to 1% w / w of biopolymer. In embodiments, the composition according to the present invention comprises about 0.01% w / w of biopolymer or about 0.05% w / w of biopolymer or about 0.1% w / w of biopolymer or about 0.25% w / w of biopolymer or about 0.5% w / w of biopolymer or about 0.75% w / w of biopolymer or about 1% w / w of biopolymer or about 1.5% w / w of biopolymer or about 2.5% w / w of biopolymer or about 5% w / w of biopolymer.

[0092] The composition for drug delivery according to the present invention can also be formulated as a stable emulsion, which comprises fatty acids (e.g., C10-C22 fatty acids), oils and / or waxes, and / or comprises N-acetylglucosamine, and / or emulsifiers and preservatives, and / or comprises additives, the additives comprising preservatives, stabilizers and emulsifiers, but not limited thereto. In an embodiment, the additive is selected from cetyl alcohol, glyceryl stearate, soybean oil, PC90, tara gum, PSC3, PEG, guar gum, xanthan gum, agarose, sodium hyaluronate, Tween 80 TM The additives may be added before, during and / or after combining the biopolymer with the API.

[0093] The drug delivery composition of the present invention may also be provided in a dry form and formulated into tablets, capsules, pills, granules, films, transdermal patches, implants, stents, suppositories, and the like.

[0094] Delivery methods and related uses

[0095] The compositions of the present invention may have numerous applications in delivering a beneficial compound (eg, an API) to a subject in need thereof.

[0096] In many aspects, the present invention relates to a method for delivering an active pharmaceutical ingredient (API) to a subject in need thereof. In one embodiment, the method comprises providing a composition as defined herein and administering the composition to the subject. Any suitable route that allows delivery and release of the API at the desired site can be used to administer the composition.

[0097] For example, the formulation can be prepared to provide a composition formulated in a form suitable for any administration route such as topical, oral, sublingual, buccal, rectal, vaginal, ocular, otic, nasal, dermal, and transdermal. In a preferred embodiment, the administration route is topical or oral.

[0098] According to a specific aspect, the administration is topical administration and the invention relates to a method for topical delivery. In one embodiment, the method comprises providing an aqueous composition comprising a biopolymer and at least one API and topically administering the composition to the body of a subject.

[0099] The composition can be applied to any desired surface of the subject's body, including, but not limited to, the hands, arms, legs, feet, torso, chest, face, neck, scalp, etc. In an embodiment, the composition is applied to an area of ​​the skin including wounds, scars, wrinkles, and / or any other type of injury. For topical use, the composition can be formulated as a paste, ointment, cream, lotion, gel, or emulsion.

[0100] According to a specific aspect, the administration is oral administration, and the present invention relates to a method for local delivery. In one embodiment, the method comprises: (i) providing a mixture comprising an API mixed in a biopolymer composition; (ii) drying the mixture to obtain a dry product; and (iii) orally administering the dry product to a subject. For oral use, the dry product can take the form of tablets, capsules, pills, granules, etc. For other modes of administration, the dry product can take the form of a film, a transdermal patch, a graft, a stent, a suppository, etc.

[0101] Those skilled in the art may recognize or be able to determine many equivalents to the specific procedures, embodiments, claims and examples described herein using only routine experimentation. Such equivalents are considered to be within the scope of the present invention and are covered by the appended claims. The present invention is further illustrated by the following examples, which should not be construed as further or specific limitations.

[0102] Example

[0103] Experiments were performed to demonstrate the release of small drug molecules or API from the biopolymer compositions according to the present invention.

[0104] Briefly, a biopolymer suspension is prepared by adding a known amount of API to the suspension. The suspension with the API is then dried into pellets. These pellets are then added to a known volume of water, and aliquots of the water are periodically taken out to determine the release rate of the API. The API concentration is measured using UV / VIS spectroscopy.

[0105] Example 1: Acetaminophen in Chitosan

[0106] The paracetamol-biopolymer suspension was produced by milling 21.88 g of chitosan suspension (1.05:20) and 0.50 g of paracetamol together at 670 RPM using the 10+1 Alt method with 50 10 mm ball components for ten minutes followed by a one minute pause and then ten minutes in the opposite direction for a total of two hours. The concentration of paracetamol in the aqueous suspension thus obtained was 2.23% w / w. The chitosan suspension was passed through a 1.5 L Supermill Plus with 1.4 to 1.7 mm zirconium oxide beads. TM It was prepared by grinding in 20 L batches, with typical grinding conditions being a rotation speed of 2400 FPM (feet per minute) and a pump flow of 7.3 GPH (gallons per hour), using 982 mL of 1.4 to 1.7 mm zirconia beads, wherein 20 liters of slurry were processed at 5% solids content (1.05:20).

[0107] The following table shows the viscosity of the final aqueous suspension:

[0108] Shear rate (Hz) Viscosity (mPa·s) 0.14 181500 0.28 81170 0.56 38330 1.4 15350 2.24 9042 2.8 6983

[0109] The sample was dried in air for 10 hours and in an oven at 50° C. for 3 hours. The concentration of acetaminophen in the dried material was 29.58% w / w.

[0110] like Figure 1 As shown, the acetaminophen-biopolymer suspension can successfully release acetaminophen. The figure shows the release of acetaminophen from a dried acetaminophen-incorporated chitin suspension into water, where the concentration of acetaminophen in g / L is plotted over time in minutes. It can be seen that the largest portion of acetaminophen is released in the first 35 to 50 minutes, followed by a slow release over the next 23 hours, indicating zero-order controlled release.

[0111] Example 2: Acetaminophen in Chitosan

[0112] The paracetamol-biopolymer suspension was produced by milling 22.64 g of chitosan suspension (1.05:20) and 0.50 g of paracetamol together using the 10+1 Alt method with 50 10 mm ball components at 670 RPM for ten minutes followed by a one minute pause and then ten minutes in the opposite direction for a total of two hours. The concentration of paracetamol in the aqueous suspension thus obtained was 2.16% w / w. The chitosan suspension was passed through a 1.5 L Supermill Plus with 1.4 to 1.7 mm zirconium oxide beads. TM It was prepared by grinding in 20 L batches, with typical grinding conditions being a rotation speed of 2400 FPM (feet per minute) and a pump flow of 7.3 GPH (gallons per hour), using 982 mL of 1.4 to 1.7 mm zirconia beads, wherein 20 liters of slurry were processed at 5% solids content (1.05:20).

[0113] The following table shows the viscosity of the final aqueous suspension:

[0114] Shear rate (Hz) Viscosity (mPa·s) 0.28 471500 0.56 208300 1.4 64450 2.24 29760 2.8 21710

[0115] The samples were dried in air for 10 hours and in an oven at 50° C. for 3 hours. The acetaminophen concentration in the dried material was 25.23% w / w.

[0116] like Figure 2 As shown, the acetaminophen-biopolymer suspension can successfully release acetaminophen. The figure shows the release of acetaminophen from a dried acetaminophen-incorporated chitosan suspension into water, where the concentration of acetaminophen in g / L is plotted over time in minutes. It can be seen that the largest portion of acetaminophen is released in the first 35 to 50 minutes, followed by a slow release over the next 23 hours, indicating zero-order controlled release.

[0117] Example 3: Acetylsalicylic acid in chitosan

[0118] The acetylsalicylic acid-biopolymer suspension was produced by milling 22.09 g chitosan and 0.50 g acetylsalicylic acid together using the 10+1 Alt method with 50 10 mm ball pieces at 670 RPM for ten minutes followed by a one minute pause and then ten minutes in the opposite direction for a total of two hours. The concentration of acetylsalicylic acid in the aqueous suspension thus obtained was 2.21% w / w. The chitosan suspension was passed through a 1.5 L Supermill Plus with 1.4 to 1.7 mm zirconium oxide beads. TMIt was prepared by grinding in 20 L batches, with typical grinding conditions being a rotation speed of 2400 FPM (feet per minute) and a pump flow of 7.3 GPH (gallons per hour), using 982 mL of 1.4 to 1.7 mm zirconia beads, wherein 20 liters of slurry were processed at 5% solids content (1.05:20).

[0119] The following table shows the viscosity of the final aqueous suspension:

[0120] Shear rate (Hz) Viscosity (mPa·s) 0.14 210300 0.28 99750 0.56 53040 1.4 23150 2.24 16120 2.8 13310

[0121] The sample was dried in air for 10 hours and in an oven at 50° C. for 3 hours. The acetylsalicylic acid concentration in the dried material was 34.99% w / w.

[0122] like Figure 3 As shown, the acetylsalicylic acid-biopolymer suspension can successfully release acetaminophen. The figure shows the release of acetylsalicylic acid from a dried chitosan suspension doped with acetylsalicylic acid into water, where the concentration of acetylsalicylic acid in g / L is plotted against time in minutes. It can be seen that the largest portion of acetylsalicylic acid is released in the first 35 to 50 minutes, followed by a slow release over the next 23 hours, indicating zero-order controlled release.

[0123] discuss

[0124] The examples of the present application show that the biopolymer composition according to the present invention can be successfully used for drug delivery, because both acetaminophen and acetylsalicylic acid are added to the biopolymer suspension and then released from the dried suspension.

[0125] The examples of the present application also show that the present biopolymer suspension can help control the release of different drugs, as acetaminophen showed a slower release from the dry biopolymer matrix than acetylsalicylic acid.

[0126] In this regard, without wishing to be bound by theory, the particle size of the polymer may have an effect on the release rate. Thus, the release rate of the desired API may be controlled by varying the particle size of the polymer suspension.

[0127] ***

[0128] Headings are included herein for reference and to help locate certain sections. These headings are not intended to limit the scope of the concepts described therein, and these concepts may have applicability throughout other parts of the specification. Therefore, the present invention is not intended to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

[0129] The singular forms "a", "an", and "the" include corresponding plural references unless the context clearly dictates otherwise. Thus, for example, reference to "a biopolymer" includes one or more such biopolymers, and reference to "a method" includes reference to equivalent steps and methods known to those of ordinary skill in the art, which steps and methods may be modified or substituted for the methods described herein.

[0130] Unless otherwise stated, all numerical values ​​of the amount of the expression composition, reaction conditions, concentration, property, etc. used in the specification and claims should be understood to be modified by the term "about" in all cases. At least, each numerical parameter should be interpreted at least according to the reported significant digits and using conventional rounding techniques. Therefore, unless otherwise stated, the numerical parameters described in this specification and the appended claims are approximate values, which may change according to the properties sought to be obtained. Although the wide range of numerical ranges and parameters stating the embodiments are approximate values, the numerical values ​​described in the specific examples are reported as accurately as possible. However, any numerical value inherently contains certain errors caused by the changes in experiments, test measurements, statistical analysis, etc.

[0131] It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes thereto may be suggested to those skilled in the art, which are included within the scope of the present invention and the appended claims.

Claims

1. A composition for delivering an active pharmaceutical ingredient (API), comprising: a biopolymer and at least one API.

2. The composition according to claim 1, wherein The API and the biopolymer are stably dispersed, thereby together forming the composition.

3. The composition according to claim 1 or 2, wherein The composition comprises biopolymer molecules that have been mechanically processed into a stable homogeneous aqueous suspension.

4. The composition according to any one of claims 1 to 3, wherein The composition comprises a homogenous aqueous suspension of insoluble and / or semi-soluble biopolymer particles.

5. The composition according to claim 4, wherein The stable homogeneous aqueous suspension comprises insoluble and / or semi-soluble biopolymer particles stably dispersed in a polar solvent.

6. The composition according to any one of claims 1 to 5, wherein The biopolymer consists of a stable homogeneous aqueous suspension comprising insoluble and / or semi-soluble biopolymer particles.

7. The composition according to any one of claims 1 to 6, wherein The biopolymer is selected from the group consisting of chitin, chitosan, cellulose, hemicellulose, lignin, amylose, actin, fibrin, collagen, silk, fibroin, keratin, wool, alginic acid and mixtures thereof.

8. The composition according to any one of claims 1 to 6, wherein The biopolymer is selected from gelatin, pectin, starch, pullulan, agarose, alginic acid, alginate, hyaluronic acid, RNA, DNA, xanthan gum, guar gum, latex, polymannos, suberin, keratin, horny carbon and mixtures thereof.

9. The composition according to any one of claims 1 to 8, wherein The composition is formulated as a paste, ointment, cream, lotion, gel or emulsion.

10. The composition according to any one of claims 1 to 8, wherein The composition is in dry form.

11. The composition according to claim 10, wherein The composition is formulated as a tablet, capsule, pill, granule, transdermal patch, implant, stent or suppository.

12. The composition according to any one of claims 1 to 11, wherein The API is a drug selected from the following: analgesics, anesthetics, anti-addiction agents, antibacterial agents, anticonvulsants, antidementia agents, antidepressants, antiemetics, antifungals, antigout agents, anti-inflammatory agents, anti-migraine agents, anti-myasthenia gravis agents, anti-mycobacterial agents, anti-tumor agents, anti-obesity agents, anti-parasitic agents, anti-Parkinson's agents, antipsychotic agents, anticonvulsants, antivirals, antianxiety agents, bipolar disorder agents, blood sugar regulators, blood products, cardiovascular agents, central nervous system agents, contraceptive agents, dental and oral agents, skin Pathological agents, electrolytes, minerals, metals, vitamins, gastrointestinal agents, genitourinary agents, hormone agents (adrenal), hormone agents (pituitary), hormone agents (prostaglandins), hormone agents (sex hormones), hormone agents (thyroid), hormone inhibitors (adrenal), hormone inhibitors (pituitary), hormone inhibitors (thyroid), immunological agents, infertility agents, inflammatory bowel disease agents, metabolic bone disease agents, ophthalmic agents, otic agents, respiratory agents, sexual disorder agents, skeletal muscle relaxants, sleep disorder agents and mixtures thereof.

13. The composition according to claim 12, wherein The drug is selected from acetaminophen, acetylsalicylic acid, acyclovir (including Zovirax TM ), acrivastine, adalimumab, alenclavulanic acid, allopurinol, alogliptin, amitriptyline for depression, amitriptyline for pain and migraine, amlodipine, amoxicillin, anastrozole, apixaban, Aspirin TM , atenolol, atorvastatin, azathioprine, azithromycin, baclofen, beclomethasone inhaler, beclomethasone nasal spray, beclomethasone skin cream, bendrofluazide, benzoyl peroxide, benzydamine, betahistine, betamethasone for eyes, ears, and nose, betamethasone for skin application, bimatoprost, bisacodyl, bisoprolol, brinzolamide, budesonide inhaler, budesonide nasal spray, budesonide rectal foam and enema, bumetanide, buprenorphine for pain, scopolamine butylbromide, candesartan, carbamazepine, carbimazole, carbocisteine, sodium carboxymethylcellulose, carvedilol, cephalexin, cetirizine, Champix TM (varenicline), chloramphenicol, chlorhexidine, chlorpheniramine (Piriton TM ), cinnarizine, ciprofloxacin, citalopram, clarithromycin, clobetasol, clobetasone, clonazepam, clopidogrel, clotrimazole, clotrimazole for thrush (Canesten TM ), combined amoxicillin-clavulanic acid, combined benserazide-levodopa, combined carbidopa-levodopa, combined codeine-acetaminophen for adults, combined codeine-acetaminophen for children, combined codeine-aspirin (aspirin and codeine), combined dihydrocodeine-acetaminophen, codeine, colchicine, cyanocobalamin, cyclizine, dabigatran, dapagliflozin, dexamethasone tablets and liquid, diazepam, diclofenac Fenac, digoxin, dihydrocodeine, diltiazem, diphenhydramine, dipyridamole, docusate, domperidone, donepezil, dosulpiride, doxazosin, doxycycline, duloxetine, edoxaban, empagliflozin, enalapril, eplerenone, erythromycin, escitalopram, esomeprazole, ezetimibe, felodipine, fentanyl, ferrous fumarate, ferrous sulfate, fexofenadine, finasteride, flucloxacillin, fluconazole, fluoxetine (Prozac TM ), fluticasone inhaler, fluticasone nasal spray and drops, fluticasone skin cream, folic acid, furosemide, fusidic acid, fybogel (Psyllium ovale husk), gabapentin, gabapentin T (alginic acid), gliclazide, glimepiride, glyceryl trinitrate (gtn), heparinoids, hydrocortisone, hydrocortisone lozenges, hydrocortisone for hemorrhoids and itchy buttocks, hydrocortisone for skin, hydrocortisone injection, hydrocortisone rectal foam, hydrocortisone tablets, hydroxocobalamin, scopolamine hydrobromide (hyoscyamine hydrobromide and for driving), ibuprofen and codeine, ibuprofen for adults (Nurofen TM ), ibuprofen for children, indapamide, irbesartan, isosorbide mononitrate and isosorbide dinitrate, isotretinoin capsules (Roaccutane TM ), isotretinoin gel (Isotrex TM ), ketoconazole, labetalol, lactulose, lamotrigine, lansoprazole, latanoprost, lercanidipine, letrozole, levetiracetam, levothyroxine, lidocaine for mouth and throat, lidocaine for hemorrhoids and itchy buttocks, lidocaine skin cream, linagliptin, lisinopril, lithium, loperamide, loratadine (Clarityn TM ), lorazepam, losartan, low-dose aspirin, lymecycline, polyethylene glycol, mebendazole, mebeverine, melatonin, mesalamine, metformin, methadone, methotrexate, methylphenidate for adults, methylphenidate for children, metoclopramide, metoprolol, metronidazole, mirabegron, mirtazapine, monolavil (Lagevrio TM ), mometasone for skin application, mometasone inhaler, mometasone nasal spray, montelukast, morphine, naproxen, nefopam, nicorandil, nifedipine, nitrofurantoin, nortriptyline, nystatin, olanzapine, olmesartan, omeprazole, oxybutynin, oxycodone, pantoprazole, acetaminophen for adults, acetaminophen (including paracetamol) for children, paroxetine, paroved, peppermint oil, Pepto-Bismol TM , perindopril, phenoxymethylpenicillin, phenytoin, pioglitazone, pravastatin, prednisolone tablets and liquid, pregabalin, prochlorperazine, promethazine (Phenergan TM ), propranolol, pseudoephedrine (including Sudafed TM ), rabeprazole, ramipril, ranitidine, remdesivir (VekluryT), risedronate, risperidone, rivaroxaban, ropinirole, rosuvastatin, albuterol inhaler, saxagliptin, senna, sertraline, sildenafil (Viagra TM ), simethicone, simvastatin, sitagliptin, sodium valproate, solifenacin, sotalol, sotovir monoclonal antibody (Xevudy TM ), sulfasalazine, sumatriptan, tadalafil, tamsulosin, temazepam, terbinafine, thiamine (vitamin B1), ticagrelor, tolterodine, topiramate, tramadol, tranexamic acid, trazodone, trimethoprim, valproic acid, valsartan, varenicline (Champix TM ), venlafaxine, verapamil, zolpidem, zopiclone and mixtures thereof.

14. The composition according to any one of claims 1 to 11, wherein The API is a cosmetic selected from the group consisting of compounds for moisturizing the skin, compounds for improving the appearance of the skin, compounds for protecting against environmental damage, compounds for combating the effects of aging, compounds for removing wrinkles and / or sun spots, and / or compounds for preventing any of the following skin conditions, and mixtures thereof: acne, acne / folliculitis, acne scars, aging skin, blemishes, broken blood vessels, brown spots or other discolored skin, cellulite, wrinkles around the mouth or nose, indentations or creases around the cheeks, temples, lips and eyes Dimples, dull and discolored skin, excess facial or body hair, enlarged pores, a tired or exhausted appearance, fine lines and wrinkles, flaking and cracked skin, a reddish appearance, freckles, furrows or wrinkles on the forehead, hair loss, hair loss, hirsutism and excess hair, hyperpigmentation, melasma, rosacea, sagging or volume loss, skin scarring, skin cancer, spider veins on the legs and face, sun damaged skin, sun spots, tattoo removal, changes in texture and tone, fine lines near the eyes or mouth, visible facial blood vessels, wrinkles and fine lines.

15. The composition according to any one of claims 1 to 11, wherein The API is a cosmetic compound selected from the group consisting of antioxidants (e.g., resveratrol, vitamin C), alpha hydroxy acids (AHA), hyaluronic acid, retinoids (e.g., retinol), vitamins (e.g., vitamin A, vitamin E), resorcinol, benzoyl peroxide, salicylic acid, ceramide, niacinamide, sulfur, sodium fluoride, sodium monophosphate, clioquinol, chloropropene iodine, miconazole nitrate, povidone iodine, tolnaftate, undecylenic acid, calcium undecylenate, copper undecylenate, zinc undecylenate, clotrimazole, chlortetracycline, neomycin sulfate, tetracycline hydrochloride, aluminum chloride, aluminum chlorohydrate, aluminum chlorohydrate polyethylene glycol, aluminum chlorohydrate propylene glycol, aluminum dichlorohydrate, Aluminum dichlorohydrate polyethylene glycol, aluminum dichlorohydrate propylene glycol, aluminum sesquichlorohydrate, aluminum sesquichlorohydrate polyethylene glycol, aluminum sesquichlorohydrate propylene glycol, aluminum zirconium octachlorohydrate, aluminum zirconium octachlorohydrate glycine, aluminum zirconium pentachlorohydrate, aluminum zirconium pentachlorohydrate glycine, aluminum zirconium tetrachlorohydrate, aluminum zirconium tetrachlorohydrate glycine, aluminum zirconium trichlorohydrate, aluminum zirconium trichlorohydrate glycine, allantoin, aluminum hydroxide gel, calamine, cocoa butter, cod liver oil, polydimethylsiloxane, glycerin, kaolin, lanolin, mineral oil, sodium bicarbonate, zinc acetate, zinc carbonate, zinc oxide, aluminum acetate, aluminum sulfate, witch hazel, selenium sulfide, zinc pyrithione, selenium sulfide, coal tar, hydroquinone, benzocaine, lidocaine, and mixtures thereof.

16. A method for delivering an active pharmaceutical ingredient (API) to a subject in need thereof, comprising: (i) providing a composition for delivery as defined in any one of claims 1 to 15; and (ii) administering the composition to a subject.

17. The method according to claim 16, wherein: The composition is administered by an administration route selected from the group consisting of topical administration, oral administration, sublingual administration, buccal administration, rectal administration, vaginal administration, ocular administration, ear administration, nasal administration, skin administration, and transdermal administration.

18. The method according to claim 16 or 17, wherein: The composition is formulated as a paste, ointment, cream, lotion, gel or emulsion.

19. The method according to claim 16 or 17, wherein: The composition is in the form of tablets, capsules, pills, granules, films, transdermal patches, implants, stents or suppositories.

20. A method for local delivery of an active pharmaceutical ingredient (API) to a subject in need thereof, comprising: (i) providing a composition for delivery as defined in any one of claims 1 to 15, said composition comprising a biopolymer and at least one API; and (ii) administering the composition to the body of the subject.

21. The method according to claim 20, wherein: The composition is applied to a surface of the subject's body selected from the group consisting of the hands, arms, legs, feet, torso, chest, face, neck, and scalp.

22. The method according to claim 20, wherein: The composition is applied as a paste, ointment, cream, lotion, gel or emulsion.

23. The method according to claim 20, wherein: The composition is administered as a transdermal patch.

24. A method for oral delivery of an active pharmaceutical ingredient (API) to a subject in need thereof, comprising: (i) providing a mixture comprising an API mixed in a biopolymer composition; (ii) drying the mixture to obtain a dry product; and (iii) orally administering the dried product to a subject.

25. The method according to claim 24, wherein: The composition is formulated as tablets, capsules, pills or granules.

26. A method for manufacturing a composition for delivery as defined in any one of claims 1 to 15, the method comprising: The API is mechanically processed together with the biopolymer under high shear conditions and / or at high mechanical energy to obtain a stable homogeneous aqueous composition.

27. The method according to claim 26, wherein: The mechanical processing is performed until a stable homogeneous aqueous suspension is obtained, comprising insoluble and / or semi-soluble particles of the API dispersed therein.

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