Absorbent articles

Abstract

In one aspect, the disclosure relates to articles, comprising: a first layer configured to be fluid-permeable; a second layer configured to be fluid-resistant; and a core configured to absorb and retain a fluid; wherein the core comprises at least one absorbent layer, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol. Also disclosed herein are articles comprising: a material configured to absorb and retain a fluid, the material comprising at least one absorbent layer, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol. The articles disclosed herein can further comprise at least one therapeutic agent. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present disclosure.

Description

ABSORBENT ARTICLESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims the benefit of and priority to U.S. Provisional Application No. 63 / 560,082 filed on March 1 , 2024, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Absorbent articles are products configured to absorb and / or retain soils and wastes (e.g., urine, blood, feces, menses). Examples of absorbent articles include menstrual products, such as tampons and sanitary napkins. Poor performance of menstrual products can negatively impact those who menstruate, especially in regions where menstruation is considered taboo. Additional concerns with menstrual products and other absorbent articles is the environmental consequences of waste generated by single-use disposable products. Many products contain synthetic materials either as supporting components (e.g., topsheets and backsheets in sanitary napkins or strings in tampons), as packaging, or as the absorbent component for some products (e.g., superabsorbent polymers). Regardless of the type of menstrual product, challenges associated with menstrual care, such as leakage and spillage during use and management, can result in user’s feeling shame, feeling distressed, and / or withdrawal from daily activities. Despite advances in the production of absorbent articles, there is still a scarcity of absorbent articles that can effectively absorb and / or retain soils and wastes and have the potential to be more environmentally friendly. These needs and other needs are satisfied by the present disclosure.SUMMARY

[0003] In accordance with the purpose(s) of the disclosure, as embodied and broadly described herein, the disclosure, in one aspect, relates to articles comprising: a first layer configured to be fluid-permeable; a second layer configured to be fluid-resistant; and a core configured to absorb and retain a fluid; wherein the first layer and second layer are independently chemically attached to the core, physically attached to the core, or a combination thereof; wherein the core is positioned between the first layer and the second layer; and wherein the core comprises at least one absorbent layer, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol, wherein the weight ratio of the polysaccharide to glycerol is from about 4:1 to about 1 :4. In a further aspect, the article can further comprise a therapeutic agent.

[0004] In another aspect, the disclosure relates to articles comprising a material configured to absorb and retain a fluid, the material comprising at least one absorbent layer, the absorbent layer comprising a polymer composition, and the polymer composition comprising apolysaccharide and glycerol, wherein the weight ratio of the polysaccharide to glycerol is from about 4:1 to about 1 :4. In a further aspect, the article can further comprise a therapeutic agent.

[0005] In another aspect, the disclosure relates to articles comprising a material configured to absorb and retain a fluid, the material comprising at least one absorbent layer and at least one therapeutic agent, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol, wherein the weight ratio of the polysaccharide to glycerol is from about 4:1 to about 1 :4.

[0006] Other systems, methods, features, and advantages of the present disclosure will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the present disclosure, and be protected by the accompanying claims. In addition, all optional and preferred features and modifications of the described aspects are usable in all aspects of the disclosure taught herein. Furthermore, the individual features of the dependent claims, as well as all optional and preferred features and modifications of the described aspects are combinable and interchangeable with one another.BRIEF DESCRIPTION OF THE FIGURES

[0007] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.

[0008] FIG. 1 A shows a setup of a representative droplet flow test.

[0009] FIG. 1 B shows representative droplet flow time scales proportionately with the kinematic viscosity of the alginate solution.

[0010] FIG. 1C shows representative screens of flow times for biopolymer solutions well mixed with water or defibrinated blood to a final concentration of 0.5 % wt., where for each biopolymer, results from mixtures with water and mixtures with blood are presented as the left bar and right bar, respectively.

[0011] FIGS. 1 D-1 E show representative pictures demonstrating that highly viscous biopolymer solutions can remain phase separated from blood if not well mixed, which affects their ability to solidify blood.

[0012] FIG. 2A shows pictures of representative processed alginate-glycerol formulation after drying, grinding, and sieving, with particle sizes ranging from 0.2 mm to 0.5 mm.

[0013] FIG. 2B shows a representative schematic of the setup used for testing powder blood retention.

[0014] FIGS. 2C-2D show the impact on blood retention by various alginate formulations presenting different alginate to glycerol ratios (particle size of 0.2 to 0.5 mm) after 3 min of incubation (FIG. 2C) and by particle size for AlgGly05after 15 min incubation at room temperature (FIG. 2D).

[0015] FIG. 2E shows results from a representative time series experiment to determine blood retention for super-absorbent PAA, high-molecular-weight alginate reagent, and AlgGly05(particle size 0.2 mm-0.5 mm).

[0016] FIG. 3A shows representative water contact angle measurements of alginate or AlgGly05films over time with corresponding representative images.

[0017] FIGS. 3B-3D show SEM micrographs of alginate (FIG. 3B), AlgGly05(FIG. 3C), and cross-linked polyacrylate (FIG. 3D) particles, with scale bars representing 500 pm for the low magnification figures and 50 pm for the higher magnification inset figures.

[0018] FIG. 3E shows a representative frequency sweep of pristine alginate or AlgGly05powders mixed with blood or calcium chloride solutions.

[0019] FIGS. 4A-4B show a representative experimental set up with a scheme pad assembly (FIG. 4A) and an attachment to a silicone-based artificial vagina (FIG. 4B).

[0020] FIG. 4C shows results from a representative experiment demonstrating the result of blood application to the device of FIG. 4B and permeation through a pad.

[0021] FIG. 4D shows measurement results of blood retained within the pad as well as blood that has permeated the pad or remained unabsorbed and pooling above the pad.

[0022] FIGS. 4E-4F show representative results of testing for blood retention in used pads via pictures (FIG. 4E) and the measured results (FIG. 4F).

[0023] FIGS. 4G-4H show pictures depicting a representative experimental setup for testing alginate-glycerol formulations to solidify blood in menstrual cups: powders were spread in the stockinette which were then coiled into the cups (FIG. 4G) and the cups were inserted into a Syngina, received blood, and incubated for 4 h at 37 °C (FIG. 4H).

[0024] FIG. 4I shows a representative image demonstrating the impact of alginate-glycerol formulations on blood consistency with menstrual cups.

[0025] FIG. 4J shows representative measurement of the fraction of blood spilled after individuals removed the incubated menstrual cups.

[0026] FIG. 4K shows representative compiled results, which demonstrate that significantly less blood is spilled when a stockinette containing the alginate-glycerol formulation is used.

[0027] FIGS. 5A-5B show representative results from formulations containing 20 mg of AlgGly05and varying amounts of TMC mixed with blood inoculated with 5 x 105cfu / mL (FIG. 5A) or 5 x 106cfu / mL (FIG. 5B) of S. aureus and incubated for 4 and 8 hours at 37°C.

[0028] FIG. 5C shows representative results from flow tests of powders mixed with blood.

[0029] FIG. 5D shows a schematic representation of powder function when mixed with blood and S. aureus.

[0030] FIG. 6 shows representative measurements of the impact of tube tilt angle on droplet flow time, conducted with aqueous solutions of LMW alginate in triplicate.

[0031] FIGS. 7A-7D show droplet flow time for representative alginate aqueous and defibrinated blood mixtures incubated at 37 °C and 200 rpm for 0 h (FIG. 7A), 2 h (FIG. 7B), 4 h (FIG. 7C), and 8 h (FIG. 7D), where measurements were conducted in triplicate.

[0032] FIGS. 8A-8B show droplet flow time for representative alginate aqueous, Na2EDTA blood, and defibrinated blood for alginate with G / M ratio <1.0 (FIG. 8A) or >1.5 (FIG. 8B). Measurements were performed with a solution final concentration of 1.5 % wt / v and for each viscosity, alginate aqueous (i.e. , in water), Na2EDTA blood, and defibrinated blood results are presented as the left bar, middle bar, and right bar, respectively.

[0033] FIGS. 9A-9B show strain sweep results of representative alginate-glycerol powders mixed with 0.25 mM CaCk (FIG. 9A) or blood (FIG. 9B).

[0034] FIGS. 10A-10C show panels of spillage due to removal of a menstrual cup with no filler (FIG. 10A), stockinette (FIG. 10B), and stockinette + Alginate-glycerol powder (FIG. 10C).

[0035] FIGS. 11A-11B show antimicrobial activity of 20 mg of representative alginate-glycerol powders mixed with TMC against S. aureus inoculated at 5 x 105cfu / mL (FIG. 11 A) or 5 x 106cfu / mL (FIG. 11B) and incubated for 4 hours or 8 hours at 37°C.

[0036] FIG. 12 shows a representative schematic depicting use of a tampon as a drug delivery system for menstrual-related symptoms, such as menstrual cramping.

[0037] FIG. 13A shows a representative schematic (top) and pictures (bottom) depicting the addition of 3 mL of blood to 300 mg of various formulations of materials (in sheets, strips, or powder), which were examined for their ability to absorb and retain blood.

[0038] FIG. 13B shows absorption capacity measures for representative formulations containing either 0 mg, 12 diclofenac, or 75 mg of diclofenac per gram of material.

[0039] FIG. 13C shows a schematic of a representative method for determining absorptive capacity of materials using a tampon-like shape.

[0040] FIGS. 13D shows capacity over time of representative materials alone (i.e., without alginate-glycerol material).

[0041] FIG. 14A shows a picture depicting a simulated menstruation model for testing absorptive capacity of tampon formulations, where blood was added at 50 mL / h to the top of a simulated vaginal tract containing various tampon formulations until leakage was observed.

[0042] FIGS. 14B-14D show the amount of blood added until leakage for representative dry formulations (FIG. 14B) and representative pre-hydrated formulations (FIG. 14D) and the distribution of blood absorbed in the tampon formulation or unabsorbed but retained for representative dry formulations (FIG. 14C) and representative pre-hydrated formulations (FIG.14E).

[0043] FIGS. 15A-15B show in vitro release of diclofenac from representative tampon formulations containing diclofenac-loaded film strips with gauze (1 :1 by mass), measured over time in blood, for both dry tampons containing 12 mg diclofenac per gram film (FIG. 15A) and pre-hydrated tampons containing 75 mg diclofenac per gram film (FIG. 15B).

[0044] FIG. 16A shows a schematic depicting representative intravaginal delivery of diclofenac in a mouse model, where female CD1 mice received a pre-hydrated tampon formulation intravaginally, followed by serum measurements over 8 h.

[0045] FIG. 16B shows serum concentrations of diclofenac over time.

[0046] FIG. 17 shows release of Lactobacilli over time from representative tampon formulations.

[0047] Additional advantages of the disclosure will be set forth in part in the description which follows, and in part will be obvious from the description, or can be learned by practice of the disclosure. The advantages of the disclosure will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure, as claimed.DETAILED DESCRIPTION

[0048] This disclosure is not limited to particular embodiments described, and as such may, of course, vary. The terminology used herein serves the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0049] Where a range of values is provided, each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0050] Embodiments of the present disclosure will employ, unless otherwise indicated, techniques of medicine, polymer chemistry, biochemistry, and the like, which are within the skill of the art. Such techniques are explained fully in the literature.

[0051] The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to perform the methods and use the compositions and compounds disclosed and claimed herein. Efforts have been made to ensure accuracy with respect to numbers (e.g., amounts, temperature, etc.), but some errors and deviations should be accounted for. Unless indicated otherwise, parts are parts by weight, temperature is in °C, and pressure is at or near atmospheric. Standard temperature and pressure are defined as 20 °C and 1 atmosphere.

[0052] It should be noted that ratios, concentrations, amounts, and other numerical data may be expressed herein in a range format. It is to be understood that such a range format is used for convenience and brevity, and thus, should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. To illustrate, a concentration range of “about 0.1 percent to about 5 percent” should be interpreted to include not only the explicitly recited concentration of about 0.1 weight percent to about 5 weight percent but also include individual concentrations (e.g., 1 percent, 2 percent, 3 percent, and 4 percent) and the subranges (e.g., 0.5 percent, 1.1 percent, 2.2 percent, 3.3 percent, and 4.4 percent) within the indicated range. The term “about” can include traditional rounding according to significant figures of the numerical value. In addition, the phrase “about ‘x’ to ‘y’” includes “about ‘x’ to about ‘y’”.

[0053] Furthermore, the terms “about”, “approximate”, “at or about”, and “substantially” as used herein mean that the amount or value in question can be the exact value or a value that provides equivalent results or effects as recited in the claims or taught herein. That is, it is understood that amounts, sizes, formulations, parameters, and other quantities andcharacteristics are not and need not be exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art such that equivalent results or effects are obtained. In some circumstances, the value that provides equivalent results or effects cannot be reasonably determined. In such cases, it is generally understood, as used herein, that “about” and “at or about” mean the nominal value indicated ±10% variation unless otherwise indicated or inferred. In general, an amount, size, formulation, parameter or other quantity or characteristic is “about,” “approximate,” or “at or about” whether or not expressly stated to be such. It is understood that where “about,” “approximate,” or “at or about” is used before a quantitative value, the parameter also includes the specific quantitative value itself, unless specifically stated otherwise.

[0054] Before the embodiments of the present disclosure are described in detail, it is to be understood that, unless otherwise indicated, the present disclosure is not limited to particular materials, reagents, reaction materials, manufacturing processes, dimensions, frequency ranges, applications, or the like, as such can vary. It is also to be understood that the terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting. It is also possible in the present disclosure that steps can be executed in different sequence, where this is logically possible. It is also possible that the embodiments of the present disclosure can be applied to additional embodiments involving measurements beyond the examples described herein, which are not intended to be limiting. It is furthermore possible that the embodiments of the present disclosure can be combined or integrated with other measurement techniques beyond the examples described herein, which are not intended to be limiting.

[0055] It should be noted that, as used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a support”, “a bacterium”, or “an agent” includes a plurality of supports, bacteria, agents, and the like. In this specification and in the claims that follow, reference will be made to a number of terms that shall be defined to have the following meanings unless a contrary intention is apparent.

[0056] Each of the applications and patents cited in this text, as well as each document or reference cited in each of the applications and patents (including during the prosecution of each issued patent; “application cited documents”), and each of the PCT and foreign applications or patents corresponding to and / or claiming priority from any of these applications and patents, and each of the documents cited or referenced in each of the application cited documents, are hereby expressly incorporated herein by reference. Further, documents or references cited in this text, in a Reference List before the claims, or in the text itself; and eachof these documents or references (“herein cited references”), as well as each document or reference cited in each of the herein-cited references (including any manufacturer’s specifications, instructions, etc.) are hereby expressly incorporated herein by reference.

[0057] As used herein, nomenclature for compounds, including organic compounds, can be given using common names, IUPAC, IUBMB, or CAS recommendations for nomenclature. When one or more stereochemical features are present, Cahn-lngold-Prelog rules for stereochemistry can be employed to designate stereochemical priority, E / Z specification, and the like. One of skill in the art can readily ascertain the structure of a compound if given a name, either by systemic reduction of the compound structure using naming conventions, or by commercially available software, such as CHEMDRAW™ (Cambridgesoft Corporation, U.S.A.).

[0058] Compounds of the disclosure can be prepared using reactions and methods generally known to the person of ordinary skill in the art, having regard to that knowledge and the disclosure of this application including the Examples. The reactions are performed in solvent appropriate to the reagents and materials used and suitable for the reactions being effected. It will be understood by those skilled in the art of organic synthesis that the functionality present on the compounds should be consistent with the proposed reaction steps. This will sometimes require modification of the order of the synthetic steps or selection of one particular process scheme over another in order to obtain a desired compound of the disclosure. It will also be recognized that another major consideration in the development of a synthetic route is the selection of the protecting group used for protection of the reactive functional groups present in the compounds described in this disclosure. An authoritative account describing the many alternatives to the skilled artisan is Greene and Wuts (Protective Groups In Organic Synthesis, Wiley and Sons, 1991).

[0059] Prior to describing the various embodiments, the following definitions are provided and should be used unless otherwise indicated.A. DEFINITIONS

[0060] As used herein, the term “absorbent article” refers to a product configured to absorb and / or retain soils and wastes (e.g., urine, blood, feces, menses). Absorbent articles can include, but are not limited to, sanitary napkins, tampons, panty liners, interlabial pads, wound dressings, wipes, disposable diapers (e.g., taped diapers and diaper pants), inserts for diapers with a reusable outer cover, adult incontinent diapers, adult incontinent pads, adult incontinent pants, pet pads, meat pads, poultry pads, and the like.

[0061] As used herein, the terms “menstrual product” or “menstrual hygiene product” refer to a product configured to absorb and / or retain menses, blood, or vaginal discharge. Menstrualhygiene products can include tampons, sanitary napkins, panty liners, menstrual cups, and the like.

[0062] As used herein, the term "disposable" or “single-use” refers to products which are generally not intended to be laundered or otherwise restored or reused. Disposable or singleuse articles can be configured to be recycled, composted, or otherwise disposed of in an environmentally compatible manner.

[0063] As used herein, “therapeutic agent” can refer to any substance, compound, molecule, and the like, which can be biologically active or otherwise can induce a pharmacologic, immunogenic, biologic and / or physiologic effect on a subject to which it is administered to by local and / or systemic action. A therapeutic agent can be a primary active agent, or in other words, the component(s) of a composition to which the whole or part of the effect of the composition is attributed. A therapeutic agent can be a secondary therapeutic agent, or in other words, the component(s) of a composition to which an additional part and / or other effect of the composition is attributed. The term therefore encompasses those compounds or chemicals traditionally regarded as drugs, vaccines, and biopharmaceuticals including molecules such as proteins, peptides, hormones, nucleic acids, gene constructs and the like. Examples of therapeutic agents are described in well-known literature references such as the Merck Index (14th edition), the Physicians' Desk Reference (64th edition), and The Pharmacological Basis of Therapeutics (12th edition), and they include, without limitation, medicaments; vitamins; mineral supplements; substances used for the treatment, prevention, diagnosis, cure or mitigation of a disease or illness; substances that affect the structure or function of the body, or pro-drugs, which become biologically active or more active after they have been placed in a physiological environment. For example, the term “therapeutic agent” includes compounds, compositions, and the like for use in all of the major therapeutic areas including, but not limited to, adjuvants; anti-infectives such as antibiotics and antiviral agents; analgesics and analgesic combinations; anorexics; anti-inflammatories; anti-epileptics; local and general anesthetics; hypnotics; sedatives; antipsychotics; neuroleptics; antidepressants; anxiolytics; antagonists; neuron blocking; anticholinergics and cholinomimetics; antimuscarinics and muscarinics; antiadrenergics; antiarrhythmics; antihypertensives; hormones; nutrients; antiarthritics; antiasthmatics; anticonvulsants; antihistamines; antinauseants; antineoplastics; antipruritics; antipyretics; antispasmodics; antimicrobials; cardiovascular preparations (including calcium channel blockers, beta-blockers, beta-agonists and antiarrythmics); antihypertensives; diuretics; vasodilators; central nervous system stimulants; cough and cold preparations; decongestants; diagnostics; bone growth stimulants and bone resorption inhibitors; immunosuppressives; living therapeutics (e.g., altered or genetically engineered bacteria); muscle relaxants; psychostimulants; sedatives; tranquilizers;proteins, peptides, and fragments thereof (whether naturally occurring, chemically synthesized or recombinantly produced); nucleic acid molecules (polymeric forms of two or more nucleotides, either ribonucleotides (RNA) or deoxyribonucleotides (DNA) including both double- and single-stranded molecules, gene constructs, expression vectors, antisense molecules and the like); probiotics such as bacteria and yeast; small molecules (e.g., diclofenac) and other biologically active macromolecules such as, for example, proteins and enzymes. The agent may be a biologically active agent used in medical, including veterinary, applications and in agriculture, such as with plants, as well as other areas. The term therapeutic agent also includes without limitation, medicaments; vitamins; mineral supplements; substances used for the treatment, prevention, diagnosis, cure or mitigation of disease or illness; or substances which affect the structure or function of the body; or prodrugs, which become biologically active or more active after they have been placed in a predetermined physiological environment.

[0064] As used herein, the term “subject” can be a vertebrate, such as a mammal, a fish, a bird, a reptile, or an amphibian. Thus, the subject of the herein disclosed methods can be a human, non-human primate, horse, pig, rabbit, dog, sheep, goat, cow, cat, guinea pig or rodent. The term does not denote a particular age or sex. Thus, adult and juvenile subjects, whether male or female, are intended to be covered. In one aspect, the subject is a mammal. A patient refers to a subject afflicted with a disease or disorder. The term “patient” includes human and veterinary subjects.

[0065] As used herein, the terms "treating" and "treatment" can refer generally to obtaining a desired pharmacological and / or physiological effect. The effect can be, but does not necessarily have to be, prophylactic in terms of preventing or partially preventing a disease, symptom or condition thereof. The effect can be therapeutic in terms of a partial or complete cure of a disease, condition, symptom or adverse effect attributed to the disease, disorder, or condition. The term "treatment" can include any one or more of the following: (a) preventing the disease from occurring in a subject which may be predisposed to the disease but has not yet been diagnosed as having it; (b) inhibiting the disease, i.e., arresting its development; and (c) relieving the disease, i.e., mitigating or ameliorating the disease and / or its symptoms or conditions. The term "treatment" as used herein can refer to both therapeutic treatment alone, prophylactic treatment alone, or both therapeutic and prophylactic treatment. Those in need of treatment (subjects in need thereof) can include those already with the disorder and / or those in which the disorder is to be prevented. As used herein, the term "treating", can include inhibiting the disease, disorder or condition, e.g., impeding its progress; and relieving the disease, disorder, or condition, e.g., causing regression of the disease, disorder and / or condition. Treating the disease, disorder, or condition can include ameliorating at least onesymptom of the particular disease, disorder, or condition, even if the underlying pathophysiology is not affected, e.g., such as treating the pain of a subject by administration of an analgesic agent even though such agent does not treat the cause of the pain.

[0066] As used herein, “dose,” “unit dose,” or “dosage” can refer to physically discrete units suitable for use in a subject, each unit containing a predetermined quantity of a disclosed compound and / or a pharmaceutical composition thereof calculated to produce the desired response or responses in association with its administration.

[0067] As used herein, “effective amount” can refer to the amount of a disclosed therapeutic agent or pharmaceutical composition provided herein that is sufficient to effect beneficial or desired biological, emotional, medical, or clinical response of a cell, tissue, system, animal, or human. An effective amount can be administered in one or more administrations, applications, or dosages. The term can also include within its scope amounts effective to enhance or restore to substantially normal physiological function.

[0068] As used herein, the term “therapeutically effective amount” refers to an amount that is sufficient to achieve the desired therapeutic result or to have an effect on undesired symptoms, but is generally insufficient to cause adverse side effects. The specific therapeutically effective dose level for any particular patient will depend upon a variety of factors including the disorder being treated and the severity of the disorder; the specific composition employed; the age, body weight, general health, sex and diet of the patient; the time of administration; the route of administration; the rate of excretion of the specific compound employed; the duration of the treatment; drugs used in combination or coincidental with the specific compound employed and like factors within the knowledge and expertise of the health practitioner and which may be well known in the medical arts. In the case of treating a particular disease or condition, in some instances, the desired response can be inhibiting the progression of the disease or condition. This may involve only slowing the progression of the disease temporarily. However, in other instances, it may be desirable to halt the progression of the disease permanently. This can be monitored by routine diagnostic methods known to one of ordinary skill in the art for any particular disease. The desired response to treatment of the disease or condition also can be delaying the onset or even preventing the onset of the disease or condition.

[0069] For example, it is well within the skill of the art to start doses of a compound at levels lower than those required to achieve the desired therapeutic effect and to gradually increase the dosage until the desired effect is achieved. If desired, the effective daily dose can be divided into multiple doses for purposes of administration. Consequently, single dose compositions can contain such amounts or submultiples thereof to make up the daily dose. The dosage can be adjusted by the individual physician in the event of any contraindications.It is generally preferred that a maximum dose of the pharmacological agents of the invention (alone or in combination with other therapeutic agents) be used, that is, the highest safe dose according to sound medical judgment. It will be understood by those of ordinary skill in the art however, that a patient may insist upon a lower dose or tolerable dose for medical reasons, psychological reasons or for virtually any other reasons.

[0070] A response to a therapeutically effective dose of a disclosed compound and / or pharmaceutical composition, for example, can be measured by determining the physiological effects of the treatment or medication, such as the decrease or lack of disease symptoms following administration of the treatment or pharmacological agent. Other assays will be known to one of ordinary skill in the art and can be employed for measuring the level of the response. The amount of a treatment may be varied for example by increasing or decreasing the amount of a disclosed compound and / or pharmaceutical composition, by changing the disclosed compound and / or pharmaceutical composition administered, by changing the route of administration, by changing the dosage timing and so on. Dosage can vary, and can be administered in one or more dose administrations daily, for one or several days. Guidance can be found in the literature for appropriate dosages for given classes of pharmaceutical products.

[0071] The term “pharmaceutically acceptable” describes a material that is not biologically or otherwise undesirable, i.e., without causing an unacceptable level of undesirable biological effects or interacting in a deleterious manner.B. ABBREVIATIONS

[0072] CMC carboxymethyl cellulose

[0073] HMW high molecular weight

[0074] LMIC low-to-middle income countries

[0075] LMW low molecular weight

[0076] PAA polyacrylic acid

[0077] SEM scanning electron microscopy

[0078] TMC trimethyl chitosanC. DISCUSSION

[0079] In one aspect, the present disclosure provides for articles comprising an absorbent layer, or absorbent core comprising an absorbent layer, that includes a polymer composition. The polymer composition includes a polysaccharide and glycerol. In a further aspect, the articles disclosed herein can comprise a therapeutic agent. The articles can optionally beutilized to deliver a therapeutic agent to a subject. In some aspects, the articles are absorbent articles, such as menstrual hygiene products, diapers, wound dressings, and the like.

[0080] As discussed herein, the articles of the present disclosure can include menstrual products. Adequately managing menstruation is an important factor for the overall quality of life for people who menstruate. With a growing discussion of the global need for improved menstrual health and hygiene, better management of menstruation can positively influence social, educational, and professional outcomes for those who menstruate. Current menstrual products can be inaccessible or unaffordable in low-to-middle income countries. Additionally, many menstrual products, such as single-use disposable pads and tampons, generate a significant amount of waste every year. In one aspect, disclosed herein is a biodegradable material that can solidify fluids such as menses, blood, or vaginal discharge in a mechanism alternative to coagulation. The material can be deployed as both a traditional menstrual pad or tampon filler and as an additive to menstrual cups to reduce leakage and reduce spillage, respectively. This biodegradable formulation, derived from renewable resources, can improve menstrual care.

[0081] In one aspect, an article disclosed herein comprises a first layer configured to be fluid- permeable, a second layer configured to be fluid-resistant, and a core configured to absorb and retain a fluid. The fluid-permeable layer can be physically and / or chemically attached to the core. Means of attachment can include stitching, weaving, pinning, adhering, fastening, or other methods of attachment known in the art of hygiene articles. The fluid-resistant layer can also be physically and / or chemically attached to the core by the same or different means of attachment. For example, the core can be attached to the first layer or the second layer via an adhesive. In one aspect, the core is positioned or disposed between the fluid-permeable layer and the fluid-resistant layer.

[0082] The first layer or fluid-permeable layer is configured to allow fluids (e.g., urine, menses, or blood) to penetrate through the layer. The fluid-permeable layer can be a single layer or can be comprised of multiple sub-layers. In one aspect, the fluid-permeable layer is configured to wick moisture through the article to the core. The fluid-permeable layer can be comprised of woven materials, nonwoven materials, or any combination thereof. Nonwoven materials can refer to a material made from continuous (long) filaments (fibers) and / or discontinuous (short) filaments (fibers) by processes such as spunbonding, meltblowing, carding, and the like. Nonwoven materials do not have a woven or knitted filament pattern. Both woven and nonwoven materials as disclosed herein can include natural fibers, synthetic fibers, or combinations thereof. Natural fibers can include, for example, cellulose, rayon, cotton, and any combination thereof. Synthetic fibers can include, for example, cellulose acetate, polyvinyl fluoride, polyvinylidene chloride, acrylics, polyvinyl acetate, non-soluble polyvinyl alcohol,polyethylene, polypropylene, polyamides, polyesters, bicomponent fibers, tricomponent fibers, and any combinations thereof. The fluid-permeable layer can be comprised of other materials in addition to or instead of the woven or nonwoven materials, such as apertured or hydroformed thermoplastic films, porous foams, reticulated foams, reticulated thermoplastic films, thermoplastic scrims, and combinations thereof.

[0083] The second layer or fluid-resistant layer is configured to prevent fluids (e.g., urine, menses, or blood) from passing through the layer. In one aspect, the fluid-resistant layer is configured to allow water vapor and / or air to permeate through the layer (i.e., the layer is breathable) without allowing fluids to pass through. The fluid-resistant layer can be a single layer or can be comprised of multiple sub-layers. The fluid-resistant layer can be comprised of woven or nonwoven materials that include natural fibers, synthetic fibers, or combinations thereof. Natural fibers can include, for example, cellulose, rayon, cotton, and any combination thereof. Synthetic fibers can include, for example, cellulose acetate, polyvinyl fluoride, polyvinylidene chloride, acrylics, polyvinyl acetate, non-soluble polyvinyl alcohol, polyethylene, polypropylene, polyamides, polyesters, bicomponent fibers, tricomponent fibers, and any combinations thereof. The fluid-resistant layer can be comprised of other materials in addition to or instead of the woven or nonwoven materials, such as thermoplastic films comprised of a single thermoplastic polymer or a blend of thermoplastic polymers (e.g., polyethylene or polypropylene); composite materials comprising a film and a nonwoven material; or combinations thereof.

[0084] The core or absorbent core can comprise at least one absorbent layer and a polymer composition of the present disclosure. In one aspect, the polymer composition can be integrated within (e.g., impregnated), contained within, and / or disposed on and / or within the absorbent core. In another aspect, the polymer composition can be disposed on the absorbent layer and / or dispersed or integrated within the absorbent layer. The absorbent layer can further comprise woven or nonwoven materials that include natural fibers, synthetic fibers, or combinations thereof. Natural fibers can include, for example, cellulose, rayon, cotton, and any combination thereof. Synthetic fibers can include, for example, cellulose acetate, polyvinyl fluoride, polyvinylidene chloride, acrylics, polyvinyl acetate, non-soluble polyvinyl alcohol, polyethylene, polypropylene, polyamides, polyesters, bicomponent fibers, tricomponent fibers, and any combinations thereof. The absorbent layer can also comprise, in addition to or in place of the woven or nonwoven materials, additional materials such as thermoplastic films comprised of a single thermoplastic polymer or a blend of thermoplastic polymers (e.g., polyethylene or polypropylene); composite materials comprising a film and a nonwoven material; or combinations thereof. The thermoplastic films can include additional thermoplastic diluents known in the art, such as tackifying resins, plasticizers, and additives such asantioxidants. In another aspect, the first layer, second layer, and / or core can include one or more hygienic or esthetic gels, oils, lotions, creams, or other fluids, such as antibiotic ointments, moisturizers, anti-odor agents, and / or scented products. Additionally, therapeutic agents can be included within or on the first layer, second layer, and / or core.

[0085] Also disclosed herein are articles comprising a material configured to absorb and retain a fluid, the material comprising at least one absorbent layer. In one aspect, the article is an absorbent core used in an absorbent article. The absorbent layer can include a polymer composition as disclosed herein. In a further aspect, the absorbent layer can comprise a support, wherein the polymer composition is integrated within (e.g., impregnated), contained within, and / or disposed on and / or within the support.

[0086] In one aspect, the support can comprise woven or nonwoven materials that include natural fibers, synthetic fibers, or combinations thereof. Natural fibers can include, for example, cellulose, rayon, cotton, and any combination thereof. Synthetic fibers can include, for example, cellulose acetate, polyvinyl fluoride, polyvinylidene chloride, acrylics, polyvinyl acetate, non-soluble polyvinyl alcohol, polyethylene, polypropylene, polyamides, polyesters, bicomponent fibers, tricomponent fibers, and any combinations thereof. The support can also comprise, in addition to or in place of the woven or nonwoven materials, additional materials such as thermoplastic films comprised of a single thermoplastic polymer or a blend of thermoplastic polymers (e.g., polyethylene or polypropylene); composite materials comprising a film and a nonwoven material; or combinations thereof. The thermoplastic films can include additional thermoplastic diluents known in the art, such as tackifying resins, plasticizers, and additives such as antioxidants. In another aspect, the absorbent layer or the support can include one or more hygienic or esthetic gels, oils, lotions, creams, or other fluids, such as antibiotic ointments, moisturizers, anti-odor agents, and / or scented products. Additionally, therapeutic agents can be included within or on the material, for example the absorbent layer or the support.

[0087] The polymer composition can be uniform or non-uniformly distributed on or within the absorbent core and / or absorbent layer. In an aspect, the polymer composition can be embedded in the absorbent core or absorbent layer. In one aspect, the polymer composition can increase the viscosity of a fluid that it comes into contact with via gelation. In one aspect, the polymer composition comprises a polysaccharide and glycerol. The weight ratio of the polysaccharide to glycerol can range from about 8: 1 to about 1 :8, about 6: 1 to about 1 :6, about 4: 1 to about 1 :4, about 2:1 to about 1 :2, or about 1 :1. The polysaccharide can be selected from sodium alginate, xanthan gum, kappa-carrageenan (k-carrageenan), iota-carrageenan (l-carrageenan), and a combination thereof. In one aspect, the polymer composition is a biodegradable and / or biocompostable formulation. Additionally, the polymer composition canbe an absorbent polymer composition. In a further aspect, the polymer composition, the absorbent layer, and / or the absorbent core can have absorption properties that are similar to or better than commercial superabsorbent polymers (e.g., crosslinked polyacrylic acid), absorbent layers, and / or absorbent cores used in absorbent articles. Absorbency of the polymer compositions can be assessed by centrifuge retention capacity, absorption under load, absorption rate, and / or free swell capacity.

[0088] Free swell capacity (FSC) is a measure of the ability of a material or composition to absorb fluids, i.e., swell. FSC can be expressed as grams of fluid absorbed per gram weight of the absorbing composition or material. For the compositions and / or articles disclosed herein, this is grams of fluid absorbed per gram weight of the polymer composition (g / g). In one aspect, the polymer compositions and / or articles disclosed herein have a FSC in defibrinated blood of about 2 g / g to about 15 g / g, 2 g / g to about 12 g / g, 2 g / g to about 10 g / g, about 2 g / g to about 8 g / g, about 3 g / g to about 7 g / g, or about 4 g / g to about 6 g / g. In another aspect, polymer compositions and / or articles disclosed herein have a FSC in defibrinated blood of at least about 2 g / g, at least about 3 g / g, at least about 4 g / g, at least about 5 g / g, at least about 6 g / g, at least about 8 g / g, or at least about 10 g / g. In a further aspect, the polymer compositions disclosed and / or articles herein have a FSC of about 5 g / g in defibrinated blood. In a further aspect, the defibrinated blood used to test the FSC of the polymer compositions can be defibrinated porcine blood.

[0089] Centrifuge retention capacity (CRC) is a measure of the ability of a material or composition to retain a fluid after being saturated and subjected to centrifugation under controlled conditions. Tests of CRC can be performed at different spin rates and for various lengths of time. For example, in one aspect the polymer compositions and other materials disclosed herein are centrifuged at a relative centrifugal force of about 800G to about 1200G for about 2 to 8 minutes. In one aspect, CRC tests include a sample being centrifuged at approximately 1000G for approximately 5 minutes. CRC can be expressed as grams of fluid retained per gram weight of the absorbing composition or material. For the polymer compositions and / or articles disclosed herein, this is grams of fluid retained per gram weight of the polymer composition (g / g). In one aspect, the polymer compositions and / or articles disclosed herein have a CRC in defibrinated blood of about 2 g / g to about 15 g / g, 2 g / g to about 12 g / g, 2 g / g to about 10 g / g, about 2 g / g to about 8 g / g, about 3 g / g to about 7 g / g, or about 4 g / g to about 6 g / g. In another aspect, polymer compositions and / or articles disclosed herein have a CRC in defibrinated blood of at least about 2 g / g, at least about 3 g / g, at least about 4 g / g, at least about 5 g / g, at least about 6 g / g, or at least about 8 g / g. In a further aspect, the polymer compositions and / or articles disclosed herein have a CRC of about 3 g / gto about 4 g / g in defibrinated blood. In a further aspect, the defibrinated blood used to test the CRC of the polymer compositions can be defibrinated porcine blood.

[0090] In some aspects, the FSW and the CRC of the polymer compositions disclosed herein, the articles disclosed herein, and / or the absorbent layers or absorbent cores disclosed herein can be better than other commercially available absorbent materials or superabsorbent polymers, such as crosslinked polyacrylate. For example, some commercially available menstrual pads have been tested and found to have an FSC in defibrinated porcine blood of about 5 g / g and a CRC in defibrinated porcine blood of about 1.5 g / g. A crosslinked polyacrylate composition has been tested and found to have an FSC in defibrinated porcine blood of about 3 g / g and a CRC in defibrinated porcine blood of about 1 .5 g / g.

[0091] The polymer compositions can be in the form of powders, films, or liquid solutions. In one aspect, the polysaccharide and glycerol compositions comprise particles, such as polysaccharide-glycerol particles. The average particle size of particles in the polymer composition can range from about 0.1 mm to about 5.0 mm, about 0.1 mm to about 3.0 mm, about 0.1 mm to about 1.0 mm, about 0.1 mm to about 0.8 mm, or about 0.2 mm to about 0.5 mm. One method forforming a powder form of the polymer composition includes solubilization of the polysaccharide and glycerol in aqueous solutions, drying the resulting solid mixture, and then mechanically grinding the solid mixture. The solid mixture can be distributed on or within the absorbent core and / or absorbent layer.

[0092] In another aspect, the polymer compositions can be in the form of a film. The film comprising the polymer composition can be shredded and the shredded film pieces distributed on or within the absorbent core and / or absorbent layer. In another aspect, the film can be cut into a desired size and / or shape and disposed on (e.g., layered on) and / or within the absorbent core and / or absorbent layer. In one aspect, the film thickness can have a thickness of at least 10 pm, at least 25 pm, at least 50 pm, at least 75 pm, or at least 100 pm. In another aspect, range from about 10 pm to about 500 pm, about 10 pm to about 250 pm, about 250 pm to about 500 pm, about 50 pm to about 450 pm, about 100 pm to about 300 pm, about 300 pm to about 500 pm, or about 10 pm to about 100 pm. The film can comprise other components in addition to the polymer composition, such as therapeutic agents.

[0093] When the polysaccharide comprises sodium alginate, a high molecular weight or a low molecular weight sodium alginate can be used. In one aspect, the polysaccharide comprises a high molecularweight sodium alginate, where the molecularweight is from about 100 kg / mol to about 500 kg / mol, about 150 kg / mol to about 450 kg / mol, about 200 kg / mol to about 500 kg / mol, about 150 kg / mol to about 400 kg / mol, or about 200 kg / mol to about 400 kg / mol. The sodium alginate can have a D-mannuronate to L-guluronate ratio of about 1 :2 to about 2:1 .

[0094] In another aspect, disclosed herein is an article comprising: a material configured to absorb and retain a fluid, the material comprising at least one absorbent layer and at least one therapeutic agent. The absorbent layer can comprise a polymer composition as disclosed herein. In a further aspect, the absorbent layer can comprise a support, wherein the polymer composition is integrated within (e.g., impregnated), contained within, and / or disposed on and / or within the support. The therapeutic agent can be included in the material in a therapeutically effective amount. The therapeutic agent can be included in the material, for example in the absorbent layer, the support, and / or in the polymer composition. For example, the therapeutic agent can be integrated within (e.g., impregnated), contained within, and / or disposed on and / or within the support.

[0095] In one aspect, the support can comprise woven or nonwoven materials that include natural fibers, synthetic fibers, or combinations thereof. Natural fibers can include, for example, cellulose, rayon, cotton, and any combination thereof. Synthetic fibers can include, for example, cellulose acetate, polyvinyl fluoride, polyvinylidene chloride, acrylics, polyvinyl acetate, non-soluble polyvinyl alcohol, polyethylene, polypropylene, polyamides, polyesters, bicomponent fibers, tricomponent fibers, and any combinations thereof. The support can also comprise, in addition to or in place of the woven or nonwoven materials, additional materials such as thermoplastic films comprised of a single thermoplastic polymer or a blend of thermoplastic polymers (e.g., polyethylene or polypropylene); composite materials comprising a film and a nonwoven material; or combinations thereof. The thermoplastic films can include additional thermoplastic diluents known in the art, such as tackifying resins, plasticizers, and additives such as antioxidants. In another aspect, the absorbent layer or the support can include one or more hygienic or esthetic gels, oils, lotions, creams, or other fluids, such as antibiotic ointments, moisturizers, anti-odor agents, and / or scented products.

[0096] As discussed herein, the articles disclosed herein can comprise a therapeutic agent. Examples of such therapeutic agents include, but are not limited to, botanicals, vitamins, moisturizers, antifungal agents, antibacterial agents, probiotic agents, calcium, magnesium, hormones, analgesic agents, prostaglandin inhibitors, prostaglandin synthetase inhibitor agents, leukotriene receptor antagonist agents, essential fatty acids, sterols, anti-inflammatory agents, vasodilator agents, chemotherapeutic agents, and agents to treat infertility. The therapeutic agents can be formulated with one or more pharmaceutically acceptable excipients, diluents, carriers, and / or adjuvants. In one aspect, the therapeutic agents can include therapeutic agents used to treat a disease, symptom, or condition associated with menstruation, such as premenstrual syndrome, dysmenorrhea, menorrhagia, metrorrhagia, amenorrhea, oligomenorrhea, hypomenorrhea, and the like. In a further aspect, the therapeutic agent can include small molecules, bacteria, proteins, or a combination thereof.

[0097] Examples of small molecule therapeutic agents include, but are not limited to, antiinflammatory agents and / or analgesic agents (e.g., diclofenac, naproxen, ibuprofen, niflumic acid, meloxicam, lysine clonixinate, ketoprofen, other NSAIDS); antifungal agents (e.g., clotrimazole, miconazole, fluconazole); antibiotic agents (e.g., metronidazole, clindamycin, sulfonamides); hormones (e.g., estrogens, progesterone); clotting promoters (e.g., tranexamic acid); contraceptive agents and / or spermicide agents (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride); lubricants / moisturizers (e.g., hyaluronic acid); protease inhibitors (e.g., lopinavir, ritonavir, nelfinavir, saquinavir); and vitamins / cofactors (e.g., Vitamin E, Vitamin C, Vitamin D, Omega 3 fatty acid, sea buckthorn oil). Examples of protein therapeutic agents include cytokines (e.g., members of the Th1 cytokines family, interleukin (I L)-29, IL-33, TGF-p, IL-1 , IL-6, IL-8, TNF-a, IL-27); proteases (e.g., matrix metallopeptidase, alkaline phosphatases, beta-glucosidases, beta-lactamases, l-asparaginase); protease inhibitors; proteins for apoptosis (e.g., cytochrome C, caspase-3, caspase-8, tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL), granzyme B); and antibodies and their conjugates (e.g., pembrolizumab , tisotumab vedotin (brand name Tivdak®), bevacizumab (brand name Avastin®), Cimavax-EGF, Vitespen (formerly Oncophage®). In a further aspect, when the therapeutic agent includes bacteria, the bacteria can be characterized as commensal or non-pathogenic bacteria. Examples of commensal bacteria include some Lactobacilli bacteria (e.g., Lactobacillus crispatus, Lactobacillus iners, Lactobacillus paragasseri, Lactobacillus mulieris, Lactobaccillus crispatus).

[0098] In a further aspect, the therapeutic agent can include an antimicrobial polymer. In one aspect, the antimicrobial polymer can be included in the polymer composition. The antimicrobial polymer can be a polycationic polymer. In one aspect, the polycationic polymer can be selected from chitosan, s-poly-L-lysine, regular poly-L-lysine, poly-D-lysine, polyethylenimine, polyguanidine, polyarginine, derivatives thereof, and combinations thereof. In a further aspect, the antimicrobial polymer is trimethyl chitosan. The weight ratio of the polysaccharide-glycerol composition to the antimicrobial polymer in the article can be from about 15:1 to about 1 :1 , about 15:1 to about 2:1 , about 12:1 to about 2:1 , about 12:1 to about 5:1 , or about 10:1 to about 2:1. In one aspect, the antimicrobial polymer can kill microorganisms, such as bacteria (e.g., pathogenic bacteria), and / or stop and / or reduce the growth of microorganisms. In one aspect, the antimicrobial polymer targets or selectively targets pathogenic bacteria, such as Staphylococcus (e.g., Staphylococcus aureus). In a further aspect, the antimicrobial polymer targets or selectively targets other pathogenic bacteria found in the vaginal tract normally or abnormally, such as some Lactobacillus and other lactic acid species from the genera Atopobium, Leptotrichia, Leuconostoc, Megasphaera, Pediococcus, Streptococcus, and Weissella; other bacteria such as Atopobiumvaginae, Peptostreptococcus spp., Staphylococcus spp., Streptococcus spp., Bacteroides spp., Fusobacterium spp., Gardnerella vaginalis, Mobiluncus, and Prevotella spp.; gramnegative enteric organisms, such as Escherichia coir, Mycoplasma; and Ureaplasma.

[0099] While embodiments of the present disclosure are described in connection with the Examples and the corresponding text and figures, there is no intent to limit the disclosure to the embodiments in these descriptions. On the contrary, the intent is to cover all alternatives, modifications, and equivalents included within the spirit and scope of embodiments of the present disclosure.D. ASPECTS

[0100] The following listing of exemplary aspects supports and is supported by the disclosure provided herein.

[0101] Aspect 1. An article, comprising: a first layer configured to be fluid-permeable; a second layer configured to be fluid-resistant; and a core configured to absorb and retain a fluid; wherein the first layer and second layer are independently chemically attached to the core, physically attached to the core, or a combination thereof; wherein the core is positioned between the first layer and the second layer; and wherein the core comprises at least one absorbent layer, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol, wherein the weight ratio of the polysaccharide to glycerol is from about 4:1 to about 1 :4.

[0102] Aspect 2. The article of aspect 1 , wherein the polysaccharide is selected from sodium alginate, xanthan gum, kappa-carrageenan, iota-carrageenan, and a combination thereof.

[0103] Aspect 3. The article of aspect 1 or aspect 2, wherein the polysaccharide comprises sodium alginate.

[0104] Aspect 4. The article of aspect 2 or aspect 3, wherein the sodium alginate has a molecular weight of about 200 kg / mol to about 500 kg / mol.

[0105] Aspect 5. The article of any one of aspects 2-4, wherein the sodium alginate has a D- mannuronate to L-guluronate ratio of about 1 :2 to about 2:1 .

[0106] Aspect 6. The article of any one of aspects 1-5, wherein the weight ratio of the polysaccharide to glycerol is about 2:1 .

[0107] Aspect 7. The article of any one of aspects 1-6, wherein the polymer composition comprises particles having an average particle size of from about 0.1 mm to about 1.0 mm.

[0108] Aspect 8. The article of any one of aspects 1-7, wherein the polymer composition has a free swell capacity of about 2 g / g to about 15 g / g in defibrinated blood.

[0109] Aspect 9. The article of any one of aspects 1-8, wherein the article further comprises a therapeutically effective amount of a therapeutic agent.

[0110] Aspect 10. The article of aspect 9, wherein the therapeutic agent comprises a small molecule, a bacterium, or a protein.

[0111] Aspect 11. The article of aspect 9 or aspect 10, wherein the therapeutic agent comprises an antimicrobial polymer.

[0112] Aspect 12. The article of aspect 1 1 , wherein the antimicrobial polymer is a polycationic polymer.

[0113] Aspect 13. The article of aspect 1 1 or aspect 12, wherein the antimicrobial polymer is selected from chitosan, s-poly-L-lysine, polyethylenimine, polyguanidine, derivatives thereof, and combinations thereof.

[0114] Aspect 14. The article of any one of aspects 11-13, wherein the antimicrobial polymer comprises trimethyl chitosan.

[0115] Aspect 15. The article of any one of aspects 11-14, wherein the article comprises a weight ratio of the polysaccharide and glycerol to the antimicrobial polymer of from about 10:1 to about 2:1.

[0116] Aspect 16. The article of any one of aspects 1-15, wherein the article comprises a menstrual hygiene product or a component of a menstrual hygiene product.

[0117] Aspect 17. An article, comprising: a material configured to absorb and retain a fluid, the material comprising at least one absorbent layer, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol, wherein the weight ratio of the polysaccharide to glycerol is from about 4:1 to about 1 :4.

[0118] Aspect 18. The article of aspect 17, wherein the polysaccharide is selected from sodium alginate, xanthan gum, kappa-carrageenan, iota-carrageenan, and a combination thereof.

[0119] Aspect 19. The article of aspect 17 or aspect 18, wherein the polysaccharide comprises sodium alginate.

[0120] Aspect 20. The article of aspect 18 or aspect 19, wherein the sodium alginate has a molecular weight of about 200 kg / mol to about 500 kg / mol.

[0121] Aspect 21 . The article of any one of aspects 18-20, wherein the sodium alginate has a D-mannuronate to L-guluronate ratio of about 1 :2 to about 2:1.

[0122] Aspect 22. The article of any one of aspects 17-21 , wherein the weight ratio of the polysaccharide to glycerol is about 2:1 .

[0123] Aspect 23. The article of any one of aspects 17-22, wherein the polymer composition comprises particles having an average particle size of from about 0.1 mm to about 1.0 mm.

[0124] Aspect 24. The article of any one of aspects 17-23, wherein the polymer composition has a free swell capacity of about 2 g / g to about 15 g / g in defibrinated blood.

[0125] Aspect 25. The article of any one of aspects 17-24, wherein the absorbent layer further comprises a support.

[0126] Aspect 26. The article of aspect 25, wherein the polymer composition is impregnated within the support.

[0127] Aspect 27. The article of aspect 25, wherein the polymer composition is disposed on the support.

[0128] Aspect 28. The article of any one of aspects 17-27, wherein the article further comprises a therapeutically effective amount of a therapeutic agent.

[0129] Aspect 29. The article of aspect 28, wherein the therapeutic agent comprises a small molecule, a bacterium, or a protein.

[0130] Aspect 30. The article of aspect 28 or aspect 29, wherein the therapeutic agent comprises an antimicrobial polymer.

[0131] Aspect 31 . The article of aspect 30, wherein the antimicrobial polymer is a polycationic polymer.

[0132] Aspect 32. The article of aspect 30 or aspect 31 , wherein the antimicrobial polymer is selected from chitosan, e-poly-L-lysine, polyethylenimine, polyguanidine, derivatives thereof, and combinations thereof.

[0133] Aspect 33. The article of any one of aspects 30-32, wherein the antimicrobial polymer comprises trimethyl chitosan.

[0134] Aspect 34. The article of any one of aspects 30-33, wherein the article comprises a weight ratio of the polysaccharide and glycerol to the antimicrobial polymer of from about 10:1 to about 2:1 .

[0135] Aspect 35. The article of any one of aspects 17-34, wherein the article comprises a menstrual hygiene product or a component of a menstrual hygiene product.

[0136] Aspect 36. An article, comprising: a material configured to absorb and retain a fluid, the material comprising at least one absorbent layer and at least one therapeutic agent, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol, wherein the weight ratio of the polysaccharide to glycerol is from about 4:1 to about 1 :4.

[0137] Aspect 37. The article of aspect 36, wherein the at least one therapeutic agent is included in the material in a therapeutically effective amount.

[0138] Aspect 38. The article of aspect 36 or aspect 37, wherein the at least one therapeutic agent comprises a therapeutic agent used to treat a disease, symptom, or condition associated with menstruation.

[0139] Aspect 39. The article of any one of aspects 36-38, wherein the at least one therapeutic agent comprises a small molecule, a bacterium, or a protein.

[0140] Aspect 40. The article of any one of aspects 36-39, wherein the absorbent layer comprises the at least one therapeutic agent.

[0141] Aspect 41 . The article of any one of aspects 36-39, wherein the polymer composition comprises the at least one therapeutic agent.

[0142] Aspect 42. The article of any one of aspects 36-41 , wherein the absorbent layer further comprises a support.

[0143] Aspect 43. The article of any one of aspects 36-42, wherein the polymer composition is impregnated within the support.

[0144] Aspect 44. The article of any one of aspects 36-42, wherein the polymer composition is disposed on the support.

[0145] Aspect 45. The article of any one of aspects 36-44, wherein the support comprises the at least one therapeutic agent.

[0146] Aspect 46. The article of any one of aspects 36-45, wherein the polysaccharide is selected from sodium alginate, xanthan gum, kappa-carrageenan, iota-carrageenan, and a combination thereof.

[0147] Aspect 47. The article of any one of aspects 36-46, wherein the polysaccharide comprises sodium alginate.

[0148] Aspect 48. The article of aspect 47, wherein the sodium alginate has a molecular weight of about 200 kg / mol to about 500 kg / mol.

[0149] Aspect 49. The article of aspect 47 or aspect 48, wherein the sodium alginate has a D-mannuronate to L-guluronate ratio of about 1 :2 to about 2:1.

[0150] Aspect 50. The article of any one of aspects 36-49, wherein the weight ratio of the polysaccharide to glycerol is about 2:1 .

[0151] Aspect 51. The article of any one of aspects 36-50, wherein the polymer composition comprises particles having an average particle size of from about 0.1 mm to about 1.0 mm.

[0152] Aspect 52. The article of any one of aspects 36-50, wherein the polymer composition comprises a film with a thickness of about 10 pm to about 500 pm.

[0153] Aspect 53. The article of any one of aspects 36-52, wherein the therapeutic agent further comprises an antimicrobial polymer.

[0154] Aspect 54. The article of aspect 53, wherein the antimicrobial polymer is a polycationic polymer.

[0155] Aspect 55. The article of aspect 53 or aspect 53, wherein the antimicrobial polymer is selected from chitosan, s-poly-L-lysine, polyethylenimine, polyguanidine, derivatives thereof, and combinations thereof.

[0156] Aspect 56. The article of any one of aspects 53-55, wherein the antimicrobial polymer comprises trimethyl chitosan.

[0157] Aspect 57. The article of any one of aspects 53-56, wherein the articles comprise a weight ratio of the polysaccharide and glycerol to the antimicrobial polymer of from about 10:1 to about 2:1 .

[0158] Aspect 58. The article of any one of aspects 36-57, wherein the polymer composition has a free swell capacity of about 2 g / g to about 15 g / g in defibrinated blood.

[0159] Aspect 59. The article of any one of aspects 36-58, wherein the article comprises a menstrual hygiene product or a component of a menstrual hygiene product.

[0160] From the foregoing, it will be seen that aspects herein are well adapted to attain all the ends and objects hereinabove set forth together with other advantages which are obvious and which are inherent to the structure.

[0161] While specific elements and steps are discussed in connection to one another, it is understood that any element and / or steps provided herein is contemplated as being combinable with any other elements and / or steps regardless of explicit provision of the same while still being within the scope provided herein.

[0162] It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations. This is contemplated by and is within the scope of the claims.

[0163] Since many possible aspects may be made without departing from the scope thereof, it is to be understood that all matter herein set forth or shown in the accompanying drawings and detailed description is to be interpreted as illustrative and not in a limiting sense.

[0164] It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only, and is not intended to be limiting. The skilled artisan willrecognize many variants and adaptations of the aspects described herein. These variants and adaptations are intended to be included in the teachings of this disclosure and to be encompassed by the claims herein.

[0165] Now having described the aspects of the present disclosure, in general, the following Examples describe some additional aspects of the present disclosure. While aspects of the present disclosure are described in connection with the following examples and the corresponding text and figures, there is no intent to limit aspects of the present disclosure to this description. On the contrary, the intent is to cover all alternatives, modifications, and equivalents included within the spirit and scope of the present disclosure.E. EXAMPLE 1

[0166] Introduction. Menstruation is a natural biological process for which cultural stigmas and an absence of societal or infrastructural support can have profoundly negative effects for girls and women. Menstruation can last between three to seven days and occurs at monthly intervals roughly from ages 13.6 to 49.6, with a median of 451 cycles per lifetime.1Among several menstruation-associated factors that disproportionately impact women, poor performance of menstrual products is a major factor in absenteeism,2especially in regions where menstruation is considered taboo.3In low-to-middle income countries (LMIC) as well as low-income areas in the United States,4the inaccessibility or unaffordability of menstrual products can lead to alternatives (newspapers, rags, leaves) that increase the risk of vaginal infection.5

[0167] Another concern with current menstrual products is the environmental consequences of waste generated by single-use disposable pads and tampons. A woman can use up to 15,000 disposable menstrual products in her lifetime6with most products containing synthetic materials either as supporting components (topsheets and backsheets in pads, or strings in tampons), as packaging or as the absorbent component for some products (e.g., superabsorbent polymers like crosslinked polyacrylic acid (PAA)).7PAA, which is also used in other absorbent products like diapers and absorbent pads, is non-degradable with <1% degrading under landfill conditions.8Because of environmental concerns, reusable menstrual cups have become more popular. Regardless of the type of menstrual product, the challenges associated with menstrual care, such as leakage and spillage during use and management, can lead to shame and distress that leads to withdrawal from daily activities.9

[0168] To improve the quality of life in women undergoing menstruation, a biomaterials-based menstrual product was developed that could improve the management of menstrual fluid by reducing its leakage during use, by minimizing its spillage during changing, and by simplifying the process to change / replace menstrual products in the absence of appropriate facilities. Byusing a biodegradable material to absorb this fluid and increase its resultant viscosity, it was hypothesized that menstrual hygiene and care could be improved with broadly familiar products in a sustainable manner.

[0169] An array of polysaccharides are characterized herein for their ability to increase the viscosity of blood. Among these materials, it was found that high molecular weight alginate in combination with a glycerol additive could rapidly absorb and solidify blood to produce a highly viscous gel that maintained stiffness for long durations. This powder formulation was incorporated into common menstrual care products. It was found that when used as a menstrual pad filler, this formulation substantially reduced blood permeation with increased blood retention and reduced transfer when compared to other common absorptive fillers. This formulation was then examined as an additive for menstrual cups, resulting in eliminated blood spillage during in vitro menstrual cup removal. Finally, to minimize bacterial growth, the incorporation of an antimicrobial polymer into this powder formulation was shown to inhibit Staphylococcus aureus (S. aureus) without impairing the formulation’s ability to solidify blood. Collectively, described herein is a biodegradable, naturally-derived biomaterial product capable of improving menstrual care.

[0170] Results - Polysaccharide solutions well-mixed with blood can substantially increase viscosity. As a practical assessment of viscosity, an assay was developed in which time required for an 80 / A. droplet to flow down an acid-cleaned glass test tube (FIG. 1A) was measured. Using increasing concentrations of low molecular weight (LMW) alginate, droplet flow time was confirmed to be dependent on the tube tilt angle (FIG. 6) and had a good correlation with kinematic viscosity as measured by a cannon-Fenske viscometer (FIG. 1 B). Menstrual fluid is a complex mixture of blood, tissue, and mucus that is unable to coagulate10due to an abundance of fibrinolytic proteases.11To mimic human menstrual blood, defibrinated porcine blood was used, which has previously been used as the basis for simulated menstrual fluids.12To determine whether polysaccharides can increase the viscosity of blood, well-mixed equi-volume mixtures using 1 wt% polysaccharide solutions combined with water or blood (0.5 wt% final polysaccharide concentration) were prepared and their flow time measured. Several polysaccharides had high flow times when mixed with water or blood (FIG. 1 C), but only kappa-carrageenan, high molecular weight (HMW) alginate, xanthan gum, and iota- carrageenan had significantly greater flow times when mixed with blood compared to water. For FIG. 1 C, Statistical comparisons were performed by two-way ANOVA with a Bonferroni multiple comparisons test (****, p<0.0001). Alginates in this test were in the sodium form, lacking divalent cations and are hereafter referred to as alginate. When testing a LMW alginate that would be more sensitive to degradation over time than HMW alginate, flow times had an expected dependence on concentration while remaining stable over time (FIGS. 7A-7D).Despite the increased viscosity of well-mixed solutions, their practical application would depend on their miscibility with menstrual fluid. To test this, blood was added to the select polysaccharide solutions without mechanical agitation, and it was found that only alginate could reach homogeneity (FIG. 1 D). Alginate is well known for hydrogel formation by divalent cations, such as calcium-mediated crosslinking of L-guluronate residues,13a mechanism also identified in carrageenans.14Blood15and vaginal fluid throughout the menstrual cycle16contains calcium and so it is likely that calcium-mediated crosslinking contributes to the increased viscosity of alginate mixed with blood. To investigate the properties important for flow time when mixed with blood, several alginates were tested with varied molecular weights and ratios of L-guluronate to D-mannuronate (G / M) as well as comparing water, EDTA-treated blood, and defibrinated blood. At low viscosities, G / M ratios and use of EDTA as an anticoagulant influenced flow time, but these effects were dampened at high viscosities where polymer length is the dominant factor (FIGS. 8A-8B). Inversion of tubes after the 30 min incubation showed the formation of a cohesive hydrogel when blood was mixed with HMW alginate, but not the other polysaccharides (FIG. 1 E).

[0171] Results - Alginate-based powders are highly absorptive for blood. For practical application, a powder formulation was developed that could absorb and solidify blood. Powders were prepared by solubilization in specific aqueous solutions, dried, mechanically ground, and then sieved by size (FIG. 2A). To test blood retention, 0.5 g of each test powder was added to the top of a ~50 mm2mesh screen, retained within a 1” inner diameter cylinder (FIG. 2B). The absorptivity of these powder formulations was tested by adding 5 mL of blood and incubating for 3 minutes, afterwhich the cylinder was removed to allow unabsorbed blood to bypass the powder and flow through. Initial tests with non-sieved powders showed that pristine alginate performed similarly to the gold standard superabsorbent polymer, crosslinked polyacrylate (FIG. 2C). During experiments, it was found that blood did not completely permeate the alginate powder, leaving a dry core. Alginate powders containing several concentrations of glycerol were then prepared, which has previously been used as a plasticizer in films and increases its hydrophilic character.17Of the several alginate-to-glycerol ratios, it was found that a 1 :0.5 ratio led to maximal blood absorption (FIG. 2C) irrespective of particle size. For this ratio (AlgGly05), particle sizes ranging from 0.2-0.5 mm had superior performance (FIG. 2D). To determine if blood absorption was maintained over time, powderblood mixtures were incubated for up to 60 min, and it was found that the alginate-glycerol powders rapidly absorbed blood to levels that were maintained for the duration of the experiment whereas polyacrylate and alginate powders absorbed blood slowly during the first 20 min and then phase-separated by 60 min (FIG. 2E).

[0172] Results - Material properties of alqinate-qlycerol formulations. For insight into the performance of the alginate-glycerol material, its material properties were examined. Using contact angle measurements, the greater hydrophilic nature of alginate-glycerol films ( / .e., lower water contact angles) compared to alginate films ( / .e., higher contact angles) was observed, an effect that does not substantially change over 100 s (FIG. 3A). Examination of the morphology of these powders by scanning electron microscopy at low magnification shows a generally irregular particle shape for pristine alginate, AlgGly05and polyacrylate particles (FIG. 3B, FIG. 3C, and FIG. 3D, respectively). Higher magnification shows that alginate has a dense internal structure (FIG. 3B, inset), similar to what has been observed previously for alginate powders18whereas the incorporation of glycerol leads to greater texture and a more porous open structure (FIG. 3C, inset). By comparison, crosslinked polyacrylate has a smooth surface morphology that is indicative of a crystalline structure previously observed19(FIG. 3D, inset). The rheological properties of alginate-glycerol powders mixed with blood were compared to powders mixed with a calcium chloride solution in order to determine whether blood had a similar gelation effect as calcium. Using a strain sweep, the linear viscoelastic range was determined and 1 % for frequency sweep analysis was used (FIGS. 9A-9B). As shown in FIG. 3E, the storage and loss moduli are greater when mixed with blood compared to CaCI2, which suggests that other components of blood (e g., cells) play a role in the gelation process. Additionally, the greater magnitude of storage to loss modulus in both conditions supports a stiffer gel-like behavior previously observed with alginate hydrogels.20Taken together, these results indicate that the inclusion of glycerol into the alginate powders likely improves its dissolution into blood and that these AlgGly05mixtures with blood have comparable solid-like properties to mixtures with aqueous CaCI2solutions.

[0173] Results - Alginate-glycerol powders absorb blood with as high retention as menstrual pads. To test the absorptivity of the alginate-glycerol powders, their application as a menstrual pad was simulated, but without topsheets or backsheets to enable the measurement of blood leakage. As shown in FIG. 4A, various fillers (nothing, crosslinked polyacrylate, AlgGly05, or the commercial cellulose-based filler) were spread as a single layer within a folded sheet of cotton gauze and then taped to the opening of a silicone-based artificial vagina (FIG. 4B). Blood permeation was tested by rapidly (< 30 s) adding 8 mL of blood to the top of the artificial vagina. This volume within a short timeframe would simulate prolonged accumulation (e.g. , sleeping or a change in body position) or spontaneous events (e.g., laughing, sneezing, coughing). After 1 h, the pad was removed and the amount of blood that permeated the pads or was not absorbed into the pad ( / .e., retained above) was measured, as shown in FIG. 4C. The alginate-glycerol powder and the commercial cellulose filler had similarly high levels of blood absorption and low levels of excluded ( / .e., permeated or retained) blood compared tothe absence of a filler and the polyacrylate filler (FIG. 4D). While absorptivity is an important parameter, the transfer of moisture can be a source of discomfort that can lead to rashes. To mimic mild compression and contact that might lead to moisture transfer, blood-absorbed pads were placed on top of 96-well microtiter plates, centrifuged them at low speed, and measured the quantity of blood that was discharged (FIG. 4E). The commercial fillerwas found to release nearly all of the absorbed blood, comparable to the empty gauze, whereas the polyacrylate retained an intermediate quantity of blood, and the alginate-glycerol filler retained the maximum amount of blood (FIG. 4F). Collectively, these experiments show that the alginateglycerol powder rapidly absorbs blood with high retention.

[0174] Results - Alginate-glycerol powders eliminate spillage when used in menstrual cups. Menstrual cups are silicone cups that are inserted into the vaginal canal to create a seal against the vaginal wall, retaining menstrual fluid until it can be removed and cleaned. These menstrual products are favored over disposable products because they are reusable and have a low likelihood of leakage during use. However, poor placement and / or manipulation during removal can lead to leakage and spillage of fluid. To test the formulation as a sustainable material that can be used in complement with environmentally-friendly menstrual cups, 1 .5 g of alginate-glycerol powder was spread in a 1 ” cotton tube (“stockinette”) and coiled it within a menstrual cup (FIG. 4G). Cups alone or those with stockinettes filled with nothing or alginate- glycerol powder were placed in a Syngina, a device used by the FDA to test the absorptive capacity of menstrual care products21(FIG. 4H). To evaluate the retentive capacity of the menstrual cups, 15 mL of blood was added to the top to simulate a daily average of menstrual fluid.22After incubation for 4 hours at 37°C, five women were blinded to the content of the menstrual cups and asked to remove them with care to minimize spillage. As shown in representative experiments (FIG. 4I), alginate-glycerol powder improved blood retention. When examining individual attempts, each woman spilled blood when removing menstrual cups that contained nothing or the empty stockinette, which could be highly variable between attempts. By contrast, spillage was consistently rare when the alginate-glycerol powder was used (equivalent to a few drops when occurring) (FIG. 4J and FIGS. 10A-10C). The summation of results shows that the use of the stockinette with powder eliminates spillage of blood to levels significantly reduced compared to empty or stockinette conditions (FIG. 4K). Statistical analysis was performed by Kruskal-Wallis test with Dunn’s multiple comparisons test. ", p<0.005; ****, p<0.0001.

[0175] Results - Suspension of bacterial growth. Highly absorptive menstrual products have been correlated with toxic shock syndrome, where toxigenic S. aureus from the vaginal tract is able to proliferate and produce toxins. This is predominantly observed in tampons,23but is possible with other menstrual hygiene products, including menstrual cups.24Alginate canpotentially act as a nutrient source for some microbes and so including a strategy to inhibit bacterial growth would be important to minimize the risk of toxic shock syndrome. Because of the significance of the endogenous vaginal microflora,25the goal was to inhibit bacterial growth within the alginate-glycerol powder without complete eradication in a minimally-leeching formulation because of potential collateral effects to the vaginal microbiota. T rimethyl chitosan (TMC) was used because it has antimicrobial activity and will anchor in the alginate via ionic crosslinking and polymer entanglement to minimize leaching. When alginate and TMC were dissolved in solution in the first steps of preparation, significant inhibition of bacterial growth was found when mixed with blood spiked with 5*105cfu / mL (FIG. 5A) or 5x106cfu / mL of S. aureus (FIG. 5B). This effect was observed after 4 and 8 hours of incubation. For FIGS. 5A- 5B, statistical analysis was performed by one-way ANOVA compared to a TMC ratio of 0 with a Dunnett post-test. *“*, p<0.0001. Mixing alginate-glycerol with TMC in powder form, without co-solubilization, led to less consistent antimicrobial activity which is likely due to heterogeneity in TMC distribution (FIGS. 11A-1 1 B). Statistical analysis was performed by oneway ANOVA compared to 0 mg of TMC with a Dunnet post-test. To test whether including TMC altered the alginate-glycerol powder function, the flow of these powders mixed with blood was measured. As shown in FIG. 5C, the addition of a lower weight fraction of TMC led to slight increases in flow time at low powder concentrations. TMC alone can increase droplet flow times, though not to the same levels as the alginate-glycerol formulations. Interestingly, an equal amount of TMC to alginate-glycerol dramatically reduces droplet flow times, which is likely due to ionic crosslinking between the polyanionic alginate and polycationic TMC, sequestering alginate from calcium-mediated crosslinking and gel formation. As schematically shown in FIG. 5D, the inclusion of TMC can impart antimicrobial properties while retaining the ability to solidify blood.

[0176] Discussion. Herein is described the design of an eco-friendly, blood-absorbent biomaterial that improves the performance of menstrual products by minimizing blood leakage and spillage. First, a screening method was developed to quantify the gelation of blood by mixing several polysaccharides. This strategy identified high molecular weight alginate as an optimal candidate because of the dramatic increase in viscosity and spontaneous miscibility with blood when tested in liquid form. For application as an absorptive powder and to maximize the dissolution of alginate powders in blood, a glycerol-supplemented formulation was developed that both accelerated the stiffening of blood into a gel-like consistency and increased its capacity for blood absorption, an effect that depended on particle size. The practicality of this material to improve menstrual care was tested by using it as the absorptive component of a menstrual pad and as a complementary component to menstrual cups. In both cases, the use of the alginate-glycerol powder formulation minimized blood leakage andspillage. Finally, to inhibit bacterial growth, the quaternary ammonium polysaccharide trimethyl chitosan was included, which inhibited the growth of S. aureus, a bacterium responsible for toxic shock syndrome.

[0177] Traditional menstrual hygiene products manage menstrual fluids by their absorption or collection. While the principles can be traced to antiquity, their early modernized designs can be identified in products as early as the tampon patented in the US in 1933,26the Kotex menstrual (“sanitary pad”) marketed in 1921 ,27and the menstrual cup patented in the US in 1937.28Since their inception, menstrual products have focused on managing menstrual fluid in its liquid state, which faces the same challenges of any other liquid: leakage and spillage / dripping during changing or replacing the menstrual product. Although menstruation is a natural biological process and its healthy progression is not traditionally considered a disease or disorder, its poor management has a major global impact for women.29In many settings, including workplaces in LMIC, the lack of access to facilities with privacy, clean water, and discreet disposal leads to anxiety and stress. This negatively impacts the productivity of women, their ability to remain in the workforce, their income, and their quality of life.30By increasing the stiffness of blood, producing a more gel-like material, greater performance compared to traditional menstrual products is shown.

[0178] Alginate has been explored in various biological applications, including wound dressings, hemostatic products, and implantable devices,13but has not been demonstrated as a bulk absorbent material for biological fluids, especially menstrual fluid. Notably, in the use of alginate, the blood-derived divalent cations are relied on to mediate the ionic cross-linking that leads to gelation,31enabling the gelation of a non-clotting defibrinated blood that mimics the lack of coagulation in menstrual fluid.11This contrasts with other materials that leverage the presence of clotting factors within blood to mediate coagulation.32Building on its broad applications in biotechnology, the use of alginate to increase the viscosity of non-coagulating blood to improve menstrual care represents an advancement towards women’s health which is traditionally understudied.

[0179] Use of a biodegradable formulation based on renewable resources is an important consideration for menstrual care products. Current commercial products largely utilize non- degradable materials derived from non-renewable sources, such as plastics in the packaging or crosslinked polyacrylate in the absorptive material. Although menstrual products often include a cotton-based absorbent component that is biodegradable, studies have shown that manufacturer testing with saline solution dramatically overestimates the actual absorbency of tampons and pads for fluids that more closely represent menstrual blood.33Given the biodegradability of alginate,31the formulation presented in this work allows for convenient disposal of the solidified blood mixture (e.g., by flushing down the toilet). The establishedlarge-scale manufacturing of alginate from natural sources31and its the approval for use in several products by the Food and Drug Administration34also simplifies its safe and scalable implementation. An additional benefit of using a known biopolymer is the option for further functionalization. With toxic shock syndrome as an important concern, TMC is included and it is shown that at low concentrations, TMC inhibits the growth of S. aureus without impairing the blood-gelation function of alginate, illustrating the potential versatility of alginate-based menstrual products.

[0180] Materials. Low molecular weight alginate, l-carrageenan, k-carrageenan, pectin, and the super-absorbent cross-linked sodium polyacrylate were purchased from Sigma-Aldrich (USA). High molecular alginate, carboxymethylcellulose, chondroitin sulfate, gelatin type A, trimethyl chitosan and sodium hyaluronan were obtained from Thermo Scientific (USA). Highgrade alginate samples with different molecular ranges and M / G ratios were ordered from the Promega Company (USA), chitosan was purchased from Polysciences Inc (USA), carboxymethyl chitosan was purchased from Santa Cruz Biotechnology (USA), and xanthan gum was purchased from TCI Chemicals (USA). Aseptically confirmed porcine blood (defibrinated and Na2EDTA-supplemented) was purchased from Lampire Inc. (USA). Aqueous polymer solutions were prepared with ultrapure water (18.2 MQ cm at 25 °C) from a Milli-Q® system.

[0181] Methods - Biopolymer solutions. Polymers were dissolved at concentrations ranging from 0.5 to 6.0 wt % in ultrapure water, vortexed and heated in a water bath at 50 °C until complete solubilization. For measurements in polymer / blood mixtures, aqueous polymer solutions were mixed with equal volumes of aqueous polymer and blood at room temperature were homogenized by gently pipetting the mixture up and down. Solutions were set at room temperature for 15 to 30 min to eliminate bubbles during mixing.

[0182] Methods - Blood-absorbent powder synthesis. Alginate-based powder formulations were prepared by mixing high molecular weight alginate to glycerol aqueous solution to test various alginate to glycerol solution ratios (Table 1). For powder solubilization, the aqueous glycerol solution was spread in a 4” square weighing boat, and the powder high molecular weight alginate reagent was equally dispersed on the liquid surface, followed by gentle mixing at the liquid surface that formed a solid mixture. The mixture was cut into small pieces with a disposable spatula and dried at 50 °C for 48 h, followed by manual grinding with liquid nitrogen to obtain mm-sized particles. The ground mixture was manually sized with a set of sieves that ranged from 0.2 to 1 .5 mm (US Standard Sieve Series, USA, A.S.T.M. E11) to collect different particle size ranges (<0.2 mm, 0.2 - 0.5 mm, 0.5 - 0.7 mm, 0.7 - 1 .0 mm, and 1 .0 - 1 .5 mm range).Table 1. Alginate-based formulations for the production of blood-absorbent powder.Alginate: Glycerol Alginate Glycerol Water(w / w) (g) (g) (mL)1 :0 (Alg) 2.5 0 101 :0.5 (AlgGly05) 2.5 1.25 101 :1 (AlgGly1) 2.5 2.5 101 :2 (AlgGly2) 2.5 5.0 101 :3 (AlgGly3) 2.5 7.5 10

[0183] Methods - Test tube flow test. Regular glass tubes were first washed with a commercial detergent and rinsed with DI water five times. These tubes were soaked in hydrochloric acid solution (1.0 M) for 1 h, followed by copious rinsing with DI water and three final rinses with ultrapure water and drying at 70 °C. Polymer aqueous solutions were mixed with equal volumes of ultrapure water or porcine blood (defibrinated or Na2EDTA-treated) by pipetting the mixture up and down with low-retention tips (VWR, USA). After complete bubble removal, aqueous or blood polymer mixtures (80 / A.) were pipetted ~ 10 mm near the top of the pre-cleaned test tubes positioned at an angle of 45° at room temperature to track the time interval for the droplet to travel 80 mm towards the tube bottom starting (triplicate measurements) (FIG. 1A). The maximum flow time interval observed was 8 h for those mixtures that did not flow.

[0184] Methods - Flow viscometer measurements. Kinematic viscosity measurements were performed in calibrated Cannon-Manning glass viscometers (viscometer sizes 75, 150, 200, 300, 400, 500, and 600) with pre-mixed aqueous or blood polymer solutions. After sample loading, the viscometer was placed in a water bath at 40 °C and kept for 15 min to reach equilibrium before timing the mixture flow time.35The kinematic viscosity was calculated by converting the efflux time in seconds by the viscometer constant for measurements at 40 °C for measurements in triplicate.

[0185] Methods - Blood absorption capacity. Powder formulations (high molecular weight alginate reagent, PAA, and the formulated alginate-based mixture, 0.5 g) were added to a 1 ” cross-sectioned acrylic tube (~1” height) on top of a pre-weighted HDPE screen (46 mesh, ~50 mm2), above a pre-weighted Petri-dish (4” diameter) (FIG. 2A). Defibrinated blood (5 mL) was transferred at a rate of 5 mL / min using a syringe pump (Model 300, New Era Pump System, USA) at the top of the powder, and the system was maintained on the bench tomeasure blood absorption over time (static, ~25 °C). At the end of the experiment, the crosssectioned tube was removed, and the content collected in the Petri dish and retained at the top of the screen was weighed to determine the amount of blood that leaked and retained in the powder in triplicate.

[0186] Methods - External tamponade test (menstrual pads'). The powder formulation was first tested as a menstrual pad filler and challenged for blood retention in a silicone-based, anatomically similar vaginal model (Interactive Life Forms, LLC, USA) (FIGS. 4A-4C). Powder formulations (1.5 g) were added to a cotton-based gauze (1.5 g, 2” x 3”) for a simple yet practical design of the external tamponade element in a pad format for testing blood retention and loss during the pad transfer. The pads filled with different materials (AlgGly05, PAA, or the commercial absorbent element from pads) were taped underneath the vaginal model, and the defibrinated porcine blood (8 mL) was added from an opening at the top using a transfer pipette (~30 s). After 1 h of incubation at room temperature, blood leakage and retention were determined by weighing the blood that flowed through and the blood retained in the tamponade element. To determine blood release due to mechanical force, pads were detached from the vaginal model and placed on top of pre-weighted 96 well plates, followed by spinning in a swing bucket centrifuge (centrifuge 5810-R Eppendorf, rotor A-2-DWP) at 1 ,000 g for 5 min at 25 °C. The pad and the plate were weighted to determine the fractions of blood retained and released in the pad, respectively.

[0187] Methods - Internal tamponade test (menstrual cups). The alginate powder formulation (AlgGly05) was also assessed as a filler in the menstrual cups as a method to minimize spillage and blood loss during cup removal. Powder formulations (~1 .5 g) were dispersed in a 1 ” tubeshaped stockinet (~1.0 g, 6” length) and arranged in a helical shape inside of a regular menstrual cup (CVS Health, cup size A, #722537). The menstrual cup was positioned in the in-house designed Syngina (synthetic vagina) equipped with a heating system (FIGS. 4G-4H), and defibrinated blood (15 mL) was transferred to the cup with a transfer pipette (~5 mL / min) from the top opening. After the incubation period (1 h at 37 °C), the menstrual cup was removed using a pre-weighed white superabsorbent glove with a pre-weighted white absorbent pad underneath the experimental setup, and both the glove and the pads were weighted and imaged to determine the blood messiness during menstrual cup removal. A blinded, randomized test was conducted in duplicate for each sample (empty cup, filled with the empty stockinet, and filled with the stockinet containing the alginate powder) by different female coworkers from Hsu Lab to eliminate any bias during the cup removal.

[0188] Methods - Antimicrobial assay. The AlgGly05formulation was supplemented with the antimicrobial agent TMC (0.2 to 20 mg per 20 mg of alginate) to investigate the antimicrobial performance of blood-absorbent powder against S. aureus. The homogenous formulation wasprepared by adding TMC during the alginate solubilization in the glycerol aqueous solution, followed by snap freezing at -80 °C and lyophilization for at least 24 h. After drying, the powder was crushed and used for the antimicrobial test. The heterogeneous formulation was prepared by vigorously mixing the pre-processed AlgGly05formulation with TMC prior to the antimicrobial test. For the bacterial inoculum preparation, S. aureus was streaked from the frozen bacterial stock in a Luria Broth (LB) agar plate and incubated at 37 °C overnight. One single colony was used to inoculate 5 mL of LB broth in a test tube, followed by overnight incubation at 37 °C and 200 rpm. The overnight cell culture was back-diluted to an OD6oo of 0.125 (~108cfu / mL) and spiked in aseptically-tested porcine blood to a 5*105and 5*10scfu / mL of S. aureus. The TMC-supplemented powder (20 mg) was transferred to the bottom of 24-well plates, followed by the addition of 1 mL of blood with different bacterial loads (tests performed, at least, in triplicate for each powder formulation), and incubation at 37 °C and 200 rpm. To test bacterial inactivation, blood mixture aliquots (100 pL) were collected after 4 h and 8 h, serial diluted in LB broth and plated in LB agar plates. After overnight incubation at 37 °C, we determined the number of colony-forming units and converted them to the final bacterial concentration in the gelled blood mixture. The antimicrobial performance was determined as the fold-change (FC) in the bacterial concentration of polymer-containing samples compared to samples with no polymer added.

[0189] Methods - Morphological analysis. For the morphological analysis through Scanning Electron Microscopy (SEM), the powder of pristine alginate, superabsorbent, and AlgGly05were placed over the copper tape. The samples were then coated with 10 nm Pt / lr no tilt coating using the sputter for a few minutes and probed using JEOL IT500 (JEOL) with an accelerating voltage of 5 kV, and magnifications of 50X and 500X.

[0190] Methods - Contact angle measurements. The surface hydrophobicity of the pristine alginate and AlgGly05powder was investigated through water contact angle by using an optical tensiometer (Biolin Scientific Theta Flow). A thin film of alginate and alginate glycerol powder was prepared over the glass slide. The film was prepared with a 1 % solution of alginate and AlgGly05in water, which was then poured over the glass slide and dried in the oven at 50 °C. For the static contact angle measurement, the sessile drop mode of the OneAttension software was used. A 5 / zL drop of water was placed on the thin layer of the pristine alginate and AlgGly05film using an automatic dispenser. The droplet was imaged with a 5 MP resolution against monochromatic light for 100 s in the equipment software. The angle at the left and right sides of the droplet was automatically determined by the software, and their average was used as the contact angle of the sample. The contact angle measurements were repeated three times for each sample.

[0191] Methods - Rheology. The strength of the AlgGly05gels with CaCI2and blood was assessed through the oscillatory rheological technique using an Anton Paar MCR302 rheometer (Anton Paar GmbH). The strain and frequency sweep were conducted with a 50 mm parallel plate geometry of the rheometer. The gels were prepared by mixing 1 g of AlgGly05powder with 10 mL of blood or CaCh (0.25 mM) solution and leaving them on the bench to remove bubbles. The strain sweep was performed, and the optimum strain value was obtained from the linear viscoelastic region for each gel to ensure that the measurements were made in the linear regime at 37 °C. The storage (G’) and loss (G”) modulus were recorded as a function of frequency between 0.1 to 100 Hz.F. EXAMPLE 2

[0192] Building on the previously discussed materials that can absorb menstrual fluid, the same or similar material could be used as a device to provide sustained release of an agent with physiological impact in the vaginal tract or elsewhere in the body. As shown in FIG. 12, it can be expected that the presence of this material in the vaginal tract could locally release an agent intravaginally and could remain in the vaginal tract for extended durations regardless of stage of menstrual cycle (i.e., in absence or presence of menses).

[0193] As discussed in Example 1 , it was found that, among several formulations, a mixture of alginate and glycerol provided the good performance characteristics as a product for managing menstrual hygiene, in which one good formulation is labeled AlgGly05or AG05, but for simplicity in this Example here is described as the algin ate- glycerol formulation. With an aim for use in a tampon-like formulation, different shapes and formulations were tested to maximize blood absorption (FIG. 13A). As shown in FIG. 13B, smaller strip size led to increased blood absorption with 1 mm strips providing similar absorption to the powder. In addition, the presence of diclofenac did not impair this absorption capacity. Next, as an additive to the tampon formulation and for convenience in insertion or removal, the blood absorption of several materials with different compositions were tested, envisioning that when rolled with the alginate-glycerol material, it would channel blood throughout the tampon to maximize distribution (FIG. 13D). As shown in FIG. 13D, gauze and a nonwoven blend provided maximal absorption.

[0194] Tampon formulations can absorb blood. Tampon-like formulations were generated by mixing 1 mm strips of the alginate-glycerol material and rolled them with either gauze or the nonwoven blend at a mass ratio of 1 :1 . Their ability to absorb blood in a synthetic vaginal tract was tested by insertion into the vaginal side and the infusion of blood at 50 mL / h from the cervical side (FIG. 14A). The amount of blood infused until leakage was measured for a tampon formulation added dry, and it was found that the formulation had a comparable capacity to a commercially available tampon when the nonwoven blend is used as the additive,whereas there was generally a reduced capacity with gauze (FIG. 14B). When examining the distribution of blood, it was found that the majority is absorbed into the material while a small fraction remains trapped above the tampon (“excess retained”) (FIG. 14C). Because the alginate-glycerol material is capable of absorbing blood as a hydrogel in a mechanism that does not require the alginate-glycerol material to be dry, a pre-hydrated tampon was also tested. This would be expected to be more comfortable for the user during vaginal insertion. As shown in FIG. 14D, pre-hydration dramatically reduced the absorption ability for the commercial tampon, nonwoven blend, and gauze to retain blood, leading to immediate leakage. This is also reflected by a net loss in blood capacity due to the release of water along with blood (FIG. 14E). However, the incorporation of the alginate-glycerol material led to an increase in the overall capacity that includes blood absorbed and retained (FIG. 14D and FIG. 14E).

[0195] Tampon formulations provide sustained release of diclofenac. To determine the release profiles of diclofenac from the disclosed tampon formulations, the formulations were immersed in blood and the diclofenac measured in solution over a 24 h period. It was found that both a dry tampon formulation loaded with 12 mg diclofenac / g film and a pre-hydrated tampon formulation loaded with 75 mg diclofenac / g film released significant quantities of diclofenac over a 24 h period, but that the latter had a more rapid release during the early time points (FIGS. 15A-15B). In both cases, substantial amounts of diclofenac are released over the tested duration.

[0196] Intravaginal drug delivery leads to sustained release in a mouse model. Female CD-1 mice had their estrus cycle synchronized by injection with p-estradiol one day prior to vaginal insertion of a tampon formulation (FIG. 16A). A pre-hydrated tampon loaded with 75 mg diclofenac / g film was tested. At specific times up to 8 h, mice were sacrificed with their serum concentrations of diclofenac measured. As shown in FIG. 16B, serum diclofenac levels are immediately detected in the serum at the first measured point of 15 min, and in all subsequent timepoints for up to 8 h. This indicates a sustained vaginal drug delivery from the intravaginal device.

[0197] Bacterial release from pre-hydrated devices. FIG. 17 shows the results of release of bacteria (specifically, Lactobacilli) over time. Lactobacilli are loaded into films, which are then cut into strips and rolled into a tampon like device. These are the incubated into buffer (PBS) or blood to simulate menstruation. In blood, substantial bacterial release occurs in the first 4 hours and is then sustained until 24 h. Release occurs in PBS as well, though this buffer does not adequately simulate the vaginal environment.

[0198] Materials. Sodium alginic salt and glycerol were obtained from Thermo- Scientific (USA). Diclofenac sodium salt (Sigma), gauze (St Bulkee II Cotton Gauze Bandage, Medline, NON25850, composed of cotton), nonwoven blend (Nonwoven Cleaners, Medline, NON4121 , composed of 50% wood pulp fiber, 25% polypropylene and 25% viscose), cellulose (Powerclean Wypall, Kimberly-Clark, 057017471 , composed of cellulose), polyester (Tubular Cast Stockinette, Medline, MDT221200, composed of unbleached polyester), and polypropylene (Kimtech Pure W4, Kimberly-Clark, 33330, composed of polypropylene). Defibrinated porcine blood was purchased from Lampire (USA). Aqueous polymer solutions were prepared with ultrapure water (18.2 MU cm at 25°C) from a Milli-Q IQ-700 ultrapure water purification system (Millipore Sigma, USA).

[0199] Methods - Preparation of AG05powder. Briefly, glycerol was added to the HMW alginate in the ratio of 1 :2 w / w in the weighing boat. The alginate was gently mixed in the aqueous solution using the disposable spatula to get homogeneous mixture, which was dried at 50°C for 48 h. The dried mixture was then manually ground with liquid nitrogen and the powder was filtered through sieves to obtain the AG°5powder of 0.2-0.5 mm diameter. Further discussion can be found in Example 1.

[0200] Methods - Preparation of the AG05film. For the preparation of the AG05film, a 1 % w / v solution of alginate in glycerol was prepared at a 2:1 w / w ratio. Alginate was dissolved in the glycerol solution at 50°C for 2 h with vortexing. After incubation at room temperature overnight to remove bubbles, the solution was poured into a gel casting tray at 50°C for 36 h. Film thickness was 61 ± 8 pm (mean ± std dev) as measured by a digital micrometer. The AG05film containing diclofenac was prepared in the same procedure as described above, with diclofenac dissolved in glycerol prior to preparation in the 1 % w / v solution of alginate. To prepare strips, the film was cut to varying widths (5 cm, 2.5 cm, 0.5 cm, 0.25 cm, and 0.1 cm) with a 10 cm length.

[0201] Methods - Blood absorption capacity of AG05powder and film. 300 mg of the AG05powder, film, or strips were added to a pre-weighed weighing boat. Then, 3 ml of defibrinated porcine blood was added and incubated for 10 mins. After incubation, excess unabsorbed blood was poured off into a second pre-weighed weigh boat.

[0202] Methods - Blood absorption capacity of absorptive material. 1 .8 g of each absorptive material, i.e., gauze, nonwoven blend, cellulose, polypropylene, or polyester, was rolled and placed in a 50 mL conical tube. Then, 20 mL of defibrinated porcine blood was added and the weight the absorptive material was measured at different timepoints (1 , 5, 10, 15, 30, 60, and 120 min) to determine the amount of blood absorbed.

[0203] Methods - Design of the AG05formulation-based tampon. To form the tampon, 1 mm strips of alginate-glycerol material with or without drug were laid flat on top of a sheet of either gauze or nonwoven blend in 1 :1 w / w ratio, with a total weight of ~1 .75 g and length of 4.4 cm, equivalent to the weight and size of the commercially available tampon. The tampon was further used for blood absorption study either in a dry or pre-hydrated state. For a pre-hydrated tampon, 10 ml of sterile water was added to the formed tampon and allowed 5 min for complete hydration.

[0204] Methods - Blood absorption capacity of dry and hydrated AG05tampon using silicon based vaginal model. The designed AG05tampon (with or without drug) and commercially available tampon were tested for the blood absorption in a silicone-based, anatomically similar vaginal model (Ice Lady Clear, Interactive Life Forms, USA). The commercially available tampon and the designed tampon were placed inside the vaginal cavity of the model in a dry or pre-hydrated state. Defibrinated porcine blood was added to the top at 50 mL / h using syringe pump until leakage was observed at the bottom, at the vaginal opening. The time until leakage was observed was measured and then the amount of blood was measured by comparing the weight of the tampon before and after the blood addition. Under some conditions, blood was retained above the tampon but not absorbed ("excess retained”).

[0205] Methods - In vitro drug release study. For the in vitro drug release study, smaller sized tampons were prepared by rolling 1 mm strips of alginate glycerol material, containing 12 mg or 75 mg of diclofenac / g of material, in gauze such that the width and length of the tampon was 0.5 cm by 0.7 cm, with a weight of ~40 mg. The ratio of alginate-glycerol strips to gauze was maintained at 1 :1 by weight. The pre-hydrated tampon was prepared by hydration 100 pL of water. Dry and pre-hydrated tampons were then placed into microcentrifuge tubes containing 1 mL of defibrinated porcine blood and shaken at 150 rpm at 37°C. At different time points, 500 pL of blood was collected and replaced with fresh 500 pL of blood.

[0206] The diclofenac in the blood samples were measured by HPLC. A 20 pL sample volume was separated with a precolumn (100 mm x 2.0 mm I.D.) packed with pellicular reversed- phase material (Spherisorb) and a C18 reverse phase column (25 cm x 4.5 mm I.D., Spherisorb, Agilent, USA) with an isocratic mobile phase of acetonitrile:0.1 M sodium acetate (35:65) at pH 6.3 with a 1 mL / min flow rate for 15 mins at ambient temperature. The effluent was monitored at 280 nm. The detection limit of diclofenac in the blood sample was 1 ng / ml.

[0207] Samples and standard curves in blood were prepared by centrifugation 15 mins at 2,000 x g followed by the addition of 2 mL of acetonitrile to 400 pL of blood supernatant. The mixture was vortexed for 1 min, centrifuged again, and then the supernatant was transferred to a new 1 .7 mL microcentrifuge tube and evaporated to dryness at 42°C in a heat block. Theresidue was reconstituted in 400 pL of HPLC mobile phase, vortexed, and filtered with a 0.45 m syringe filter.

[0208] Methods - In vivo drug release study. CD-1 mice (8-12 weeks old) were divided into 8 groups with 3 mice per group. To synchronize the estrus cycle of mice, all the mice received 0.5 mg p-estradiol dissolved in 100pL sesame oil via intraperitoneal injection one day before the start of the experiment. The next day, mice received the small, ~40 mg AG05tampon containing 2 mg of diclofenac by intravaginal insertion. Pre-hydrated tampons were hydrated with 100 L of sterile water prior to insertion. Mice were sacrificed after 0, 0.25, 0.5, 0.75, 1 , 2, 4, and 8 h. Blood was collected by cardiac puncture.G. REFERENCES

[0001] References are cited herein throughout using the format of reference number(s) superscripted corresponding to one or more of the following numbered references.

[0209] 1. Chavez-MacGregor, M. et al. Lifetime cumulative number of menstrual cycles and serum sex hormone levels in postmenopausal women. Breast Cancer Res. Treat. 108, 101-112 (2008).

[0210] 2. Krenz, A. & Strulik, H. The impact of menstruation hygiene management on work absenteeism of women in Burkina Faso. Econ. Hum. Biol. 43, 101067 (2021).

[0211] 3. Schoep, M. E. et al. Productivity loss due to menstruation-related symptoms: a nationwide cross-sectional survey among 32 748 women. BMJ Open 9, e026186 (2019).

[0212] 4. Sebert Kuhlmann, A., Peters Bergquist, E., Danjoint, D. & Wall, L. L. Unmet Menstrual Hygiene Needs Among Low-Income Women. Obstet. Gynecol. 133, (2019).

[0213] 5. Sumpter, C. & Torondel, B. A Systematic Review of the Health and Social Effects of Menstrual Hygiene Management. PLOS ONE 8, e62004 (2013).

[0214] 6. Borowski, A. Are American women turning to reusable and greener menstrual products due to health and environmental pollution concerns? (Rochester Institute of Technology, 2011).

[0215] 7. Peberdy, E., Jones, A. & Green, D. A Study into Public Awareness of the Environmental Impact of Menstrual Products and Product Choice. Sustainability 11 , (2019).

[0216] 8. Stegmann, R., Letter, S., King, L. & Hopping, W. D. Fate Of An Absorbent Gelling Material For Hygiene Paper Products In Landfill And Composting. W / aste Manag. Res. 11 , 155-170 (1993).

[0217] 9. Munro, A. K., Hunter, E. C., Hossain, S. Z. & Keep, M. A systematic review of the menstrual experiences of university students and the impacts on their education: A global perspective. PLOS ONE 16, e0257333 (2021).

[0218] 10. ALBRECHTSEN, O. K. The fibrinolytic activity of menstrual blood. Acta Endocrinol. (Copenh.) 23, 219-226 (1956).

[0219] 11. Dockeray, C. J., Sheppard, B. L„ Daly, L. & Bonnar, J. The fibrinolytic enzyme system in normal menstruation and excessive uterine bleeding and the effect of tranexamic acid. Eur. J. Obstet. Gynecol. Reprod. Biol. 24, 309-318 (1987).

[0220] 12. Hood, W. H., Spears, M. J. & Worley, W. J. Menstrual fluid simulant.

[0221] 13. Lee, K. Y. & Mooney, D. J. Alginate: Properties and biomedical applications.Prog. Polym. Sci. 37, 106-126 (2012).

[0222] 14. Bui, V. T. N. T., Nguyen, B. T., Nicolai, T. & Renou, F. Mixed iota and kappa carrageenan gels in the presence of both calcium and potassium ions. Carbohydr. Polym. 223, 115107 (2019).

[0223] 15. Dullo, P. & Vedi, N. Changes in serum calcium, magnesium and inorganic phosphorus levels during different phases of the menstrual cycle. J. Hum. Reprod. Sci. 1, 77- 80 (2008).

[0224] 16. Wagner, G. & Levin, R. J. Electrolytes in vaginal fluid during the menstrual cycle of coitally active and inactive women. J. Reprod. Fertil. 60, 17-27 (1980).

[0225] 17. Gao, C., Pol let, E. & Averous, L. Properties of glycerol-plasticized alginate films obtained by thermo-mechanical mixing. Food Hydrocoll. 63, 414-420 (2017).

[0226] 18. Al-Hashimi, N., Babenko, M., Saaed, M., Kargar, N. & ElShaer, A. The Impact of Natural and Synthetic Polymers in Formulating Micro and Nanoparticles for Anti-Diabetic Drugs. Curr. Drug Deliv. 18, 271-288 (2021).

[0227] 19. Takematsu, M. M. et al. Development and characterization of sodium polyacrylate / bentonite hydrogel with epoxy resin coating. Polimeros Cienc. E Tecnol. 33, e20230021 (2023).

[0228] 20. Larsen, B. E., Bj0rnstad, J., Pettersen, E. O., T0nnesen, H. H. & Melvik, J. E. Rheological characterization of an injectable alginate gel system. BMC Biotechnol. 15, 29 (2015).

[0229] 21 . 21 CFR § 801 .430 - User labeling for menstrual tampons. (2022).

[0230] 22. Donoso, M. B. et al. Normality Ranges of Menstrual Fluid Volume During Reproductive Life Using Direct Quantification of Menses with Vaginal Cups. Gynecol. Obstet. Invest. 84, 390-395 (2019).

[0231] 23. Veeh, R. H. etal. Detection of Staphylococcus aureus Biofilm on Tampons and Menses Components. J. Infect. Dis. 188, 519-530 (2003).

[0232] 24. Mitchell, M. A., Bisch, S., Arntfield, S. & Hosseini-Moghaddam, S. M. A Confirmed Case of Toxic Shock Syndrome Associated with the Use of a Menstrual Cup. Can. J. Infect. Dis. Med. Microbiol. 26, 560959 (1900).

[0233] 25. France, M., Alizadeh, M., Brown, S., Ma, B. & Ravel, J. Towards a deeper understanding of the vaginal microbiota. Nat. Microbiol. 7, 367-378 (2022).

[0234] 26. Haas, Earle. Catamenial Device.

[0235] 27. Eschner, K. The Surprising Origins of Kotex Pads. Smithsonian Magazine (2017).

[0236] 28. Chalmers, L. W. Catamenial appliance.

[0237] 29. Critchley, H. O. D. et al. Menstruation: science and society. Am. J. Obstet. Gynecol. 223, 624-664 (2020).

[0238] 30. Sommer, M., Chandraratna, S., Cavill, S., Mahon, T. & Phillips-Howard, P. Managing menstruation in the workplace: an overlooked issue in low- and middle-income countries. Int. J. Equity Health 15, 86 (2016).

[0239] 31. Pawar, S. N. & Edgar, K. J. Alginate derivatization: A review of chemistry, properties and applications. Biomaterials 33, 3279-3305 (2012).

[0240] 32. Hong, C., Olsen, B. D. & Hammond, P. T. A review of treatments for non- compressible torso hemorrhage (NCTH) and internal bleeding. Biomaterials 283, 121432 (2022).

[0241] 33. Emma DeLoughery, Alyssa C Colwill, Alison Edelman, & Bethany Samuelson Bannow. Red blood cell capacity of modern menstrual products: considerations for assessing heavy menstrual bleeding. BMJ Sex. Amp Reprod. Health bmjsrh-2023-201895 (2023) doi: 10.1136 / bmjsrh-2023-201895.

[0242] 34. Cattelan, G. et al. Alginate Formulations: Current Developments in the Race for Hydrogel-Based Cardiac Regeneration. Front. Bioeng. Biotechnol. 8, (2020).

[0243] 35. Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (and Calculation of Dynamic Viscosity). ASTM D445-23.

[0244] It should be emphasized that the above-described embodiments of the present disclosure are merely possible examples of implementations set forth for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described aspects. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims.

Claims

CLAIMSWhat is claimed:

1. An article, comprising: a first layer configured to be fluid-permeable; a second layer configured to be fluid-resistant; and a core configured to absorb and retain a fluid; wherein the first layer and second layer are independently chemically attached to the core, physically attached to the core, or a combination thereof; wherein the core is positioned between the first layer and the second layer; and wherein the core comprises at least one absorbent layer, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol, wherein the weight ratio of the polysaccharide to glycerol is from about 4:1 to about 1 :4.

2. The article of claim 1 , wherein the polysaccharide is selected from sodium alginate, xanthan gum, kappa-carrageenan, iota-carrageenan, and a combination thereof.

3. The article of claim 1 , wherein the polysaccharide comprises sodium alginate.

4. The article of claim 3, wherein the sodium alginate has a molecular weight of about 200 kg / mol to about 500 kg / mol.

5. The article of claim 3, wherein the sodium alginate has a D-mannuronate to L-guluronate ratio of about 1 :2 to about 2:1 .

6. The article of claim 1 , wherein the weight ratio of the polysaccharide to glycerol is about 2:1.

7. The article of claim 1 , wherein the polymer composition comprises particles having an average particle size of from about 0.1 mm to about 1.0 mm.

8. The article of claim 1 , wherein the polymer composition has a free swell capacity of about 2 g / g to about 15 g / g in defibrinated blood.

9. The article of claim 1 , wherein the article further comprises a therapeutically effective amount of a therapeutic agent.

10. The article of claim 9, wherein the therapeutic agent comprises a small molecule, a bacterium, or a protein.11 . The article of claim 9, wherein the therapeutic agent comprises an antimicrobial polymer.

12. The article of claim 11 , wherein the antimicrobial polymer is a polycationic polymer.

13. The article of claim 1 1 , wherein the antimicrobial polymer is selected from chitosan, s-poly- L-lysine, polyethylenimine, polyguanidine, derivatives thereof, and combinations thereof.

14. The article of claim 11 , wherein the antimicrobial polymer comprises trimethyl chitosan.

15. The article of claim 11 , wherein the article comprises a weight ratio of the polysaccharide and glycerol to the antimicrobial polymer of from about 10:1 to about 2:1.

16. The article of claim 1 , wherein the article comprises a menstrual hygiene product or a component of a menstrual hygiene product.

17. An article, comprising: a material configured to absorb and retain a fluid, the material comprising at least one absorbent layer, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol, wherein the weight ratio of the polysaccharide to glycerol is from about 4:1 to about 1 :4.

18. The article of claim 17, wherein the polysaccharide is selected from sodium alginate, xanthan gum, kappa-carrageenan, iota-carrageenan, and a combination thereof.

19. The article of claim 17, wherein the polysaccharide comprises sodium alginate.

20. The article of claim 17, wherein the sodium alginate has a molecular weight of about 200 kg / mol to about 500 kg / mol.21 . The article of claim 20, wherein the sodium alginate has a D-mannuronate to L-guluronate ratio of about 1 :2 to about 2:1 .

22. The article of claim 17, wherein the weight ratio of the polysaccharide to glycerol is about 2:1.

23. The article of claim 17, wherein the polymer composition comprises particles having an average particle size of from about 0.1 mm to about 1.0 mm.

24. The article of claim 17, wherein the polymer composition has a free swell capacity of about 2 g / g to about 15 g / g in defibrinated blood.

25. The article of claim 17, wherein the absorbent layer further comprises a support.

26. The article of claim 25, wherein the polymer composition is impregnated within the support.

27. The article of claim 25, wherein the polymer composition is disposed on the support.

28. The article of claim 17, wherein the article further comprises a therapeutically effective amount of a therapeutic agent.

29. The article of claim 28, wherein the therapeutic agent comprises a small molecule, a bacterium, or a protein.

30. The article of claim 28, wherein the therapeutic agent comprises an antimicrobial polymer.31 . The article of claim 30, wherein the antimicrobial polymer is a polycationic polymer.

32. The article of claim 30, wherein the antimicrobial polymer is selected from chitosan, e-poly- L-lysine, polyethylenimine, polyguanidine, derivatives thereof, and combinations thereof.

33. The article of claim 30, wherein the antimicrobial polymer comprises trimethyl chitosan.

34. The article of claim 30, wherein the article comprises a weight ratio of the polysaccharide and glycerol to the antimicrobial polymer of from about 10:1 to about 2:1.

35. The article of claim 17, wherein the article comprises a menstrual hygiene product or a component of a menstrual hygiene product.

36. An article, comprising: a material configured to absorb and retain a fluid, the material comprising at least one absorbent layer and at least one therapeutic agent, the absorbent layer comprising a polymer composition, and the polymer composition comprising a polysaccharide and glycerol, wherein the weight ratio of the polysaccharide to glycerol is from about 4:1 to about 1 :4.

37. The article of claim 36, wherein the at least one therapeutic agent is included in the material in a therapeutically effective amount.

38. The article of claim 36, wherein the at least one therapeutic agent comprises a therapeuticagent used to treat a disease, symptom, or condition associated with menstruation.

39. The article of claim 36, wherein the at least one therapeutic agent comprises a small molecule, a bacterium, or a protein.

40. The article of claim 36, wherein the absorbent layer comprises the at least one therapeutic agent.

41. The article of claim 36, wherein the polymer composition comprises the at least one therapeutic agent.

42. The article of claim 36, wherein the absorbent layer further comprises a support.

43. The article of claim 42, wherein the polymer composition is impregnated within the support.

44. The article of claim 42, wherein the polymer composition is disposed on the support.

45. The article of claim 42, wherein the support comprises the at least one therapeutic agent.

46. The article of claim 36, wherein the polysaccharide is selected from sodium alginate, xanthan gum, kappa-carrageenan, iota-carrageenan, and a combination thereof.

47. The article of claim 36, wherein the polysaccharide comprises sodium alginate.

48. The article of claim 47, wherein the sodium alginate has a molecular weight of about 200 kg / mol to about 500 kg / mol.

49. The article of claim 47, wherein the sodium alginate has a D-mannuronate to L-guluronate ratio of about 1 :2 to about 2:1 .

50. The article of claim 36, wherein the weight ratio of the polysaccharide to glycerol is about 2:1.

51. The article of claim 36, wherein the polymer composition comprises particles having an average particle size of from about 0.1 mm to about 1.0 mm.

52. The article of claim 36, wherein the polymer composition comprises a film with a thickness of about 10 pm to about 500 pm.

53. The article of claim 36, wherein the therapeutic agent further comprises an antimicrobial polymer.

54. The article of claim 53, wherein the antimicrobial polymer is a polycationic polymer.

55. The article of claim 53, wherein the antimicrobial polymer is selected from chitosan, £-poly- L-lysine, polyethylenimine, polyguanidine, derivatives thereof, and combinations thereof.

56. The article of claim 53, wherein the antimicrobial polymer comprises trimethyl chitosan.

57. The article of claim 53, wherein the article comprises a weight ratio of the polysaccharide and glycerol to the antimicrobial polymer of from about 10:1 to about 2:1.

58. The article of claim 36, wherein the polymer composition has a free swell capacity of about 2 g / g to about 15 g / g in defibrinated blood.

59. The article of claim 36, wherein the article comprises a menstrual hygiene product or a component of a menstrual hygiene product.

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